Scholars@Duke
Susan Halabi

Susan Halabi CV

James B. Duke Distinguished Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
susan.halabi@duke.edu
Duke Box 2717, Durham, NC 27710
2424 Erwin Road 11th Floor, 11088 Hock Plaza, Durham, NC 27705
CV

Scholarly Works - Journal articles

AI-based augmentation of oncology clinical trials.

Journal article Nat Rev Clin Oncol · August 7, 2026 Oncology clinical trials are often characterized by slow accrual, high failure rates and limited generalizability, reflecting both biological complexity and operational inefficiencies. Advances in artificial intelligence (AI) - enabled by large-scale elect ... Full text Link to item Cite

Palbociclib in Patients With Ovarian Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · July 2026 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations. Results of a cohort of pat ... Full text Link to item Cite

Evolution of AR and Non-AR Alterations in ctDNA of Patients with Metastatic Prostate Cancer Treated in the Phase III Alliance A031201 Trial.

Journal article Clin Cancer Res · June 15, 2026 PURPOSE: Androgen receptor pathway inhibitors (ARPI), such as enzalutamide and abiraterone, are standard treatments for metastatic castration-resistant prostate cancer (mCRPC). However, a subset of patients display primary resistance and most eventually ac ... Full text Link to item Cite

Stratifying Risk and Treatment Benefit: A Model Predicting Overall Survival in Men with Metastatic De Novo Hormone-sensitive Prostate Cancer in Trials Investigating Docetaxel (the STOPCAP Collaboration).

Journal article Eur Urol Focus · June 2026 BACKGROUND AND OBJECTIVE: This study aimed to develop and validate a prognostic model for overall survival (OS) in men with de novo metastatic hormone-sensitive prostate cancer (mHSPC), using clinical factors from phase 3 trials to improve survival predict ... Full text Link to item Cite

Phase I design for partially ordered groups with late-onset toxicity.

Journal article Clin Trials · May 30, 2026 BACKGROUND: In this article, we introduce a Phase I clinical trial design that utilizes late-onset toxicity outcomes to determine group-specific doses when groups are partially ordered before the trial. By "partially ordered groups," we mean that the frail ... Full text Link to item Cite

Residual-Based Sieve Maximum Full Likelihood Estimation for the Proportional Hazards Model.

Journal article Commun Stat Theory Methods · May 16, 2026 The partial likelihood approach is the gold standard approach for estimating regression parameters in proportional hazards model, largely because it avoids specifying the baseline hazard function. However, this approach can lack robustness in the presence ... Full text Link to item Cite

ESMO adaptation of Lines of Systemic Therapy (EnLiST): a consensus framework for standardising the designation of lines of therapy in solid tumours.

Journal article Ann Oncol · May 2026 Enumeration of lines of therapy (LoT) is critical across oncology for ensuring optimal patient care, establishing uniform eligibility for clinical trial enrolment, standardising use of real-world data and pooling data for research purposes. Building on an ... Full text Link to item Cite

Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4.

Journal article J Clin Oncol · May 2026 PURPOSE: The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinic ... Full text Link to item Cite

Comparing adaptive treatment strategies in two-stage randomized trials with grouped survival data.

Journal article Lifetime Data Anal · April 2, 2026 Two-stage randomized trials, or the more general sequential multiple assignment randomized trials (SMART), have been increasingly used in studying adaptive treatment strategies for treating chronic diseases or conditions where treatments need to be adjuste ... Full text Link to item Cite

Cytoplasmic versus nuclear localization of androgen receptor splice variant 7 as a predictor of benefit from androgen receptor pathway inhibitors in metastatic castration-resistant prostate cancer (PROPHECY trial).

Journal article Prostate Cancer Prostatic Dis · April 2, 2026 BACKGROUND: Androgen receptor splice variant-7 (AR-V7), a constitutively active truncated protein, is linked to hormone therapy resistance. Nuclear AR-V7 in CTCs correlates with poor response and shorter progression-free survival (PFS) and overall survival ... Full text Link to item Cite

Radiotherapy- Versus Surgery-based Treatment Strategy in High-risk Prostate Cancer.

Journal article Eur Urol Oncol · April 2026 BACKGROUND AND OBJECTIVE: Optimal management for high-risk prostate cancer is unclear. Using individual patient data from two contemporaneous North American cooperative group phase 3 randomized controlled trials (RCTs), we compared the outcomes of high-ris ... Full text Link to item Cite

Pathogenic Genomic Alterations in Circulating Tumor DNA Predict Overall Survival in Men with Metastatic Castrate-resistant Prostate Cancer.

Journal article Eur Urol · April 2026 BACKGROUND AND OBJECTIVE: Although validated prognostic models exist for men with metastatic castration-resistant prostate cancer (mCRPC), current tools do not incorporate genomic biomarkers such as circulating tumor DNA (ctDNA) aneuploidy or pathogenic ge ... Full text Link to item Cite

Nivolumab Plus Ipilimumab in Patients With Solid Tumors With High Tumor Mutation Burden: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · April 2026 PURPOSE: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of targeted agents in patients with advanced cancer and genomic alterations. Results of three cohorts of patients with colorectal cancer ... Full text Link to item Cite

Temsirolimus in Patients With Solid Tumors With PIK3CA Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · April 2026 PURPOSE: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations who have no standard treatments available. Results of four cohorts of patients wi ... Full text Link to item Cite

Pertuzumab and Trastuzumab in Patients With ERBB2/3-Altered Urothelial or Ovary/Fallopian Tube Cancer: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · April 2026 PURPOSE: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations. Results of two cohorts of patients with urothelial (UC) or ovarian/fallopian tub ... Full text Link to item Cite

ESMO basic requirements for AI-based biomarkers in oncology (EBAI).

Journal article Ann Oncol · March 2026 BACKGROUND: Artificial intelligence (AI) is expected to introduce an increasing number of biomarkers in oncology. To bridge the gap between oncology and computer science, it is timely to define recommendations for AI-based biomarkers suitable for routine c ... Full text Link to item Cite

Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.

Journal article Prostate Cancer Prostatic Dis · February 12, 2026 BACKGROUND: In ARAMIS, darolutamide statistically significantly prolonged metastasis-free survival by 2 years and reduced the risk of death by 31% in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). We report post hoc analyses of ... Full text Link to item Cite

Docetaxel Rechallenge vs Cabazitaxel in Patients With Metastatic Castration-Resistant Prostate Cancer.

Journal article JAMA Netw Open · January 2, 2026 IMPORTANCE: Docetaxel has been a standard treatment for metastatic castration-resistant prostate cancer (mCRPC) since 2004. Cabazitaxel, a related taxane, was approved in 2010 for patients with mCRPC who had been previously treated with docetaxel. The comp ... Full text Link to item Cite

How To Interpret Subgroup Analyses from Prospective Randomized Clinical Trials: What Clinicians Need To Know.

Journal article Eur Urol · January 2026 Subgroup analyses must be approached with caution. Only prespecified, well-powered analyses with formal interaction testing and validation can support strong claims; exploratory findings require confirmation. Integration of statistical rigor with clinical ... Full text Link to item Cite

Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.

Journal article Cancer Med · January 2026 BACKGROUND: Darolutamide plus androgen-deprivation therapy (ADT) improved metastasis-free survival (MFS) by 2 years and reduced the risk of death by 31% in nonmetastatic castration-resistant prostate cancer (nmCRPC) in ARAMIS. Prior local therapy may influ ... Full text Link to item Cite

Olaparib in Patients With Solid Tumors With ATM Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · January 2026 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of targeted agents in patients with advanced cancer and genomic alterations. Results of four cohorts of patients with ATM-alte ... Full text Link to item Cite

Early favorable prostate-specific antigen response prediction in metastatic hormone sensitive prostate cancer.

Journal article Nat Commun · December 17, 2025 There is an unmet need for a tool that could predict early favorable prostate-specific antigen (PSA) response in metastatic hormone sensitive prostate cancer (mHSPC) patients receiving androgen receptor pathway inhibitor (ARPI). Here, we train and validate ... Full text Link to item Cite

Incorporating data from multiple ongoing trials for Bayesian two-stage phase II single-arm studies.

Journal article Clin Trials · December 2025 BACKGROUND/AIM: Basket designs have been utilized in recent oncology clinical trials due to an increased interest in precision medicine. One current successful basket trial is the American Society for Clinical Oncology Targeted Agent and Profiling Utilizat ... Full text Link to item Cite

ESMO guidance on the use of Large Language Models in Clinical Practice (ELCAP).

Journal article Ann Oncol · December 2025 BACKGROUND: Large language models (LLMs) are rapidly being integrated into health care, with substantial implications for oncology practice. The European Society for Medical Oncology (ESMO) developed the ESMO guidance on the use of Large Language Models in ... Full text Link to item Cite

National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations.

Journal article J Clin Oncol · December 2025 PURPOSE: Biochemical recurrence (BCR) of prostate cancer (PCa) after definitive surgery and/or radiation (including salvage strategies) is a burgeoning area of clinical research inspired by ultrasensitive next-generation imaging. Most phase III trials in P ... Full text Link to item Cite

Sparse-Input Neural Network using Group Concave Regularization.

Journal article Transact Mach Learn Res · December 2025 Simultaneous feature selection and non-linear function estimation is challenging in modeling, especially in high-dimensional settings where the number of variables exceeds the available sample size. In this article, we investigate the problem of feature se ... Link to item Cite

A Two-Step Variable Selection Strategy for Multiply Imputed Survival Data Using Penalized Cox Models.

Journal article Bioengineering (Basel) · November 20, 2025 Multiple imputation (MI) is widely used for handling missing data. However, applying penalized methods after MI can be challenging because variable selection may be inconsistent across imputations. We propose a two-step variable selection method for multip ... Full text Link to item Cite

Pembrolizumab Plus Platinum-Based Chemotherapy for Patients With Advanced Penile Cancer: The Nonrandomized HERCULES (LACOG 0218) Clinical Trial.

Journal article JAMA Oncol · November 1, 2025 IMPORTANCE: Advanced penile squamous cell carcinoma (PSCC) is associated with poor survival, and no new treatment strategies have changed clinical outcomes in past decades. This highlights the unmet need to understand the biology and develop more effective ... Full text Link to item Cite

Olaparib in Patients With Solid Tumors With BRCA1/2 Alterations: Results From The Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · October 2025 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of targeted agents in patients with advanced cancer and genomic alterations. Results of five cohorts of patients with BRCA1/2- ... Full text Link to item Cite

Design aspects for prognostic factor studies.

Journal article BMJ Open · August 31, 2025 Prognostic research is clinically relevant and ultimately facilitates stratified medicine. However, its quality and output are limited. More guidance is needed to improve understanding and thus quality. On behalf of the topic group 'TG5: study design' of t ... Full text Link to item Cite

Relationship Among DNA Damage Response Gene Alterations, Molecular Subtypes, and Survival Outcomes in Patients With Metastatic Bladder Cancer Treated on CALGB 90601.

Journal article JCO Precis Oncol · July 2025 PURPOSE: In urothelial carcinoma, prior studies have indicated that the basal/squamous molecular subtype and the presence of select DNA damage response (DDR) gene alterations are associated with improved benefit from cisplatin-based chemotherapy. We sought ... Full text Link to item Cite

Prognostic and predictive analyses of circulating plasma biomarkers in men with metastatic castration resistant prostate cancer treated with docetaxel/prednisone with or without bevacizumab.

Journal article Prostate Cancer Prostatic Dis · June 2025 BACKGROUND: CALGB 90401 (Alliance) was a phase III trial of 1050 patients with metastatic castration-resistant prostate cancer (mCRPC) comparing docetaxel, prednisone, bevacizumab (DP+B) versus DP alone. While this trial did not show an improvement in over ... Full text Link to item Cite

Updated 5-year results for short course abiraterone acetate and LHRH agonist for unfavorable intermediate and favorable high-risk prostate cancer.

Journal article Prostate Cancer Prostatic Dis · June 2025 Combined androgen deprivation therapy (ADT) and radiotherapy (RT) improves outcomes for intermediate and high-risk prostate cancer. Treatment intensification with abiraterone acetate/prednisone (AAP) provides additional benefit for high-risk disease. We pr ... Full text Link to item Cite

Variable Selection for Multivariate Failure Time Data via Regularized Sparse-Input Neural Network.

Journal article Bioengineering (Basel) · May 31, 2025 This study addresses the problem of simultaneous variable selection and model estimation in multivariate failure time data, a common challenge in clinical trials with multiple correlated time-to-event endpoints. We propose a unified framework that identifi ... Full text Link to item Cite

Circulating Tumor DNA and Response to Cisplatin-based Chemotherapy in Patients with Metastatic Urothelial Carcinoma Enrolled in CALGB 90601 (Alliance).

Journal article Eur Urol Open Sci · May 2025 BACKGROUND AND OBJECTIVE: Cisplatin-based chemotherapy has been a cornerstone of therapy for advanced/metastatic urothelial cancer (mUC). However, no genomic characteristics have been validated as prognostic biomarkers for this therapy. We sought to identi ... Full text Link to item Cite

Afatinib in patients with solid tumors with neuregulin 1 (NRG1) fusions: a case series from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article ESMO Open · May 2025 BACKGROUND: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and targetable genomic alterations. Results of four patients with various tumors with NRG1 fusions tre ... Full text Link to item Cite

Sample Size and Power Calculations With Win Measures Based on Hierarchical Endpoints.

Journal article Stat Med · May 2025 Win measures, such as win ratio, win odds, net benefit, and desirability of outcome ranking (DOOR), have become popular approaches for the analysis of hierarchical endpoints in clinical studies. Sample size and power calculations with win measures based on ... Full text Link to item Cite

Factors Affecting Genomic Testing in Prostate Cancer: Results From the Decision-Making, Experience, and Confidence In Determining Genomic Evaluation (DECIDE) Survey.

Journal article JCO Precis Oncol · May 2025 PURPOSE: Genomic testing for prostate cancer (PCa) clinical management and hereditary cancer assessment has grown in clinical impact; however, challenges remain regarding optimal implementation and end-user confidence. The Decision-making, Experience, and ... Full text Link to item Cite

Associations of COVID-19 vaccination with risks for post-infectious cardiovascular complications: an international cohort study in cancer patients with SARS-CoV-2 infection.

Journal article Lancet Reg Health Am · April 2025 BACKGROUND: Whether COVID-19 vaccination is associated with risks for cardiovascular complications after SARS-CoV-2 infection in patients with cancer is unknown. The objective of this study was to investigate the associations between the two. METHODS: This ... Full text Link to item Cite

Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols.

Journal article J Immunother Cancer · March 7, 2025 Immunotherapy of cancer is now an essential pillar of treatment for patients with many individual tumor types. Novel immune targets and technical advances are driving a rapid exploration of new treatment strategies incorporating immune agents in cancer cli ... Full text Link to item Cite

Refining Risk Stratification of High-risk and Locoregional Prostate Cancer: A Pooled Analysis of Randomized Trials.

Journal article Eur Urol · February 2025 BACKGROUND AND OBJECTIVE: Radiotherapy (RT) and long-term androgen deprivation therapy (ltADT; 18-36 mo) is a standard of care in the treatment of high-risk localized/locoregional prostate cancer (HRLPC). We evaluated the outcomes in patients treated with ... Full text Link to item Cite

Management of Patients with Advanced Prostate Cancer. Report from the 2024 Advanced Prostate Cancer Consensus Conference (APCCC).

Journal article Eur Urol · February 2025 BACKGROUND AND OBJECTIVE: Innovations have improved outcomes in advanced prostate cancer (PC). Nonetheless, we continue to lack high-level evidence on a variety of topics that greatly impact daily practice. The 2024 Advanced Prostate Cancer Consensus Confe ... Full text Link to item Cite

Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma.

Journal article N Engl J Med · January 2, 2025 BACKGROUND: Muscle-invasive urothelial carcinoma is an aggressive disease with high rates of relapse. Whether pembrolizumab as adjuvant therapy would be effective in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery is unkn ... Full text Link to item Cite

Global and national actions to prevent trade in substandard and adulterated medicines.

Journal article PLOS Glob Public Health · 2025 Recent mass-poisoning events caused by substandard medicines placed in global markets raise the question as to what more can be done to stop it. Efforts have been underway for years at the World Health Organization and other multilateral fora, such as the ... Full text Link to item Cite

Sample Size for Enriched Biomarker Designs With Measurement Error for Time-to-Event Outcomes.

