Scholars@Duke
Xiaofei Wang

Xiaofei Wang

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
xiaofei.wang@duke.edu
Duke Box 2721, Durham, NC 27710
2424 Erwin Road Suite 1102, 11080 Hock Plaza, Duke Box 272, Durham, NC 27705

Scholarly Works - Journal articles

Outcomes Based on Age in CALGB 140503 (Alliance): Lobar Versus Sublobar Resection for Peripheral Stage IA Non-small Cell Lung Cancer.

Journal article Clin Lung Cancer · July 2, 2026 OBJECTIVE: In CALGB trial 140503, sublobar resection was not inferior to lobar resection for T1aN0 (size ≤ 2 cm) non-small cell lung cancer (NSCLC) patients. This analysis compares the effect of age on outcomes with the 2 approaches. METHODS: Patients (N = ... Full text Link to item Cite

The design of a small Bayesian hybrid-controlled trial utilizing time-to-event data from six published sources that used best alternative care to treat liver-predominant metastasis from primary ocular melanoma.

Journal article Contemp Clin Trials Commun · June 2026 BACKGROUND: Time-to-event endpoints, such as progression-free survival (PFS), are used to evaluate clinical activity in early-phase RCTs in cancer research. Because the power to detect a reduction in the hazard rate depends on the number of events observed ... Full text Link to item Cite

Mature Outcomes of 61.2 Gy Concomitant Boost Thoracic Radiation Therapy in Limited-Stage Small Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538.

Journal article Int J Radiat Oncol Biol Phys · May 3, 2026 PURPOSE: We report mature outcomes of patients with limited-stage small cell lung cancer randomly assigned to the 61.2 Gy concomitant boost (CB) thoracic radiation therapy (TRT) arm of Cancer and Leukemia Group B (CALGB) 30610/Radiation Therapy Oncology Gr ... Full text Link to item Cite

CHIO3: CHemotherapy combined with immune checkpoint inhibitor for operable stage IIIA/B (N2) Non-Small cell lung cancer (AFT-46).

Journal article Lung Cancer · May 2026 BACKGROUND: Despite a deluge of perioperative non-small cell lung cancer (NSCLC) checkpoint inhibitor trials, none have looked exclusively at an N2+ population. This trial focused on operable N2+ NSCLC and uniquely sought to evaluate N2 nodal clearance (N2 ... Full text Link to item Cite

Win Ratio as an Effect Size Measure Under Non-Proportional Hazards: A Comparison With Difference in Restricted Mean Survival.

Journal article Stat Med · May 2026 When the proportional hazards assumption does not hold, the hazard ratio can misrepresent treatment effects in survival analysis. We evaluate the win ratio, originally proposed for prioritizing multiple outcomes, as an effect size measure for a single surv ... Full text Link to item Cite

Chemoradiation ± Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005.

Journal article J Clin Oncol · March 10, 2026 PURPOSE: NRG Oncology/Alliance LU005 (ClinicalTrials.gov identifier: NCT03811002) tested the addition of atezolizumab to concurrent chemoradiation (CRT) in this open-label, phase III international trial. METHODS: Patients with limited-stage small cell lung ... Full text Link to item Cite

A Powerful and Self-Adaptive Weighted Logrank Test.

Journal article Stat Med · February 2026 In a weighted logrank test, such as the Harrington-Fleming test and the Tarone-Ware test, predetermined weights are used to emphasize early, middle, or late differences in survival distributions to maximize the test's power. The optimal weight function und ... Full text Link to item Cite

Nonparametric Estimations of Quantile Difference for Survival Data Under General Biased Samples

Journal article Statistics in Biopharmaceutical Research · January 1, 2026 Quantile difference is a critical measure for summarizing the random fluctuations of an outcome and has gained much attention. However, existing methods for quantile difference encounter challenges with general biased samples, which are common in fields su ... Full text Cite

Multiplicity Control in Clinical Trials with Adaptive Selection Followed by Group-Sequential Testing

Journal article Statistics in Biopharmaceutical Research · January 1, 2026 We propose a strategy for managing the issue of multiplicity in clinical trials with adaptive selection followed by group-sequential testing. The approach employs a two-stage design and addresses trials with multiple hypotheses. The first stage adaptively ... Full text Cite

Diagnostic Delays in Thoracic Cancer Care: A Data-Linkage, Cohort Study between Primary Care, Hospital, and Registry Data.

