Scholars@Duke
Sin-Ho Jung

Sin-Ho Jung

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Integrative Genomics
sinho.jung@duke.edu
Duke Box 2721, Durham, NC 27710
2424 Erwin Road Ste 1102, 11076 Hock Plaza, Durham, NC 27705-3858

Scholarly Works - Journal articles

Alirocumab Plus Cemiplimab in Immunorefractory NSCLC: A Single Arm Phase 2 Study.

Journal article Res Sq · June 24, 2026 In preclinical models, PCSK9 mediates cancer immunotherapy resistance and may serve as a novel immuno-inhibitory target. Herein, we report the results from a multi-center, single arm, phase II study evaluating the clinical activity and safety of the PCSK9 ... Full text Link to item Cite

Alirocumab plus cemiplimab in advanced immuno-refractory metastatic non-small cell lung cancer: an ongoing multi-center phase II study.

Journal article Future Oncol · April 2026 Immunotherapy resistance represents a major unmet clinical need for patients with metastatic non-small cell lung cancer (NSCLC). Preclinical studies have identified PCSK9 as an immunosuppressive regulator of antigen presentation, providing a compelling rat ... Full text Link to item Cite

Novel niclosamide stearate prodrug therapeutic shows potential efficacy against naturally occurring canine osteosarcoma in a clinical feasibility study.

Journal article Am J Vet Res · January 1, 2026 OBJECTIVE: To manufacture and characterize a modified niclosamide stearate (NS) prodrug therapeutic (mNSPT) for use in a small clinical trial in a metastatic canine osteosarcoma (OS) model. ANIMALS: 10 dogs that presented for treatment of nondetectable met ... Full text Link to item Cite

Design and analysis of individually randomized group-treatment trials with time to event outcomes.

Journal article Lifetime Data Anal · July 2025 In a typical individually randomized group-treatment (IRGT) trial, subjects are randomized between a control arm and an experimental arm. While the subjects randomized to the control arm are treated individually, those in the experimental arm are assigned ... Full text Open Access Link to item Cite

Low intensity focused ultrasound stimulation in stroke: A phase I safety & feasibility trial.

Journal article Brain Stimul · 2025 OBJECTIVE: We aimed to determine the maximum safe spatial-peak pulse-average intensity (ISPPA) of low-intensity focused ultrasound stimulation (LIFUS) in stroke patients and explore its effect on motor learning and corticospinal excitability. METHODS: We a ... Full text Link to item Cite

Randomized Phase II Cancer Clinical Trials to Validate Predictive Biomarkers.

Journal article Biomedicines · September 26, 2024 OBJECTIVES: The design of cancer clinical trials incorporating biomarkers depends on various factors, including the trial phase, the type of biomarker and whether its role has been validated. This article aims to present a method for designing and analyzin ... Full text Link to item Cite

A Dunnett-Type Test and Its Sample Size Calculation for Comparing K ROC Curves with a Control.

Journal article Diagnostics (Basel) · August 20, 2024 Diagnostic biomarkers are key components of diagnostics. In this paper, we consider diagnostic biomarkers taking continuous values that are associated with a dichotomous disease status, called malignant or benign. The performance of such a biomarker is eva ... Full text Link to item Cite

Repeated Sieving for Prediction Model Building with High-Dimensional Data.

Journal article J Pers Med · July 19, 2024 Background: The prediction of patients' outcomes is a key component in personalized medicine. Oftentimes, a prediction model is developed using a large number of candidate predictors, called high-dimensional data, including genomic data, lab tests, electro ... Full text Link to item Cite

Percutaneous lumbar interbody fusion results in less perioperative opioid usage compared to minimally invasive transforaminal lumbar interbody fusion: a single institution, multi-surgeon retrospective study.

Journal article J Spine Surg · June 21, 2024 BACKGROUND: Ultra-minimally invasive percutaneous lumbar interbody fusion (percLIF) has been demonstrated to further minimize tissue trauma and has been associated with improved clinical outcomes including decreased blood loss, post-operative pain and leng ... Full text Link to item Cite

Confidence intervals for odds ratio from multistage randomized phase II trials.

Journal article Stat Med · May 30, 2024 A multi-stage randomized trial design can significantly improve efficiency by allowing early termination of the trial when the experimental arm exhibits either low or high efficacy compared to the control arm during the study. However, proper inference met ... Full text Link to item Cite

Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial.

Journal article Clin Nutr · January 2024 BACKGROUND & AIMS: The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, additional strategies to mitigate the spread/severity of COVID-19 continue to be needed. Emerging evidence suggests susce ... Full text Link to item Cite

Sample size calculation for comparing two ROC curves.

Journal article Pharm Stat · 2024 Biomarkers are key components of personalized medicine. In this paper, we consider biomarkers taking continuous values that are associated with disease status, called case and control. The performance of such a biomarker is evaluated by the area under the ... Full text Link to item Cite

Estimation of the odds ratio from multi-stage randomized trials.

Journal article Pharm Stat · 2024 A multi-stage design for a randomized trial is to allow early termination of the study when the experimental arm is found to have low or high efficacy compared to the control during the study. In such a trial, an early stopping rule results in bias in the ... Full text Link to item Cite

Efficient Use of Data for Prediction and Validation

Journal article Advances in Artificial Intelligence and Machine Learning · January 1, 2024 Prediction model building is one of the most important tasks in analysis of high-dimensional data. A fitted prediction model should be validated for future use. So, when conducting such an analysis, we have to use the whole data for both training and valid ... Full text Cite

Regional anesthesia is associated with improved metastasis free survival after surgical resection of bone sarcomas.

Journal article J Orthop Res · December 2023 There is increasing evidence that perioperative factors, including type of anesthesia, may be an important consideration regarding oncological disease progression. Previous studies have suggested that regional anesthesia can improve oncological outcomes by ... Full text Link to item Cite

Timing of Adjuvant Immunotherapy in Stage III Melanoma, Does it Matter?

Journal article Ann Surg Oncol · October 2023 BACKGROUND: The optimal time to initiate adjuvant immune checkpoint inhibitors (ICI) following resection remains undefined. Herein, we investigated the impact of time to adjuvant ICI on survival in patients with stage III melanoma. METHODS: Patients with r ... Full text Link to item Cite

LASSO and Elastic Net Tend to Over-Select Features

Journal article Mathematics · September 1, 2023 Machine learning methods have been a standard approach to select features that are associated with an outcome and to build a prediction model when the number of candidate features is large. LASSO is one of the most popular approaches to this end. The LASSO ... Full text Cite

Improving patient outcomes with a mobile digital health platform for patients undergoing transcatheter aortic valve replacement.

Journal article J Invasive Cardiol · September 2023 PURPOSE: ManageMySurgery (MMS) is a digital health application (app) for patients undergoing surgery, including Transcatheter Aortic Valve Replacement (TAVR). Patients using MMS review procedure-specific education, view FAQs, and report patient-reported ou ... Full text Link to item Cite

Quantifying the Opportunity Cost of Neurosurgical Resident Education.

Journal article World Neurosurg · July 2023 BACKGROUND/OBJECTIVE: Education is at the core of neurosurgical residency, but little research in to the cost of neurosurgical education exists. This study aimed to quantify costs of resident education in an academic neurosurgery program using traditional ... Full text Link to item Cite

Survival and tumor characteristics of patients presenting with single primary versus second primary melanoma lesions.

Journal article J Am Acad Dermatol · May 2023 BACKGROUND: Patients with single primary melanomas have an increased risk of developing subsequent melanomas. Secondary tumors diagnosed within and after 3 months are termed "synchronous" and "asynchronous," respectively. OBJECTIVE: To compare tumor distri ... Full text Link to item Cite

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

Journal article J Thorac Cardiovasc Surg · February 2023 OBJECTIVE: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aort ... Full text Link to item Cite

Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials.

Journal article J Clin Oncol · January 10, 2023 PURPOSE: Bone marrow biopsies (BMB) are performed before/after therapy to confirm complete response (CR) in patients with lymphoma on clinical trials. We sought to establish whether BMB add value in assessing response or predict progression-free survival ( ... Full text Link to item Cite

Neoadjuvant Radiation Therapy and Surgery Improves Metastasis-Free Survival over Surgery Alone in a Primary Mouse Model of Soft Tissue Sarcoma.

Journal article Mol Cancer Ther · January 3, 2023 This study aims to investigate whether adding neoadjuvant radiotherapy (RT), anti-programmed cell death protein-1 (PD-1) antibody (anti-PD-1), or RT + anti-PD-1 to surgical resection improves disease-free survival for mice with soft tissue sarcomas (STS). ... Full text Open Access Link to item Cite

Optimal designs for phase II clinical trials with heterogeneous patient populations.

Journal article J Biopharm Stat · January 2, 2023 We consider single-arm phase II cancer clinical trials with tumor response as the primary outcome. Oftentimes, the patient population of a phase II clinical trial consists of subpopulations with different expected response rates. A well-accepted design in ... Full text Link to item Cite

Nasal Cavity Squamous Cell Carcinoma: Factors Associated With Treatment Outcomes and Potential Organ Preservation.

Journal article Am J Rhinol Allergy · January 2023 BACKGROUND: Squamous cell carcinoma of the nasal cavity (NCSCC) is a rare, challenging malignancy. Surgical resection of this tumor can cause significant facial deformity, and indications for adjuvant or organ preservation therapies are not well-described. ... Full text Link to item Cite

Revisiting flow augmentation bypass for cerebrovascular atherosclerotic vaso-occlusive disease: Single-surgeon series and review of the literature.

Journal article PLoS One · 2023 OBJECTIVE: Despite advances in the nonsurgical management of cerebrovascular atherosclerotic steno-occlusive disease, approximately 15-20% of patients remain at high risk for recurrent ischemia. The benefit of revascularization with flow augmentation bypas ... Full text Link to item Cite

A pilot study to assess the feasibility of a remotely monitored high-intensity interval training program prior to allogeneic hematopoietic stem cell transplantation.

Journal article PLoS One · 2023 INTRODUCTION: Although allogeneic hematopoietic stem cell transplantation (HCT) can be a curative therapy for hematologic disorders, it is associated with treatment-related complications and losses in cardiorespiratory fitness and physical function. High-i ... Full text Link to item Cite

Group sequential testing for cluster randomized trials with time-to-event endpoint.

Journal article Biometrics · December 2022 We propose group sequential methods for cluster randomized trials (CRTs) with time-to-event endpoint. The alpha spending function approach is used for sequential data monitoring. The key to this approach is determining the joint distribution of test statis ... Full text Link to item Cite

Outcomes With a Mobile Digital Health Platform for Patients Undergoing Spine Surgery: Retrospective Analysis.

Journal article JMIR Perioper Med · October 26, 2022 BACKGROUND: Digital health solutions have been shown to enhance outcomes for individuals with chronic medical illnesses, but few have been validated for surgical patients. The digital health platform ManageMySurgery (MMS) has been validated for spine surge ... Full text Link to item Cite

Antibiotic Prophylaxis for Megaprosthetic Reconstructions: Drug and Dosing May Matter More than Duration.

Journal article Antimicrob Agents Chemother · October 18, 2022 In orthopedic oncology, the implant of a megaprosthetic device is standard of care after large-scale tumor resection involving segmental removal of bone. Infection remains the leading cause of implant failure, often resulting in major morbidity. Perioperat ... Full text Link to item Cite

Prediction model to estimate overall survival benefit of postoperative radiotherapy for resected major salivary gland cancers.

Journal article Oral Oncol · September 2022 OBJECTIVES: To develop and validate a prediction model to estimate overall survival (OS) with and without postoperative radiotherapy (PORT) for resected major salivary gland (SG) cancers. MATERIALS AND METHODS: Adults in the National Cancer Database diagno ... Full text Link to item Cite

Multimodality analysis confers a prognostic benefit of a T-cell infiltrated tumor microenvironment and peripheral immune status in patients with melanoma.

Journal article J Immunother Cancer · September 2022 BACKGROUND: We previously reported results from a phase 1 study testing intratumoral recombinant poliovirus, lerapolturev, in 12 melanoma patients. All 12 patients received anti-PD-1 systemic therapy before lerapolturev, and 11 of these 12 patients also re ... Full text Link to item Cite

Investigating readmission rates for patients undergoing oncologic resection and endoprosthetic reconstruction for primary sarcomas and tumors involving bone.

Journal article J Surg Oncol · August 2022 BACKGROUND: Little is known about the drivers of readmission in patients undergoing Orthopaedic oncologic resection. The goal of this study was to identify factors independently associated with 90-day readmission for patients undergoing oncologic resection ... Full text Link to item Cite

Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S.

Journal article Neurosurgery · July 1, 2022 BACKGROUND: Deep brain stimulation (DBS) is an effective therapy in advanced Parkinson disease (PD). Although both subthalamic nucleus (STN) and globus pallidus (GP) DBS show equivalent efficacy in PD, combined stimulation may demonstrate synergism. OBJECT ... Full text Open Access Link to item Cite

Home-Based Hematopoietic Cell Transplantation in the United States.

Journal article Transplant Cell Ther · April 2022 Patients undergoing allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT) require extensive hospitalizations or daily clinic visits for the duration of their transplantation. Home HCT, wherein patients live at home and providers ... Full text Link to item Cite

Adjuvant durvalumab for esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a placebo-controlled, randomized, double-blind, phase II study.

Journal article ESMO Open · February 2022 BACKGROUND: We evaluated the efficacy of adjuvant durvalumab after neoadjuvant concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC). PATIENTS AND METHODS: This randomized, double-blind, phase II study included pati ... Full text Link to item Cite

Diagnostic Performance of an Artificial Intelligence System in Breast Ultrasound.

Journal article J Ultrasound Med · January 2022 OBJECTIVES: We study the performance of an artificial intelligence (AI) program designed to assist radiologists in the diagnosis of breast cancer, relative to measures obtained from conventional readings by radiologists. METHODS: A total of 10 radiologists ... Full text Link to item Cite

Sample size calculation for clustered survival data under subunit randomization.

Journal article Lifetime Data Anal · January 2022 Each cluster consists of multiple subunits from which outcome data are collected. In a subunit randomization trial, subunits are randomized into different intervention arms. Observations from subunits within each cluster tend to be positively correlated du ... Full text Link to item Cite

Financial incentives to increase stool collection rates for microbiome studies in adult bone marrow transplant patients.

Journal article PLoS One · 2022 INTRODUCTION: In order to study the role of the microbiome in hematopoietic stem cell transplantation (HCT), researchers collect stool samples from patients at various time points throughout HCT. However, stool collection requires active subject participat ... Full text Link to item Cite

Design and Analysis Methods for Trials with AI-Based Diagnostic Devices for Breast Cancer.