Journal article Pharm Stat · 2025 A major emphasis in personalized medicine is to optimally treat subgroups of patients who may benefit from certain therapeutic agents. One relevant study design is the targeted design, in which patients have consented for their specimens to be obtained at ... Full text Link to item Cite

Joint Modelling of Longitudinal Measurements and Time-to-Event Outcomes With a Cure Fraction Using Functional Principal Component Analysis.

Journal article Stat Med · December 30, 2024 In studying the association between clinical measurements and time-to-event outcomes within a cure model, utilizing repeated observations rather than solely baseline values may lead to more accurate estimation. However, there are two main challenges in thi ... Full text Link to item Cite

AR alterations inform circulating tumor DNA detection in metastatic castration resistant prostate cancer patients.

Journal article Nat Commun · December 11, 2024 Circulating tumor DNA (ctDNA) in plasma cell free DNA (cfDNA) of cancer patients is associated with poor prognosis, but is challenging to detect from low plasma volumes. In metastatic castration-resistant prostate cancer (mCRPC), ctDNA assays are needed to ... Full text Link to item Cite

The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development.

Journal article Ann Oncol · November 2024 BACKGROUND: Advances in precision oncology led to approval of tumour-agnostic molecularly guided treatment options (MGTOs). The minimum requirements for claiming tumour-agnostic potential remain elusive. METHODS: The European Society for Medical Oncology ( ... Full text Link to item Cite

Androgen production, uptake, and conversion (APUC) genes define prostate cancer patients with distinct clinical outcomes.

Journal article JCI Insight · October 22, 2024 BACKGROUNDProstate cancer (PC) is driven by aberrant signaling of the androgen receptor (AR) or its ligands, and androgen deprivation therapies (ADTs) are a cornerstone of treatment. ADT responsiveness may be associated with germline changes in genes that ... Full text Link to item Cite

Palbociclib in Patients With Head and Neck Cancer and Other Tumors With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · October 2024 PURPOSE: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and targetable genomic alterations. Two cohorts of patients w ... Full text Link to item Cite

Pertuzumab Plus Trastuzumab in Patients With Biliary Tract Cancer With ERBB2/3 Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article J Clin Oncol · September 20, 2024 PURPOSE: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of ... Full text Link to item Cite

Adaptation of the socioecological model to address disparities in engagement of Black men in prostate cancer genetic testing.

Journal article BMC Public Health · September 18, 2024 BACKGROUND: Black men consistently have higher rates of prostate cancer (PCA)- related mortality. Advances in PCA treatment, screening, and hereditary cancer assessment center around germline testing (GT). Of concern is the significant under-engagement of ... Full text Link to item Cite

Reply to J.A. Garcia et al.

Journal article J Clin Oncol · August 20, 2024 Full text Link to item Cite

Palbociclib in Patients With Soft Tissue Sarcoma With CDK4 Amplifications: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · July 2024 PURPOSE: Targeted Agent and Profiling Utilization Registry (TAPUR) is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Res ... Full text Link to item Cite

The impact of cancer metastases on COVID-19 outcomes: A COVID-19 and Cancer Consortium registry-based retrospective cohort study.

Journal article Cancer · June 15, 2024 BACKGROUND: COVID-19 can have a particularly detrimental effect on patients with cancer, but no studies to date have examined if the presence, or site, of metastatic cancer is related to COVID-19 outcomes. METHODS: Using the COVID-19 and Cancer Consortium ... Full text Link to item Cite

Current issues in dose-finding designs: A response to the US Food and Drug Adminstration's Oncology Center of Excellence Project Optimus.

Journal article Clin Trials · June 2024 With the advent of targeted agents and immunological therapies, the medical research community has become increasingly aware that conventional methods for determining the best dose or schedule of a new agent are inadequate. It has been well established tha ... Full text Link to item Cite

Common variation in a long non-coding RNA gene modulates variation of circulating TGF-β2 levels in metastatic colorectal cancer patients (Alliance).

Journal article BMC Genomics · May 14, 2024 BACKGROUND: Herein, we report results from a genome-wide study conducted to identify protein quantitative trait loci (pQTL) for circulating angiogenic and inflammatory protein markers in patients with metastatic colorectal cancer (mCRC). The study was cond ... Full text Link to item Cite

The Lancet Commission on prostate cancer: planning for the surge in cases.

Journal article Lancet · April 27, 2024 Prostate cancer is the most common cancer in men in 112 countries, and accounts for 15% of cancers. In this Commission, we report projections of prostate cancer cases in 2040 on the basis of data for demographic changes worldwide and rising life expectancy ... Full text Link to item Cite

PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19).

Journal article J Clin Oncol · April 1, 2024 PURPOSE: Patients with biochemically recurrent prostate cancer (BRPC) after radical prostatectomy and a short PSA doubling time are at risk for distant metastases. Apalutamide, an androgen receptor antagonist, and abiraterone acetate plus prednisone (AAP) ... Full text Link to item Cite

Regorafenib in Patients With Solid Tumors With BRAF Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · April 2024 PURPOSE: Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer with genomic alterations known to be drug targets. Results of ... Full text Link to item Cite

Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer.

Journal article J Clin Oncol · March 20, 2024 PURPOSE: Despite major increases in the longevity of men with metastatic hormone-sensitive prostate cancer (mHSPC), most men still die of prostate cancer. Phase III trials assessing new therapies in mHSPC with overall survival (OS) as the primary end point ... Full text Link to item Cite

The Impact of Circulating Tumor Cell HOXB13 RNA Detection in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Abiraterone or Enzalutamide.

Journal article Clin Cancer Res · March 15, 2024 PURPOSE: HOXB13 is an androgen receptor (AR) coregulator specifically expressed in cells of prostatic lineage. We sought to associate circulating tumor cell (CTC) HOXB13 expression with outcomes in men with mCRPC treated with abiraterone or enzalutamide. E ... Full text Link to item Cite

Pharmacogenetic and clinical risk factors for bevacizumab-related gastrointestinal hemorrhage in prostate cancer patients treated on CALGB 90401 (Alliance).

Journal article Pharmacogenomics J · March 4, 2024 The objective of this study was to discover clinical and pharmacogenetic factors associated with bevacizumab-related gastrointestinal hemorrhage in Cancer and Leukemia Group B (Alliance) 90401. Patients with metastatic castration-resistant prostate cancer ... Full text Link to item Cite

Validation of metastasis-free survival as a surrogate endpoint for overall survival in localized prostate cancer in the era of docetaxel for castration-resistant prostate cancer.

Journal article Ann Oncol · March 2024 BACKGROUND: Prior work from the Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) consortium (ICECaP-1) demonstrated that metastasis-free survival (MFS) is a valid surrogate for overall survival (OS) in localized prostate cancer (PCa). Thi ... Full text Link to item Cite

Toward Informed Selection and Interpretation of Clinical Genomic Tests in Prostate Cancer.

Journal article JCO Precis Oncol · March 2024 Clinical genomic testing of patient germline, tumor tissue, or plasma cell-free DNA can enable a personalized approach to cancer management and treatment. In prostate cancer (PCa), broad genotyping tests are now widely used to identify germline and/or soma ... Full text Link to item Cite

Sunitinib in Patients With Breast Cancer With FGFR1 or FGFR2 Amplifications or Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · February 2024 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. R ... Full text Link to item Cite

Olaparib in Patients With Pancreatic Cancer With BRCA1/2 Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study

Journal article JCO Precision Oncology · February 2024 PURPOSE Targeted Agent and Profiling Utilization Registry (TAPUR) is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic ... Full text Cite

Molecular features of prostate cancer after neoadjuvant therapy in the phase 3 CALGB 90203 trial.

Journal article J Natl Cancer Inst · January 10, 2024 BACKGROUND: The phase 3 CALGB 90203 (Alliance) trial evaluated neoadjuvant chemohormonal therapy for high-risk localized prostate cancer before radical prostatectomy. We dissected the molecular features of post-treated tumors with long-term clinical outcom ... Full text Link to item Cite

End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?

Journal article Future Oncol · 2024 We observed lack of clarity and consistency in end point definitions of large randomized clinical trials in diffuse large B-cell lymphoma. These inconsistencies are such that trials might, in fact, address different clinical questions. They complicate inte ... Full text Link to item Cite

Overall survival from PANTHER: A multicenter trial of apalutamide, abiraterone acetate plus prednisone in Black and White patients with metastatic castration-resistant prostate cancer (mCRPC).

Journal article Journal of Clinical Oncology · January 1, 2024 Background: ACIS was an international phase III trial comparing apalutamide (A) plus abiraterone acetate and prednisone (AAP) to AAP in patients (pts) with mCRPC. Recognizing that lack of diversity in clinical trials is a major challenge to real-world tran ... Full text Cite

Common variation in a long non-coding RNA gene modulates variation of circulating TGF-β2 levels in metastatic colorectal cancer patients (Alliance).

Journal article medRxiv · December 4, 2023 BACKGROUND: Herein, we report results from a genome-wide study conducted to identify protein quantitative trait loci (pQTL) for circulating angiogenic and inflammatory protein markers in patients with metastatic colorectal cancer (mCRC).The study was condu ... Full text Link to item Cite

Randomized Phase I Trials - One Size Fits All?

Journal article NEJM Evid · December 2023 In this issue of NEJM Evidence, Gaudet et al. present the safety profile and pharmacodynamics of ARO-APOC3, a small interfering RNA therapeutic that inhibits apolipoprotein C-III (APOC3) mRNA expression in a phase I trial.1 Assignment to treatment was base ... Full text Link to item Cite

Pembrolizumab in Patients With Tumors With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article J Clin Oncol · November 20, 2023 PURPOSE: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a pragmatic basket trial evaluating antitumor activity of approved targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data ... Full text Link to item Cite

Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in the Treatment of Metastatic Castration-Resistant Prostate Cancer.

Journal article J Clin Oncol · November 10, 2023 PURPOSE: Improving clinical outcomes with novel drug combinations to treat metastatic castration-resistant prostate cancer (mCRPC) is challenging. Preclinical studies showed cabazitaxel had superior antitumor efficacy compared with docetaxel. Gene expressi ... Full text Link to item Cite

Nivolumab Plus Ipilimumab in Patients With Solid Tumors With ATM Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · September 2023 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers with genomic alterations known to be drug targets. ... Full text Link to item Cite

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Journal article JAMA · July 25, 2023 IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19. OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Ra ... Full text Open Access Link to item Cite

Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial).

Journal article J Clin Oncol · June 20, 2023 PURPOSE: Enzalutamide and abiraterone both target androgen receptor signaling but via different mechanisms. The mechanism of action of one drug may counteract the resistance pathways of the other. We sought to determine whether the addition of abiraterone ... Full text Link to item Cite

Safety and efficacy of hydroxychloroquine as prophylactic against COVID-19 in healthcare workers: a meta-analysis of randomised clinical trials.

Journal article BMJ Open · June 16, 2023 OBJECTIVE: We studied the safety and efficacy of hydroxychloroquine (HCQ) as pre-exposure prophylaxis for COVID-19 in healthcare workers (HCWs), using a meta-analysis of randomised controlled trials (RCTs). DATA SOURCES: PubMed and EMBASE databases were se ... Full text Link to item Cite

Pertuzumab Plus Trastuzumab in Patients With Lung Cancer With ERBB2 Mutation or Amplification: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · June 2023 PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. ... Full text Link to item Cite

External Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Journal article J Clin Oncol · May 20, 2023 PURPOSE: We have previously developed and externally validated a prognostic model of overall survival (OS) in men with metastatic, castration-resistant prostate cancer (mCRPC) treated with docetaxel. We sought to externally validate this model in a broader ... Full text Link to item Cite

PSMA-positive Circulating Tumor Cell Detection and Outcomes with Abiraterone or Enzalutamide Treatment in Men with Metastatic Castrate-resistant Prostate Cancer.

Journal article Clin Cancer Res · May 15, 2023 PURPOSE: In men with metastatic castration-resistant prostate cancer (mCRPC), prostate-specific membrane antigen (PSMA)-targeted radioligand therapy has drastically improved clinical outcomes. A liquid biopsy characterizing PSMA expression could be useful ... Full text Link to item Cite

Quality of life outcomes for patients with metastatic castration-resistant prostate cancer and pretreatment prognostic score.

Journal article Prostate · May 2023 BACKGROUND: A prognostic risk score (Halabi score) in metastatic castration-resistant prostate cancer (mCRPC) accurately predicts overall survival, but its association with quality of life (QOL) has not been defined. We hypothesize that a higher pretreatme ... Full text Link to item Cite

Management of patients with advanced prostate cancer-metastatic and/or castration-resistant prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference (APCCC) 2022.

Journal article Eur J Cancer · May 2023 BACKGROUND: Innovations in imaging and molecular characterisation together with novel treatment options have improved outcomes in advanced prostate cancer. However, we still lack high-level evidence in many areas relevant to making management decisions in ... Full text Link to item Cite

Bayesian Way.

Journal article NEJM Evid · May 2023 Bayesian WayThis animated video explores two possible approaches to analyzing data in a randomized controlled trial: "Frequentist" versus "Bayesian." ... Full text Link to item Cite

Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study.

Journal article JCO Precis Oncol · April 2023 PURPOSE: The TAPUR Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with endomet ... Full text Link to item Cite

Impact of COVID-19 in patients on active melanoma therapy and with history of melanoma.

Journal article BMC Cancer · March 23, 2023 INTRODUCTION: COVID-19 particularly impacted patients with co-morbid conditions, including cancer. Patients with melanoma have not been specifically studied in large numbers. Here, we sought to identify factors that associated with COVID-19 severity among ... Full text Link to item Cite

Management of Patients with Advanced Prostate Cancer. Part I: Intermediate-/High-risk and Locally Advanced Disease, Biochemical Relapse, and Side Effects of Hormonal Treatment: Report of the Advanced Prostate Cancer Consensus Conference 2022.

Journal article Eur Urol · March 2023 BACKGROUND: Innovations in imaging and molecular characterisation and the evolution of new therapies have improved outcomes in advanced prostate cancer. Nonetheless, we continue to lack high-level evidence on a variety of clinical topics that greatly impac ... Full text Link to item Cite

Breakthrough SARS-CoV-2 infections among patients with cancer following two and three doses of COVID-19 mRNA vaccines: a retrospective observational study from the COVID-19 and Cancer Consortium.

Journal article Lancet Reg Health Am · March 2023 BACKGROUND: Breakthrough SARS-CoV-2 infections following vaccination against COVID-19 are of international concern. Patients with cancer have been observed to have worse outcomes associated with COVID-19 during the pandemic. We sought to evaluate the clini ... Full text Link to item Cite

Olaparib in Patients With Metastatic Prostate Cancer With BRCA1/2 Mutation: Results From the TAPUR Study.

Journal article JCO Precis Oncol · February 2023 PURPOSE: The TAPUR Study is a phase II basket trial that aims to evaluate activity of approved targeted agents in patients with advanced cancers with potentially actionable genomic variants. Data from a cohort of patients with metastatic castrate-resistant ... Full text Link to item Cite

A clinical-grade liquid biomarker detects neuroendocrine differentiation in prostate cancer.

Journal article J Clin Invest · November 1, 2022 BackgroundNeuroendocrine prostate cancer (NEPC) is an aggressive subtype, the presence of which changes the prognosis and management of metastatic prostate cancer.MethodsWe performed analytical validation of a Circulating Tumor Cell (CTC) multiplex RNA qPC ... Full text Link to item Cite

Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · November 2022 PURPOSE: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. The results of a cohort of patients with colorectal can ... Full text Link to item Cite

Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges.

Journal article Clin Trials · October 2022 BACKGROUND/AIM: The number of coronavirus disease 2019 deaths and cases continues to increase globally. Novel therapies are urgently needed to treat patients with coronavirus disease 2019. We sought to provide a critical review of trials designed during th ... Full text Link to item Cite

Pertuzumab Plus Trastuzumab in Patients With Colorectal Cancer With ERBB2 Amplification or ERBB2/3 Mutations: Results From the TAPUR Study.