Journal article Health Data Sci · 2026 Background: Nearly half of patients with thoracic cancer are diagnosed at a late stage, contributing to poor survival. This may be due to delays in diagnosis. Methods: This study established a longitudinal cohort by linking data between primary care, hospi ... Full text Link to item Cite

Data fusion methods for the heterogeneity of treatment effect and confounding function.

Journal article Bernoulli (Andover) · November 2025 The heterogeneity of treatment effect (HTE) lies at the heart of precision medicine. Randomized controlled trials are gold-standard for treatment effect estimation but are typically underpowered for heterogeneous effects. In contrast, large observational s ... Full text Link to item Cite

Statistical inference for heterogeneous treatment effect with right-censored data from synthesizing randomized clinical trials and real-world data.

Journal article Biometrics · October 8, 2025 The heterogeneous treatment effect plays a crucial role in precision medicine. There is evidence that real-world data, even subject to biases, can be employed as supplementary evidence for randomized clinical trials to improve the statistical efficiency of ... Full text Link to item Cite

Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome.

Journal article J Biopharm Stat · October 2025 Biomarker-guided designs are increasingly used to evaluate personalized treatments based on patients' biomarker status in Phase II and III clinical trials. With adaptive enrichment, these designs can improve the efficiency of evaluating the treatment effec ... Full text Link to item Cite

The extent of lymph node dissection is not associated with disease-free survival following lobar or sublobar resection: Results from Cancer and Leukemia Group B 140503 (Alliance).

Journal article J Thorac Cardiovasc Surg · October 2025 OBJECTIVE: The extent of lymphadenectomy in patients with c-stage I non-small cell lung cancer is controversial. Cancer and Leukemia Group B 140503 (Alliance; NCT00499330) randomized patients with peripheral clinical stage 1A non-small cell lung cancer 2 c ... Full text Link to item Cite

Endobronchial ultrasound diagnostic yield for sarcoidosis in hilar vs. mediastinal lymph nodes.

Journal article J Thorac Dis · September 30, 2025 BACKGROUND: Pulmonary sarcoidosis is diagnosed by endobronchial ultrasound-guided transbronchial needle aspirate (EBUS-TBNA) of hilar and mediastinal lymph nodes and the finding of non-caseating granulomatous inflammation. There are currently no guidelines ... Full text Link to item Cite

Enhancing statistical validity and power in hybrid controlled trials: A randomization inference approach with conformal selective borrowing

Journal article Proceedings of the 42nd International Conference on Machine Learning (ICML), PMLR · August 1, 2025 Open Access Link to item Cite

Integrative analysis of high-dimensional RCT and RWD subject to censoring and hidden confounding.

Journal article Lifetime Data Anal · July 2025 In this study, we focus on estimating the heterogeneous treatment effect (HTE) for survival outcome. The outcome is subject to censoring and the number of covariates is high-dimensional. We utilize data from both the randomized controlled trial (RCT), cons ... Full text Link to item Cite

Evaluating the agreement between sensitivity and primary analyses in observational studies using routinely collected healthcare data: a meta-epidemiology study.

Journal article BMC Med · July 1, 2025 BACKGROUND: Sensitivity analysis is a crucial approach to assessing the "robustness" of research findings. Previous reviews have revealed significant concerns regarding the misuse and misinterpretation of sensitivity analyses in observational studies using ... Full text Link to item Cite

Optimal timing of cancer treatments: a call for emerging evidence from clinical trials and real-world studies.

Journal article Br J Cancer · June 2025 Cancer treatment has entered the era of personalised or precision medicine. Biomarker-driven therapies provide improved treatment efficacy and manageable toxicity profiles compared to systemic standard-of-care therapies. They also drive the development of ... Full text Link to item Cite

Convolutional Neural Networks for Segmentation of Pleural Mesothelioma: Analysis of Probability Map Thresholds (CALGB 30901, Alliance).