Journal article J Pers Med · November 4, 2021 Imaging is important in cancer diagnostics. It takes a long period of medical training and clinical experience for radiologists to be able to accurately interpret diagnostic images. With the advance of big data analysis, machine learning and AI-based devic ... Full text Link to item Cite

Outcomes of adjunctive therapies post hedgehog inhibitors in the management of locally advanced basal cell carcinoma: A systematic review and pooled analysis.

Journal article Dermatol Ther · November 2021 Management of patients with locally advanced basal cell carcinoma (laBCC) with traditional strategies has yielded suboptimal outcomes. Targeted treatments including hedgehog inhibitor therapy (HHIT) present limitations when utilized as monotherapy. Herein, ... Full text Link to item Cite

Decreased Mortality in 1-Year Survivors of Umbilical Cord Blood Transplant vs. Matched Related or Matched Unrelated Donor Transplant in Patients with Hematologic Malignancies.

Journal article Transplant Cell Ther · August 2021 Allogeneic hematopoietic stem cell transplantation (HCT) has the potential to cure hematologic malignancies but is associated with significant morbidity and mortality. Although deaths during the first year after transplantation are often attributable to tr ... Full text Open Access Link to item Cite

Deep-Learning-Driven Quantification of Interstitial Fibrosis in Digitized Kidney Biopsies.

Journal article Am J Pathol · August 2021 Interstitial fibrosis and tubular atrophy (IFTA) on a renal biopsy are strong indicators of disease chronicity and prognosis. Techniques that are typically used for IFTA grading remain manual, leading to variability among pathologists. Accurate IFTA estima ... Full text Link to item Cite

Characterization of Sentinel Lymph Node Immune Signatures and Implications for Risk Stratification for Adjuvant Therapy in Melanoma.

Journal article Ann Surg Oncol · July 2021 BACKGROUND: Although sentinel lymph node (SLN) biopsy is a standard procedure used to identify patients at risk for melanoma recurrence, it fails to risk-stratify certain patients accurately. Because processes in SLNs regulate anti-tumor immune responses, ... Full text Link to item Cite

The Contribution of Material, Behavioral, Psychological, and Social-Relational Factors to Income-Related Disparities in Cardiovascular Risk Among Older Adults.

Journal article J Cardiovasc Nurs · July 2021 BACKGROUND: Understanding the factors underlying health disparities is vital to developing strategies to improve health equity in old age. Such efforts should be encouraged in Korea. OBJECTIVE: This study explored how material, behavioral, psychological, a ... Full text Link to item Cite

The Influence of Vitamin D on Mammographic Density: Results from CALGB 70806 (Alliance) a Randomized Clinical Trial.

Journal article Cancer Prev Res (Phila) · July 2021 Current therapies for breast cancer prevention only prevent estrogen receptor positive (ER+) disease and toxicity limits use of these agents. Vitamin D is a potential prevention therapy for both ER+ and ER- disease and is safe with few side effects. This s ... Full text Link to item Cite

Bacteremia in solid organ transplant recipients as compared to immunocompetent patients: Acute phase cytokines and outcomes in a prospective, matched cohort study.

Journal article Am J Transplant · June 2021 We undertook a prospective, matched cohort study of patients with Staphylococcus aureus bacteremia (SAB) and gram-negative bacteremia (GNB) to compare the characteristics, outcomes, and chemokine and cytokine response in transplant recipients to immunocomp ... Full text Open Access Link to item Cite

Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol.

Journal article BMJ Open · May 5, 2021 INTRODUCTION: The COVID-19 pandemic has proven to be an unprecedented challenge to worldwide health, and strategies to mitigate the spread and severity of COVID-19 infection are urgently needed. Emerging evidence suggests that the composition of the gut mi ... Full text Open Access Link to item Cite

Design and analysis of cancer clinical trials for personalized medicine

Journal article Journal of Personalized Medicine · May 4, 2021 Biomarkers play a key role in the development of personalized medicine. Cancer clinical trials with biomarker should be appropriately designed and analyzed reflecting the various factors, such as the phase of trials, the type of biomarker, the study object ... Full text Cite

Survival Outcomes in Sinonasal Poorly Differentiated Squamous Cell Carcinoma.

Journal article Laryngoscope · April 2021 OBJECTIVE: Sinonasal squamous cell carcinoma (SCC) is rare with no consensus on treatment regimen. Our goal is to analyze treatment outcomes in poorly differentiated SCC (PDSCC) using a large national database. STUDY DESIGN: Retrospective database study. M ... Full text Link to item Cite

Phase I trial of intratumoral PVSRIPO in patients with unresectable, treatment-refractory melanoma.

Journal article J Immunother Cancer · April 2021 BACKGROUND: While programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) antagonists have improved the prognosis for many patients with melanoma, around 60% fail therapy. PVSRIPO is a non-neurovirulent rhinovirus:poliovirus chimera th ... Full text Link to item Cite

Biomarkers for Risk Stratification in Patients With Previously Untreated Follicular Lymphoma Receiving Anti-CD20-based Biological Therapy.

Journal article Am J Surg Pathol · March 1, 2021 Follicular lymphoma (FL) is an indolent B-cell neoplasm of germinal center origin. Standard treatment regimens consist of anti-CD20 therapy with or without chemotherapy. While high response rates to initial therapy are common, patients ultimately relapse o ... Full text Link to item Cite

Chlorhexidine Gluconate Bathing Reduces the Incidence of Bloodstream Infections in Adults Undergoing Inpatient Hematopoietic Cell Transplantation.

Journal article Transplant Cell Ther · March 2021 Bloodstream infections (BSIs) occur in 20% to 45% of inpatient autologous and allogeneic hematopoietic cell transplant (HCT) patients. Daily bathing with the antiseptic chlorhexidine gluconate (CHG) has been shown to reduce the incidence of BSIs in critica ... Full text Link to item Cite

Survival outcomes in sinonasal carcinoma with neuroendocrine differentiation: A NCDB analysis.

Journal article Am J Otolaryngol · 2021 BACKGROUND: Sinonasal carcinoma with neuroendocrine differentiation (SCND) is a rare group of tumors with poor prognosis. Treatment and sequence of therapies are still unclear. The goal of this study is to analyze treatment outcomes in SCND using a nationa ... Full text Link to item Cite

A 10-year trend in income disparity of cardiovascular health among older adults in South Korea.

Journal article SSM Popul Health · December 2020 OBJECTIVES: Although cardiovascular disease (CVD) risk has lessened in Korea, it is unclear whether older adults in all socioeconomic strata have benefited equally. This study explored trends in income disparities in CVD risk among older adults in Korea. M ... Full text Link to item Cite

Sample size calculation for cluster randomization trials with a time-to-event endpoint.

Journal article Stat Med · November 10, 2020 Cluster randomization trials randomize groups (called clusters) of subjects (called subunits) between intervention arms, and observations are collected from each subject. In this case, subunits within each cluster share common frailties, so that the observ ... Full text Link to item Cite

Sinonasal Squamous Cell Carcinoma Outcomes: Does Treatment at a High-Volume Center Confer Survival Benefit?

Journal article Otolaryngol Head Neck Surg · November 2020 OBJECTIVE: To determine whether treatment of sinonasal squamous cell carcinoma (SCC) at a high-volume facility affects survival. STUDY DESIGN: Retrospective database analysis. SETTING: National Cancer Database (2004-2014). SUBJECTS AND METHODS: The Nationa ... Full text Link to item Cite

Higher BMI, But Not Sarcopenia, Is Associated With Pembrolizumab-related Toxicity in Patients With Advanced Melanoma.

Journal article Anticancer Res · September 2020 BACKGROUND/AIM: To determine whether BMI and sarcopenia were related to treatment-limiting toxicity or efficacy of pembrolizumab treatment in melanoma patients. PATIENTS AND METHODS: Medical records for melanoma patients undergoing pembrolizumab treatment ... Full text Link to item Cite

Nomogram to predict lymph node metastasis in patients with early gastric cancer: a useful clinical tool to reduce gastrectomy after endoscopic resection.

Journal article Endoscopy · June 2020 BACKGROUND: The indications for endoscopic dissection have been expanded to improve the quality of life of patients with early gastric cancer (EGC). This study aimed to develop a nomogram to predict the status of lymph node metastasis with the aim of avoid ... Full text Link to item Cite

Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.

Journal article Lancet Haematol · June 2020 Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conven ... Full text Link to item Cite

Clinical Factors Affecting Survival in Pediatric Vascular Tumors of the Head and Neck.

Journal article J Craniofac Surg · 2020 Clinical factors associated with the behavior and outcomes of nonbenign, head, and neck vascular tumors in children are not well described. Our aim is to provide descriptive information and identify prognostic factors associated with lower overall survival ... Full text Link to item Cite

Pre-transplant hepatic steatosis (fatty liver) is associated with chronic graft-vs-host disease but not mortality.

Journal article PLoS One · 2020 Allogeneic-HCT (allo-HCT), while potentially curative, can result in significant complications including graft versus host disease (GVHD). Prior studies suggest that metabolic syndrome may be one risk factor for GVHD. We hypothesized that hepatic steatosis ... Full text Link to item Cite

Impact of Microbiological Organism Type on Surgically Managed Endocarditis.

Journal article Ann Thorac Surg · November 2019 BACKGROUND: This study describes the impact of organism and valve type on surgically managed infective endocarditis (IE) from The Society of Thoracic Surgeons (STS) database. We developed a risk model for surgically managed endocarditis that includes the m ... Full text Link to item Cite

Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance).

Journal article Cancer · October 1, 2019 BACKGROUND: This multicenter, randomized phase 2 trial evaluated complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib in patients with untreated, high-risk follicular lymphoma (FL ... Full text Link to item Cite

Tracing Tumor Evolution in Sarcoma Reveals Clonal Origin of Advanced Metastasis.

Journal article Cell Rep · September 10, 2019 Cellular heterogeneity is frequently observed in cancer, but the biological significance of heterogeneous tumor clones is not well defined. Using multicolor reporters and CRISPR-Cas9 barcoding, we trace clonal dynamics in a mouse model of sarcoma. We show ... Full text Link to item Cite

Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.

Journal article J Clin Oncol · July 20, 2019 PURPOSE: Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincri ... Full text Link to item Cite

K-Sample comparisons using propensity analysis.

Journal article Biom J · May 2019 In this paper, we investigate K-group comparisons on survival endpoints for observational studies. In clinical databases for observational studies, treatment for patients are chosen with probabilities varying depending on their baseline characteristics. Th ... Full text Link to item Cite

A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13.

Journal article Cancer Res Treat · April 2019 PURPOSE: The optimal cytotoxic regimens have not been established for patients with non-small cell lung cancer (NSCLC) who develop disease progression on first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). MATERIALS AND METHOD ... Full text Link to item Cite

Phase 2 multicentre study of single-agent ofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance).

Journal article Br J Haematol · April 2019 Rituximab monotherapy has proven efficacy in treatment-naïve, asymptomatic advanced-stage follicular lymphoma (FL). Ofatumumab is a fully humanized anti-CD20 monoclonal antibody with increased CD20 affinity and complement-dependent cytotoxicity. This phase ... Full text Link to item Cite

Physical Activity Protects Against the Risk of Erosive Esophagitis on the Basis of Body Mass Index.

Journal article J Clin Gastroenterol · February 2019 GOAL: To determine whether physical activity lowers the risk for erosive esophagitis on the basis of body mass index (BMI). BACKGROUND: Although previous studies have shown that physical activity is closely associated with erosive esophagitis, these data m ... Full text Link to item Cite

The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials.

Journal article Cancer Med · January 2019 Follicular lymphoma (FL) patients treated with firstline R-CHOP who experience progression of disease (POD) within 2 years have a shorter survival than those who do not have POD within 2 years. Whether this observation holds for patients treated initially ... Full text Link to item Cite

Robotic Mitral Valve Repair in Older Individuals: An Analysis of The Society of Thoracic Surgeons Database.

Journal article Ann Thorac Surg · November 2018 BACKGROUND: National outcomes of robotic mitral valve repair (rMVr) compared with sternotomy (sMVr) in older patients are currently unknown. METHODS: From 2011 to 2014, all patients aged 65 years and older undergoing MVr in The Society of Thoracic Surgeons ... Full text Open Access Link to item Cite

CALGB 50604: risk-adapted treatment of nonbulky early-stage Hodgkin lymphoma based on interim PET.

Journal article Blood · September 6, 2018 A negative interim positron emission tomography/computerized tomography (PET/CT) after 1 to 3 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in patients with newly diagnosed, nonbulky stage I or II Hodgkin lymphoma (HL) predicts a lo ... Full text Link to item Cite

Frequency and impact of grade three or four toxicities of novel agents on outcomes of older patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma (alliance A151611).

Journal article J Geriatr Oncol · July 2018 OBJECTIVE: Older patients with cancer suffer from chemotherapy-related toxicities more frequently than younger patients. As novel agents are being used more commonly in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL), toxicities of these ... Full text Link to item Cite

Hepatobiliary MRI as novel selection criteria in liver transplantation for hepatocellular carcinoma.

Journal article J Hepatol · June 2018 BACKGROUND & AIMS: Hepatobiliary magnetic resonance imaging (MRI) provides additional information beyond the size and number of tumours, and may have prognostic implications. We examined whether pretransplant radiological features on MRI could be used to s ... Full text Link to item Cite

The Role of Reconstructive Surgery After Skeletal and Soft Tissue Sarcoma Resection.

Journal article Ann Plast Surg · June 2018 BACKGROUND: Skeletal and soft tissue reconstruction after sarcoma resection remains challenging. The use of advanced reconstructive techniques has been shown to improve function and increase rates of limb salvage. This study aims to analyze the utilization ... Full text Link to item Cite

Men's Eating and Living (MEAL) study (CALGB 70807 [Alliance]): recruitment feasibility and baseline demographics of a randomized trial of diet in men on active surveillance for prostate cancer.

Journal article BJU Int · April 2018 OBJECTIVE: To assess the feasibility of performing national, randomized trials of dietary interventions for localized prostate cancer. METHODS: The Men's Eating and Living (MEAL) study (CALGB 70807 [Alliance]) is a phase III clinical trial testing the effi ... Full text Link to item Cite

Characterizing the Potency and Impact of Carbon Ion Therapy in a Primary Mouse Model of Soft Tissue Sarcoma.

Journal article Mol Cancer Ther · April 2018 Carbon ion therapy (CIT) offers several potential advantages for treating cancers compared with X-ray and proton radiotherapy, including increased biological efficacy and more conformal dosimetry. However, CIT potency has not been characterized in primary ... Full text Link to item Cite

Pazopanib maintenance after first-line etoposide and platinum chemotherapy in patients with extensive disease small-cell lung cancer: a multicentre, randomised, placebo-controlled Phase II study (KCSG-LU12-07).