Journal article JCO Precis Oncol · October 2022 PURPOSE: The TAPUR Study is a pragmatic phase II basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from two cohorts of patients ... Full text Link to item Cite

Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Journal article medRxiv · September 26, 2022 BACKGROUND: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19. METHODS: We conducted a master protocol to investigate immunomodulators ... Full text Link to item Cite

Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Journal article medRxiv · September 26, 2022 BACKGROUND: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care. METHODS: We conducted a maste ... Full text Link to item Cite

PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer.

Journal article Prostate Cancer Prostatic Dis · September 2022 PURPOSE: Prostate cancer is a heterogeneous disease with variable clinical outcomes. Despite numerous recent approvals of novel therapies, castration-resistant prostate cancer remains lethal. A "real-world" clinical-genomic database is urgently needed to e ... Full text Link to item Cite

Log-Rank Test vs MaxCombo and Difference in Restricted Mean Survival Time Tests for Comparing Survival Under Nonproportional Hazards in Immuno-oncology Trials: A Systematic Review and Meta-analysis.

Journal article JAMA Oncol · September 1, 2022 IMPORTANCE: The log-rank test is considered the criterion standard for comparing 2 survival curves in pivotal registrational trials. However, with novel immunotherapies that often violate the proportional hazards assumptions over time, log-rank can lose po ... Full text Link to item Cite

Penalized weighted proportional hazards model for robust variable selection and outlier detection.

Journal article Stat Med · July 30, 2022 Identifying exceptional responders or nonresponders is an area of increased research interest in precision medicine as these patients may have different biological or molecular features and therefore may respond differently to therapies. Our motivation ste ... Full text Link to item Cite

Predictive Biomarkers of Overall Survival in Patients with Metastatic Renal Cell Carcinoma Treated with IFNα ± Bevacizumab: Results from CALGB 90206 (Alliance).

Journal article Clin Cancer Res · July 1, 2022 PURPOSE: CALGB 90206 was a phase III trial of 732 patients with metastatic renal cell carcinoma (mRCC) comparing bevacizumab plus IFNα (BEV + IFN) with IFNα alone (IFN). No difference in overall survival (OS) was observed. Baseline samples were analyzed to ... Full text Link to item Cite

What Experts Think About Prostate Cancer Management During the COVID-19 Pandemic: Report from the Advanced Prostate Cancer Consensus Conference 2021.

Journal article Eur Urol · July 2022 Patients with advanced prostate cancer (APC) may be at greater risk for severe illness, hospitalisation, or death from coronavirus disease 2019 (COVID-19) due to male gender, older age, potential immunosuppressive treatments, or comorbidities. Thus, the op ... Full text Link to item Cite

Management of Patients with Advanced Prostate Cancer: Report from the Advanced Prostate Cancer Consensus Conference 2021.

Journal article Eur Urol · July 2022 BACKGROUND: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but various areas of management still lack high-level evidence to inform clinical practice. The 2021 Advanced Prostate Cancer ... Full text Link to item Cite

Prospective clinical trial of disulfiram plus copper in men with metastatic castration-resistant prostate cancer.

Journal article Prostate · May 2022 BACKGROUND: In preclinical models of prostate cancer (PC), disulfiram (DSF) reduced tumor growth only when co-administered with copper (Cu), and Cu uptake in tumors is partially regulated by androgen-receptor signaling. However, prior trials of DSF in PC u ... Full text Link to item Cite

A phase 2 trial of avelumab in men with aggressive-variant or neuroendocrine prostate cancer.

Journal article Prostate Cancer Prostatic Dis · April 2022 BACKGROUND: Men with progressive neuroendocrine or aggressive-variant metastatic prostate cancer (NEPC/AVPC) have a poor prognosis and limited treatment options, and immunotherapy has not been tested in such patients. METHODS: We conducted an open label si ... Full text Link to item Cite

Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer.

Journal article JAMA Netw Open · March 1, 2022 IMPORTANCE: Non-Hispanic Black individuals experience a higher burden of COVID-19 than the general population; hence, there is an urgent need to characterize the unique clinical course and outcomes of COVID-19 in Black patients with cancer. OBJECTIVE: To i ... Full text Link to item Cite

Prostate Cancer Racial Disparities: A Systematic Review by the Prostate Cancer Foundation Panel.

Journal article Eur Urol Oncol · February 2022 CONTEXT: Prostate cancer (PCa) is a complex disease that disproportionately impacts Black men in the USA. The structural factors that drive heterogeneous outcomes for patients of differing backgrounds are probably the same ones that result in population-le ... Full text Link to item Cite

Lack of consensus identifies important areas for future clinical research: Advanced Prostate Cancer Consensus Conference (APCCC) 2019 findings.

Journal article Eur J Cancer · January 2022 BACKGROUND: Innovations in treatments, imaging and molecular characterisation have improved outcomes for people with advanced prostate cancer; however, many aspects of clinical management are devoid of high-level evidence. At the Advanced Prostate Cancer C ... Full text Link to item Cite

Regulatory genes in the androgen production, uptake and conversion (APUC) pathway in advanced prostate cancer.

Journal article Endocr Oncol · January 2022 The androgen receptor (AR) signaling pathway regulates the progression of prostate cancer (PC). Metastatic castration-resistant prostate cancer (mCRPC) patients generally receive AR-targeted therapies (ART) or androgen-deprivation therapies (ADT) with the ... Full text Link to item Cite

Letter to the editor.

Journal article Nurs Outlook · 2022 Full text Open Access Link to item Cite

A semiparametric modeling approach for analyzing clinical biomarkers restricted to limits of detection.

Journal article Pharm Stat · November 2021 Before biomarkers can be used in clinical trials or patients' management, the laboratory assays that measure their levels have to go through development and analytical validation. One of the most critical performance metrics for validation of any assay is ... Full text Link to item Cite

Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19.

Journal article JAMA Netw Open · November 1, 2021 IMPORTANCE: Androgen deprivation therapy (ADT) has been theorized to decrease the severity of SARS-CoV-2 infection in patients with prostate cancer owing to a potential decrease in the tissue-based expression of the SARS-CoV-2 coreceptor transmembrane prot ... Full text Link to item Cite

Tissue based biomarkers in non-clear cell RCC: Correlative analysis from the ASPEN clinical trial.

Journal article Kidney Cancer J · October 2021 Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC), particularly papillary renal cell carcinoma, in order to inform on initial treatment selection and identify potentially novel targets for therapy. We enrolled 108 patient ... Full text Link to item Cite

Prospective Evaluation of Clinical Outcomes Using a Multiplex Liquid Biopsy Targeting Diverse Resistance Mechanisms in Metastatic Prostate Cancer.

Journal article J Clin Oncol · September 10, 2021 PURPOSE: Nearly all men with prostate cancer treated with androgen receptor (AR) signaling inhibitors (ARSIs) develop resistance via diverse mechanisms including constitutive activation of the AR pathway, driven by AR genomic structural alterations, expres ... Full text Link to item Cite

Prostate Cancer Foundation Hormone-Sensitive Prostate Cancer Biomarker Working Group Meeting Summary.

Journal article Urology · September 2021 Androgen deprivation therapy remains the backbone therapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). In recent years, several treatments, including docetaxel, abiraterone + prednisone, enzalutamide, and apalutamide, have eac ... Full text Link to item Cite

A prospective trial of abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer.

Journal article Cancer · August 15, 2021 BACKGROUND: Retrospective analyses of randomized trials suggest that Black men with metastatic castration-resistant prostate cancer (mCRPC) have longer survival than White men. The authors conducted a prospective study of abiraterone acetate plus prednison ... Full text Link to item Cite

Indirect Comparison of Darolutamide versus Apalutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer.

Journal article J Urol · August 2021 PURPOSE: No published head-to-head randomized trials have compared the safety and efficacy of darolutamide vs apalutamide or enzalutamide in nonmetastatic castration-resistant prostate cancer. This study compares prespecified adverse events and metastasis- ... Full text Link to item Cite

Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance).

Journal article J Clin Oncol · August 1, 2021 PURPOSE: The combination of gemcitabine and cisplatin (GC) is a standard therapy for metastatic urothelial carcinoma. Based on data that angiogenesis plays a role in urothelial carcinoma growth and progression, a randomized placebo-controlled trial was per ... Full text Link to item Cite

Combined Longitudinal Clinical and Autopsy Phenomic Assessment in Lethal Metastatic Prostate Cancer: Recommendations for Advancing Precision Medicine.

Journal article Eur Urol Open Sci · August 2021 BACKGROUND: Systematic identification of data essential for outcome prediction in metastatic prostate cancer (mPC) would accelerate development of precision oncology. OBJECTIVE: To identify novel phenotypes and features associated with mPC outcome, and to ... Full text Link to item Cite

Circulating Tumor Cell Chromosomal Instability and Neuroendocrine Phenotype by Immunomorphology and Poor Outcomes in Men with mCRPC Treated with Abiraterone or Enzalutamide.

Journal article Clin Cancer Res · July 15, 2021 PURPOSE: While the detection of AR-V7 in circulating tumor cells (CTC) is associated with resistance to abiraterone or enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC), it only accounts for a minority of this resistance. Neu ... Full text Link to item Cite

Angiokines Associated with Targeted Therapy Outcomes in Patients with Non-Clear Cell Renal Cell Carcinoma.

Journal article Clin Cancer Res · June 15, 2021 PURPOSE: Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC) to inform treatment selection but also to identify novel therapeutic targets. We thus sought to profile circulating angiokines in the context of a randomized trea ... Full text Link to item Cite

Association of clinical factors and recent anticancer therapy with COVID-19 severity among patients with cancer: a report from the COVID-19 and Cancer Consortium.

Journal article Ann Oncol · June 2021 BACKGROUND: Patients with cancer may be at high risk of adverse outcomes from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We analyzed a cohort of patients with cancer and coronavirus 2019 (COVID-19) reported to the COVID-19 and ... Full text Link to item Cite

Development and validation of circulating tumour cell enumeration (Epic Sciences) as a prognostic biomarker in men with metastatic castration-resistant prostate cancer.

Journal article Eur J Cancer · June 2021 PURPOSE: To evaluate the prognostic significance of circulating tumour cell (CTC) number determined on the Epic Sciences platform in men with metastatic castration-resistant prostate cancer (mCRPC) treated with an androgen receptor signalling inhibitor (AR ... Full text Link to item Cite

On the design and the analysis of stratified biomarker trials in the presence of measurement error.

Journal article Stat Med · May 30, 2021 A major emphasis in precision medicine is to optimally treat subgroups of patients who may benefit from certain therapeutic agents. And as such, enormous resources and innovative clinical trials designs in oncology are devoted to identifying predictive bio ... Full text Link to item Cite

Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer.

Journal article Int J Radiat Oncol Biol Phys · April 1, 2021 PURPOSE: Long-term androgen-deprivation therapy (ADT) is the standard of care in combination with radiation therapy (RT) in high-risk prostate cancer (PC), despite substantial toxicity from the resulting hypogonadism. We hypothesized that a combination of ... Full text Link to item Cite

In-depth analysis of the 2019 Advanced Prostate Cancer Consensus Conference (APCCC) - The importance of representation of medical specialty and geographic regions.

Journal article Eur Urol Open Sci · April 2021 The rapid innovation of the treatment and diagnostic procedures in advanced prostate cancer has led to improved outcomes, though uncertainty remains regarding the best management approach in many clinical situations. The Advanced Prostate Cancer Consensus ... Full text Link to item Cite

Estimand framework: Are we asking the right questions? A case study in the solid tumor setting.

Journal article Pharm Stat · March 2021 The estimand framework requires a precise definition of the clinical question of interest (the estimand) as different ways of accounting for "intercurrent" events post randomization may result in different scientific questions. The initiation of subsequent ... Full text Link to item Cite

Intermediate clinical endpoints for surrogacy in localised prostate cancer: an aggregate meta-analysis.

Journal article Lancet Oncol · March 2021 BACKGROUND: The international Intermediate Clinical Endpoints in Cancer of the Prostate working group has established metastasis-free survival as a surrogate for overall survival in localised prostate cancer based on the findings of 19 predominantly radiot ... Full text Link to item Cite

A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19: CCC19 Governance, Protocol, and Quality Assurance.

Journal article Cancer Cell · December 14, 2020 When the COVID-19 pandemic began, formal frameworks to collect data about affected patients were lacking. The COVID-19 and Cancer Consortium (CCC19) was formed to collect granular data on patients with cancer and COVID-19 at scale and as rapidly as possibl ... Full text Open Access Link to item Cite

Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT-3 Amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article Target Oncol · December 2020 BACKGROUND: TAPUR is a pragmatic, phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Sunitinib is an oral multikinase i ... Full text Link to item Cite

Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article Target Oncol · December 2020 BACKGROUND: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a phase II basket study, evaluates anti-tumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known as drug ... Full text Link to item Cite

Score and deviance residuals based on the full likelihood approach in survival analysis.

Journal article Pharm Stat · November 2020 Assuming the proportional hazards model and non-informative censoring, the full likelihood approach is used to obtain two new residuals. The first residual is based on the ideas used in obtaining score-type residuals similar to the partial likelihood appro ... Full text Link to item Cite

Palbociclib in Patients With Non-Small-Cell Lung Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Journal article JCO Precis Oncol · November 2020 PURPOSE: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a phase II pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancer with genomic alterations known to be ... Full text Link to item Cite

Best (but oft-forgotten) practices: sample size and power calculation for a dietary intervention trial with episodically consumed foods.

Journal article Am J Clin Nutr · October 1, 2020 Dietary interventions often target foods that are underconsumed relative to dietary guidelines, such as vegetables, fruits, and whole grains. Because these foods are only consumed episodically for some participants, data from such a study often contains a ... Full text Link to item Cite

Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.

Journal article J Clin Oncol · September 10, 2020 PURPOSE: Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free su ... Full text Link to item Cite

Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer.

Journal article J Clin Oncol · September 10, 2020 PURPOSE: Radical prostatectomy (RP) alone is often inadequate in curing men with clinically localized, high-risk prostate cancer (PC). We hypothesized that chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel before RP would improve ... Full text Link to item Cite

Comparison of regression imputation methods of baseline covariates that predict survival outcomes.

Journal article J Clin Transl Sci · September 4, 2020 INTRODUCTION: Missing data are inevitable in medical research and appropriate handling of missing data is critical for statistical estimation and making inferences. Imputation is often employed in order to maximize the amount of data available for statisti ... Full text Open Access Link to item Cite

Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.

Journal article Ann Oncol · July 2020 BACKGROUND: We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary go ... Full text Link to item Cite

Androgens and Overall Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Docetaxel.

Journal article Clin Genitourin Cancer · June 2020 BACKGROUND: Pre-treatment androgen levels are associated with overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) treated with androgen synthesis inhibitors. The current study sought to determine whether pre-treatm ... Full text Link to item Cite

Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes.

Journal article Lifetime Data Anal · April 2020 We discuss the multivariate (2L-variate) correlation structure and the asymptotic distribution for the group-sequential weighted logrank statistics formulated when monitoring two correlated event-time outcomes in clinical trials. The asymptotic distributio ... Full text Link to item Cite

Discordant and heterogeneous clinically relevant genomic alterations in circulating tumor cells vs plasma DNA from men with metastatic castration resistant prostate cancer.

Journal article Genes Chromosomes Cancer · April 2020 Circulating tumor cell (CTC) and cell-free (cf) DNA-based genomic alterations are increasingly being used for clinical decision-making in oncology. However, the concordance and discordance between paired CTC and cfDNA genomic profiles remain largely unknow ... Full text Link to item Cite

Comparative Survival of Asian and White Metastatic Castration-Resistant Prostate Cancer Men Treated With Docetaxel.

Journal article JNCI Cancer Spectr · April 2020 There are few data regarding disparities in overall survival (OS) between Asian and white men with metastatic castration-resistant prostate cancer (mCRPC). We compared OS of Asian and white mCRPC men treated in phase III clinical trials with docetaxel and ... Full text Link to item Cite

Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).

Journal article Prostate Cancer Prostatic Dis · March 2020 BACKGROUND: Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs mi ... Full text Link to item Cite

Phase 2 clinical trial of TORC1 inhibition with everolimus in men with metastatic castration-resistant prostate cancer.

Journal article Urol Oncol · March 2020 BACKGROUND: Activation of the PI3K-Akt-mTOR signaling pathway is common in advanced castration resistant prostate cancer (CRPC), typically through PTEN loss. Preclinical studies suggest that Akt-driven CaP cells are genetically susceptible to mammalian tar ... Full text Link to item Cite

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

Journal article Oncologist · March 2020 A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a ... Full text Link to item Cite

Prospective Multicenter Study of Circulating Tumor Cell AR-V7 and Taxane Versus Hormonal Treatment Outcomes in Metastatic Castration-Resistant Prostate Cancer.