Journal article J Imaging Inform Med · April 2025 The purpose of this study was to evaluate the impact of probability map threshold on pleural mesothelioma (PM) tumor delineations generated using a convolutional neural network (CNN). One hundred eighty-six CT scans from 48 PM patients were segmented by a ... Full text Link to item Cite

Temporal Trends in the Utilization and Survival Outcomes of Lobar, Segmental, and Wedge Resection for Early-Stage NSCLC, 2004 to 2020.

Journal article JTO Clin Res Rep · March 2025 INTRODUCTION: Although lobectomy has long been the standard of surgical treatment for early-stage NSCLC, segmental and wedge resections have become another option often used over the past two decades. METHODS: To examine the trends over time in the utiliza ... Full text Link to item Cite

Network Meta-Analysis With Individual Participant-Level Data of Time-to-Event Outcomes Using Cox Regression.

Journal article Stat Med · February 28, 2025 The accessibility of individual participant-level data (IPD) enhances the evaluation of moderation effects of patient covariates. It facilitates the provision of accurate estimation of intervention effects and confidence intervals by incorporating covariat ... Full text Link to item Cite

Perioperative pembrolizumab in early-stage non-small cell lung cancer (NSCLC): safety, efficacy, and exploratory biomarker analysis.

Journal article J Immunother Cancer · February 4, 2025 BACKGROUND: Our study was designed to determine the safety, efficacy, and immunological effects of perioperative pembrolizumab in early-stage NSCLC. METHODS: This is a single-arm phase II study of perioperative pembrolizumab in patients with untreated, cli ... Full text Link to item Cite

Network Meta-Analysis of Time-to-Event Endpoints With Individual Participant Data Using Restricted Mean Survival Time Regression.

Journal article Biom J · February 2025 Network meta-analysis (NMA) extends pairwise meta-analysis to compare multiple treatments simultaneously by combining "direct" and "indirect" comparisons of treatments. The availability of individual participant data (IPD) makes it possible to evaluate tre ... Full text Link to item Cite

Assessment of treatment effect heterogeneity for multiregional randomized clinical trials.

Journal article Stat Biopharm Res · 2025 Multiregional clinical trials (MRCTs) have become increasingly common in recent years. Detecting underlying regional heterogeneity is a critical issue for these trials. Existing methods for assessing treatment effect heterogeneity across regions have ignor ... Full text Link to item Cite

genRCT: a statistical analysis framework for generalizing RCT findings to real-world population.

Journal article J Biopharm Stat · October 2024 When evaluating the real-world treatment effect, the analysis based on randomized clinical trials (RCTs) often introduces generalizability bias due to the difference in risk factors between the trial participants and the real-world patient population. This ... Full text Link to item Cite

Prognostic Factors in Limited-Stage Small Cell Lung Cancer: A Secondary Analysis of CALGB 30610-RTOG 0538.

Journal article JAMA Netw Open · October 1, 2024 IMPORTANCE: The impact of patient-specific, disease-related, and social factors on outcomes in limited-stage small cell lung cancer (LS-SCLC) is not well defined. A post hoc secondary analysis of such factors from the Cancer and Leukemia Group B (CALGB) 30 ... Full text Link to item Cite

Recurrence of Non-Small Cell Lung Cancer With Visceral Pleural Invasion: A Secondary Analysis of a Randomized Clinical Trial.

Journal article JAMA Oncol · September 1, 2024 IMPORTANCE: The randomized clinical trial Cancer and Leukemia Group B (CALGB) 140503 showed that for patients with clinically staged T1N0 non-small cell lung cancer (NSCLC; ≤2 cm), sublobar resections were associated with similar oncological outcomes to th ... Full text Link to item Cite

Inference for restricted mean survival time as a function of restriction time under length-biased sampling.