Journal article Br J Cancer · March 6, 2018 BACKGROUND: We investigated whether pazopanib maintenance following first-line chemotherapy would improve survival in patients with extensive disease small-cell lung cancer (ED-SCLC). METHODS: This study is a randomised, placebo-controlled, phase II study ... Full text Link to item Cite

Predictive Model for Neoplastic Potential of Gallbladder Polyp.

Journal article J Clin Gastroenterol · March 2018 GOAL: To provide the statistical predictive model for neoplastic potential of gallbladder polyp (GBP). BACKGROUND: Many studies have attempted to define the risk factors for neoplastic potential of GBP. It remains difficult to precisely adapt the reported ... Full text Link to item Cite

Imaging genotyping of functional signaling pathways in lung squamous cell carcinoma using a radiomics approach.

Journal article Sci Rep · February 19, 2018 Imaging features can be useful for identifying distinct genomic differences and have predictive power for certain phenotypes attributed to genomic mutations. We aimed to identify predictive imaging biomarkers that underpin genomic alterations and clinical ... Full text Link to item Cite

Phase II cancer clinical trials for biomarker-guided treatments.

Journal article J Biopharm Stat · 2018 The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the de ... Full text Link to item Cite

The Value of MRI in Distinguishing Subtypes of Lipomatous Extremity Tumors Needs Reassessment in the Era of MDM2 and CDK4 Testing.

Journal article Sarcoma · 2018 INTRODUCTION: Extremity lipomas and well-differentiated liposarcomas (WDLs) are difficult to distinguish on MR imaging. We sought to evaluate the accuracy of MRI interpretation using MDM2 amplification, via fluorescence in-situ hybridization (FISH), as the ... Full text Link to item Cite

Statistical Methods for Conditional Survival Analysis.

Journal article J Biopharm Stat · 2018 We investigate the survival distribution of the patients who have survived over a certain time period. This is called a conditional survival distribution. In this paper, we show that one-sample estimation, two-sample comparison and regression analysis of c ... Full text Link to item Cite

Iodized Oil Transarterial Chemoembolization and Radiofrequency Ablation for Small Periportal Hepatocellular Carcinoma: Comparison with Nonperiportal Hepatocellular Carcinoma.

Journal article Cardiovasc Intervent Radiol · January 2018 PURPOSE: This study aims to evaluate the treatment outcomes of iodized oil transarterial chemoembolization (TACE) and subsequent radiofrequency ablation (RFA) for small (≤3 cm) periportal hepatocellular carcinoma (HCC) compared with nonperiportal HCC. METH ... Full text Link to item Cite

Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer.

Journal article Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · December 2017 IntroductionWe investigated whether concurrent chemoradiotherapy (CCRT) would increase survival in patients with completely resected unsuspected N2-positive NSCLC versus in patients who received adjuvant chemotherapy alone.MethodsEligible ... Full text Cite

Uterine fibroids: Influence of "T2-Rim sign" on immediate therapeutic responses to magnetic resonance imaging-guided high-intensity focused ultrasound ablation.

Journal article Eur J Radiol · December 2017 OBJECTIVES: To investigate the influence of a high-signal-intensity peripheral rim on T2-weighted MR images (i.e., T2-rim sign) on the immediate therapeutic responses of MR-guided high intensity focused ultrasound (MR-HIFU) ablation of uterine fibroids. ME ... Full text Link to item Cite

Obesity-related parameters and colorectal adenoma development.

Journal article J Gastroenterol · December 2017 BACKGROUND: Obesity increases the risk of colorectal adenoma and colorectal cancer. However, the obesity-related parameters that are best for assessing the risk of colorectal adenoma development remain unclear. We analyzed the parameters that may best desc ... Full text Link to item Cite

A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance).

Journal article Ann Oncol · November 1, 2017 BACKGROUND: This multicenter, phase II trial tested the tolerability and efficacy of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma (FL). PATIENTS AND METHODS: Patients with grade 1-3a FL, stage 3-4 or bulky stage 2, ... Full text Link to item Cite

Predictive Factors of Renal Adaptation After Nephrectomy in Kidney Donors.

Journal article Transplant Proc · November 2017 BACKGROUND: Despite compensatory hyperfiltration in remaining nephrons following donor nephrectomy, some donors show impaired renal adaptation and low estimated glomerular filtration rate (eGFR). We investigated the factors predicting early renal adaptatio ... Full text Link to item Cite

Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis.

Journal article J Clin Oncol · October 10, 2017 Purpose Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed ... Full text Link to item Cite

Design of Phase II Non-inferiority Trials.

Journal article Contemporary clinical trials communications · September 2017 With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar ... Full text Cite

Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial.

Journal article Lancet Haematol · September 2017 BACKGROUND: In the CALGB (Alliance) 100104 study, lenalidomide versus placebo after autologous stem-cell transplantation (ASCT) was investigated for patients with newly diagnosed myeloma. That study showed improved time to progression and overall survival ... Full text Link to item Cite

Preservation of the endometrial enhancement after magnetic resonance imaging-guided high-intensity focused ultrasound ablation of submucosal uterine fibroids.

Journal article Eur Radiol · September 2017 OBJECTIVE: To evaluate the integrity of endometrial enhancement after magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) ablation of submucosal uterine fibroids based on contrast-enhanced MRI findings, and to identify the risk fa ... Full text Link to item Cite

Gadoxetic acid-enhanced magnetic resonance imaging characteristics of hepatocellular carcinoma occurring in liver transplants.

Journal article Eur Radiol · August 2017 OBJECTIVES: Characteristics of hepatocellular carcinoma (HCC) on magnetic resonance (MR) images were compared in patients who did or did not undergo liver transplantation (LT), and we evaluated the relationship of these findings with overall survival (OS) ... Full text Link to item Cite

Patterns of Initial Recurrence in Completely Resected Papillary Thyroid Carcinoma.

Journal article Thyroid · July 2017 BACKGROUND: Despite improvements in the surgical and medical treatment of papillary thyroid carcinoma (PTC), subsets of patients suffer from structural recurrence after initial treatment. This study evaluated the timing and patterns of recurrence in comple ... Full text Link to item Cite

Apneic oxygen insufflation decreases the incidence of hypoxemia during one-lung ventilation in open and thoracoscopic pulmonary lobectomy: A randomized controlled trial.

Journal article J Thorac Cardiovasc Surg · July 2017 OBJECTIVE: Hypoxemia is common during one-lung ventilation (OLV) for thoracic surgery. When hypoxemia occurs, surgery is interrupted for rescue ventilation. Apneic oxygen insufflation (AOI), which provides O2 without applying pressure, may prevent hypoxemi ... Full text Link to item Cite

Risk score model for the development of hepatocellular carcinoma in treatment-naïve patients receiving oral antiviral treatment for chronic hepatitis B.

Journal article Clin Mol Hepatol · June 2017 BACKGROUND/AIMS: This study aimed to develop and validate a risk prediction model for the development of hepatocellular carcinoma (HCC) in treatment-naïve patients receiving oral antiviral treatment for chronic hepatitis B (CHB). METHODS: We investigated 2 ... Full text Link to item Cite

Dynamic prognostication using conditional survival analysis for patients with operable lung adenocarcinoma.

Journal article Oncotarget · May 9, 2017 PURPOSE: To evaluate conditional survival among patients with surgically resected stage I-IIIa lung adenocarcinoma and identify changes in prognostic contributions for various prognostic factors over time. PATIENTS AND METHODS: We performed conditional sur ... Full text Link to item Cite

Early gastric cancer with a mixed-type Lauren classification is more aggressive and exhibits greater lymph node metastasis.

Journal article J Gastroenterol · May 2017 BACKGROUND: The clinicopathological features of mixed-type (MT) early gastric cancer (EGC) according to Lauren's classification remain uninvestigated. This study aimed to clarify the clinicopathological features of MT EGC, particularly in relation to lymph ... Full text Link to item Cite

Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials.

Journal article Lancet Haematol · April 2017 BACKGROUND: A new generation of biological and targeted agents might potentially replace traditional cytotoxic agents in lymphoma. Lenalidomide plus rituximab was felt to be a safe and promising backbone based on available data. Idelalisib is an oral phosp ... Full text Link to item Cite

Optimal cut-off age in the TNM Staging system of differentiated thyroid cancer: is 55 years better than 45 years?

Journal article Clin Endocrinol (Oxf) · March 2017 OBJECTIVE: Age >45 years is included as a variable in the tumor, node, metastases (TNM) staging of differentiated thyroid cancer (DTC), but a higher cut-off value has been suggested to be more clinically relevant and prevent over-staging. We evaluated the ... Full text Link to item Cite

A phase II trial of concurrent chemoradiotherapy with weekly docetaxel plus cisplatin treatment for unresectable locally advanced head and neck cancer

Journal article Radiotherapy and Oncology · February 1, 2017 Purpose Although concurrent chemoradiotherapy (CCRT) is the standard of care for locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN), the optimal CCRT regimen is not yet defined. We conducted a phase II study of weekly doceta ... Full text Cite

Radiofrequency ablation and transarterial chemoembolisation as first-line treatment for recurrent hepatocellular carcinoma or isolated intrahepatic recurrent hepatocellular carcinoma in transplanted livers.

Journal article Clin Radiol · February 2017 AIM: To evaluate the efficacy of radiofrequency ablation (RFA) and transarterial chemoembolisation (TACE) as a first-line treatment for isolated intrahepatic recurrent hepatocellular carcinoma (IIR-HCC) after liver transplantation (LT). MATERIALS AND METHO ... Full text Link to item Cite

Optimal two-stage log-rank test for randomized phase II clinical trials.

Journal article J Biopharm Stat · 2017 Randomized controlled clinical trials are conducted to determine whether a new treatment is safe and efficacious compared to a standard therapy. We consider randomized clinical trials with right censored time to event endpoint, called survival time here. T ... Full text Link to item Cite

Host immune response index in gastric cancer identified by comprehensive analyses of tumor immunity.

Journal article Oncoimmunology · 2017 Tumor infiltrating lymphocytes (TIL) in Epstein-Barr virus (EBV)-associated/microsatellite-unstable (MSI) gastric carcinomas (GC) constitute immune-active principal cellular components of tumor microenvironment and contribute to better prognosis. With the ... Full text Link to item Cite

A prediction model for advanced colorectal neoplasia in an asymptomatic screening population.

Journal article PLoS One · 2017 BACKGROUND: An electronic medical record (EMR) database of a large unselected population who received screening colonoscopies may minimize sampling error and represent real-world estimates of risk for screening target lesions of advanced colorectal neoplas ... Full text Link to item Cite

Non-alcoholic fatty liver diseases and risk of colorectal neoplasia.

Journal article Aliment Pharmacol Ther · January 2017 BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is associated with colorectal neoplasia. Yet, NAFLD ranges from simple steatosis to steatohepatitis with advanced fibrosis. AIM: To investigate the risk of colorectal neoplasia according to the presence ... Full text Link to item Cite

Clinicopathological Features and Prognosis of Mixed-Type T1a Gastric Cancer Based on Lauren's Classification.

Journal article Ann Surg Oncol · December 2016 BACKGROUND: Recent studies have reported that mixed-type (MT) gastric cancer, as per Lauren's classification, exhibits aggressive behavior. However, the behavior of early gastric cancer is unclear. In this study, we addressed the influence of mucosa-confin ... Full text Link to item Cite

Does the interval of screening endoscopy affect survival in gastric cancer patients?: A cross-sectional study.

Journal article Medicine (Baltimore) · December 2016 Gastric cancer remains the second most common cancer in Korea; however, its mortality has decreased due to earlier diagnosis. In Korea, screening endoscopy has been performed nationwide since 1999. The aim of this study was to elucidate the benefit of scre ... Full text Link to item Cite

Randomized trial of subfascial infusion of ropivacaine for early recovery in laparoscopic colorectal cancer surgery

Journal article Korean Journal of Anesthesiology · December 1, 2016 Background: There is a need for investigating the analgesic method as part of early recovery after surgery tailored for laparoscopic colorectal cancer (LCRC) surgery. In this randomized trial, we aimed to investigate the analgesic efficacy of an inverse “v ... Full text Cite

Evaluation of the risk factors associated with rectal neuroendocrine tumors: a big data analytic study from a health screening center.

Journal article J Gastroenterol · December 2016 BACKGROUND: Rectal neuroendocrine tumor (NET) is the most common NET in Asia. The risk factors associated with rectal NETs are unclear because of the overall low incidence rate of these tumors and the associated difficulty in conducting large epidemiologic ... Full text Link to item Cite

A Risk-prediction Model Based on Lymph-node Metastasis for Incorporation Into a Treatment Algorithm for Signet Ring Cell-type Intramucosal Gastric Cancer.

Journal article Ann Surg · December 2016 OBJECTIVE: The aim of the study was to develop a reliable and easy-to-use risk-scoring system (RSS) to predict lymph-node metastasis (LNM) and determine the feasibility of endoscopic submucosal dissection for mucosa-confined signet ring cell carcinomas (SR ... Full text Link to item Cite

Phase 1 trial of rituximab, lenalidomide, and ibrutinib in previously untreated follicular lymphoma: Alliance A051103.

Journal article Blood · November 24, 2016 Chemoimmunotherapy in follicular lymphoma is associated with significant toxicity. Targeted therapies are being investigated as potentially more efficacious and tolerable alternatives for this multiply-relapsing disease. Based on promising activity with ri ... Full text Link to item Cite

Diabetic biomarkers and the risk of proximal or distal gastric cancer.

Journal article J Gastroenterol Hepatol · October 2016 BACKGROUND AND AIM: The role of diabetes mellitus as a risk factor for gastric cancer has been controversial. We studied the association between diabetic biomarkers and the risk of gastric cancer and whether these associations depend on cancer location. ME ... Full text Link to item Cite

The recommended treatment algorithms of the BCLC and HKLC staging systems: does following these always improve survival rates for HCC patients?

Journal article Liver Int · October 2016 BACKGROUND & AIMS: Several staging systems have been proposed for hepatocellular carcinoma (HCC). Among them, only the Barcelona Clinic Liver Cancer (BCLC) and Hong Kong Liver Cancer (HKLC) staging systems also recommend treatment modality. This study was ... Full text Link to item Cite

Magnetic resonance imaging with gadoxetic acid for local tumour progression after radiofrequency ablation in patients with hepatocellular carcinoma.