Journal article JCO Precis Oncol · 2020 PURPOSE: Androgen receptor splice variant 7 (AR-V7) detection in circulating tumor cells (CTCs) is associated with a low probability of response and short progression-free (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate ... Full text Link to item Cite

Cabozantinib Versus Sunitinib for Untreated Patients with Advanced Renal Cell Carcinoma of Intermediate or Poor Risk: Subgroup Analysis of the Alliance A031203 CABOSUN trial.

Journal article Oncologist · November 2019 Cabozantinib treatment prolonged progression-free survival (PFS) and improved objective response rate (ORR) compared with sunitinib in patients with advanced renal cell carcinoma (RCC) of intermediate or poor risk by International Metastatic Renal Cell Car ... Full text Link to item Cite

Phase 1b trial of docetaxel, prednisone, and pazopanib in men with metastatic castration-resistant prostate cancer.

Journal article Prostate · November 2019 BACKGROUND: Docetaxel prednisone is a standard of care for men with metastatic castration-resistant prostate cancer (mCRPC), and plasma vascular endothelial growth factor (VEGF) levels are a poor prognostic factor in this population; therefore, we evaluate ... Full text Link to item Cite

Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality.

Journal article JAMA Oncol · July 1, 2019 IMPORTANCE: Black men are more likely to die of prostate cancer than white men. In men with similar stages of disease, the contribution of biological vs nonbiological differences to this observed disparity is unclear. OBJECTIVE: To quantify the association ... Full text Link to item Cite

The evolution and understanding of skeletal complication endpoints in clinical trials of tumors with metastasis to the bone.

Journal article Crit Rev Oncol Hematol · July 2019 Bone metastases are a frequent complication of solid tumors, leading to significant skeletal sequelae that negatively impact quality of life and survival. Prevention and management of skeletal-related complications are critical treatment goals in oncology. ... Full text Link to item Cite

Management of recurrent prostate cancer after radiotherapy: long-term results from CALGB 9687 (Alliance), a prospective multi-institutional salvage prostatectomy series.

Journal article Prostate Cancer Prostatic Dis · May 2019 BACKGROUND: To evaluate efficacy and morbidity prospectively in a contemporary multi-institutional salvage radical prostatectomy (SRP) series. METHODS: Forty-one men were enrolled between 1997 and 2006, who suffered biopsy-proven recurrent prostate cancer ... Full text Link to item Cite

Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.

Journal article J Clin Oncol · May 1, 2019 PURPOSE: Androgen receptor splice variant 7 (AR-V7) results in a truncated receptor, which leads to ligand-independent constitutive activation that is not inhibited by anti-androgen therapies, including abiraterone or enzalutamide. Given that previous repo ... Full text Link to item Cite

Evidence Synthesis to Accelerate and Improve the Evaluation of Therapies for Metastatic Hormone-sensitive Prostate Cancer.

Journal article Eur Urol Focus · March 2019 There are many ongoing randomised trials of promising therapies for metastatic hormone-sensitive prostate cancer (mHSPC), but standard systematic reviews may not synthesise these in a timely or reliable way. We demonstrate how a novel approach to evidence ... Full text Link to item Cite

A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses.

Journal article JNCI Cancer Spectr · March 2019 BACKGROUND: Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given to the adequacy of reporting and interpretation. This review evaluated the ... Full text Link to item Cite

Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.

Journal article J Clin Oncol · February 10, 2019 PURPOSE: Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was t ... Full text Link to item Cite

On the use of min-max combination of biomarkers to maximize the partial area under the ROC curve.

Journal article J Probab Stat · 2019 BACKGROUND: Evaluation of diagnostic assays and predictive performance of biomarkers based on the receiver operating characteristic (ROC) curve and the area under the ROC curve (AUC) are vital in diagnostic and targeted medicine. The partial area under the ... Full text Link to item Cite

Pharmacodynamic study of radium-223 in men with bone metastatic castration resistant prostate cancer.

Journal article PLoS One · 2019 BACKGROUND: Radium-223 is a targeted alpha-particle therapy that improves survival in men with metastatic castration resistant prostate cancer (mCRPC), particularly in men with elevated serum levels of bone alkaline phosphatase (B-ALP). We hypothesized tha ... Full text Link to item Cite

Developing and Validating Risk Assessment Models of Clinical Outcomes in Modern Oncology.

Journal article JCO Precis Oncol · 2019 The identification of prognostic factors and building of risk assessment prognostic models will continue to play a major role in 21st century medicine in patient management and decision making. Investigators are often interested in examining the relationsh ... Full text Open Access Link to item Cite

Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance).

Journal article Clin Cancer Res · October 1, 2018 Purpose: Bevacizumab is a VEGF-specific angiogenesis inhibitor indicated as an adjunct to chemotherapy for the treatment of multiple cancers. Hypertension is commonly observed during bevacizumab treatment, and high-grade toxicity can limit therapy or lead ... Full text Link to item Cite

Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update.

Journal article Eur J Cancer · May 2018 BACKGROUND: The randomised phase 2 CABOSUN trial comparing cabozantinib with sunitinib as initial therapy for advanced renal cell carcinoma (RCC) of intermediate or poor risk met the primary end-point of improving progression-free survival (PFS) as assesse ... Full text Link to item Cite

Role of Bone-Modifying Agents in Multiple Myeloma: American Society of Clinical Oncology Clinical Practice Guideline Update.

Journal article J Clin Oncol · March 10, 2018 Purpose To update guideline recommendations on the role of bone-modifying agents in multiple myeloma. Methods An update panel conducted a targeted systematic literature review by searching PubMed and the Cochrane Library for randomized controlled trials, s ... Full text Link to item Cite

Management of Patients with Advanced Prostate Cancer: The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017.

Journal article Eur Urol · February 2018 BACKGROUND: In advanced prostate cancer (APC), successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is lack of evidence or low level of evidence. The Advanced Prostate Cancer ... Full text Link to item Cite

Combined Performance of Screening and Variable Selection Methods in Ultra-High Dimensional Data in Predicting Time-To-Event Outcomes.

Journal article Diagn Progn Res · 2018 BACKGROUND: Building prognostic models of clinical outcomes is an increasingly important research task and will remain a vital area in genomic medicine. Prognostic models of clinical outcomes are usually built and validated utilizing variable selection met ... Full text Link to item Cite

Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Journal article JCO Precis Oncol · 2018 PURPOSE: Case reports and small prospective trials suggest that administering targeted therapies to patients with advanced cancer and an identified genomic target may be associated with clinical benefit. The TAPUR Study, a phase II, prospective, non-random ... Full text Link to item Cite

Personalizing prognosis in colorectal cancer: A systematic review of the quality and nature of clinical prognostic tools for survival outcomes.

Journal article J Surg Oncol · December 2017 Integrating diverse types of prognostic information into accurate, individualized estimates of outcome in colorectal cancer is challenging. Significant heterogeneity in colorectal cancer prognostication tool quality exists. Methodology is incompletely or i ... Full text Link to item Cite

Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.

Journal article J Clin Oncol · September 20, 2017 Purpose Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods By June 2013, 102 ... Full text Link to item Cite

Reply to B. Rini et al and S. Buti et al.

Journal article J Clin Oncol · June 1, 2017 Full text Link to item Cite

Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial.

Journal article J Clin Oncol · February 20, 2017 Purpose Cabozantinib is an oral potent inhibitor of vascular endothelial growth factor receptor 2, MET, and AXL and is a standard second-line therapy for metastatic renal cell carcinoma (mRCC). This randomized phase II multicenter trial evaluated cabozanti ... Full text Link to item Cite

Comparison of futility monitoring guidelines using completed phase III oncology trials.

Journal article Clin Trials · February 2017 BACKGROUND: Futility (inefficacy) interim monitoring is an important component in the conduct of phase III clinical trials, especially in life-threatening diseases. Desirable futility monitoring guidelines allow timely stopping if the new therapy is harmfu ... Full text Link to item Cite

A Simple Method for Deriving the Confidence Regions for the Penalized Cox's Model via the Minimand Perturbation.

Journal article Commun Stat Theory Methods · 2017 We propose a minimand perturbation method to derive the confidence regions for the regularized estimators for the Cox's proportional hazards model. Although the regularized estimation procedure produces a more stable point estimate, it remains challenging ... Full text Link to item Cite

Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy.

Journal article Clin Cancer Res · October 1, 2016 PURPOSE: Discovery of SNPs that predict a patient's risk of docetaxel-induced neuropathy would enable treatment individualization to maximize efficacy and avoid unnecessary toxicity. The objectives of this analysis were to discover SNPs associated with doc ... Full text Link to item Cite

American Joint Committee on Cancer acceptance criteria for inclusion of risk models for individualized prognosis in the practice of precision medicine.

Journal article CA Cancer J Clin · September 2016 The American Joint Committee on Cancer (AJCC) has increasingly recognized the need for more personalized probabilistic predictions than those delivered by ordinal staging systems, particularly through the use of accurate risk models or calculators. However ... Full text Link to item Cite

Critical Assessment of Clinical Prognostic Tools in Melanoma.

Journal article Ann Surg Oncol · September 2016 The 7th edition American Joint Committee on Cancer (AJCC) melanoma staging system classifies patients according to prognosis. Significant within-stage heterogeneity remains and the inclusion of additional clinicopathologic and other host- and tumor-based p ... Full text Link to item Cite

Residential metal contamination and potential health risks of exposure in adobe brick houses in Potosí, Bolivia.

Journal article Sci Total Environ · August 15, 2016 Potosí, Bolivia, is the site of centuries of historic and present-day mining of the Cerro Rico, a mountain known for its rich polymetallic deposits, and was the site of large-scale Colonial era silver refining operations. In this study, the concentrations ... Full text Open Access Link to item Cite

Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer.

Journal article J Clin Oncol · May 10, 2016 PURPOSE: Reports have suggested that metastatic site is an important predictor of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC), but these were based on a limited number of patients. We investigate the impact of ... Full text Open Access Link to item Cite

Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3.

Journal article J Clin Oncol · April 20, 2016 PURPOSE: Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Pro ... Full text Link to item Cite

Evaluation of an epithelial plasticity biomarker panel in men with localized prostate cancer.

Journal article Prostate Cancer Prostatic Dis · March 2016 BACKGROUND: Given the potential importance of epithelial plasticity (EP) to cancer metastasis, we sought to investigate biomarkers related to EP in men with localized prostate cancer (PC) for the association with time to PSA recurrence and other clinical o ... Full text Open Access Link to item Cite

Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial.

Journal article Lancet Oncol · March 2016 BACKGROUND: Non-clear cell renal cell carcinomas are histologically and genetically diverse kidney cancers with variable prognoses, and their optimum initial treatment is unknown. We aimed to compare the mTOR inhibitor everolimus and the VEGF receptor inhi ... Full text Link to item Cite

High Dimensional Variable Selection with Error Control.

Journal article Biomed Res Int · 2016 Background. The iterative sure independence screening (ISIS) is a popular method in selecting important variables while maintaining most of the informative variables relevant to the outcome in high throughput data. However, it not only is computationally i ... Full text Open Access Link to item Cite

The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).

Journal article J Natl Cancer Inst · December 2015 New systemic therapies have prolonged the lives of men with metastatic castration-resistant prostate cancer (mCRPC). Use of these therapies in the adjuvant setting when the disease may be micrometastatic and potentially more sensitive to therapies may decr ... Full text Link to item Cite

Refining Prognosis in Lung Cancer: A Report on the Quality and Relevance of Clinical Prognostic Tools.

Journal article J Thorac Oncol · November 2015 INTRODUCTION: Accurate, individualized prognostication for lung cancer patients requires the integration of standard patient and pathologic factors, biological, genetic, and other molecular characteristics of the tumor. Clinical prognostic tools aim to agg ... Full text Link to item Cite

A Molecular Model for Predicting Overall Survival in Patients with Metastatic Clear Cell Renal Carcinoma: Results from CALGB 90206 (Alliance).

Journal article EBioMedicine · November 2015 BACKGROUND: Prognosis associated with metastatic renal cell carcinoma (mRCC) can vary widely. METHODS: This study used pretreatment nephrectomy specimens from a randomized phase III trial. Expression levels of candidate genes were determined from archival ... Full text Link to item Cite

Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015.

Journal article Ann Oncol · August 2015 The first St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) Expert Panel identified and reviewed the available evidence for the ten most important areas of controversy in advanced prostate cancer (APC) management. The successful registration ... Full text Link to item Cite

Mercury hair levels and factors that influence exposure for residents of Huancavelica, Peru.

Journal article Environ Geochem Health · June 2015 Between 1564 and 1810, nearly 17,000 metric tons of mercury (Hg) vapor was released to the environment during cinnabar refining in the small town of Huancavelica, Peru. The present study characterizes individual exposure to mercury using total and speciate ... Full text Link to item Cite

Bevacizumab and the risk of arterial and venous thromboembolism in patients with metastatic, castration-resistant prostate cancer treated on Cancer and Leukemia Group B (CALGB) 90401 (Alliance).

Journal article Cancer · April 1, 2015 BACKGROUND: Bevacizumab is associated with an increased risk of arterial thromboembolism (ATE); however, its effect on venous thromboembolism (VTE) remains controversial. Scant data exist on the factors that increase the risk of ATE/VTE in patients with pr ... Full text Link to item Cite

Clinical phenotypes associated with circulating tumor cell enumeration in metastatic castration-resistant prostate cancer.

Journal article Urol Oncol · March 2015 BACKGROUND: The presence of ≥5 circulating tumor cells (CTCs) is prognostic for shorter survival in men with metastatic castration-resistant prostate cancer (mCRPC). However, some men have low CTCs despite widespread disease, suggesting heterogeneity in CT ... Full text Link to item Cite

Independent data monitoring committees: an update and overview.

Journal article Urol Oncol · March 2015 An independent data monitoring committee׳s (IDMC's) duty is to ensure that the interests of the patients entered in the trial are being well served (i.e., the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained d ... Full text Link to item Cite

Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome.

Journal article Commun Stat Theory Methods · 2015 In this paper we develop the methodology for designing clinical trials with any factorial arrangement when the primary outcome is time to event. We provide a matrix formulation for calculating the sample size and study duration necessary to test any effect ... Full text Link to item Cite

A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events.

Journal article Pharm Stat · 2015 In a clinical trial comparing two treatment groups, one commonly-used endpoint is time to death. Another is time until the first nonfatal event (if there is one) or until death (if not). Both endpoints have drawbacks. The wrong choice may adversely affect ... Full text Link to item Cite

Interaction between digoxin and dronedarone in the PALLAS trial.

Journal article Circ Arrhythm Electrophysiol · December 2014 BACKGROUND: Elevated serum digoxin concentration can cause toxicity, including death. Dronedarone increases digoxin concentration by P-glycoprotein interaction. In Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy Tri ... Full text Link to item Cite

Reply to F. Valcamonico et al.

Journal article J Clin Oncol · November 10, 2014 Full text Link to item Cite

Adjusting for misclassification in a stratified biomarker clinical trial.

Journal article Stat Med · August 15, 2014 Clinical trials utilizing predictive biomarkers have become a research focus in personalized medicine. We investigate the effects of biomarker misclassification on the design and analysis of stratified biomarker clinical trials. For a variety of inference ... Full text Link to item Cite

ERRATA

Journal article Journal of Clinical Oncology · May 1, 2014 Full text Cite

Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases: results of CALGB 90202 (alliance).

Journal article J Clin Oncol · April 10, 2014 PURPOSE: Zoledronic acid decreases the risk for skeletal-related events (SREs) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown. This phase III study evaluated the ef ... Full text Link to item Cite

Erratum

Journal article JNCI Journal of the National Cancer Institute · April 8, 2014 Full text Cite

Updated prognostic model for predicting overall survival in first-line chemotherapy for patients with metastatic castration-resistant prostate cancer.

Journal article J Clin Oncol · March 1, 2014 PURPOSE: Prognostic models for overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC) are dated and do not reflect significant advances in treatment options available for these patients. This work developed and vali ... Full text Link to item Cite

Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic renal cell carcinoma.