Journal article Stat Methods Med Res · September 2024 The restricted mean survival time (RMST) is often of direct interest in clinical studies involving censored survival outcomes. It describes the area under the survival curve from time zero to a specified time point. When data are subject to length-biased s ... Full text Link to item Cite

Atezolizumab Before and After Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II Nonrandomized Controlled Trial.

Journal article JAMA Oncol · September 1, 2024 IMPORTANCE: Outcomes for patients with unresectable stage III non-small cell lung cancer (NSCLC) treated with chemoradiation therapy (CRT) have improved with adjuvant immune checkpoint inhibitors, with a reported 5-year overall survival benefit of approxim ... Full text Link to item Cite

Sintilimab in combination with stereotactic body radiotherapy and granulocyte-macrophage colony-stimulating factor in metastatic non-small cell lung cancer: The multicenter SWORD phase 2 trial.

Journal article Nat Commun · August 22, 2024 This single-arm, multicenter, phase 2 trial (NCT04106180) investigated the triple combination of sintilimab (anti-PD1 antibody), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony-stimulating factor (GM-CSF) in metastatic non-small cel ... Full text Link to item Cite

Secondary Analysis of the Rate of Second Primary Lung Cancer From Cancer and Leukemia Group B 140503 (Alliance) Trial of Lobar Versus Sublobar Resection for T1aN0 Non-Small-Cell Lung Cancer.

Journal article J Clin Oncol · April 1, 2024 Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial up ... Full text Link to item Cite

Lobectomy, segmentectomy, or wedge resection for peripheral clinical T1aN0 non-small cell lung cancer: A post hoc analysis of CALGB 140503 (Alliance).

Journal article J Thorac Cardiovasc Surg · January 2024 BACKGROUND: We have recently reported the primary results of CALGB 140503 (Alliance), a randomized trial in patients with peripheral cT1aN0 non-small cell lung cancer (American Joint Committee on Cancer seventh) treated with either lobar resection (LR) or ... Full text Link to item Cite

The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials.

Journal article J Clin Transl Sci · 2024 The proposal of improving reproducibility by lowering the significance threshold to 0.005 has been discussed, but the impact on conducting clinical trials has yet to be examined from a study design perspective. The impact on sample size and study duration ... Full text Open Access Link to item Cite

Futility monitoring for randomized clinical trials with non-proportional hazards: An optimal conditional power approach.

Journal article Clin Trials · December 2023 BACKGROUND: Standard futility analyses designed for a proportional hazards setting may have serious drawbacks when non-proportional hazards are present. One important type of non-proportional hazards occurs when the treatment effect is delayed. That is, th ... Full text Link to item Cite

Trends and age, sex, and race disparities in time to second primary cancer from 1990 to 2019.

Journal article Cancer Med · December 2023 BACKGROUND: Despite the growth in primary cancer (PC) survivors, the trends and disparities in this population have yet to be comprehensively examined using competing risk analysis. The objective is to examine trends in time to second primary cancer (SPC) ... Full text Open Access Link to item Cite

Convolutional Neural Networks for Segmentation of Malignant Pleural Mesothelioma: Analysis of Probability Map Thresholds (CALGB 30901, Alliance).

Journal article ArXiv · November 30, 2023 Malignant pleural mesothelioma (MPM) is the most common form of malignant mesothelioma, with exposure to asbestos being the primary cause of the disease. To assess response to treatment, tumor measurements are acquired and evaluated based on a patient's lo ... Link to item Cite

Enrollment Success, Factors, and Prediction Models in Cancer Trials (2008-2019).

Journal article JCO Oncol Pract · November 2023 PURPOSE: To investigate the enrollment success rate of cancer clinical trials conducted in 2008-2019 and various factors lowering the enrollment success rate. METHODS: This is a cross-sectional study with clinical trial information from the largest registr ... Full text Link to item Cite

High Yield of Pleural Cell-Free DNA for Diagnosis of Oncogenic Mutations in Lung Adenocarcinoma.

Journal article Chest · July 2023 BACKGROUND: Pleural cytology is currently used to assess targetable mutations in patients with advanced lung adenocarcinoma. However, it is fraught with low diagnostic yield. RESEARCH QUESTION: Can pleural cell-free DNA (cfDNA) be used to assess targetable ... Full text Link to item Cite

Elastic integrative analysis of randomised trial and real-world data for treatment heterogeneity estimation.