Journal article Eur Radiol · October 2016 OBJECTIVES: To develop and validate a prediction model using magnetic resonance imaging (MRI) for local tumour progression (LTP) after radiofrequency ablation (RFA) in hepatocellular carcinoma (HCC) patients. METHODS: Two hundred and eleven patients who ha ... Full text Link to item Cite

Prediction of the Risk of Hepatocellular Carcinoma in Chronic Hepatitis C Patients after Sustained Virological Response by Aspartate Aminotransferase to Platelet Ratio Index.

Journal article Gut Liver · September 15, 2016 BACKGROUND/AIMS: Following sustained virological response (SVR) for chronic hepatitis C (CHC) infection, patients with advanced fibrosis require regular monitoring for hepatocellular carcinoma (HCC). The aspartate aminotransferase to platelet ratio index ( ... Full text Link to item Cite

FGFR2 in gastric cancer: protein overexpression predicts gene amplification and high H-index predicts poor survival.

Journal article Mod Pathol · September 2016 FGFR2 gene amplification, and resulting FGFR2 protein overexpression, is rare in gastric cancer patients, and development of an accurate and widely available method for mass screening to identify patients who may respond to treatment with fibroblast growth ... Full text Link to item Cite

A nCounter CNV Assay to Detect HER2 Amplification: A Correlation Study with Immunohistochemistry and In Situ Hybridization in Advanced Gastric Cancer.

Journal article Mol Diagn Ther · August 2016 AIM: Screening amplified genes for targeted therapy with high-throughput technology is very important. The NanoString nCounter system allows multiplexed digital quantification of target molecules through the use of color-coded barcodes with the great advan ... Full text Link to item Cite

Effect of oral antiviral treatment on long-term outcomes of radiofrequency ablation therapy for hepatitis B virus-related hepatocellular carcinoma.

Journal article Oncotarget · July 26, 2016 OBJECTIVES: This study aimed to investigate the effect of oral antiviral treatment on the prognosis of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radiofrequency (RF) ablation. METHODS: Between January 2003 and December 2010, 228 p ... Full text Link to item Cite

Risk factors for renal impairment revealed after unilateral adrenalectomy in patients with primary aldosteronism.

Journal article Medicine (Baltimore) · July 2016 Primary aldosteronism (PA) may induce significant decline of renal function and structural damage of kidney. However, it is difficult to evaluate accurate renal function in patients with PA, because glomerular hyperfiltration and aldosterone escape can con ... Full text Link to item Cite

Safety of Percutaneous Biopsy for Hepatic Angiosarcoma: Results of a Multicenter Korean Survey.

Journal article J Vasc Interv Radiol · June 2016 PURPOSE: To evaluate the incidence of severe bleeding and mortality associated with percutaneous biopsy for hepatic angiosarcoma in a multicenter retrospective cohort. MATERIALS AND METHODS: A retrospective review of 33 patients with biopsy-proven hepatic ... Full text Link to item Cite

Clinical outcome and predictors of treatment response in foam sodium tetradecyl sulfate sclerotherapy of venous malformations.

Journal article Eur Radiol · May 2016 OBJECTIVES: To evaluate clinical outcomes and their predictors in patients with venous malformation (VM) treated with foam sodium tetradecyl sulfate (STS) sclerotherapy. METHODS: We retrospectively evaluated clinical outcomes of foam STS sclerotherapy in 8 ... Full text Link to item Cite

Quantification of Aortic Valve Calcifications Detected During Lung Cancer-Screening CT Helps Stratify Subjects Necessitating Echocardiography for Aortic Stenosis Diagnosis.

Journal article Medicine (Baltimore) · May 2016 No study has been published on aortic valve calcification (AVC) extent at lung cancer screening low-dose CT (LDCT) and its relationship with aortic stenosis (AS). The purpose of this study was to estimate the cutoff value of AVC on LDCT for detecting AS in ... Full text Link to item Cite

Prospective phase II trial of pazopanib plus CapeOX (capecitabine and oxaliplatin) in previously untreated patients with advanced gastric cancer.

Journal article Oncotarget · April 26, 2016 We designed a single-arm, open label phase II study to determine the efficacy and toxicity of the combination of pazopanib with CapeOx (capecitabine and oxaliplatin) in metastatic /recurrent advanced gastric cancer (AGC) patients. Previously untreated AGC ... Full text Link to item Cite

Serum protein profiling using an aptamer array predicts clinical outcomes of stage IIA colon cancer: A leave-one-out crossvalidation.

Journal article Oncotarget · March 29, 2016 BACKGROUND: In this study, we established and validated a model for predicting prognosis of stage IIA colon cancer patients based on expression profiles of aptamers in serum. METHODS: Bloods samples were collected from 227 consecutive patients with patholo ... Full text Link to item Cite

Coronary Microvascular Dysfunction as a Mechanism of Angina in Severe AS: Prospective Adenosine-Stress CMR Study.

Journal article J Am Coll Cardiol · March 29, 2016 BACKGROUND: Although a common symptom in patients with severe aortic stenosis (AS) without obstructive coronary artery disease (CAD), little is known about the pathogenesis of exertional angina. OBJECTIVES: This study sought to prove that microvascular dys ... Full text Link to item Cite

A prognostic index for natural killer cell lymphoma after non-anthracycline-based treatment: a multicentre, retrospective analysis.

Journal article Lancet Oncol · March 2016 BACKGROUND: The clinical outcome of extranodal natural killer T-cell lymphoma (ENKTL) has improved substantially as a result of new treatment strategies with non-anthracycline-based chemotherapies and upfront use of concurrent chemoradiotherapy or radiothe ... Full text Link to item Cite

The impact of slow graft function on graft outcome is comparable to delayed graft function in deceased donor kidney transplantation.

Journal article Int Urol Nephrol · March 2016 PURPOSE: Slow graft function (SGF) can influence overall prognosis in patients receiving deceased donor kidney transplantation (DKT). However, the impact of SGF on renal function remains uncertain. We investigated retrospectively renal function in cases wi ... Full text Link to item Cite

Longitudinal monitoring of EGFR mutations in plasma predicts outcomes of NSCLC patients treated with EGFR TKIs: Korean Lung Cancer Consortium (KLCC-12-02).

Journal article Oncotarget · February 9, 2016 We hypothesized that plasma-based EGFR mutation analysis for NSCLC may be feasible for monitoring treatment response to EGFR TKIs and also predict drug resistance.Clinically relevant mutations including exon 19 deletion (ex19del), L858R and T790M were anal ... Full text Link to item Cite

Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02).

Journal article Radiother Oncol · February 2016 PURPOSE: Triweekly delivery of cisplatin concurrent with a course of radiation therapy (RT) has been the standard regimen for treatment of locally advanced nasopharyngeal carcinoma (NPC) despite a high level of concern regarding treatment-related complicat ... Full text Link to item Cite

Changes in tumour expression of programmed death-ligand 1 after neoadjuvant concurrent chemoradiotherapy in patients with squamous oesophageal cancer.

Journal article Eur J Cancer · January 2016 BACKGROUND: Programmed death-ligand 1 (PD-L1) expression has been suggested as a potential predictive biomarker of response to anti-PD-1/PD-L1 therapy. In this study, we investigated whether the expression of PD-L1 in tumour cells is affected by neoadjuvan ... Full text Link to item Cite

A Risk Prediction Model Based on Lymph-Node Metastasis in Poorly Differentiated-Type Intramucosal Gastric Cancer.

Journal article PLoS One · 2016 BACKGROUND AND AIM: Endoscopic submucosal dissection (ESD) for undifferentiated type early gastric cancer is regarded as an investigational treatment. Few studies have tried to identify the risk factors that predict lymph-node metastasis (LNM) in intramuco ... Full text Link to item Cite

The effects of cytotoxic therapy in progressive IgA nephropathy.

Journal article Ann Med · 2016 BACKGROUND: IgA nephropathy (IgAN) is not always benign, and some patients at high risk of end-stage renal disease (ESRD) experience a rapid decline in renal function. This study retrospectively examined the beneficial effects of cytotoxic therapy. METHODS ... Full text Link to item Cite

Risk Factors for Renal Functional Decline in Chronic Hepatitis B Patients Receiving Oral Antiviral Agents.

Journal article Medicine (Baltimore) · January 2016 Renal functional decline that is frequently seen during chronic hepatitis B (CHB) treatment can exert adverse effects on overall prognosis. It, however, is difficult to distinguish vulnerable patients who may experience renal dysfunction because most previ ... Full text Link to item Cite

Screening Magnetic Resonance Imaging-Based Prediction Model for Assessing Immediate Therapeutic Response to Magnetic Resonance Imaging-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids.

Journal article Invest Radiol · January 2016 OBJECTIVES: The aim of this study was to fit and validate screening magnetic resonance imaging (MRI)-based prediction models for assessing immediate therapeutic responses of uterine fibroids to MRI-guided high-intensity focused ultrasound (MR-HIFU) ablatio ... Full text Link to item Cite

New 3-Tiered Circumferential Resection Margin Criteria in Esophageal Squamous Cell Carcinoma.

Journal article Ann Surg · December 2015 OBJECTIVE: We aimed to investigate the optimal cutoff value of circumferential resection margin (CRM) of esophageal squamous cell carcinoma (ESCC) in patients who underwent radical esophagectomy. BACKGROUND: Tumor involvement of a CRM in ESCC has not been ... Full text Link to item Cite

A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer.

Journal article Br J Cancer · November 17, 2015 BACKGROUND: The purpose of this randomised phase III trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3methyglutaryl coenzyme A reductase inhibitor, to XELIRI/FOLFIRI chemotherapy regimens confers a clinical benefit to patie ... Full text Link to item Cite

Ideal number of biopsy tumor fragments for predicting HER2 status in gastric carcinoma resection specimens.

Journal article Oncotarget · November 10, 2015 Intratumoral heterogeneity of HER2 expression is common in gastric cancers and pose a challenge for identifying patients who would benefit from anti-HER2 therapy. The aim of this study is to compare HER2 expression in biopsy and resection specimens of gast ... Full text Link to item Cite

Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance).

Journal article J Clin Oncol · November 1, 2015 PURPOSE: Lenalidomide and rituximab (LR) are active agents in follicular lymphoma (FL). Combination regimens have not been previously assessed in randomized studies. PATIENTS AND METHODS: The Cancer and Leukemia Group B (Alliance) 50401 trial is a randomiz ... Full text Link to item Cite

Hepatocellular Carcinoma Risk of Compensated Cirrhosis Patients with Elevated HBV DNA Levels according to Serum Aminotransferase Levels.

Journal article J Korean Med Sci · November 2015 Sometimes, hepatitis B virus (HBV)-related cirrhotic patients with normal aminotransferase levels are closely followed-up for the elevation of aminotransferase levels instead of prompt antiviral therapy (AVT). We analyzed the long-term hepatocellular carci ... Full text Link to item Cite

The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis.

Journal article Oncotarget · October 20, 2015 We conducted a prospective genomic screening trial with high throughput sequencing and copy number variation (CNV) assay, and immunohistochemistry array in metastatic solid cancer patients. We used Ion AmpliSeq Cancer Hotspot Panel v2 and nCounter Copy Num ... Full text Link to item Cite

Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses.

Journal article J Clin Oncol · October 1, 2015 PURPOSE: The Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial tested whether the addition of radiotherapy to adjuvant chemotherapy improved disease-free survival (DFS) in patients with D2-resected gastric cancer (GC). PATIENTS AND METHODS: Betwe ... Full text Link to item Cite

Two sample test for high-dimensional partially paired data

Journal article Journal of Applied Statistics · September 2, 2015 In this paper, we study two sample test for the equality of mean vectors of high-dimensional partially paired data. Extending the results of Lim et al. [12], we propose a new type of regularized statistics, denoted by (Formula presented.) , which is a conv ... Full text Cite

Subcentimeter hypervascular nodule with typical imaging findings of hepatocellular carcinoma in patients with history of hepatocellular carcinoma: natural course on serial gadoxetic acid-enhanced MRI and diffusion-weighted imaging.

Journal article Eur Radiol · September 2015 OBJECTIVES: To evaluate the natural course of subcentimeter hypervascular nodules at high risk for developing into hepatocellular carcinomas (SHNHR) using serial magnetic resonance imaging (MRI) in patients with a history of hepatocellular carcinoma (HCC). ... Full text Link to item Cite

Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04.

Journal article J Clin Oncol · August 20, 2015 PURPOSE: To determine the efficacy of consolidation chemotherapy (CC) with docetaxel and cisplatin (DP) after concurrent chemoradiotherapy (CCRT) with the same agents in locally advanced non-small-cell lung cancer (LA-NSCLC). PATIENT AND METHODS: Patients ... Full text Link to item Cite

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial.

Journal article J Clin Oncol · August 1, 2015 PURPOSE: We investigated whether thymidylate synthase (TS) expression is a predictive marker for the clinical outcome of pemetrexed/cisplatin in patients with nonsquamous non-small-cell lung cancer. PATIENTS AND METHODS: Eligible patients were tested for T ... Full text Link to item Cite

Comparison of operational characteristics for binary tests with clustered data.

Journal article Stat Med · July 10, 2015 Although statistical methodology is well-developed for comparing diagnostic tests in terms of their sensitivity and specificity, comparative inference about predictive values is not. In this paper, we consider the analysis of studies comparing operating ch ... Full text Link to item Cite

Postoperative prognosis prediction of pancreatic cancer with seven microRNAs.

Journal article Pancreas · July 2015 OBJECTIVES: The aim of this study was to investigate microRNAs related to postoperative prognosis of pancreatic cancer by applying microarray analysis to stored surgical specimens. METHODS: We retrospectively analyzed the relationship between microRNA expr ... Full text Link to item Cite

Development and external validation of nomograms predictive of response to radiation therapy and overall survival in nasopharyngeal cancer patients.

Journal article Eur J Cancer · July 2015 INTRODUCTION: Large variability in the clinical outcomes has been observed among the nasopharyngeal cancer (NPC) patients with the same stage receiving similar treatment. This suggests that the current Tumour-Node-Metastasis staging systems need to be refi ... Full text Link to item Cite

Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02).

Journal article Breast Cancer Res Treat · July 2015 The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with ... Full text Link to item Cite

Statistical issues for design and analysis of single-arm multi-stage phase II cancer clinical trials.

Journal article Contemp Clin Trials · May 2015 BACKGROUND: Phase II trials have been very widely conducted and published every year for cancer clinical research. In spite of the fast progress in design and analysis methods, single-arm two-stage design is still the most popular for phase II cancer clini ... Full text Link to item Cite

Molecular analysis of gastric cancer identifies subtypes associated with distinct clinical outcomes.

Journal article Nat Med · May 2015 Gastric cancer, a leading cause of cancer-related deaths, is a heterogeneous disease. We aim to establish clinically relevant molecular subtypes that would encompass this heterogeneity and provide useful clinical information. We use gene expression data to ... Full text Link to item Cite

A seven-gene signature can predict distant recurrence in patients with triple-negative breast cancers who receive adjuvant chemotherapy following surgery.