Journal article Cancer · January 1, 2014 BACKGROUND: The current study was conducted to investigate the dependence between progression-free survival (PFS) and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC) and to explore whether PFS can be used as an intermediate en ... Full text Link to item Cite

A phase II trial of temsirolimus in men with castration-resistant metastatic prostate cancer.

Journal article Clin Genitourin Cancer · December 2013 BACKGROUND: Phosphatase and tensin homologue (PTEN) loss is common in advanced prostate cancer, leading to constitutive activation of the PI3 kinase pathway. Temsirolimus blocks mammalian target of rapamycin (mTOR)/target of rapamycin complex 1 (TORC1), a ... Full text Link to item Cite

On model specification and selection of the Cox proportional hazards model.

Journal article Stat Med · November 20, 2013 Prognosis plays a pivotal role in patient management and trial design. A useful prognostic model should correctly identify important risk factors and estimate their effects. In this article, we discuss several challenges in selecting prognostic factors and ... Full text Link to item Cite

Prognostic model predicting metastatic castration-resistant prostate cancer survival in men treated with second-line chemotherapy.

Journal article J Natl Cancer Inst · November 20, 2013 BACKGROUND: Several prognostic models for overall survival (OS) have been developed and validated in men with metastatic castration-resistant prostate cancer (mCRPC) who receive first-line chemotherapy. We sought to develop and validate a prognostic model ... Full text Link to item Cite

Prostate-specific antigen changes as surrogate for overall survival in men with metastatic castration-resistant prostate cancer treated with second-line chemotherapy.

Journal article J Clin Oncol · November 1, 2013 PURPOSE: Prostate-specific antigen (PSA) kinetics, and more specifically a ≥ 30% decline in PSA within 3 months after initiation of first-line chemotherapy with docetaxel, are associated with improvement in overall survival (OS) in men with metastatic cast ... Full text Open Access Link to item Cite

The effect of prior androgen synthesis inhibition on outcomes of subsequent therapy with docetaxel in patients with metastatic castrate-resistant prostate cancer: results from a retrospective analysis of a randomized phase 3 clinical trial (CALGB 90401) (Alliance).

Journal article Cancer · October 15, 2013 BACKGROUND: Preliminary data suggest a potential decreased benefit of docetaxel in patients with metastatic, castration-resistant prostate cancer (mCRPC) who previously received abiraterone acetate, a novel androgen synthesis inhibitor (ASI). Cancer and Le ... Full text Link to item Cite

Prognostic model for predicting survival of patients with metastatic urothelial cancer treated with cisplatin-based chemotherapy.

Journal article J Natl Cancer Inst · April 3, 2013 A prognostic model that predicts overall survival (OS) for metastatic urothelial cancer (MetUC) patients treated with cisplatin-based chemotherapy was developed, validated, and compared with a commonly used Memorial Sloan-Kettering Cancer Center (MSKCC) ri ... Full text Link to item Cite

Reply to M A Khattak et al.

Journal article J Clin Oncol · March 1, 2013 Full text Link to item Cite

A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed.

Journal article J Clin Oncol · February 20, 2013 24 Background: Several prognostic models for overall survival (OS) have been developed and validated in men with chemotherapy naïve mCRPC. The primary objective was to develop and validate a prognostic model that can be used to predict OS in men who have f ... Full text Link to item Cite

Residential mercury contamination in adobe brick homes in Huancavelica, Peru.

Journal article PLoS One · 2013 This is the first study of adobe brick contamination anywhere in the world. Huancavelica, Peru is the site of historic cinnabar refining and one of the most mercury (Hg) contaminated urban areas in the world. Over 80% of homes in Huancavelica are construct ... Full text Link to item Cite

Measurement of affective and activity pain interference using the Brief Pain Inventory (BPI): Cancer and Leukemia Group B 70903.

Journal article Pain Med · November 2012 OBJECTIVE: The Brief Pain Inventory (BPI) was designed to yield separate scores for pain intensity and interference. It has been proposed that the pain interference factor can be further broken down into unique factors of affective (e.g., mood) and activit ... Full text Link to item Cite

Serum lactate dehydrogenase predicts for overall survival benefit in patients with metastatic renal cell carcinoma treated with inhibition of mammalian target of rapamycin.

Journal article J Clin Oncol · September 20, 2012 Featured Publication PURPOSE: Lactate dehydrogenase (LDH) is an enzyme involved in anaerobic glycolysis and regulated by the phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin (mTOR)-containing complex 1 (PI3K/Akt/TORC1) pathway as well as tumor hypoxia/necrosis. ... Full text Link to item Cite

Efficacy of peripheral androgen blockade in prostate cancer patients with biochemical failure after definitive local therapy: results of Cancer and Leukemia Group B (CALGB) 9782.

Journal article Cancer · September 1, 2012 BACKGROUND: The treatment for prostate cancer patients with biochemical failure after local therapy remains controversial. Peripheral androgen blockade using a combination of a 5-alpha reductase inhibitor and an antiandrogen may allow control of the prosta ... Full text Link to item Cite

Estimations of historical atmospheric mercury concentrations from mercury refining and present-day soil concentrations of total mercury in Huancavelica, Peru.

Journal article Sci Total Environ · June 1, 2012 Detailed Spanish records of cinnabar mining and mercury production during the colonial period in Huancavelica, Peru were examined to estimate historical health risks to the community from exposure to elemental mercury (Hg) vapor resulting from cinnabar ref ... Full text Link to item Cite

Adjustment on the Type I Error Rate for a Clinical Trial Monitoring for both Intermediate and Primary Endpoints.

Journal article J Biom Biostat · May 19, 2012 In many clinical trials, a single endpoint is used to answer the primary question and forms the basis for monitoring the experimental therapy. Many trials are lengthy in duration and investigators are interested in using an intermediate endpoint for an acc ... Full text Link to item Cite

Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401.

Journal article J Clin Oncol · May 1, 2012 Featured Publication PURPOSE: A randomized, placebo-controlled study based on preclinical and clinical data that supports the potential role of vascular endothelial growth factor in prostate cancer was performed to evaluate the addition of bevacizumab to standard docetaxel and ... Full text Link to item Cite

Biomarkers in the management and treatment of men with metastatic castration-resistant prostate cancer.

Journal article Eur Urol · March 2012 CONTEXT: We have recently witnessed a rapid increase in the number of effective systemic agents for men with metastatic castration-resistant prostate cancer (CRPC), including novel hormonal therapies (abiraterone acetate and MDV3100), immunotherapies (sipu ... Full text Link to item Cite

Design issues in randomized phase II/III trials.

Journal article J Clin Oncol · February 20, 2012 Featured Publication Phase II trials are used to show sufficient preliminary activity of a new treatment (in single-arm designs or randomized screening designs) or to select among treatments with demonstrated activity (in randomized selection designs). The treatments prioritiz ... Full text Link to item Cite

Evaluating the effect of tobacco on prostate cancer outcomes with VEGF-targeted therapy.

Journal article Journal of Clinical Oncology · February 10, 2012 129 Background: Docetaxel/prednisone (DP) plus bevacizumab (B) demonstrated a superior progression-free survival (PFS) but did not prolong overall survival (OS) in comparison to DP monotherapy in CALGB 90401, a study of 1,050 pat ... Full text Cite

Evaluating the effect of tobacco on prostate cancer outcomes with VEGF-targeted therapy.

Journal article J Clin Oncol · February 10, 2012 129 Background: Docetaxel/prednisone (DP) plus bevacizumab (B) demonstrated a superior progression-free survival (PFS) but did not prolong overall survival (OS) in comparison to DP monotherapy in CALGB 90401, a study of 1,050 patients with metastatic castr ... Link to item Cite

Relationship of opioid analgesic (OA) use at 3 months and overall survival in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Journal article J Clin Oncol · February 10, 2012 200 Background: Baseline pain has been shown to be a significant predictor of overall survival (OS) in mCRPC pts. The objectives of this analysis were to identify predictors of OA use at 3-months after initiating frontline chemotherapy, and to determine if ... Link to item Cite

Estimation and testing of the relative risk of disease in case-control studies with a set of k matched controls per case with known prevalence of disease.

Journal article Stat Med · January 13, 2012 Featured Publication The analysis of case-control studies with matched controls per case is well documented in the medical literature. Of primary interest is the estimation of the relative risk of disease. Matched case-control studies fall into two scenarios: the probability o ... Full text Link to item Cite

Combination external beam radiation and brachytherapy boost with androgen deprivation for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809.

Journal article Cancer · December 15, 2011 BACKGROUND: Combined transperineal prostate brachytherapy and external beam radiation therapy (EBRT) is widely used for treatment of prostate cancer. Long-term efficacy and toxicity results of a multicenter phase 2 trial assessing combination of EBRT and t ... Full text Link to item Cite

A min-max combination of biomarkers to improve diagnostic accuracy

Journal article Statistics in Medicine · November 30, 2011 Full text Cite

A min-max combination of biomarkers to improve diagnostic accuracy.

Journal article Stat Med · July 20, 2011 Featured Publication Diagnostic accuracy can be improved considerably by combining multiple biomarkers. Although the likelihood ratio provides optimal solution to combination of biomarkers, the method is sensitive to distributional assumptions which are often difficult to just ... Full text Link to item Cite

Investigator-initiated pilot study of sunitinib malate in patients with newly diagnosed prostate cancer prior to prostatectomy: A trial of the DoD/PCF Prostate Cancer Clinical Trials Consortium.

Journal article J Clin Oncol · May 20, 2011 4664 Background: Sunitinib malate (Sutent, Pfizer) is an oral multi-targeted tyrosine kinase inhibitor of VEGF/PDGF receptors that may function in part to inhibit prostate tumor growth via anti-angiogenic mechanisms. METHODS: We conducted a multi-site stud ... Link to item Cite

Comorbidities predict overall survival (OS) in men with metastatic castrate-resistant prostate cancer (CRPC).

Journal article Journal of Clinical Oncology · March 1, 2011 189 Background: Management of prostate cancer in senior adults represents an important challenge as the median age at diagnosis is 68 and comorbidities in patients increase with advancing age. The objective of this analysis was t ... Full text Cite

Comorbidities predict overall survival (OS) in men with metastatic castrate-resistant prostate cancer (CRPC).

Journal article J Clin Oncol · March 2011 189 Background: Management of prostate cancer in senior adults represents an important challenge as the median age at diagnosis is 68 and comorbidities in patients increase with advancing age. The objective of this analysis was to determine if baseline com ... Link to item Cite

Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809.

Journal article Eur J Cancer · March 2011 BACKGROUND: Chemotherapy-induced ovarian failure (CIOF) is a frequent side-effect of adjuvant chemotherapy that results in rapid bone loss. We hypothesised that zoledronic acid (ZA), a third-generation amino bisphosphonate, would prevent bone loss in preme ... Full text Link to item Cite

A phase 2 study of estramustine, docetaxel, and bevacizumab in men with castrate-resistant prostate cancer: results from Cancer and Leukemia Group B Study 90006.

Journal article Cancer · February 1, 2011 BACKGROUND: The use of docetaxel prolongs survival for patients with castrate-resistant prostate cancer (CRPC). Inhibition of vascular endothelial growth factor (VEGF) with bevacizumab may further enhance the antitumor effect of docetaxel and estramustine ... Full text Link to item Cite

Estimating historical atmospheric mercury concentrations from silver mining and their legacies in present-day surface soil in Potosí, Bolivia

Journal article Atmospheric Environment · November 2010 Detailed Spanish records of mercury use and silver production during the colonial period in Potosí, Bolivia were evaluated to estimate atmospheric emissions of mercury from silver smelting. Mercury was used in the silver production process in Potosí and ne ... Full text Link to item Cite

Factor V Leiden mutation and thromboembolism risk in women receiving adjuvant tamoxifen for breast cancer.

Journal article J Natl Cancer Inst · July 7, 2010 Featured Publication BACKGROUND: Tamoxifen use has been associated with increased risk of thromboembolic events (TEs) in women with breast cancer and women at high risk for the disease. Factor V Leiden (FVL) is the most common inherited clotting factor mutation and also confer ... Full text Link to item Cite

A randomized, double-blind, placebo-controlled phase III trial comparing docetaxel, prednisone, and placebo with docetaxel, prednisone, and bevacizumab in men with metastatic castration-resistant prostate cancer (mCRPC): Survival results of CALGB 90401.

Journal article Journal of Clinical Oncology · June 20, 2010 LBA4511 Background: The preclinical activity of vascular endothelial growth factor (VEGF) blockade, the inverse relationship of plasma and urine VEGF levels and survival in mCRPC patients (pts), and encouraging phase II data test ... Full text Cite

A randomized, double-blind, placebo-controlled phase III trial comparing docetaxel, prednisone, and placebo with docetaxel, prednisone, and bevacizumab in men with metastatic castration-resistant prostate cancer (mCRPC): Survival results of CALGB 90401.

Journal article J Clin Oncol · June 20, 2010 LBA4511 Background: The preclinical activity of vascular endothelial growth factor (VEGF) blockade, the inverse relationship of plasma and urine VEGF levels and survival in mCRPC patients (pts), and encouraging phase II data testing estramustine and doceta ... Link to item Cite

A pharmacodynamic study of rapamycin in men with intermediate- to high-risk localized prostate cancer.

Journal article Clin Cancer Res · June 1, 2010 PURPOSE: Given discrepancies between preclinical and clinical observations of mammalian target of rapamycin (mTOR) inhibition in prostate cancer, we sought to determine the pharmacodynamic effects of the mTOR/TORC1 inhibitor rapamycin in men with intermedi ... Full text Link to item Cite

Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206.

Journal article J Clin Oncol · May 1, 2010 Featured Publication PURPOSE: Bevacizumab is an antibody that binds vascular endothelial growth factor and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN-alpha) is the historic standard initial treatment for RCC. A prospective, randomized, phase II ... Full text Link to item Cite

Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer.

Journal article Cancer Immunol Immunother · May 2010 A concurrent multicenter, randomized Phase II trial employing a recombinant poxviral vaccine provided evidence of enhanced median overall survival (OS) (p = 0.0061) in patients with metastatic castrate-resistant prostate cancer (mCRPC). The study reported ... Full text Link to item Cite

The importance of identifying and validating prognostic factors in oncology.

Journal article Semin Oncol · April 2010 Featured Publication Prognosis plays a vital role in patient management and decision making. The assessment of prognostic factors, which relate baseline clinical and experimental covariables to outcomes, is one of the major objectives in clinical research. Historically, the im ... Full text Link to item Cite

The COMPARE Registry: design and baseline patterns of care for men with biochemical failure after definitive treatment of localized prostate cancer.

Journal article Urology · March 2010 OBJECTIVES: To define current standards of care for patients with prostate-specific antigen (PSA) failure after initial definitive local treatment of prostate cancer using Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma Registry (COMPARE ... Full text Link to item Cite

Efficacy of carboplatin-taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials.

Journal article Ann Oncol · February 2010 BACKGROUND: Docetaxel is associated with prolonged survival in castration-resistant prostate cancer (CRPC). Platinum compounds have modest but distinct single-agent activity. Carboplatin may have greatest potential for benefit when combined with taxanes. W ... Full text Link to item Cite

The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival.

Journal article Eur J Cancer · February 2010 AIMS OF THE STUDY: There are no known predictive factors of response in men receiving chemotherapy for metastatic castration-resistant prostate cancer (mCRPC). We investigated pre-treatment factors that predicted a 30% PSA decline (30% PSAD) within 3 month ... Full text Link to item Cite

Arsenic trioxide in recurrent urothelial cancer: a cancer and leukemia group B phase II trial (CALGB 99903).

Journal article Clin Genitourin Cancer · October 2009 BACKGROUND: Arsenic trioxide is highly active in patients with acute promyelocytic leukemia. There are also preclinical data to suggest that this drug might be active in nonhematopoietic malignancies, and transitional cell carcinoma cell lines are particul ... Full text Link to item Cite

Treatment Decisions for Advanced Genitourinary Cancers: From Symptoms to Risk Assessment

Journal article European Urology Supplements · September 1, 2009 Context: Current and emerging treatment options for advanced prostate, renal, and bladder cancer were discussed at the annual Interactive Genitourinary Cancer Conference (IGUCC) held in February 2009 in connection with the 2nd World Congress on Controversi ... Full text Cite

Management of kidney cancer: Canadian Kidney Cancer Forum Consensus Update (vol 3, pg 200, 2009)

Journal article CUAJ-CANADIAN UROLOGICAL ASSOCIATION JOURNAL · August 2009 Link to item Cite

Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206.