Journal article J R Stat Soc Series B Stat Methodol · July 2023 We propose a test-based elastic integrative analysis of the randomised trial and real-world data to estimate treatment effect heterogeneity with a vector of known effect modifiers. When the real-world data are not subject to bias, our approach combines the ... Full text Link to item Cite

Improving trial generalizability using observational studies.

Journal article Biometrics · June 2023 Complementary features of randomized controlled trials (RCTs) and observational studies (OSs) can be used jointly to estimate the average treatment effect of a target population. We propose a calibration weighting estimator that enforces the covariate bala ... Full text Link to item Cite

High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538.

Journal article J Clin Oncol · May 1, 2023 PURPOSE: Although level 1 evidence supports 45-Gy twice-daily radiotherapy as standard for limited-stage small-cell lung cancer, most patients receive higher-dose once-daily regimens in clinical practice. Whether increasing radiotherapy dose improves outco ... Full text Link to item Cite

A single-arm, multicenter, phase II trial of osimertinib in patients with epidermal growth factor receptor exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations.

Journal article ESMO Open · April 2023 BACKGROUND: For patients with stage IV non-small-cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions and exon 21 L858R mutations, osimertinib is the standard of care. Investigating the activity and safety of osimertinib in patie ... Full text Link to item Cite

Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer.

Journal article N Engl J Med · February 9, 2023 BACKGROUND: The increased detection of small-sized peripheral non-small-cell lung cancer (NSCLC) has renewed interest in sublobar resection in lieu of lobectomy. METHODS: We conducted a multicenter, noninferiority, phase 3 trial in which patients with NSCL ... Full text Link to item Cite

New reporting items and recommendations for randomized trials impacted by COVID-19 and force majeure events: a targeted approach.

Journal article Ann Transl Med · January 15, 2023 BACKGROUND: Appropriate analyses and reporting are essential to the reproducibility and interpretation of clinical trials. However, the coronavirus disease 19 (COVID-19) pandemic and other force majeure events, like the war in Ukraine, have impacted the co ... Full text Link to item Cite

Associations between body mass index, weight loss and overall survival in patients with advanced lung cancer.

Journal article J Cachexia Sarcopenia Muscle · December 2022 BACKGROUND: Weight loss (WL) has been associated with shorter survival in patients with advanced cancer, while obesity has been associated with longer survival. Integrating body mass index (BMI) and WL provides a powerful prognostic tool but has not been w ... Full text Open Access Link to item Cite

Characteristics of toxicity occurrence patterns in concurrent chemoradiotherapy after induction chemotherapy for patients with locally advanced non-small cell lung cancer: a pooled analysis based on individual patient data of CALGB/Alliance trials.

Journal article Transl Cancer Res · October 2022 BACKGROUND: For patients with locally advanced non-small cell lung cancer (NSCLC), concurrent chemoradiotherapy is the foundational treatment strategy. Adding induction chemotherapy did not achieve a superior efficacy but increased the burden from toxicity ... Full text Open Access Link to item Cite

Latent Profile/Class Analysis Identifying Differentiated Intervention Effects.

Journal article Nurs Res · September 2022 BACKGROUND: The randomized clinical trial is generally considered the most rigorous study design for evaluating overall intervention effects. Because of patient heterogeneity, subgroup analysis is often used to identify differential intervention effects. I ... Full text Link to item Cite

Cluster-based content caching driven by popularity prediction

Journal article CCF Transactions on High Performance Computing · September 2022 Full text Cite

Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer.

Journal article Clin Lung Cancer · July 2022 INTRODUCTION: Treatment of advanced stage non-small cell lung cancer (NSCLC) has changed dramatically due to immunotherapy. However, patients without Programmed Death-Ligand 1 (PD-L1) protein expression often benefit less from immunotherapy. This trial is ... Full text Link to item Cite

A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.