Journal article Int J Cancer · April 15, 2015 The aim of this study was to investigate candidate genes that might function as biomarkers to differentiate triple negative breast cancers (TNBCs) among patients, who received adjuvant chemotherapy after curative surgery. We tested whether the results of a ... Full text Link to item Cite

A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer.

Journal article Ann Oncol · April 2015 BACKGROUND: It is unclear whether treating brain metastasis before starting systemic chemotherapy can improve survival compared with upfront chemotherapy in non-small-cell lung cancer (NSCLC) with asymptomatic cerebral oligo-metastases. PATIENTS AND METHOD ... Full text Link to item Cite

Therapy with bortezomib plus lenalidomide for relapsed/refractory mantle cell lymphoma: final results of a phase II trial (CALGB 50501).

Journal article Leuk Lymphoma · April 2015 Cancer and Leukemia Group B designed a phase II trial of lenalidomide + bortezomib for relapsed/refractory mantle cell lymphoma (MCL). Induction therapy was lenalidomide (days 1-14) plus bortezomib (days 1/4/8/11), every 21 days for eight cycles. Complete/ ... Full text Link to item Cite

The clinical significance of activated p-AKT expression in peripheral T-cell lymphoma.

Journal article Anticancer Res · April 2015 BACKGROUND: The oncogenic PI3K/serine-threonine kinase (PI3K/AKT) pathway is a downstream pathway of B-cell receptor (BCR) signaling pathway and plays a crucial role in the pathogenesis of B-cell lymphoma. However, there have been preclinical data showing ... Link to item Cite

Lymphoepithelioma-like carcinoma: a distinct type of gastric cancer.

Journal article J Surg Res · April 2015 BACKGROUND: Lymphoepithelioma-like carcinoma (LELC) is a rare type of gastric carcinoma and has histologic features of intense lymphocytic infiltration. In this study, we attempted to analyze the clinicopathologic characteristics and survival outcome of pa ... Full text Link to item Cite

EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity?

Journal article Ann Oncol · March 2015 BACKGROUND: Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma (DLBCL) of the elderly is defined only in adults older than 50 years. However, EBV-positive DLBCL can affect younger patients. We investigated the prevalence, clinical characterist ... Full text Link to item Cite

Endobronchial ultrasound versus mediastinoscopy for mediastinal nodal staging of non-small-cell lung cancer.

Journal article J Thorac Oncol · February 2015 INTRODUCTION: Correct mediastinal staging is critical for determination of the most appropriate management strategy in patients with non-small-cell lung cancer (NSCLC). The purpose of this study was to compare the diagnostic performance of endobronchial ul ... Full text Link to item Cite

Practical approach to determine sample size for building logistic prediction models using high-throughput data.

Journal article J Biomed Inform · February 2015 An empirical method of sample size determination for building prediction models was proposed recently. Permutation method which is used in this procedure is a commonly used method to address the problem of overfitting during cross-validation while evaluati ... Full text Link to item Cite

Risk stratification on the basis of Deauville score on PET-CT and the presence of Epstein-Barr virus DNA after completion of primary treatment for extranodal natural killer/T-cell lymphoma, nasal type: a multicentre, retrospective analysis.

Journal article Lancet Haematol · February 2015 BACKGROUND: Assessment of tumour viability after treatment is essential for prediction of treatment failure in patients with extranodal natural killer/T-cell lymphoma (ENKTL). We aimed to assess the use of the post-treatment Deauville score on PET-CT and E ... Full text Link to item Cite

Optimal estimation for regression models on Ï„-year survival probability.

Journal article J Biopharm Stat · 2015 A logistic regression method can be applied to regressing the [Formula: see text]-year survival probability to covariates, if there are no censored observations before time [Formula: see text]. But if some observations are incomplete due to censoring befor ... Full text Link to item Cite

T2-Weighted Liver MRI Using the MultiVane Technique at 3T: Comparison with Conventional T2-Weighted MRI.

Journal article Korean J Radiol · 2015 OBJECTIVE: To assess the value of applying MultiVane to liver T2-weighted imaging (T2WI) compared with conventional T2WIs with emphasis on detection of focal liver lesions. MATERIALS AND METHODS: Seventy-eight patients (43 men and 35 women) with 86 hepatic ... Full text Link to item Cite

Clinical relevance of procalcitonin and C-reactive protein as infection markers in renal impairment: a cross-sectional study.

Journal article Crit Care · November 19, 2014 INTRODUCTION: Although the clinical application of procalcitonin (PCT) as an infection marker in patients with impaired renal function (estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m(2)) has been increasing recently, it is unclear whether P ... Full text Link to item Cite

CALGB 150905 (Alliance): rituximab broadens the antilymphoma response by activating unlicensed NK cells.

Journal article Cancer Immunol Res · September 2014 Natural killer (NK) cells contribute to clinical responses in patients treated with rituximab, but the rules determining NK-cell responsiveness to mAb therapies are poorly defined. A deeper understanding of the mechanisms responsible for antibody-dependent ... Full text Link to item Cite

A randomized trial of diet in men with early stage prostate cancer on active surveillance: rationale and design of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]).

Journal article Contemp Clin Trials · July 2014 BACKGROUND: Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) i ... Full text Link to item Cite

Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.

Journal article Stat Med · May 30, 2014 Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored su ... Full text Link to item Cite

Reply to M.C. Chamberlain.

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

Gene expression profiles for the prediction of progression-free survival in diffuse large B cell lymphoma: results of a DASL assay.

Journal article Ann Hematol · March 2014 We performed the whole genome cDNA-mediated annealing, selection and ligation assay with 164 formalin-fixed paraffin-embedded (FFPE) tumor samples to develop robust prognostic gene expression profiles in patients with diffuse large B cell lymphoma. The pro ... Full text Link to item Cite

Stratified Fisher's exact test and its sample size calculation.

Journal article Biom J · January 2014 Chi-squared test has been a popular approach to the analysis of a 2 × 2 table when the sample sizes for the four cells are large. When the large sample assumption does not hold, however, we need an exact testing method such as Fisher's test. When the study ... Full text Link to item Cite

Nanostring-based multigene assay to predict recurrence for gastric cancer patients after surgery.

Journal article PLoS One · 2014 Despite the benefits from adjuvant chemotherapy or chemoradiotherapy, approximately one-third of stage II gastric cancer (GC) patients developed recurrences. The aim of this study was to develop and validate a prognostic algorithm for gastric cancer (GCPS) ... Full text Link to item Cite

The impact of activated p-AKT expression on clinical outcomes in diffuse large B-cell lymphoma: a clinicopathological study of 262 cases.

Journal article Ann Oncol · January 2014 BACKGROUND: Oncogenic phosphatidylinositol-3-kinase/serine-threonine kinase (PI3K/AKT) pathway plays a critical role in cell proliferation and growth. Phosphorylated AKT (p-AKT) has been reported to be abnormally overexpressed and to have poor prognostic i ... Full text Link to item Cite

Randomized phase II clinical trials.

Journal article J Biopharm Stat · 2014 Traditionally, Phase II trials have been conducted as single-arm trials to compare the response probabilities between an experimental therapy and a historical control. Historical control data, however, often have a small sample size, are collected from a d ... Full text Link to item Cite

Type I error control for tree classification.

Journal article Cancer Inform · 2014 Binary tree classification has been useful for classifying the whole population based on the levels of outcome variable that is associated with chosen predictors. Often we start a classification with a large number of candidate predictors, and each predict ... Full text Link to item Cite

Genetic profiling to predict recurrence of early cervical cancer.

Journal article Gynecol Oncol · December 2013 OBJECTIVE: Recurrence is the major cause of death in early cervical cancer. We compared the prediction powers for disease recurrence between the gene set prognostic model and the clinical prognostic model. MATERIALS AND METHODS: A gene set model to predict ... Full text Link to item Cite

Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients.

Journal article Invest New Drugs · December 2013 BACKGROUND: The aim of this study was to assess the efficacy and safety of combination regimen of capecitabine plus everolimus in patients with refractory gastric cancer who have failed to at least two cytotoxic regimens. METHODS: Patients received capecit ... Full text Link to item Cite

Designs for randomized phase II clinical trials with two treatment arms.

Journal article Stat Med · November 10, 2013 The most common primary statistical end point of a phase II clinical trial is the categorization of a patient as either a 'responder' or 'nonresponder'. The primary objective of typical randomized phase II anticancer clinical trials is to evaluate experime ... Full text Link to item Cite

A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701.

Journal article Cancer · November 1, 2013 BACKGROUND: Rituximab combined with chemotherapy has improved the survival of previously untreated patients with follicular lymphoma (FL). Nevertheless, many patients neither want nor can tolerate chemotherapy, leading to interest in biological approaches. ... Full text Link to item Cite

Prediction of disease-free survival in hepatocellular carcinoma by gene expression profiling.

Journal article Ann Surg Oncol · November 2013 BACKGROUND: Progression of hepatocellular carcinoma (HCC) often leads to vascular invasion and intrahepatic metastasis, which correlate with recurrence after surgical treatment and poor prognosis. The molecular prognostic model that could be applied to the ... Full text Link to item Cite

Intensive chemotherapy and immunotherapy in patients with newly diagnosed primary CNS lymphoma: CALGB 50202 (Alliance 50202).

Journal article J Clin Oncol · September 1, 2013 PURPOSE: Concerns regarding neurocognitive toxicity of whole-brain radiotherapy (WBRT) have motivated development of alternative, dose-intensive chemotherapeutic strategies as consolidation in primary CNS lymphoma (PCNSL). We performed a multicenter study ... Full text Link to item Cite

Journal Club: Shoulder MRI utilization: relationship of physician MRI equipment ownership to negative study frequency.

Journal article AJR Am J Roentgenol · September 2013 OBJECTIVE: The purpose of this article is to determine whether ownership of MRI equipment by ordering physicians influences the frequency of negative shoulder MRI scans. MATERIALS AND METHODS: A retrospective review was performed of 1140 consecutive should ... Full text Link to item Cite

Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small-cell lung cancer.

Journal article Ann Oncol · August 2013 BACKGROUND: We compared late thoracic radiotherapy (TRT) with early TRT in the treatment of limited-disease small-cell lung cancer (LD-SCLC). PATIENTS AND METHODS: Patients with LD-SCLC received four cycles of etoposide plus cisplatin every 21 days. Patien ... Full text Link to item Cite

The anti-CD80 primatized monoclonal antibody, galiximab, is well-tolerated but has limited activity in relapsed Hodgkin lymphoma: Cancer and Leukemia Group B 50602 (Alliance).

Journal article Leuk Lymphoma · July 2013 Relapsed Hodgkin lymphoma remains a clinical challenge, with few non-cytotoxic treatment options. CD80 is a surface antigen that normally functions as a co-stimulatory molecule but is aberrantly and uniformly expressed on Reed-Sternberg cells. Galiximab is ... Full text Link to item Cite

Prospective analysis of quality of life in elderly patients treated with adjuvant chemotherapy for non-small-cell lung cancer.

Journal article Ann Oncol · June 2013 BACKGROUND: Given the more comorbidities with a decline in physiologic reserve, it can be challenging to make appropriate treatment decisions in the elderly. PATIENTS AND METHODS: Here, we prospectively evaluated and compared the health-related quality of ... Full text Link to item Cite

Sample size considerations of prediction-validation methods in high-dimensional data for survival outcomes.

Journal article Genet Epidemiol · April 2013 A variety of prediction methods are used to relate high-dimensional genome data with a clinical outcome using a prediction model. Once a prediction model is developed from a data set, it should be validated using a resampling method or an independent data ... Full text Link to item Cite

Prediction of a time-to-event trait using genome wide SNP data.

Journal article BMC Bioinformatics · February 19, 2013 BACKGROUND: A popular objective of many high-throughput genome projects is to discover various genomic markers associated with traits and develop statistical models to predict traits of future patients based on marker values. RESULTS: In this paper, we pre ... Full text Link to item Cite

Appropriate design of prospective studies.

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

Stratified Fisher's exact test and its sample size calculation

Journal article Biometrical Journal · 2013 Cite

Genetic profiling to predict recurrence of early cervical cancer

Journal article Gynecologic Oncology · 2013 Cite

SNP selection in genome-wide association studies via penalized support vector machine with MAX test.

Journal article Comput Math Methods Med · 2013 One of main objectives of a genome-wide association study (GWAS) is to develop a prediction model for a binary clinical outcome using single-nucleotide polymorphisms (SNPs) which can be used for diagnostic and prognostic purposes and for better understandi ... Full text Link to item Cite

Interim [(18)F]fluorodeoxyglucose positron emission tomography imaging in stage I-II non-bulky Hodgkin lymphoma: would using combined positron emission tomography and computed tomography criteria better predict response than each test alone?

Journal article Leuk Lymphoma · November 2012 Our objective was to validate the International Harmonization Project (IHP) positron emission tomography (PET) response criteria and correlate with the Deauville criteria and diagnostic computed tomography-based (dCT) lesion size changes. All patients were ... Full text Link to item Cite

Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness.

Journal article Ann Oncol · September 2012 BACKGROUND: This phase II CALGB trial evaluated the activity and safety of an extended induction schedule of galiximab (G) plus rituximab (R) in untreated follicular lymphoma (FL). PATIENTS AND METHODS: Patients with previously untreated FL (grades 1, 2, 3 ... Full text Link to item Cite

Power and sample size calculations for SNP association studies with censored time-to-event outcomes.

Journal article Genet Epidemiol · September 2012 For many clinical studies in cancer, germline DNA is prospectively collected for the purpose of discovering or validating single-nucleotide polymorphisms (SNPs) associated with clinical outcomes. The primary clinical endpoint for many of these studies are ... Full text Link to item Cite

Alveolar macrophages from overweight/obese subjects with asthma demonstrate a proinflammatory phenotype.

Journal article Am J Respir Crit Care Med · September 1, 2012 RATIONALE: Obesity is associated with increased prevalence and severity of asthma. Adipose tissue macrophages can contribute to the systemic proinflammatory state associated with obesity. However, it remains unknown whether alveolar macrophages have a uniq ... Full text Link to item Cite

Analysis of survival data with group lasso

Journal article Communications in Statistics Simulation and Computation · July 2, 2012 Identification of influential genes and clinical covariates on the survival of patients is crucial because it can lead us to better understanding of underlying mechanism of diseases and better prediction models. Most of variable selection methods in penali ... Full text Cite

A regression model for the AUC of clustered ordinal test results and working independent optimal weights

Journal article Communications in Statistics Simulation and Computation · July 2, 2012 We study a regression model on the area under the receiver operating characteristic curves (AUC) for clustered (or repeatedly measured) test results. To account for cluster information, we consider a weighted estimating equation for Dodd and Pepe (2003)'s ... Full text Cite

Physician self-referral of lumbar spine MRI with comparative analysis of negative study rates as a marker of utilization appropriateness.