Journal article J Clin Oncol · June 20, 2009 LBA5019 Background: Bevacizumab (BEV) plus interferon alpha (IFN) demonstrated a superior objective response rate and progression-free survival (PFS) versus IFN monotherapy in renal cell carcinoma (RCC) patients in 2 phase III trials. The primary objective ... Link to item Cite

Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer.

Journal article J Clin Oncol · June 10, 2009 Featured Publication PURPOSE: To explore whether progression-free survival (PFS) or biochemical PFS can be used as a predictor of overall survival (OS) and to investigate the dependence between PFS and OS in men with castrate-resistant prostate cancer. PATIENTS AND METHODS: Da ... Full text Link to item Cite

A phase II trial of cisplatin (C), gemcitabine (G) and gefitinib for advanced urothelial tract carcinoma: results of Cancer and Leukemia Group B (CALGB) 90102.

Journal article Ann Oncol · June 2009 BACKGROUND: This phase II trial (Cancer and Leukemia Group B 90102) sought to determine the efficacy of cisplatin, standard infusion of gemcitabine and gefitinib in patients with advanced urothelial carcinoma. PATIENTS AND METHODS: Eligible patients had pr ... Full text Link to item Cite

Development of risk groups in metastatic castration-resistant prostate cancer (mCRPC) to facilitate the identification of active chemotherapy regimens.

Journal article J Clin Oncol · May 20, 2009 5137 Background: Our aim was to develop and validate clinically applicable predictive factors for a >30% PSA decline 3 months following chemotherapy initiation, and to assess the performance of a risk-group based classification in predicting PSA declines a ... Link to item Cite

Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial.

Journal article J Clin Oncol · May 20, 2009 5150 Background: It has been shown in chemotherapy naïve patients that PFS is a statistically significant predictor of OS. The main objectives of this analysis were to explore whether PFS at 3-months is a predictor of OS and to investigate the dependence b ... Link to item Cite

Use of pain at baseline and pain progression to predict overall survival (OS) in patients (pts) with docetaxel pretreated metastatic castration-refractory prostate cancer (CRPC): Results from the SPARC trial.

Journal article J Clin Oncol · May 20, 2009 5148 Background: First-line chemotherapy trials have reported that pain predicts OS in CRPC. We report relationships between OS and baseline pain -a major component of CRPC patient reported outcomes (PRO) -and pain at progression, for docetaxel pre-treated ... Link to item Cite

Comparability of health-related quality of life (HRQOL), treatment decision making, and treatment satisfaction after PSA recurrence among prostate cancer patients who receive hormone therapy (HT) versus observation (OBS): Results from the COMPARE registry.

Journal article J Clin Oncol · May 20, 2009 5131 Background: HT may lower PSA, but it may also cause hot flashes and sexual dysfunction. OBS is not associated with hot flashes or lower testosterone production, but PSA may rise. Examining patient satisfaction with treatment decision making, treatment ... Link to item Cite

Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206.

Journal article J Clin Oncol · May 20, 2009 LBA5019 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. ... Link to item Cite

Aspirin for the chemoprevention of colorectal adenomas: meta-analysis of the randomized trials.

Journal article J Natl Cancer Inst · February 18, 2009 Featured Publication BACKGROUND: Multiple lines of evidence indicate that aspirin has an antineoplastic effect in the large bowel. Randomized clinical trials have been conducted to evaluate the effectiveness of aspirin for reducing the risk of colorectal adenomas. A meta-analy ... Full text Link to item Cite

The relationship of body mass index and serum testosterone with disease outcomes in men with castration-resistant metastatic prostate cancer.

Journal article Prostate Cancer Prostatic Dis · 2009 The purpose of this study was to evaluate the relationship of baseline body mass index (BMI) and serum testosterone level with prostate cancer outcomes in men with castration-resistant metastatic prostate cancer (CRPC). BMI and testosterone levels were eva ... Full text Link to item Cite

Use of nonsteroidal antiinflammatory drugs and distal large bowel cancer in whites and African Americans.

Journal article Am J Epidemiol · December 1, 2008 Despite the belief that the etiology of and risk factors for rectal cancer might differ from those for colon cancer, relatively few studies have examined rectal cancer in relation to use of nonsteroidal antiinflammatory drugs (NSAIDs). The authors evaluate ... Full text Link to item Cite

Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811.

Journal article Cancer · December 1, 2008 BACKGROUND: A multicenter phase 2 trial was conducted to evaluate the safety and feasibility of radiotherapy after paclitaxel, estramustine phosphate, and carboplatin (TEC) plus androgen deprivation therapy in previously untreated unfavorable-risk localize ... Full text Link to item Cite

Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206.

Journal article J Clin Oncol · November 20, 2008 Featured Publication PURPOSE: Bevacizumab is an antibody that binds to vascular endothelial growth factor (VEGF) and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN) is a historic standard first-line treatment for RCC. A prospective, randomized phas ... Full text Link to item Cite

Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809.

Journal article Int J Radiat Oncol Biol Phys · November 1, 2008 PURPOSE: Transperineal prostate brachytherapy (TPPB) can be used with external beam radiation therapy (EBRT) to provide a high-dose conformal boost to the prostate. The results of a multicenter Phase II trial assessing safety of combination of EBRT and TPP ... Full text Link to item Cite

Flexible Frames and Control Sampling in Case-Control Studies: Weighters (Survey Statisticians) Versus Anti-Weighters (Epidemiologists).

Journal article Am Stat · November 1, 2008 We propose two innovations in statistical sampling for controls to enable better design of population-based case-control studies. The main innovation leads to novel solutions, without using weights, of the difficult and long-standing problem of selecting a ... Full text Link to item Cite

In reply

Journal article Journal of Clinical Oncology · September 18, 2008 Full text Cite

In reply

Journal article Journal of Clinical Oncology · September 15, 2008 Full text Cite

A phase II study of estramustine, docetaxel, and exisulind in patients with hormone- refractory prostate cancer: results of cancer and leukemia group B trial 90004.

Journal article Clin Genitourin Cancer · September 2008 PURPOSE: Docetaxel/estramustine is a known active regimen in hormonerefractory prostate cancer (HRPC). A phase II study was conducted to assess the safety and efficacy of docetaxel/estramustine combined with exisulind, an apoptotic antineoplastic drug. PAT ... Full text Link to item Cite

Pain predicts overall survival in men with metastatic castration-refractory prostate cancer.

Journal article J Clin Oncol · May 20, 2008 Featured Publication PURPOSE: Pain from castration-refractory prostate cancer (CRPC) bone metastases is a common event. Although it is assumed that pain represents an adverse prognostic factor, this variable has not been extensively evaluated. The objective of this study was t ... Full text Link to item Cite

Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207.

Journal article Ann Oncol · May 2008 BACKGROUND: There is no standard second-line treatment for advanced urothelial carcinoma (UC). Response rates to second-line chemotherapy for advanced UC are low and response duration is short. Bortezomib is a proteasome inhibitor with preclinical activity ... Full text Link to item Cite

Tumor volume changes on 1.5 tesla endorectal MRI during neoadjuvant androgen suppression therapy for higher-risk prostate cancer and recurrence in men treated using radiation therapy results of the phase II CALGB 9682 study.

Journal article Int J Radiat Oncol Biol Phys · May 1, 2008 PURPOSE: We prospectively determined whether the change in tumor volume (TV) during 2 months of neoadjuvant androgen suppression therapy (nAST) measured using conventional 1.5 Tesla endorectal magnetic resonance imaging (eMRI) was associated with the risk ... Full text Link to item Cite

p53 protein expression status and recurrence in men treated with radiation and androgen suppression therapy for higher-risk prostate cancer: a prospective phase II Cancer and Leukemia Group B Study (CALGB 9682).

Journal article Urology · May 2008 OBJECTIVES: It has been hypothesized that abnormal p53 protein expression is associated with a worse prognosis after radiation (RT) and androgen suppression therapy (AST). This hypothesis was prospectively tested. METHODS: Between May 1997 and April 2001, ... Full text Link to item Cite

Hormonal risk factors for ovarian cancer in premenopausal and postmenopausal women.

Journal article Am J Epidemiol · May 1, 2008 Ovarian cancer is most frequently diagnosed in postmenopausal women; however, the strongest risk predictors, pregnancy and oral contraceptive use, occur in most women in their twenties and thirties. Relatively few studies have examined how reproductive ris ... Full text Link to item Cite

Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.

Journal article J Clin Oncol · March 1, 2008 Featured Publication PURPOSE: To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. METHODS: A committee of investigators experienced in conducting trials for pro ... Full text Link to item Cite

Cyclin E overexpression in epithelial ovarian cancer characterizes an etiologic subgroup.

Journal article Cancer Epidemiol Biomarkers Prev · March 2008 BACKGROUND: The objective of this study was to determine whether cyclin E overexpression defines an etiologically distinct subgroup of ovarian cancer. METHODS: We analyzed data from 538 epithelial ovarian cancer cases and 629 controls enrolled in a populat ... Full text Link to item Cite

Second-line chemotherapy for advanced hormone-refractory prostate cancer.

Journal article Clin Adv Hematol Oncol · February 2008 Prostate cancer is the most common cancer occurring among men in the United States. In spite of the disease's favorable prognosis, approximately 30,000 U.S. men develop incurable metastatic disease each year, making prostate cancer the second-leading cause ... Link to item Cite

Statistical considerations for the design and analysis of Phase III clinical trials in prostate cancer.

Journal article Urol Oncol · 2008 This article reviews the basic principles involved in the design, conduct, and analysis of Phase III treatment trials in prostate cancer. It begins with a brief review of Phase III trials, and subsequently describes the process of hypothesis testing and th ... Full text Link to item Cite

Circulating levels of inflammatory cytokines and risk of colorectal adenomas.

Journal article Cancer Res · January 1, 2008 The association between obesity and colorectal neoplasia may be mediated by inflammation. Circulating levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) are elevated in the obese. Adipose tissue can produc ... Full text Link to item Cite

Sample Size Selection in Clinical Trials when Population Means Are Subject to a Partial Order: One-sided Ordered Alternatives.

Journal article J Appl Stat · 2008 The statistical methodology under order restriction is very mathematical and complex. Thus, we provide a brief methodological background of order restricted likelihood ratio tests for the normal theory case for the basic understanding of its applications, ... Full text Link to item Cite

A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102.

Journal article BJU Int · January 2008 OBJECTIVE: To conduct a phase II trial to determine the efficacy of cisplatin, a fixed dose-rate infusion of gemcitabine and gefitinib (an orally active epidermal growth factor receptor tyrosine kinase inhibitor) in patients with advanced urothelial carcin ... Full text Link to item Cite

Flexible Frames and Control Sampling in Case-Control Studies

Journal article The American Statistician · 2008 Cite

Inverse correlation between body mass index and clinical outcomes in men with advanced castration-recurrent prostate cancer.

Journal article Cancer · October 1, 2007 BACKGROUND: Obesity has a variety of adverse health outcomes, but to the authors' knowledge, the effect of obesity on outcome in patients with advanced prostate cancer is not known. For this reason, the correlation between an elevated body mass index (BMI) ... Full text Link to item Cite

American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma.

Journal article J Clin Oncol · June 10, 2007 PURPOSE: To update the recommendations for the use of bisphosphonates in the prevention and treatment of bone disease in multiple myeloma. The Update Committee expanded the guideline to include a discussion of osteonecrosis of the jaw (ONJ). METHODS: For t ... Full text Link to item Cite

Adrenal androgen levels as predictors of outcome in prostate cancer patients treated with ketoconazole plus antiandrogen withdrawal: results from a cancer and leukemia group B study.

Journal article Clin Cancer Res · April 1, 2007 PURPOSE: Adrenal androgens activate the androgen receptor and stimulate prostate cancer growth. Ketoconazole is used as an inhibitor of adrenal androgen synthesis in men with androgen-independent prostate cancer. This study analyzes the relationship betwee ... Full text Link to item Cite

Trinucleotide repeat polymorphisms in the androgen receptor gene and risk of ovarian cancer.

Journal article Cancer Epidemiol Biomarkers Prev · March 2007 INTRODUCTION: Androgens may play a role in the development of ovarian cancers. Two trinucleotide repeat polymorphisms have been described in exon 1 of the androgen receptor (AR) gene that may affect its function. Previous studies of ovarian cancer and AR r ... Full text Link to item Cite

The impact of prior radical prostatectomy in men with metastatic castration recurrent prostate cancer: a pooled analysis of 9 Cancer and Leukemia Group B Trials.

Journal article J Urol · February 2007 PURPOSE: A prior report suggested that radical prostatectomy may confer a survival advantage to patients with metastatic castration recurrent prostate cancer. Therefore, a pooled analysis of 9 trials performed by Cancer and Leukemia Group B was done to det ... Full text Link to item Cite

A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B protocol 90008.

Journal article Cancer · September 15, 2006 BACKGROUND: The objective of this study was to verify previous reports of activity with gemcitabine plus a fluoropyrimidine in patients with metastatic renal cell cancer in a multiinstitutional setting. METHODS: Eligibility included a Zubrod performance st ... Full text Link to item Cite

Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study.

Journal article Biol Blood Marrow Transplant · July 2006 A graft-versus-tumor effect through nonmyeloablative allogeneic stem cell transplantation (N-SCT) in metastatic renal cell carcinoma (RCC) has been reported. An Intergroup phase II trial was undertaken to define further the feasibility, toxicity and effica ... Full text Link to item Cite

Clinical outcomes by age in men with hormone refractory prostate cancer: a pooled analysis of 8 Cancer and Leukemia Group B (CALGB) studies.

Journal article J Urol · July 2006 PURPOSE: We determined if age is a prognostic factor of clinical outcomes, specifically overall survival, disease-free survival and progression-free survival in men with hormone refractory prostate cancer. MATERIALS AND METHODS: Data from 8 multi-instituti ... Full text Link to item Cite

An elevated body mass (BMI) index predicts for better clinical outcomes in men with metastatic hormone refractory prostate cancer (HRPC).

Journal article J Clin Oncol · June 20, 2006 4556 Background: Previous articles have reported that an elevated BMI was associated with an increased risk of biochemical failure in hormone sensitive patients. We asked the question as to whether an elevated BMI predicts for worst clinical outcomes, name ... Link to item Cite

Race/ethnicity, literacy, and prostate cancer: Initial findings from the COMPARE registry.

Journal article J Clin Oncol · June 20, 2006 4620 Background: Comprehensive Multicenter Prostate Adenocarcinoma Registry (COMPARE) evaluates variations in initial prostate cancer (PCa) therapy according to race/ethnicity. Similar studies for prostate cancer patients with PSA failure following radiati ... Link to item Cite

Long term efficacy of peripheral androgen blockade on prostate cancer: CALGB 9782.

Journal article J Clin Oncol · June 20, 2006 4573 Background: The treatment of patients with a rising PSA after definitive local therapy is controversial. Patients are reluctant to undergo androgen suppression due to side effects and interest focuses on the timing and intensity of additional therapy. ... Link to item Cite

CALGB 90207: Phase II trial of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma (TCC).

Journal article J Clin Oncol · June 20, 2006 4582 Background: No standard 2(nd)-line chemotherapy exists for metastatic TCC. Response rates to 2(nd)-line chemotherapy for advanced TCC are low and response duration tends to be short. Bortezomib is a proteasome inhibitor with preclinical activity again ... Link to item Cite

Phase II study of cisplatin (C), gemcitabine (G) and gefitinib for advanced urothelial carcinoma (UC): Analysis of the second cohort of CALGB 90102.

Journal article J Clin Oncol · June 20, 2006 4578 Background: The epidermal growth factor receptor (EGFR) is frequently expressed in UC and carries a poor prognosis. C has preclinical synergy with gefitinib and GC plus gefitinib was safe in lung cancer patients (pts). In a UC trial of GC using fixed ... Link to item Cite

Activities and accomplishments of the cancer and leukemia group B genitourinary committee.