Journal article JTO Clin Res Rep · June 2022 INTRODUCTION: Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes. METHODS: We conducted an open-label, nonrandomized, phase 2 trial in patients with treatment-naiv ... Full text Link to item Cite

Assessing surrogacy using restricted mean survival time ratio for overall survival in liver cancer immunotherapy studies.

Journal article Journal of Clinical Oncology · June 1, 2022 e16222 Background: Recently, immunotherapy has played a crucial role in treating liver cancer, one of the major cancers that contributes to global cancer burden. Overall survival (OS) is widely applied in cancer trials to evaluat ... Full text Cite

Time to diagnosis and treatment of lung cancer: A systematic overview of risk factors, interventions and impact on patient outcomes.

Journal article Lung Cancer · April 2022 Over half of patients with lung cancer are diagnosed at a stage when curative treatment is not possible, suggesting an earlier diagnosis could improve outcomes. This comprehensive overview summarises the evidence on 1) times to diagnosis and treatment, 2) ... Full text Link to item Cite

Nomogram Predicting Overall Survival Benefit of Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer.

Journal article Clin Lung Cancer · March 2022 OBJECTIVES: To develop and validate a nomogram that predicts overall survival (OS) for patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR) vs. observation. MATERIALS AND METHODS: Adults with b ... Full text Link to item Cite

Short communication: The activity of brigatinib in patients with disease progression after next generation anaplastic lymphoma tyrosine kinase inhibitors and an exploratory analysis of circulating tumor DNA.

Journal article Lung Cancer · March 2022 BACKGROUND: Brigatinib, a second generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), is central nervous system (CNS) penetrant and active against anaplastic lymphoma kinase (ALK) resistance mutations. We prospectively studied the a ... Full text Link to item Cite

Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer.

Journal article J Thorac Cardiovasc Surg · February 2022 OBJECTIVES: Pembrolizumab is a programmed death receptor-1 masking antibody approved for metastatic non-small cell lung cancer. This Phase 2 study (NCT02818920) of neoadjuvant pembrolizumab in non-small cell lung cancer had a primary end point of safety an ... Full text Link to item Cite

Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies.

Journal article Chin Clin Oncol · February 2022 BACKGROUND: Proportional hazards (PH) assumption is often violated in cancer immunotherapy studies. Restricted mean survival time (RMST) ratio is a valid metric to quantify the size of treatment effect when non-proportional hazard (NPH) is present. This st ... Full text Link to item Cite

Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.

Journal article Clin Cancer Res · January 1, 2022 Clinical trials that have a pharmacokinetic or a pharmacodynamic immunologic mechanism of action-based primary outcome could substantially improve the validity and efficiency of early development of immuno-oncology agents. Here, we outline different trial ... Full text Link to item Cite

Comparison of Forceps, Cryoprobe, and Thoracoscopic Lung Biopsy for the Diagnosis of Interstitial Lung Disease - The CHILL Study.

Journal article Respiration · 2022 RATIONALE: Transbronchial lung cryobiopsy (TBLC) has emerged as a less invasive method to obtain a tissue diagnosis in patients with interstitial lung disease (ILD). The diagnostic yield of TBLC compared to surgical lung biopsy (SLB) remains uncertain. OBJ ... Full text Link to item Cite

Doubly robust estimators for generalizing treatment effects on survival outcomes from randomized controlled trials to a target population.

Journal article J Causal Inference · 2022 In the presence of heterogeneity between the randomized controlled trial (RCT) participants and the target population, evaluating the treatment effect solely based on the RCT often leads to biased quantification of the real-world treatment effect. To addre ... Full text Link to item Cite

Sintilimab, stereotactic body radiotherapy and granulocyte-macrophage colony stimulating factor as second-line therapy for advanced non-small cell lung cancer: safety run-in results of a multicenter, single-arm, phase II trial.

Journal article Radiat Oncol · September 15, 2021 OBJECTIVES: The SWORD trial is the first multicenter, single arm, phase II study assessing the safety and efficacy of a PD-1 inhibitor (Sintilimab), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony stimulating factor (GM-CSF) in adva ... Full text Link to item Cite

Alliance Foundation Trial 09: A Randomized, Multicenter, Phase 2 Trial Evaluating Two Sequences of Pembrolizumab and Standard Platinum-Based Chemotherapy in Patients With Metastatic NSCLC.