Journal article AJR Am J Roentgenol · June 2012 OBJECTIVE: Financial interest in imaging equipment may affect the imaging referral patterns of ordering physicians. The purpose of this article is to determine whether ownership of MRI equipment by ordering physicians predicts the likelihood and prevalence ... Full text Link to item Cite

A Cancer and Leukemia Group B multi-center study of DA-EPOCH-rituximab in untreated diffuse large B-cell lymphoma with analysis of outcome by molecular subtype.

Journal article Haematologica · May 2012 BACKGROUND: A phase II trial of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (DA-EPOCH-R) from the National Cancer Institute showed promising activity in untreated diffuse large B-cell lymphoma. The Cancer a ... Full text Link to item Cite

Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial.

Journal article J Clin Oncol · January 20, 2012 PURPOSE: The ARTIST (Adjuvant Chemoradiation Therapy in Stomach Cancer) trial was the first study to our knowledge to investigate the role of postoperative chemoradiotherapy therapy in patients with curatively resected gastric cancer with D2 lymph node dis ... Full text Link to item Cite

On sample size calculation for comparing survival curves under general hypothesis testing.

Journal article J Biopharm Stat · 2012 The log-rank test is commonly used to test the equivalence of two survival distributions under right censoring. Jung et al. (2005) proposed a modified log-rank test for noninferiority trials and its corresponding sample size calculation. In this article, w ... Full text Link to item Cite

Phase II cancer clinical trials with heterogeneous patient populations.

Journal article J Biopharm Stat · 2012 The patient population for a Phase II trial often consists of multiple subgroups in terms of risk level. In this case, a popular design approach is to specify the response rate and the prevalence of each subgroup, to calculate the response rate of the whol ... Full text Link to item Cite

Power and sample size calculation for microarray studies.

Journal article J Biopharm Stat · 2012 Microarray is a technology to screen a large number of genes to discover those differentially expressed between clinical subtypes or different conditions of human diseases. Gene discovery using microarray data requires adjustment for the large-scale multip ... Full text Link to item Cite

Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy.

Journal article Lung Cancer · January 2012 PURPOSE: Gefitinib and erlotinib are potent EGFR TKIs, with antitumor activity. In this randomized, single-center, non-comparative phase II trial, the efficacy and safety of gefitinib and erlotinib was evaluated as the second-line therapy for advanced non- ... Full text Link to item Cite

Statistical considerations for analysis of microarray experiments.

Journal article Clin Transl Sci · December 2011 Microarray technologies enable the simultaneous interrogation of expressions from thousands of genes from a biospecimen sample taken from a patient. This large set of expressions generates a genetic profile of the patient that may be used to identify poten ... Full text Link to item Cite

Rupture of benign thyroid tumors after radio-frequency ablation.

Journal article AJNR Am J Neuroradiol · December 2011 Rupture of benign thyroid tumors after RFA is very rare. We experienced 6 cases in 4 institutions. All patients presented with abrupt neck swelling and pain between 9 and 60 days after RFA. Imaging and clinical findings of the ruptured tumors were anterior ... Full text Link to item Cite

A SAS macro for a clustered logrank test.

Journal article Comput Methods Programs Biomed · November 2011 The clustered logrank test is a nonparametric method of significance testing for correlated survival data. Examples of its application include cluster randomized trials where groups of patients rather than individuals are randomized to either a treatment o ... Full text Link to item Cite

Two-stage designs with additional futility tests for phase ii clinical trials with heterogeneous patient populations

Journal article Sequential Analysis · July 1, 2011 The patient population for a phase II clinical trial sometimes consists of multiple subgroups categorized by different prognostic factors such as age, disease stage, etc. Response rates across such subgroups often are heterogeneous; that is, the therapy un ... Full text Cite

Multiple testing for gene sets from microarray experiments.

Journal article BMC Bioinformatics · May 26, 2011 BACKGROUND: A key objective in many microarray association studies is the identification of individual genes associated with clinical outcome. It is often of additional interest to identify sets of genes, known a priori to have similar biologic function, a ... Full text Open Access Link to item Cite

A phase II trial of bortezomib plus lenalidomide for relapsed/refractory mantle cell lymphoma (MCL) (CALGB 50501).

Journal article J Clin Oncol · May 20, 2011 TPS223 Background: Despite high response rates to MCL induction therapy, relapse is common. Stem cell transplant (SCT) is often utilized, though not curative in most patients (pts), and many are not candidates due to age or comorbidities. Thalidomide and b ... Link to item Cite

Doxorubicin, vinblastine, and gemcitabine (CALGB 50203) for stage I/II nonbulky Hodgkin lymphoma: pretreatment prognostic factors and interim PET.

Journal article Blood · May 19, 2011 To reduce doxorubicin, bleomycin, vinblastine and dacarbazine toxicity, the Cancer and Leukemia Group B conducted a phase 2 trial of doxorubicin, vinblastine, and gemcitabine for newly diagnosed, nonbulky stages I and II Hodgkin lymphoma. Ninety-nine asses ... Full text Link to item Cite

A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254.

Journal article Leuk Lymphoma · April 2011 Anti-B4-blocked ricin (anti-B4-bR) is a potent immunotoxin directed against the CD19 antigen. Previous phase I and II studies suggested a possible role for anti-B4-bR as consolidation after high-dose chemotherapy and autologous stem cell transplant. Cancer ... Full text Link to item Cite

Mutational hotspots in the mitochondrial genome of lung cancer.

Journal article Biochem Biophys Res Commun · April 1, 2011 We determined the somatic mutations in the mitochondrial genomes of 70 lung cancer patients by pair-wise comparative analyses of the normal- and tumor-genome sequences acquired using Affymetrix Mitochondrial Resequencing Array 2.0. The overall mutation rat ... Full text Link to item Cite

Serious pulmonary toxicity in patients with Hodgkin's lymphoma with SGN-30, gemcitabine, vinorelbine, and liposomal doxorubicin is associated with an FcγRIIIa-158 V/F polymorphism.

Journal article Ann Oncol · November 2010 BACKGROUND: Based on in vitro synergistic cytotoxicity when anti-CD30 antibodies are combined with gemcitabine, the Cancer and Leukemia Group B conducted a double-blind, randomized, phase II trial of SGN-30 with gemcitabine, vinorelbine, and pegylated lipo ... Full text Link to item Cite

Robust test method for time-course microarray experiments.

Journal article BMC Bioinformatics · July 22, 2010 BACKGROUND: In a time-course microarray experiment, the expression level for each gene is observed across a number of time-points in order to characterize the temporal trajectories of the gene-expression profiles. For many of these experiments, the scienti ... Full text Open Access Link to item Cite

Sorafenib, a multikinase inhibitor, enhances the response of melanoma to regional chemotherapy.

Journal article Mol Cancer Ther · July 2010 Melanoma responds poorly to standard chemotherapy due to its intrinsic chemoresistance. Multiple genetic and molecular defects, including an activating mutation in the BRaf kinase gene, are associated with melanoma, and the resulting alterations in signal ... Full text Link to item Cite

permGPU: Using graphics processing units in RNA microarray association studies.

Journal article BMC Bioinformatics · June 16, 2010 BACKGROUND: Many analyses of microarray association studies involve permutation, bootstrap resampling and cross-validation, that are ideally formulated as embarrassingly parallel computing problems. Given that these analyses are computationally intensive, ... Full text Open Access Link to item Cite

Reply to K. Shimada et al

Journal article Journal of Clinical Oncology · May 10, 2010 Full text Cite

Gene expression signatures as a guide to treatment strategies for in-transit metastatic melanoma.

Journal article Mol Cancer Ther · April 2010 In-transit metastatic melanoma, which typically presents as multifocal lesions, provides a unique setting to evaluate the utility of gene signatures for defining optimal regional therapeutic strategies and assessing the efficacy of treatment. The goal of t ... Full text Link to item Cite

Sample size and power calculation for molecular biology studies.

Journal article Methods Mol Biol · 2010 Sample size calculation is a critical procedure when designing a new biological study. In this chapter, we consider molecular biology studies generating huge dimensional data. Microarray studies are typical examples, so that we state this chapter in terms ... Full text Link to item Cite

Regression on quantile residual life.

Journal article Biometrics · December 2009 A time-specific log-linear regression method on quantile residual lifetime is proposed. Under the proposed regression model, any quantile of a time-to-event distribution among survivors beyond a certain time point is associated with selected covariates und ... Full text Link to item Cite

A permutation-based multiple testing method for time-course microarray experiments.

Journal article BMC Bioinformatics · October 15, 2009 BACKGROUND: Time-course microarray experiments are widely used to study the temporal profiles of gene expression. Storey et al. (2005) developed a method for analyzing time-course microarray studies that can be applied to discovering genes whose expression ... Full text Link to item Cite

Gradient lasso for Cox proportional hazards model.

Journal article Bioinformatics · July 15, 2009 MOTIVATION: There has been an increasing interest in expressing a survival phenotype (e.g. time to cancer recurrence or death) or its distribution in terms of a subset of the expression data of a subset of genes. Due to high dimensionality of gene expressi ... Full text Link to item Cite

Sample size calculation for microarray experiments with blocked one-way design.

Journal article BMC Bioinformatics · May 28, 2009 BACKGROUND: One of the main objectives of microarray analysis is to identify differentially expressed genes for different types of cells or treatments. Many statistical methods have been proposed to assess the treatment effects in microarray experiments. R ... Full text Link to item Cite

Photoreceptor layer thinning over drusen in eyes with age-related macular degeneration imaged in vivo with spectral-domain optical coherence tomography.

Journal article Ophthalmology · March 2009 PURPOSE: Detect changes in the neurosensory retina using spectral-domain optical coherence tomography (SD OCT) imaging over drusen in age-related macular degeneration (AMD). Quantitative imaging biomarkers may aid in defining risk of disease progression. D ... Full text Link to item Cite

Between-arm comparisons in randomized Phase II trials.

Journal article J Biopharm Stat · 2009 In a Phase II trial, we may randomize patients to multiple arms of experimental therapies and evaluate their efficacy to determine if any of them is worthy of a large scale Phase III trial. Usually the primary objective of such a study is to identify exper ... Full text Link to item Cite

Authors' response

Journal article Clinical Trials · December 1, 2008 Full text Cite

Ki67 and PIM1 expression predict outcome in mantle cell lymphoma treated with high dose therapy, stem cell transplantation and rituximab: a Cancer and Leukemia Group B 59909 correlative science study.

Journal article Leuk Lymphoma · November 2008 The proliferation index in mantle cell lymphoma (MCL) has not been validated in the context of aggressive therapy regimens in the rituximab era. We assessed Ki67 and PIM1 (a cell cycle-related gene upregulated in blastoid MCL) expression by immunohistochem ... Full text Link to item Cite

Statistical challenges in preprocessing in microarray experiments in cancer.

Journal article Clin Cancer Res · October 1, 2008 Many clinical studies incorporate genomic experiments to investigate the potential associations between high-dimensional molecular data and clinical outcome. A critical first step in the statistical analyses of these experiments is that the molecular data ... Full text Link to item Cite

A distribution-free test of constant mean in linear mixed effects models.

Journal article Stat Med · August 30, 2008 We propose a distribution-free procedure, an analogy of the DIP test in non-parametric regression, to test whether the means of responses are constant over time in repeated measures data. Unlike the existing tests, the proposed procedure requires very mini ... Full text Link to item Cite

Sample size calculation for the weighted rank statistics with paired survival data.

Journal article Stat Med · July 30, 2008 This paper introduces a sample size calculation method for the weighted rank test statistics with paired two-sample survival data. Our sample size formula requires specification of joint survival and censoring distributions. For modelling the distribution ... Full text Link to item Cite

Ki67 and PIM1 expression in aggressively treated mantle cell lymphoma (MCL): A Cancer and Leukemia Group B (CALGB) 59909 correlative science study.

Journal article J Clin Oncol · May 20, 2008 8560 Background: Gene expression profiling has suggested that the proliferation signature is an important predictor of outcome in MCL. Retrospective studies have suggested that the proliferative index, measured by mitoses or Ki67, is an important prognosti ... Link to item Cite

Gene expression signatures as a guide to treatment strategies for in-transit metastatic melanoma.

Journal article J Clin Oncol · May 20, 2008 9077 Background: In an era of targeted therapeutics biopsies are increasingly used to personalize cancer treatment. The utility of a single biopsy from a melanoma patient with multifocal disease to define the characteristics of that patient's tumor is uncl ... Link to item Cite

A retrospective analysis of facial fracture etiologies.

Journal article Ann Plast Surg · April 2008 The medical records of 437 patients with 929 facial fractures were retrospectively analyzed. Fracture patterns were classified based on the presence or absence of fractures in each of 4 anatomic subunits (frontal, upper midface, lower midface, and mandible ... Full text Link to item Cite

Sample size calculation for the log-rank tests for multi-arm trials with a control

Journal article Journal of the Korean Statistical Society · March 1, 2008 Suppose that there are K experimental arms and a control arm in a study with survival as the primary endpoint. We consider a Dunnett-type testing procedure to discover the experimental arms that have longer survival distributions than the control arm using ... Full text Cite

Nonparametric inference on median residual life function.

Journal article Biometrics · March 2008 A simple approach to the estimation of the median residual lifetime is proposed for a single group by inverting a function of the Kaplan-Meier estimators. A test statistic is proposed to compare two median residual lifetimes at any fixed time point. The te ... Full text Link to item Cite

Randomized phase II trials with a prospective control.

Journal article Stat Med · February 20, 2008 We consider phase II trials randomizing patients between a prospective control and an experimental therapy. Proposed are two-stage designs allowing for early termination of the study when the experimental arm does not show promising efficacy at the interim ... Full text Link to item Cite

Sample size calculation for paired survival data: A simulation method

Journal article Journal of Statistical Computation and Simulation · January 28, 2008 This paper proposes a sample size calculation method for rank tests for paired two-sample survival data using simulation method. A paired exponential survival model is specified by the marginal hazard rates and the correlation coefficient. Input variables ... Full text Cite

Sample size for comparing correlated concordance rates.

Journal article J Biopharm Stat · 2008 We consider collecting the measurements of a gold standard and two methods with error from each site of subjects. We propose an asymptotic test statistic to compare the concordance rates of two methods with the gold standard and a closed-form sample size f ... Full text Link to item Cite

Designing phase II studies in cancer with time-to-event endpoints.