Journal article Clin Cancer Res · June 1, 2006 The Cancer and Leukemia Group B Genitourinary (GU) Committee has developed a multidisciplinary approach to treatment of GU cancer and has integrated correlative science research into the major research themes of the GU Committee. In localized prostate canc ... Full text Link to item Cite

Prognostic significance of plasma scatter factor/hepatocyte growth factor levels in patients with metastatic hormone- refractory prostate cancer: results from cancer and leukemia group B 150005/9480.

Journal article Clin Genitourin Cancer · March 2006 BACKGROUND: Scatter factor, also known as hepatocyte growth factor (SF/HGF), is a polypeptide growth factor thought to be important in the growth and spread of prostatic carcinoma. PATIENTS AND METHODS: Scatter factor/HGF levels in pretreatment plasma samp ... Full text Link to item Cite

Analgesic drug use and risk of ovarian cancer.

Journal article Epidemiology · January 2006 BACKGROUND: Previous epidemiologic research suggests that analgesic use may reduce the risk of ovarian cancer, although results are not consistent. METHODS: In a population-based, case-control study, we analyzed data from 586 ovarian cancer cases and 627 m ... Full text Link to item Cite

Predictors of prostate cancer tissue acquisition by an undirected core bone marrow biopsy in metastatic castration-resistant prostate cancer--a Cancer and Leukemia Group B study.

Journal article Clin Cancer Res · November 15, 2005 PURPOSE: Analyzing metastatic prostate cancer tissue is of considerable importance in evaluating new targeted agents, yet acquiring such tissue presents a challenge due to the predominance of bone metastases. We assessed factors predicting a successful tum ... Full text Link to item Cite

ZD6474, a novel tyrosine kinase inhibitor of vascular endothelial growth factor receptor and epidermal growth factor receptor, inhibits tumor growth of multiple nervous system tumors.

Journal article Clin Cancer Res · November 15, 2005 PURPOSE: Primary central nervous system (CNS) tumors represent a diverse group of tumor types with heterogeneous molecular mechanisms that underlie their formation and maintenance. CNS tumors depend on angiogenesis and often display increased activity of E ... Full text Link to item Cite

Anthropometric measurements and epithelial ovarian cancer risk in African-American and White women.

Journal article Cancer Causes Control · October 2005 Previous studies of anthropometric factors and ovarian cancer risk have been inconsistent and none have evaluated the association among African-American women. Data from a population-based, case-control study of 593 cases and 628 controls were used to eval ... Full text Link to item Cite

Prognostic significance of plasma chromogranin a levels in patients with hormone-refractory prostate cancer treated in Cancer and Leukemia Group B 9480 study.

Journal article Urology · August 2005 OBJECTIVES: To test the hypothesis that chromogranin A (CgA) levels are prognostic in patients with metastatic hormone-refractory prostate cancer (HRPC). The extent of neuroendocrine differentiation in prostate cancer correlates with aggressive disease and ... Full text Link to item Cite

Menopausal hormones and risk of ovarian cancer.

Journal article Am J Obstet Gynecol · July 2005 OBJECTIVE: The objective of this study was to determine if use of menopausal hormones was associated with ovarian cancer and if risk varied by type of hormone used. STUDY DESIGN: Data from a population-based, case-control study of ovarian cancer in North C ... Full text Link to item Cite

Transforming growth factor beta receptor I polyalanine repeat polymorphism does not increase ovarian cancer risk.

Journal article Gynecol Oncol · May 2005 OBJECTIVES: It has been suggested that the 6A allele of the type I TGFbeta receptor (TGFbetaR1) polyalanine repeat tract polymorphism may increase susceptibility to various types of cancer including ovarian cancer. METHODS: The TGFbetaR1 polyalanine polymo ... Full text Link to item Cite

Antidepressant medication use [corrected] and risk of ovarian cancer.

Journal article Obstet Gynecol · April 2005 OBJECTIVE: It has been hypothesized that antidepressants may enhance cancer growth. Previous studies of antidepressant use and ovarian cancer have been inconsistent and have been limited in their ability to examine the association with selective serotonin ... Full text Link to item Cite

The prognostic significance of plasma interleukin-6 levels in patients with metastatic hormone-refractory prostate cancer: results from cancer and leukemia group B 9480.

Journal article Clin Cancer Res · March 1, 2005 UNLABELLED: Interleukin-6 signaling can activate androgen receptor in a ligand-independent manner and may play an important functional role in hormone-refractory prostate cancer (HRCaP) progression and patient survival. Plasma and serum IL-6 levels have be ... Full text Link to item Cite

Flushing and papules in a middle-aged woman.

Journal article Obstet Gynecol · February 2005 Full text Link to item Cite

Progesterone receptor promoter +331A polymorphism is associated with a reduced risk of endometrioid and clear cell ovarian cancers.

Journal article Cancer Epidemiol Biomarkers Prev · December 2004 OBJECTIVE: The progestagenic milieu of pregnancy and oral contraceptive use is protective against epithelial ovarian cancer. A functional single nucleotide polymorphism in the promoter of the progesterone receptor (+331A) alters the relative abundance of t ... Link to item Cite

Impact of race on survival in men with metastatic hormone-refractory prostate cancer.

Journal article Urology · August 2004 OBJECTIVES: To determine whether blacks with hormone-refractory prostate cancer have shorter survival compared with whites with the same disease. METHODS: Data from eight multicenter trials (four Phase II and four randomized Phase III studies) conducted by ... Full text Link to item Cite

Scatter factor/hepatocyte growth factor as a prognostic indicator in metastatic prostate cancer: A plasma study in CALGB 9480.

Journal article J Clin Oncol · July 15, 2004 9613 Background: Scatter factor, also known as hepatocyte growth factor, (SF/HGF) is a polypeptide growth factor thought to be important in prostate cancer growth and spread. We have previously shown circulating SF/HGF levels were related to stage and Glea ... Link to item Cite

A phase II study of gemcitabine (G) and capecitabine (C) in patients with metastatic renal cell cancer (mRCC): A report of Cancer and Leukemia Group B #90008.

Journal article J Clin Oncol · July 15, 2004 4515 Background: Low but consistent responses have been observed in mRCC patients (pts) treated with 5FU, G, or the combination. A phase II multi-center study to assess the activity of G plus the oral 5FU analog C was thus conducted. METHODS: Pts with adeq ... Link to item Cite

Phase II trial of cisplatin (C), fixed-dose rate gemcitabine (G) and gefitinib for advanced transitional cell carcinoma (TCC) of the urothelial tract: Preliminary results of CALGB 90102.

Journal article J Clin Oncol · July 15, 2004 4540 Background: The GC combination has become a standard of care for advanced TCC. The epidermal growth factor receptor (EGFR) is frequently expressed in TCC and is associated with a poor prognosis. While gefitinib alone has minimal activity in advanced T ... Link to item Cite

A reduction in the rate of PSA rise following chemotherapy in patients with metastatic hormone refractory prostate cancer (HRPC) predicts survival: Results of a pooled analysis of CALGB HRPC trials.

Journal article J Clin Oncol · July 15, 2004 4506 Background: A prostate-specific antigen (PSA) decline of > 50% is associated with a prolongation in survival for patients with metastatic hormone refractory prostate cancer (HRPC). However, whether any reduction in the rate of PSA rise following chemo ... Link to item Cite

The effect of race on progression-free survival in patients with metastatic hormone-refractory prostate cancer (HRPC): a pooled analysis of CALGB studies.

Journal article J Clin Oncol · July 15, 2004 4573 Background: To determine if African-American (AA) men have different progression-free survival (PFS) than non-African-American (non-AA) patients with hormone refractory prostate cancer (HRPC). METHODS: Data from eight multicenter trials (four phase II ... Link to item Cite

Prognostic significance of plasma chromogranin A levels in hormone-refractory prostate cancer patients treated on Cancer and Leukemia Group B (CALGB) 9480.

Journal article J Clin Oncol · July 15, 2004 4557 Background: The extent of neuroendocrine differentiation in prostate cancer correlates with aggressive disease and progression to hormone refractory prostate cancer (HRPC). Elevated plasma chromogranin A (CgA) levels in prostate cancer patients may re ... Link to item Cite

Efficacy of peripheral androgen blockade on prostate cancer: Results of CALGB 9782.

Journal article J Clin Oncol · July 15, 2004 4559 Background: The treatment of patients with elevated PSA after definitive local therapy continues to be elusive. Many patients are reluctant to undergo androgen suppression therapy due to long-term effects. Enthusiasm has been seen for peripheral andro ... Link to item Cite

Use of adrenal androgen levels to predict response to ketoconazole in patients with androgen independent prostate cancer: Results from CALGB 9583.

Journal article J Clin Oncol · July 15, 2004 4558 Background Adrenal androgens can activate the androgen receptor and stimulate prostate cancer growth. Because of its adrenolytic properties, ketoconazole (keto) is active as a secondary hormonal therapy in men with androgen-independent prostate cancer ... Link to item Cite

Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia.

Journal article Cancer · July 15, 2004 BACKGROUND: The authors undertook a multiinstitutional Phase II cooperative group study to examine the potential of oral fish oil fatty acid supplements administered at high doses to slow weight loss and to improve quality of life in patients with malignan ... Full text Link to item Cite

Sample size determination for comparing several survival curves with unequal allocations.

Journal article Stat Med · June 15, 2004 Featured Publication Ahnn and Anderson derived sample size formulae for unstratified and stratified designs assuming equal allocation of subjects to three or more treatment groups. We generalize the sample size formulae to allow for unequal allocation. In addition, we define t ... Full text Link to item Cite

Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma.

Journal article Clin Cancer Res · April 15, 2004 The majority of sporadic clear cell renal cell carcinoma (RCC) is characterized by loss of heterozygosity of the von Hippel-Lindau (VHL) tumor suppressor gene and somatic inactivation of the remaining VHL allele. The resulting VHL gene silencing leads to i ... Full text Link to item Cite

Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583).

Journal article J Clin Oncol · March 15, 2004 Featured Publication PURPOSE: Antiandrogen withdrawal (AAWD) results in a prostate-specific antigen (PSA) response (decline in PSA level of > or =50%) in 15% to 30% of androgen-independent prostate cancer (AiPCa) patients. Thereafter, adrenal androgen ablation with agents such ... Full text Link to item Cite

Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group.

Journal article J Clin Oncol · February 1, 2004 Featured Publication PURPOSE: To define methodology to show clinical benefit for patients in the state of a rising prostate-specific antigen (PSA). HYPOTHESIS: A clinical states framework was used to address the hypothesis that definitive phase III trials could not be conducte ... Full text Link to item Cite

Law and colonial cultures: Legal regimes in world history, 1400-1900.

Journal article HARVARD INTERNATIONAL LAW JOURNAL · 2004 Link to item Cite

9-Nitrocamptothecin as second line chemotherapy for men with progressive, metastatic, hormone refractory prostate cancer: Results of the CALGB 99901.

Journal article Urol Oncol · 2004 BACKGROUND: Institution of early hormone therapy in the PSA era coupled with demonstration of clinical benefit with chemotherapy in hormone refractory prostate cancer (HRPC) and acceptance of PSA decline as a surrogate for response has resulted in introduc ... Full text Link to item Cite

A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813.

Journal article Cancer · December 15, 2003 BACKGROUND: The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor (G-CSF) support in patients with hormone-refractory prostate carcinoma. METHODS: In the current multicenter, c ... Full text Link to item Cite

Androgen receptor mutations in androgen-independent prostate cancer: Cancer and Leukemia Group B Study 9663.

Journal article J Clin Oncol · July 15, 2003 Featured Publication PURPOSE: The mechanisms responsible for prostate cancer androgen independence are diverse. Mutations of the androgen receptor (AR) gene that broaden ligand specificity have been implicated. Bone marrow specimens containing prostate tumor were obtained from ... Full text Link to item Cite

Analysis of survival data with missing measurements of a time-dependent binary covariate.

Journal article J Biopharm Stat · May 2003 Featured Publication The objective of this study was to investigate the influence of the number and timing of a binary time-dependent covariate on the bias using the last-observation carried forward in the proportional hazards model. Under various assumptions of censoring rate ... Full text Link to item Cite

Overview of bladder cancer trials in the Cancer and Leukemia Group B.

Journal article Cancer · April 15, 2003 The Cancer and Leukemia Group B (CALGB) Genitourinary Committee has developed a broad range of clinical trials across most stages of bladder cancer. Recurrence rates of superficial bladder cancer after transurethral resection range from 50-70%. Although ad ... Full text Link to item Cite

Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer.

Journal article J Clin Oncol · April 1, 2003 Featured Publication PURPOSE: To develop and validate a model that can be used to predict the overall survival probability among metastatic hormone-refractory prostate cancer patients (HRPC). PATIENTS AND METHODS: Data from six Cancer and Leukemia Group B protocols that enroll ... Full text Link to item Cite

A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer.

Journal article N Engl J Med · March 6, 2003 BACKGROUND: Experimental studies in animals and observational studies in humans suggest that regular aspirin use may decrease the risk of colorectal adenomas, the precursors to most colorectal cancers. METHODS: We conducted a randomized, double-blind trial ... Full text Link to item Cite

Prognostic significance of reverse transcriptase polymerase chain reaction for prostate-specific antigen in metastatic prostate cancer: a nested study within CALGB 9583.

Journal article J Clin Oncol · February 1, 2003 Featured Publication PURPOSE: To determine whether reverse transcriptase polymerase chain reaction (RT-PCR) to detect circulating prostate-specific antigen (PSA)-positive cells is a prognostic factor for survival in hormone refractory prostate cancer and to validate the progno ... Full text Link to item Cite

A randomized trial of aspirin to prevent colorectal adenomas in patients with previous

Journal article European Journal of Gastroenterology and Hepatology · January 1, 2003 Full text Cite

Ovulation and ovarian cancer: a comparison of two methods for calculating lifetime ovulatory cycles (United States).

Journal article Cancer Causes Control · November 2002 OBJECTIVE: To compare two methods for calculating lifetime ovulatory cycles (LOC) to determine if more detailed menstrual cycle information results in stronger associations with ovarian cancer. METHODS: Using data from 232 cases and 242 controls in a popul ... Full text Link to item Cite

Randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: results of intergroup 0159, cancer and leukemia group B 9480.

Journal article J Clin Oncol · August 15, 2002 Featured Publication PURPOSE: To test the hypothesis that the efficacy and toxicity of suramin in the treatment of patients with hormone-refractory prostate cancer was dose dependent. PATIENTS AND METHODS: Patients were randomized with equal probability to receive low-, interm ... Full text Link to item Cite

Effects of a mammography decision-making intervention at 12 and 24 months.

Journal article Am J Prev Med · May 2002 BACKGROUND: Most women are not getting regular mammograms, and there is confusion about several mammography-related issues, including the age at which women should begin screening. Numerous groups have called for informed decision making about mammography, ... Full text Link to item Cite

Higher doses of mitoxantrone among men with hormone-refractory prostate carcinoma: a Cancer and Leukemia Group B study.

Journal article Cancer · February 1, 2002 BACKGROUND: Mitoxantrone in combination with a low-dose glucocorticoid has been shown to produce more favorable outcomes among men with hormone-refractory prostate carcinoma than glucocorticoid alone. Therefore, the authors sought to determine the safety a ... Full text Link to item Cite

Serum prostate specific antigen as a predictor of survival in prostate cancer patients treated with second-line hormonal therapy (CALGB 9181)

Journal article Prostate Journal · September 27, 2001 Objectives: To explore whether serum prostate specific antigen (PSA) decline can be used as a prognostic factor for survival among patients with androgen-independent prostate cancer (AIPC) who are treated with a secondary hormonal therapy, megestrol acetat ... Full text Cite

Women's interest in chemoprevention for breast cancer.

Journal article Arch Intern Med · July 9, 2001 BACKGROUND: Chemoprevention is the use of pharmacologic or natural agents to inhibit the development of cancer. Tamoxifen citrate is the only approved chemopreventive agent for breast cancer. We sought to determine whether women are interested in taking a ... Full text Link to item Cite

Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormone-refractory prostate cancer treated on Cancer and Leukemia Group B 9480.

Journal article Clin Cancer Res · July 2001 PURPOSE: Plasma vascular endothelial growth factor (VEGF) levels are significantly elevated in patients with hormone-refractory prostate cancer (HRPC) compared with patients with localized disease and have been associated with disease progression in other ... Link to item Cite

Age at natural menopause and the risk of epithelial ovarian cancer.