Journal article Clin Trials · 2008 BACKGROUND: The primary clinical endpoint in many phase II studies in cancer is a time-to-event outcome subject to potential censoring. The decision in favor of abandoning or continuing investigation of the protocol regimen is typically based on the amount ... Full text Link to item Cite

Thrombospondin-1 and thrombospondin-2 mRNA and TSP-1 and TSP-2 protein expression in uterine fibroids and correlation to the genes COL1A1 and COL3A1 and to the collagen cross-link hydroxyproline.

Journal article Reprod Sci · December 2007 Uterine fibroids are composed of altered collagen fibrils and represent an arrested response to injury-initiating fibrosis. In many tissues, TSP-1 is secreted by adult macrophages and monocytes upon wounding and is involved in the activation of transformin ... Full text Link to item Cite

Loss of beta-catenin impairs the renewal of normal and CML stem cells in vivo.

Journal article Cancer Cell · December 2007 A key characteristic of stem cells and cancer cells is their ability to self-renew. To test if Wnt signaling can regulate the self-renewal of both stem cells and cancer cells in the hematopoietic system, we developed mice that lack beta-catenin in their he ... Full text Link to item Cite

A copula approach for detecting prognostic genes associated with survival outcome in microarray studies.

Journal article Biometrics · December 2007 A challenging and crucial issue in clinical studies in cancer involving gene microarray experiments is the discovery, among a large number of genes, of a relatively small panel of genes whose elements are associated with a relevant clinical outcome variabl ... Full text Link to item Cite

Accuracy of ROPtool vs individual examiners in assessing retinal vascular tortuosity.

Journal article Arch Ophthalmol · November 2007 OBJECTIVE: To prospectively determine if tortuosity assessment by a computer program (ROPtool) that traces retinal blood vessels and measures their tortuosity was more accurate than that of individual pediatric ophthalmologists. METHODS: One hundred eighty ... Full text Link to item Cite

Bayesian analysis of paired survival data using a bivariate exponential distribution.

Journal article Lifetime Data Anal · March 2007 We consider a Bayesian analysis method of paired survival data using a bivariate exponential model proposed by Moran (1967, Biometrika 54:385-394). Important features of Moran's model include that the marginal distributions are exponential and the range of ... Full text Link to item Cite

A note on sample size calculation based on propensity analysis in nonrandomized trials.

Journal article J Biopharm Stat · 2007 In nonrandomized trials, patients are not randomly assigned to treatment groups with equal probability. Instead, the probability of assignment varies from patient to patient depending on patients baseline covariates. This often results in a non-comparable ... Full text Link to item Cite

Sample size calculation for weighted rank tests comparing survival distributions under cluster randomization: a simulation method.

Journal article J Biopharm Stat · 2007 We propose a sample size calculation method for rank tests comparing two survival distributions under cluster randomization with possibly variable cluster sizes. Here, sample size refers to number of clusters. Our method is based on simulation procedure ge ... Full text Link to item Cite

Rejoinder

Journal article Journal of Biopharmaceutical Statistics · December 1, 2006 Full text Cite

How accurately can we control the FDR in analyzing microarray data?

Journal article Bioinformatics · July 15, 2006 We want to evaluate the performance of two FDR-based multiple testing procedures by Benjamini and Hochberg (1995, J. R. Stat. Soc. Ser. B, 57, 289-300) and Storey (2002, J. R. Stat. Soc. Ser. B, 64, 479-498) in analyzing real microarray data. These procedu ... Full text Link to item Cite

High expression of nucleoside transporter hENT1 predicts a worse event-free survival in relapsed/refractory Hodgkin lymphoma patients treated with gemcitabine, vinorelbine, and liposomal doxorubicin-A CALGB 59804 correlative study.

Journal article J Clin Oncol · June 20, 2006 7581 Background: CALGB 59804 was a phase I/II trial of gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) for pts with relapsed Hodgkin lymphoma (HL). Overall response rate (RR) was 70% (manuscript in review). Plasma membrane nucleoside transporters ... Link to item Cite

Rank tests for clustered survival data when dependent subunits are randomized.

Journal article Stat Med · February 15, 2006 In clustered survival data, subunits within each cluster share similar characteristics, so that observations made from them tend to be positively correlated. In clinical trials, the correlated subunits from the same cluster are often randomized to differen ... Full text Link to item Cite

P-value calculation for multistage phase II cancer clinical trials.

Journal article J Biopharm Stat · 2006 Due to ethical and practical issues, clinical trials are conducted in multiple stages, but the reported p-values often fail to reflect the design aspect of the trials. We investigate some approaches to p-value calculation in analyzing multi-stage Phase II ... Full text Link to item Cite

A multiple testing procedure to associate gene expression levels with survival.

Journal article Stat Med · October 30, 2005 In many microarray studies the primary objective is to identify, from a large panel of genes, those which are prognostic markers of a censored survival endpoint such as time to disease recurrence or death. Often, these genes are considered prognostic in th ... Full text Link to item Cite

Sample size for a two-group comparison of repeated binary measurements using GEE.

Journal article Stat Med · September 15, 2005 Controlled clinical trials often randomize subjects to two treatment groups and repeatedly evaluate them at baseline and intervals across a treatment period of fixed duration. A popular primary objective in these trials is to compare the change rates in th ... Full text Link to item Cite

Sample size for FDR-control in microarray data analysis.

Journal article Bioinformatics · July 15, 2005 We consider identifying differentially expressing genes between two patient groups using microarray experiment. We propose a sample size calculation method for a specified number of true rejections while controlling the false discovery rate at a desired le ... Full text Link to item Cite

A phase II study of single agent gemcitabine in relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphomas: a Hoosier Oncology Group Study.

Journal article Am J Clin Oncol · April 2005 Gemcitabine is a pyrimidine analog that is active in patients with aggressive lymphomas and Hodgkin disease. This study assessed tumor response in patients with previously treated follicular or small lymphocytic non-Hodgkin lymphoma. This was a 2-stage pha ... Full text Link to item Cite

Sample size calculation for simulation-based multiple-testing procedures.

Journal article J Biopharm Stat · 2005 In this article, we present a simple method to calculate sample size and power for a simulation-based multiple testing procedure which gives a sharper critical value than the standard Bonferroni method. The method is especially useful when several highly c ... Full text Link to item Cite

Sample size computation for two-sample noninferiority log-rank test.

Journal article J Biopharm Stat · 2005 When an experimental therapy is less extensive, less toxic, or less expensive than a standard therapy, we may want to prove that the former is not worse than the latter through a noninferiority trial. In this article, we discuss a modification of the log-r ... Full text Link to item Cite

Sample size calculation for multiple testing in microarray data analysis.

Journal article Biostatistics · January 2005 Microarray technology is rapidly emerging for genome-wide screening of differentially expressed genes between clinical subtypes or different conditions of human diseases. Traditional statistical testing approaches, such as the two-sample t-test or Wilcoxon ... Full text Link to item Cite

Effect of dropouts on sample size estimates for test on trends across repeated measurements.

Journal article J Biopharm Stat · 2005 Sample size calculation is an important component at the design stage of clinical trials. We investigate the implications of dropouts for the sample size estimates in testing differences in the rates of changes produced by two treatments in a randomized pa ... Full text Link to item Cite

On the estimation of the binomial probability in multistage clinical trials.

Journal article Stat Med · March 30, 2004 Due to the optional sampling effect in a sequential design, the maximum likelihood estimator (MLE) following sequential tests is generally biased. In a typical two-stage design employed in a phase II clinical trial in cancer drug screening, a fixed number ... Full text Link to item Cite

Admissible two-stage designs for phase II cancer clinical trials.

Journal article Stat Med · February 28, 2004 In a typical two-stage design for a phase II cancer clinical trial for efficacy screening of cytotoxic agents, a fixed number of patients are initially enrolled and treated. The trial may be terminated for lack of efficacy if the observed number of tumour ... Full text Link to item Cite

Efficiency of the slope estimator in repeated measurements

Journal article Drug Information Journal · 2004 In repeated measurement studies, one of the popular primary interests is to investigate the rate of changes in a response variable. Efficiency of the slope estimator is examined with different numbers of equally-spaced measurements imposed across a specifi ... Cite

Weighted random regression models and dropouts

Journal article Drug Information Journal · 2004 In studies with repeated measurements, one of the popular primary interests is the comparison of the rates of change in a response variable between groups. The random regression model (RRM) has been offered as a potential solution to statistical problems p ... Cite

K-sample test and sample size calculation for comparing slopes in data with repeated measurements

Journal article Biometrical Journal · January 1, 2004 Sample size calculations based on two-sample comparisons of slopes in repeated measurements have been reported by many investigators. In contrast, the literature has paid relatively little attention to the design and analysis of K-sample trials in repeated ... Full text Cite

A phase I trial of olanzapine (Zyprexa) for the prevention of delayed emesis in cancer patients: a Hoosier Oncology Group study.

Journal article Cancer Invest · 2004 Chemotherapy-induced delayed emesis (DE) can affect up to 50% to 70% of patients receiving moderately and highly emetogenic chemotherapy, although rates are improving. DE most commonly occurs within the first 24 to 48 hours of chemotherapy administration a ... Full text Link to item Cite

Characterization of gains, losses, and regional amplification in testicular germ cell tumor cell lines by comparative genomic hybridization.

Journal article Cancer Genet Cytogenet · January 1, 2004 We have performed comparative genomic hybridization on 12 testicular germ cell tumor (TGCT) cell lines and one paraffin-embedded surgical specimen to identify and characterize genome-wide gains and losses of chromosomes in these specimens. All specimens de ... Full text Link to item Cite

Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non-small cell lung cancer.

Journal article J Thorac Cardiovasc Surg · December 2003 OBJECTIVES: The American College of Surgeons Oncology Group undertook a trial to ascertain whether positron emission tomography with 18F-fluorodeoxyglucose could detect lesions that would preclude pulmonary resection in a group of patients with documented ... Full text Link to item Cite

Sample Size Calculation for Dichotomous Outcomes in Cluster Randomization Trials with Varying Cluster Size

Journal article Drug Information Journal · November 3, 2003 It is common to assume a constant cluster size in the estimation of sample size for cluster randomized trials. Manalunga et al. (1) derived sample size estimation for continuous response variables in cases of varying cluster size. This paper discusses a pa ... Cite

Rank-based regression with repeated measurements data

Journal article Biometrika · September 1, 2003 A rank-based regression method is proposed for repeated measurements data. It is a generalisation of the classical Wilcoxon-Mann-Whitney rank statistic for independent observations. The method is valid under a weak condition on the error terms that can acc ... Full text Cite

Patterns of initial recurrence and prognosis after sentinel lymph node biopsy and selective lymphadenectomy for melanoma.

Journal article Plast Reconstr Surg · August 2003 The histologic status of the sentinel lymph node is a highly significant prognostic factor for patients with clinically localized cutaneous melanoma. The patterns of initial treatment failure of patients with positive sentinel lymph node biopsy versus thos ... Full text Link to item Cite

Assessment of quality of life in outpatients with advanced cancer: the accuracy of clinician estimations and the relevance of spiritual well-being--a Hoosier Oncology Group Study.

Journal article J Clin Oncol · July 15, 2003 PURPOSE: To evaluate the association between quality-of-life (QOL) impairment as reported by patients and QOL impairment as judged by nurses or physicians, with and without consideration of spiritual well-being (SWB). PATIENTS AND METHODS: A total of 163 p ... Full text Link to item Cite

Fluoxetine versus placebo in advanced cancer outpatients: a double-blinded trial of the Hoosier Oncology Group.

Journal article J Clin Oncol · May 15, 2003 PURPOSE: To determine whether fluoxetine improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression revealed by a simple survey. PATIENTS AND METHODS: One hundred sixty-three patients with an advanced solid tumor and exp ... Full text Link to item Cite

Chi-square test for R x C contingency tables with clustered data.

Journal article J Biopharm Stat · May 2003 In ophthalmologic or dental studies, observations are frequently taken from multiple sites (called units), such as eyes or teeth, of each subject. In this case, observations within each subject (called clusters) may be dependent, although those from differ ... Full text Link to item Cite

Sample size estimation for GEE method for comparing slopes in repeated measurements data.

Journal article Stat Med · April 30, 2003 Sample size calculation is an important component at the design stage of clinical trials. Controlled clinical trials often use a repeated measurement design in which individuals are randomly assigned to treatment groups and followed-up for measurements at ... Full text Link to item Cite

Melanoma patients evaluated by four different positron emission tomography reconstruction techniques.

Journal article Nuclear medicine communications · March 1, 2003 One hundred and nineteen patients with malignant melanoma were studied using 2-[ F]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG PET). The images were reconstructed using ordered subset expectation maximization with and without attenuation co ... Cite

Rank tests for clustered survival data.

Journal article Lifetime Data Anal · March 2003 In a clinical trial, we may randomize subjects (called clusters) to different treatments (called groups), and make observations from multiple sites (called units) of each subject. In this case, the observations within each subject could be dependent, where ... Full text Link to item Cite

Melanoma patients evaluated by four different positron emission tomography reconstruction techniques.

Journal article Nucl Med Commun · March 2003 One hundred and nineteen patients with malignant melanoma were studied using 2-[ F]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG PET). The images were reconstructed using ordered subset expectation maximization with and without attenuation co ... Full text Link to item Cite

A parametric model for long-term follow-up data from phase III breast cancer clinical trials.

Journal article Stat Med · February 15, 2003 We propose a parametric version of a univariate gamma frailty model. The proposed model is shown to be flexible enough to model long-term follow-up survival data from breast cancer clinical trials when the treatment effect diminishes as time progresses, a ... Full text Link to item Cite

An Evaluation of Weighted Chi-Square Statistics for Clustered Binary Data

Journal article Drug Information Journal · 2003 Clustered binary responses occur frequently in many fields of application. Examples include the development of tumors in one or more animals of a litter, the presence of retinitis in either or both eyes of an AIDS patient, and spontaneous abortion of one o ... Cite

Update on late relapse of germ cell tumor: a clinical and molecular analysis.

Journal article J Clin Oncol · January 1, 2003 PURPOSE: Analysis of patients with late relapse (LR) of germ cell tumor (GCT) with reports on clinical characteristics, outcomes, and molecular and cytogenetic features. PATIENTS AND METHODS: Eighty-three patients evaluated at Indiana University from 1993 ... Full text Link to item Cite

Efficiency of General Estimating Equations Estimators of Slopes in Repeated Measurements: Adding Subjects or Adding Measurements?