Journal article Obstet Gynecol · July 2001 OBJECTIVE: To investigate the relationship between age at natural menopause and risk of developing epithelial ovarian cancer. METHODS: Using data from six population-based, case-control studies conducted in the United States, age at natural menopause among ... Full text Link to item Cite

Prognostic significance of reverse transcriptase polymerase chain reaction for prostate-specific antigen in men with hormone-refractory prostate cancer.

Journal article J Clin Oncol · June 15, 2001 Featured Publication PURPOSE: To evaluate the prognostic significance of reverse transcriptase polymerase chain reaction (RT-PCR) detection of prostate-specific antigen (PSA) mRNA in the blood of men with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Periphe ... Full text Link to item Cite

The short-term impact of tailored mammography decision-making interventions.

Journal article Patient Educ Couns · June 2001 BACKGROUND: We assessed the short-term impact of decision-making interventions on knowledge about mammography, accuracy of women's breast cancer risk perceptions, attitudes toward mammography, satisfaction with decisions, and mammography use since the inte ... Full text Link to item Cite

Comparison of two methods for calculating lifetime ovulatory cycles.

Journal article AMERICAN JOURNAL OF EPIDEMIOLOGY · June 1, 2001 Link to item Cite

Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B.

Journal article J Clin Oncol · May 1, 2001 PURPOSE: To investigate the combination of docetaxel, estramustine (EM), and low-dose hydrocortisone in men with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Combinations of EM with other antimitotic agents such as docetaxel are synergi ... Full text Link to item Cite

Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: a cancer and leukemia group B study.

Journal article Cancer Res · March 15, 2001 Better prognostic markers are needed for hormone-refractory prostate cancer (HRPC) patients. No single biochemical or clinical parameter can reliably predict patient response to therapy or rapidity of disease progression. Peptide factors involved in major ... Link to item Cite

Use of vitamins, minerals, and nutritional supplements by participants in a chemoprevention trial.

Journal article Cancer · March 1, 2001 BACKGROUND: The growing use of vitamins, minerals, and nutritional supplements has the potential to influence the design and interpretation of randomized controlled trials of chemopreventive agents. To the extent that these complementary agents are effecti ... Link to item Cite

De novo establishment and cost-effectiveness of Papanicolaou cytology screening services in the Socialist Republic of Vietnam.

Journal article Cancer · March 1, 2001 BACKGROUND: Cervical carcinoma is the leading cause of cancer-related death among women in the developing world. The absence of cervical screening in Vietnam and other developing countries is due in large part to the perceived expense of implementing Papan ... Link to item Cite

Factors associated with repeat mammography screening.

Journal article J Fam Pract · December 2000 BACKGROUND: Even organizations with differing mammography recommendations agree that regular repeat screening is required for mortality reduction. However, most studies have focused on one-time screening rather than repeat adherence. We compare trends in b ... Link to item Cite

Relationships among breast cancer perceived absolute risk, comparative risk, and worries.

Journal article Cancer Epidemiol Biomarkers Prev · September 2000 When trying to predict breast cancer screening, it may be important to understand the relationships between perceived breast cancer risks and worries about getting breast cancer. This study examines the extent to which women's worries about breast cancer c ... Link to item Cite

Validation of the surveillance system for tuberculosis in Botswana.

Journal article Int J Tuberc Lung Dis · August 2000 SETTING: Gaborone and Francistown, Botswana, where surveillance data in the 1997 Electronic Tuberculosis (TB) Register suggest that 39% of pulmonary TB patients did not have pre-treatment sputum smear microscopy performed. OBJECTIVE: To determine the propo ... Link to item Cite

A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma: cancer and leukemia group B study 9181.

Journal article Cancer · February 15, 2000 BACKGROUND: Megestrol acetate (MA) is a synthetic progestin with reported activity in both hormone-sensitive and hormone-refractory prostate carcinoma (HRPC). Based on limited data suggesting a possible dose-response effect, a trial was initiated to compar ... Link to item Cite

Increased weight & body fatness associated with chemotherapy for breast cancer ... & what can be done?

Journal article CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION · February 1, 2000 Link to item Cite

Prognostic factors in early-onset epithelial ovarian cancer: a population-based study.

Journal article Obstet Gynecol · January 2000 OBJECTIVE: To investigate the clinical prognostic factors that influence ovarian cancer survival in women with early-onset epithelial ovarian cancer using population-based data. METHODS: Subjects in the current study were from a population-based series of ... Full text Link to item Cite

Maximizing the motivational impact of feedback of lung cancer susceptibility on smokers' desire to quit.

Journal article J Health Commun · 2000 This two-by-two factorially designed study evaluate approaches for communicating feedback of lung cancer susceptibility to smokers as a method for motivating smoking cessation. The study factors were: method of communicating feedback (by mail with telephon ... Full text Link to item Cite

The impact of abnormal mammograms on psychosocial outcomes and subsequent screening.

Journal article Psychooncology · 2000 Few studies have examined the impact of abnormal mammograms on subsequent mammography screening and psychosocial outcomes specifically as a function of the length of time that has passed since the abnormal test result. This cross-sectional report compared ... Full text Link to item Cite

Can tailored interventions increase mammography use among HMO women?

Journal article Am J Prev Med · January 2000 BACKGROUND: Telephone counseling and tailored print communications have emerged as promising methods for promoting mammography screening. However, there has been little research testing, within the same randomized field trial, of the efficacy of these two ... Full text Link to item Cite

Phase I clinical study of fish oil fatty acid capsules for patients with cancer cachexia: cancer and leukemia group B study 9473.

Journal article Clin Cancer Res · December 1999 The purpose of this study was to determine the maximum tolerated dose and dose-limiting toxicities of fish oil fatty acid capsules containing omega-3 fatty acid ethyl esters. Twenty-two patients with neoplastic disease not amenable to curative therapy who ... Link to item Cite

A phase II study of docetaxel (Taxotere), estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: Preliminary results of cancer and leukemia group B trial 9780

Journal article Seminars in Oncology · December 1, 1999 Combinations of estramustine with other antimitotic agents, such as docetaxel (Taxotere; Rhone-Poulenc Rorer, Collegeville, PA), are synergistic in vitro and show significant clinical activity in hormone-refractory prostate cancer (HRPC). We have studied i ... Cite

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group.

Journal article J Clin Oncol · November 1999 PURPOSE: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not al ... Full text Link to item Cite

A phase II study of docetaxel (Taxotere), estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: preliminary results of cancer and leukemia group B Trial 9780.

Journal article Semin Oncol · October 1999 Combinations of estramustine with other antimitotic agents, such as docetaxel (Taxotere; Rhône-Poulenc Rorer, Collegeville, PA), are synergistic in vitro and show significant clinical activity in hormone-refractory prostate cancer (HRPC). We have studied i ... Link to item Cite

Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study.

Journal article J Clin Oncol · August 1999 PURPOSE: Approximately 40,000 men die each year of hormone-refractory prostate cancer (HRPC). The results of treatment with chemotherapy have been disappointing to date, with no trials demonstrating a benefit with respect to survival duration. Corticostero ... Full text Link to item Cite

Confusion about mammography: prevalence and consequences.

Journal article J Womens Health Gend Based Med · May 1999 Over the last decade, there has been significant controversy about the schedule on which women, particularly women in their 40s, should have mammograms. The purpose of the analysis reported here was to assess whether women in their 40s and 50s were confuse ... Full text Link to item Cite

p53, c-erbB2, and PCNA status in benign, proliferative and malignant ovarian surface epithelial neoplasms: a study of 75 cases.

Journal article Arch Pathol Lab Med · April 1999 Low malignant potential tumors of the ovary are believed to behave in a manner intermediate to their benign and malignant counterparts. However, recent evidence suggests these lesions are in fact benign and better classified as proliferative. Based on our ... Full text Link to item Cite

Detection of low level benzene exposure in supermarket wrappers by urinary muconic acid.

Journal article Biomarkers · 1999 Women who use the 'hot wire' and 'cool rod' machines to wrap meat in supermarkets are potentially exposed to low levels of benzene and polycyclic aromatic hydrocarbons present in fumes emitted during the thermal decomposition of the plastic used to wrap me ... Full text Link to item Cite

Untitled

Journal article JOURNAL OF ANDROLOGY · September 1, 1998 Link to item Cite

Barriers to cardiac transplantation in idiopathic dilated cardiomyopathy: the Washington, DC, Dilated Cardiomyopathy Study.

Journal article J Natl Med Assoc · June 1998 Although cardiac transplantation offers prolonged survival and improved quality of life to patients with end-stage heart failure, many patients with idiopathic dilated cardiomyopathy do not undergo this procedure. Possible barriers to cardiac transplantati ... Link to item Cite

Response

Journal article JNCI Journal of the National Cancer Institute · November 19, 1997 Full text Cite

Serum androgens: associations with prostate cancer risk and hair patterning.

Journal article J Androl · 1997 Cancer of the prostate is the leading cancer among American men, yet few risk factors have been established. Hair growth and development are influenced by androgens, and it has long been suspected that prostate cancer also is responsive to these hormones. ... Link to item Cite

Automated image microscopy

Journal article Chemical Analysis · December 1, 1996 Cite

Epirubicin and ifosfamide in metastatic breast cancer

Journal article Seminars in Oncology · August 27, 1996 In a randomized, phase II trial, we evaluated the effectiveness of continued chemotherapy with epirubicin/ifosfamide versus unmaintained treatment interruption in advanced metastatic breast cancer. Three hundred fifty-seven patients were enrolled and 331 w ... Cite

Correlation between selected environmental exposures and karyotype in acute myelocytic leukemia.

Journal article Cancer Epidemiol Biomarkers Prev · August 1996 Many bone marrow cytogenetic abnormalities in acute myelogenous leukemia (AML) are tumor specific, clonal, nonrandom, and related to prognosis; it has been hypothesized that they may be markers of exposure to etiological agents. A previous report from our ... Link to item Cite

Epirubicin and ifosfamide in metastatic breast cancer.

Journal article Semin Oncol · June 1996 In a randomized, phase II trial, we evaluated the effectiveness of continued chemotherapy with epirubicin/ ifosfamide versus unmaintained treatment interruption in advanced metastatic breast cancer. Three hundred fifty-seven patients were enrolled and 331 ... Link to item Cite

The presence of human papillomavirus-16/-18 E6, p53, and Bcl-2 protein in cervicovaginal smears from patients with invasive cervical cancer.

Journal article Cancer Epidemiol Biomarkers Prev · May 1996 Cervical cancer is the second leading cause of death from cancer in women worldwide, and recent epidemiological studies have strongly implicated the sexually transmitted human papillomavirus (HPV) as a causative agent. The ability of high-risk HPVs to cont ... Link to item Cite

Frequent detection of bcl-2/JH translocations in human blood and organ samples by a quantitative polymerase chain reaction assay.

Journal article Cancer Res · July 1, 1995 Using an ultrasensitive assay involving the PCR, we have examined the frequency of a follicular lymphoma-associated translocation in peripheral blood from 132 individuals, most of whom were healthy blood donors. This translocation occurs between the bcl-2 ... Link to item Cite

Validation of a breast cancer risk assessment model in women with a positive family history.

Journal article J Natl Cancer Inst · April 20, 1994 BACKGROUND: Gail et al. developed a statistical model for estimating the risk of developing breast cancer in white women screened annually with mammography. This model is used for counseling and for admission to clinical trials. PURPOSE: We evaluated the m ... Full text Link to item Cite

Factors associated with perceived risk of breast cancer among women attending a screening program.

Journal article Breast Cancer Res Treat · November 1993 A person's perception of the risk of, or susceptibility to, developing a disease is believed to be an important determinant of health-related behavior, yet little is known about the determinants of perceived risk. Knowledge of these correlates may be usefu ... Full text Link to item Cite

Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report.

Journal article Ann Plast Surg · July 1993 OBJECTIVE: To test the hypothesis that there is a higher incidence of autoimmune disorders in patients who have undergone breast reconstruction with silicone gel implants rather than autogenous tissue. DESIGN: Prospective study. SETTING: Tertiary referral ... Link to item Cite

The Texas Breast Screening Project: Part I. Mammographic and clinical results.

Journal article South Med J · April 1993 The 1987 Texas Breast Screening Project was designed to educate women about the benefits and safety of mammographic screening. During the 2-week promotion, 109,339 women called toll-free telephone numbers to inquire about the program, and 64,459 (65%) of 9 ... Full text Link to item Cite

The Texas Breast Screening Project: Part II. Demographics, risk profiles, and health practices of participants.

Journal article South Med J · April 1993 More than 36,000 of the 64,459 women who had $50 mammograms after a media campaign in 1987 completed a demographic and risk factor questionnaire. The screened women were young and well educated with high annual incomes. Only 32% had had mammograms before 1 ... Full text Link to item Cite

Mutagen sensitivity in upper aerodigestive tract cancer: a case-control analysis.

Journal article Cancer Epidemiol Biomarkers Prev · 1993 Variability in DNA repair capability may be a determinant of interindividual difference in susceptibility to carcinogenic exposures. A cytogenetic assay which quantifies chromosomal breakage induced by in vitro exposure to a clastogen provides an indirect ... Link to item Cite

Association between family history of cancer and mutagen sensitivity in upper aerodigestive tract cancer patients.

Journal article Cancer Epidemiol Biomarkers Prev · 1993 This study evaluated the relationship between family history of cancer and bleomycin-induced mutagen sensitivity. The study included 108 patients who registered at The University of Texas M.D. Anderson Cancer Center from June 1987 to June 1991 with histolo ... Link to item Cite

Recruiting older women for screening mammography.

Journal article Cancer Detect Prev · 1993 We compared health behavior and attitudes of older and younger women toward breast cancer screening by using data from the 1987 Texas Breast Screening Project, a community-based, low-cost screening program sponsored by the American Cancer Society, Texas Di ... Link to item Cite

Low incidence of familial breast cancer among Hispanic women.

Journal article Cancer Causes Control · July 1992 There is a paucity of data on familial patterns of breast cancer among minority populations. This study compared the frequency of cancer in 1,095 first-degree relatives of 50 White, 46 Black, and 49 Hispanic breast-cancer patients referred to The Universit ... Full text Link to item Cite

Reliability and validity of self and proxy reporting of morbidity data: a case study from Beirut, Lebanon.

Journal article Int J Epidemiol · June 1992 We compared the self-reported illnesses (heart disease, back pain, rheumatoid arthritis, hypertension, and pulmonary disease) and smoking histories of 100 cases and 100 controls matched for age and sex with reports of this information from proxy informants ... Full text Link to item Cite

Identification of women at increased risk for breast cancer in a population-based screening program.

Journal article Cancer Epidemiol Biomarkers Prev · 1992 A multivariate model to assess breast cancer risk was developed by Gail et al. (M. H. Gail, L. A. Brinton, D. B. Byar, D. K. Corle, S. B. Green, C. Schairer, and J. J. Mulvihill, J. Natl. Cancer Inst., 81: 1879-1886, 1989) based on data analysis of the Bre ... Link to item Cite

Breast cancer screening behaviors and attitudes in three racial/ethnic groups.

Journal article Cancer · January 1, 1992 Data from a multiethnic sample of women participating in the American Cancer Society 1987 Texas Breast Screening Project was used to compare attitudes and behaviors related to breast cancer screening for whites, blacks, and Hispanics. In general, similar p ... Full text Link to item Cite

Epidemiology of primary health problems in Beirut.

Journal article J Epidemiol Community Health · December 1989 As a result of 12 years of civil war in Lebanon, it has been impossible to collect regular morbidity information at the primary level. This report is based on a case-control analysis of various health problems as identified from a population based health s ... Full text Link to item Cite

Hospital visitors as controls.

Journal article Am J Epidemiol · February 1988 Full text Link to item Cite

Measures of social class based on education for use in health studies in developing countries.

Journal article J Epidemiol Community Health · June 1987 In this paper we consider the appropriateness of education, compared to occupation and income, as a measure of social class for use in health-related studies in developing societies in transition. Three evaluation criteria were used, namely, the feasibilit ... Full text Link to item Cite

Perception of consanguineous marriages and their genetic effects among a sample of couples from Beirut.

Journal article Am J Med Genet · October 1986 We interviewed 100 women who had married a relative and 100 other women of the same age, religious affiliation, and socioeconomic status, but who were not related to their husbands. Both women were selected from a hospital setting in Beirut, and were quest ... Full text Link to item Cite