Journal article Therapeutic Innovation Regulatory Science · January 1, 2003 In controlled clinical trials, subjects are often evaluated at baseline and intervals across a treatment period. In most trials, the treatment period and the number of time points are predetermined by design. When the primary goal is to estimate and compar ... Full text Cite

Sample Size Calculation for Dichotomous Outcomes in Cluster Randomization Trials with Varying Cluster Size

Journal article Therapeutic Innovation Regulatory Science · January 1, 2003 It is common to assume a constant cluster size in the estimation of sample size for cluster randomized trials. Manatunga et al. (1) derived sample size estimation for continuous response variables in cases of varying cluster size. This paper discusses a pa ... Full text Cite

Sample size calculation for rank tests comparing K survival distributions.

Journal article Lifetime Data Anal · December 2002 Rank tests, such as logrank or Wilcoxon rank sum tests, have been popularly used to compare survival distributions of two or more groups in the presence of right censoring. However, there has been little research on sample size calculation methods for rank ... Full text Link to item Cite

Role for c-jun N-terminal kinase in treatment-refractory acute myeloid leukemia (AML): signaling to multidrug-efflux and hyperproliferation.

Journal article Leukemia · May 2002 A relationship was proved between constitutive activity of leukemic cell c-jun-N-terminal kinase (JNK) and treatment failure in AML. Specifically, early treatment failure was predicted by the presence of constitutive JNK activity. The mechanistic origins o ... Full text Link to item Cite

Etoposide, ifosfamide and cisplatin (VIP) plus concurrent radiation therapy for previously untreated limited small cell lung cancer (SCLC): a Hoosier Oncology Group (HOG) phase II study.

Journal article Lung Cancer · March 2002 Results of a previous Hoosier Oncology Group (HOG) study revealed a small survival advantage for VIP versus etoposide and cisplatin (EP) for patients with extensive stage small cell lung cancer (SCLC). This phase II study evaluated VIP with concurrent thor ... Full text Link to item Cite

A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer.

Journal article Ann Oncol · March 2002 BACKGROUND: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. PATIENTS AND METHODS: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvi ... Full text Link to item Cite

Application of an adjusted chi2 statistic to site-specific data in observational dental studies.

Journal article J Clin Periodontol · January 2002 Featured Publication BACKGROUND: When a binary response is observed on teeth from each subject belonging to 2 or more exposure groups, application of the usual Pearson chi2 tests is invalid, since such responses within the same subject are not independent. Consequently, specia ... Full text Link to item Cite

Maintenance daily oral etoposide versus no further therapy following induction chemotherapy with etoposide plus ifosfamide plus cisplatin in extensive small-cell lung cancer: a Hoosier Oncology Group randomized study.

Journal article Ann Oncol · January 2002 BACKGROUND: We performed this phase III study to determine whether the addition of 3 months of oral etoposide in non-progressing patients with extensive small-cell lung cancer (SCLC) treated with four cycles of etoposide plus ifosfamide plus cisplatin (VIP ... Full text Link to item Cite

Accuracy of predicting long-term prostate specific antigen outcome based on early prostate specific antigen recurrence results after radical prostatectomy.

Journal article J Urol · December 2001 Featured Publication PURPOSE: We determined how prostate specific antigen (PSA) doubling time changed with time and whether an early measure of doubling time would accurately predict long-term PSA values and clinical outcome in a cohort of patients followed expectantly after r ... Link to item Cite

Cell cycle effects of nonsteroidal anti-inflammatory drugs and enhanced growth inhibition in combination with gemcitabine in pancreatic carcinoma cells.

Journal article J Pharmacol Exp Ther · September 2001 Increased cyclooxygenase-2 (COX-2) expression in human pancreatic adenocarcinomas, as well as the growth-inhibitory effect of nonsteroidal anti-inflammatory drugs (NSAIDs) in vitro, suggests that NSAIDs may be an effective treatment for pancreatic cancer. ... Link to item Cite

Graphical search for two-stage designs for phase II clinical trials.

Journal article Control Clin Trials · August 2001 Featured Publication In a typical two-stage design employed in a phase II cancer clinical trial for efficacy screening, a fixed number of patients are initially enrolled. The trial may be terminated for lack of clinical efficacy of treatment if the observed number of treatment ... Full text Link to item Cite

FDG-PET sensitivity for melanoma lymph node metastases is dependent on tumor volume.

Journal article J Surg Oncol · August 2001 Featured Publication BACKGROUND AND OBJECTIVES: The purpose of this study is to determine the tumor volume threshold for successful positron emission tomography (PET) imaging of melanoma nodal metastases. METHODS: Review of a clinical series of patients who had FDG-PET imaging ... Full text Link to item Cite

DNA methylation and ovarian cancer. I. Analysis of CpG island hypermethylation in human ovarian cancer using differential methylation hybridization.

Journal article Gynecol Oncol · August 2001 OBJECTIVE: The aim of this study was to examine CpG island methylation patterns in ovarian cancer and determine whether epigenetic information can be related to clinical data of patients. CpG island (CpGI) hypermethylation is commonly associated with cance ... Full text Link to item Cite

Evaluation of an adjusted chi-square statistic as applied to observational studies involving clustered binary data.

Journal article Stat Med · July 30, 2001 A simple adjustment to the Pearson chi-square test has been proposed for comparing proportions estimated from clustered binary observations. However, the assumptions needed to assure the validity of this test have not yet been thoroughly addressed. These a ... Full text Link to item Cite

Sample size calculations for clustered binary data.

Journal article Stat Med · July 15, 2001 In this paper we propose a sample size calculation method for testing on a binomial proportion when binary observations are dependent within clusters. In estimating the binomial proportion in clustered binary data, two weighting systems have been popular: ... Full text Link to item Cite

Tests for 2 x K contingency tables with clustered ordered categorical data.

Journal article Stat Med · March 15, 2001 Ordered categorical data summarized in a 2 x K table usually consist of two-sample multinomial or K-sample binomial observations. In analysing these data, we usually assign scores to the K columns and perform a testing for the equality of two multinomial d ... Full text Link to item Cite

Generating correlated binary variables with complete specification of the joint distribution

Journal article Biometrical Journal · 2001 Most statistical methods for the analysis of correlated binary data are based on asymptotic theory. Therefore it is important to generate correlated binary data efficiently for Monte Carlo simulation studies to investigate the finite sample performance of ... Full text Cite

Environmentally relevant xenoestrogen tissue concentrations correlated to biological responses in mice.

Journal article Environ Health Perspect · October 2000 The effects of xenoestrogens have been extensively studied in rodents, generally under single, high-dose conditions. Using a continuous-release, low-dose system in ovariectomized mice, we correlated the estrogenic end points of uterine epithelial height (U ... Full text Link to item Cite

Characterization and predictors of prostate specific antigen progression rates after radical retropubic prostatectomy.

Journal article J Urol · September 2000 Featured Publication PURPOSE: Detectable serum prostate specific antigen (PSA) after radical prostatectomy indicates recurrent disease and treatment failure. We characterized PSA recurrence after prostatectomy and identified predictors of rapid PSA progression. MATERIALS AND M ... Full text Link to item Cite

Predicting sentinel and residual lymph node basin disease after sentinel lymph node biopsy for melanoma.

Journal article Cancer · July 15, 2000 BACKGROUND: The selection of patients for sentinel lymph node biopsy (SNB) and selective lymphadenectomy for histologically positive sentinel lymph nodes (SLND) are areas of debate. The authors of the current study attempted to identify predictors of metas ... Full text Link to item Cite

Comparison of diagnostic markers with repeated measurements: a non-parametric ROC curve approach.

Journal article Stat Med · February 29, 2000 In this paper we study a class of non-parametric statistics for comparing diagnostic markers with repeated measurements. Using adapted definitions of specificity and sensitivity, we suggest methods to compare the average of sensitivities across all specifi ... Full text Link to item Cite

Estimation of response probability in correlated binary data: A new approach

Journal article Drug Information Journal · 2000 We consider analysis of binary observations from multiple sites of each subject. In this case, observations from the same subject tend to be correlated. In estimating the common response probability in correlated binary data, two weighting systems have bee ... Cite

Characterization and predictors of prostate specific antigen progression rates after radical retropubic prostatectomy

Journal article Journal of Urology · January 1, 2000 Purpose: Detectable serum prostate specific antigen (PSA) after radical prostatectomy indicates recurrent disease and treatment failure. We characterized PSA recurrence after prostatectomy and identified predictors of rapid PSA progression. Materials and M ... Full text Cite

Analysis of goodness-of-fit for Cox regression model

Journal article Statistics and Probability Letters · February 15, 1999 If the proportional hazards model (PHM) holds, the regression coefficients for t-year survival probability using the log-log link are equal to those of Cox's PHM with reverse sign for any time point t. In this article, the goodness-of-fit of Cox's model is ... Full text Cite

Rank tests for matched survival data.

Journal article Lifetime Data Anal · 1999 Featured Publication In a clinical trial with the time to an event as the outcome of interest, we may randomize a number of matched subjects, such as litters, to different treatments. The number of treatments equals the number of subjects per litter, two in the case of twins. ... Full text Link to item Cite

Phase II study of docetaxel in advanced soft tissue sarcomas.

Journal article Am J Clin Oncol · December 1996 Because of its unusual mechanism of action, docetaxel was selected for study in advanced soft tissue sarcomas of adults as part of a search for new active antisarcoma agents. Patients at least 18 years old with measurable histologically proven advanced non ... Full text Link to item Cite

Neuroendocrine differentiation is an independent prognostic factor in chemotherapy-treated nonsmall cell lung carcinoma.

Journal article Cancer · April 1, 1996 Featured Publication BACKGROUND: Neuroendocrine differentiation can be identified in 10-30% of patients with nonsmall cell lung carcinoma (NSCLC) by immunohistochemical or electron microscopic techniques. However, its clinical significance is not well established. METHODS: Tum ... Full text Link to item Cite

Quasi-likelihood for median regression models

Journal article Journal of the American Statistical Association · March 1, 1996 This article proposes quasi-likelihood equations for median regression models. The quasi-likelihood can be used for dependent observations such as repeated measurements or time series data. To construct a quasi-likelihood equation, we need to specify the r ... Full text Cite

Quasi-likelihood for median regression models

Journal article Journal of the American Statistical Association · January 1, 1996 This article proposes quasi-likelihood equations for median regression models. The quasi-likelihood can be used for dependent observations such as repeated measurements or time series data. To construct a quasi-likelihood equation, we need to specify the r ... Full text Cite

Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study.

Journal article J Clin Oncol · January 1996 PURPOSE: Megestrol acetate has been reported to improve appetite and quality of life and to decrease nausea and vomiting in patients with cancer anorexia/cachexia. The present trial was formulated to evaluate the impact of megestrol acetate on quality of l ... Full text Link to item Cite

Regression analysis for long-term survival rate

Journal article Biometrika · January 1, 1996 A method of regression analysis for long-term survival rate, when the survival times are subject to right censoring, is proposed. Under some mild conditions, the regression estimate is consistent and has an asymptotically normal distribution. The procedure ... Full text Cite

Randomized, surgical adjuvant clinical trial of recombinant interferon alfa-2a in selected patients with malignant melanoma.

Journal article J Clin Oncol · November 1995 Featured Publication PURPOSE: We conducted a randomized prospective trial in selected patients with fully resected high-risk stage I and II malignant melanoma. PATIENTS AND METHODS: Interferon alfa-2a (IFN-alpha 2a) 20 x 10(6) U/m2 was administered three times each week for 12 ... Full text Link to item Cite

A statistic for comparing two correlated markers which are prognostic for time to an event.

Journal article Stat Med · October 30, 1995 Featured Publication A proliferation of biologic markers has led to increased interest in methods for comparing the prognostic value of markers in predicting time to recurrence of or death from disease. This paper proposes a nonparametric test statistic for comparing two conti ... Full text Link to item Cite

A phase II study of paclitaxel and granulocyte colony-stimulating factor in previously untreated patients with extensive-stage small cell lung cancer: A study of the North Central Cancer Treatment Group

Journal article Seminars in Oncology · July 10, 1995 In 1994, approximately 34,000 to 43,000 Americans will be diagnosed with small cell lung cancer, and 60% to 70% of these individuals will have extensive-stage disease. The median survival time of patients with extensive- stage small cell lung cancer is 8 t ... Cite

A phase II study of paclitaxel and granulocyte colony-stimulating factor in previously untreated patients with extensive-stage small cell lung cancer: a study of the North Central Cancer Treatment Group.

Journal article Semin Oncol · June 1995 Featured Publication In 1994, approximately 34,000 to 43,000 Americans will be diagnosed with small cell lung cancer, and 60% to 70% of these individuals will have extensive-stage disease. The median survival time of patients with extensive-stage small cell lung cancer is 8 to ... Link to item Cite

Cancer screening behaviors and attitudes of women in southeastern Minnesota.

Journal article JAMA · April 12, 1995 OBJECTIVES: To determine the rates at which women received screening Papanicolaou tests, clinical breast examinations, and mammography and to determine the extent to which these women might be expected to respond to screening recommendations from their phy ... Link to item Cite

Non-parametric estimation for the difference or ratio of median failure times for paired observations.

Journal article Stat Med · February 15, 1995 We propose a non-parametric method to calculate a confidence interval for the difference or ratio of two median failure times for paired observations with censoring. The new method is simple to calculate, does not involve non-parametric density estimates, ... Full text Link to item Cite

Survival analysis with median regression models

Journal article Journal of the American Statistical Association · January 1, 1995 The median is a simple and meaningful measure for the center of a long-tailed survival distribution. To examine the covariate effects on survival, a natural alternative to the usual mean regression model is to regress the median of the failure time variabl ... Full text Cite

Evaluation of piroxantrone in women with metastatic breast cancer and failure on nonanthracycline chemotherapy.

Journal article Cancer · September 15, 1994 BACKGROUND: Doxorubicin generally is considered to be the most effective single chemotherapeutic agent for the treatment of breast cancer. The major cumulative dose-limiting toxicity is cardiac toxicity, which may be related to the formation of free radica ... Full text Link to item Cite

Randomized trial of cyclophosphamide, methotrexate, and 5-fluorouracil with or without estrogenic recruitment in women with metastatic breast cancer.

Journal article Cancer · May 1, 1994 Featured Publication BACKGROUND: The fraction of breast cancer cells undergoing DNA synthesis at any one time is relatively low, which is problematic because most chemotherapeutic agents are most effective against dividing cells. Estrogens administered in vitro and in vivo can ... Full text Link to item Cite

Breast biopsy: a comparative study of stereotaxically guided core and excisional techniques.

Journal article AJR Am J Roentgenol · April 1994 OBJECTIVE: The major objectives of this prospective study were to compare pathologic findings from stereotaxic core and excisional biopsies performed on patients with impalpable breast lesions and to compare the initial mammographic impression with the fin ... Full text Link to item Cite