Journal article JTO Clin Res Rep · August 2021 INTRODUCTION: The sequence of chemotherapy and pembrolizumab may affect antitumor immune response and efficacy of immunotherapy. METHODS: This multicenter, randomized, phase 2 trial was designed to evaluate the efficacy of two sequences of chemotherapy and ... Full text Link to item Cite

Pilot Study of the Performance of 19-G Needle in Endobronchial Ultrasound-guided Transbronchial Aspiration for the Diagnosis and Testing of Molecular Markers in Lung Cancer.

Journal article J Bronchology Interv Pulmonol · July 1, 2021 BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become the standard for diagnosis and staging of lung cancer. Historically, 21- and 22-G needles have been paired with EBUS. We evaluated the performance of EBUS-T ... Full text Link to item Cite

Time-To-Event Data: An Overview and Analysis Considerations.

Journal article J Thorac Oncol · July 2021 In oncology, overall survival and progression-free survival are common time-to-event end points used to measure treatment efficacy. Analyses of this type of data rely on a complex statistical framework and the analysis results are only valid when the data ... Full text Link to item Cite

Short Communication: Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on CALGB 30610 (Alliance) / RTOG 0538.

Journal article Lung Cancer · June 2021 INTRODUCTION: The CALGB 30610/RTOG 0538 randomized trial was designed to test whether high-dose thoracic radiotherapy (TRT) would improve survival compared with 45 Gy twice-daily (BID) TRT in limited stage small cell lung cancer (LSCLC). Two piloted experi ... Full text Link to item Cite

Role of dietary carbohydrates on risk of lung cancer.

Journal article Lung Cancer · May 2021 OBJECTIVES: Inconsistent findings have been reported on the link between dietary carbohydrates and lung cancer. This study aims to comprehensively evaluate the role of dietary carbohydrates on lung cancer risk. MATERIALS AND METHODS: The prospective study ... Full text Link to item Cite

Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).

Journal article Oncologist · March 2021 BACKGROUND: Prior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes. MATERIALS AND METHODS: To compare fatigue and ... Full text Link to item Cite

Preliminary Clinical and Molecular Analysis Results From a Single-Arm Phase 2 Trial of Brigatinib in Patients With Disease Progression After Next-Generation ALK Tyrosine Kinase Inhibitors in Advanced ALK+ NSCLC.

Journal article J Thorac Oncol · January 2021 INTRODUCTION: Brigatinib is a potent next-generation ALK tyrosine kinase inhibitor (TKI) with activity against ALK resistance mutations and central nervous system activity. We prospectively studied the activity and safety of brigatinib in patients with dis ... Full text Link to item Cite

Oncological and prognostic impact of lymphovascular invasion in Colorectal Cancer patients.

Journal article Int J Med Sci · 2021 Objectives: Lymphovascular invasion (LVI) is correlated with unfavorable prognoses in several types of cancers. We aimed to identify the informative features associated with LVI and to determine its prognostic value in colorectal cancer (CRC) patients. Met ... Full text Link to item Cite

Promotional effect of indium on Cu/SiO 2 catalysts for the hydrogenation of dimethyl oxalate to ethylene glycol

Journal article Catalysis Science & Technology · 2021 CuIn/SiO 2 with 1.0 wt% indium shows the best catalytic performance for DMO hydrogenation to EG. The synergistic effect of Cu 0 Full text Cite

Weight loss over time and survival: a landmark analysis of 1000+ prospectively treated and monitored lung cancer patients.

Journal article J Cachexia Sarcopenia Muscle · December 2020 BACKGROUND: Eligibility criteria and endpoints for cancer cachexia trials-and whether weight loss should be included-remain controversial. Although most cachexia trials enrol patients after initial cancer diagnosis, few studies have addressed whether weigh ... Full text Link to item Cite

Multi-Institutional Prospective Validation of Prognostic mRNA Signatures in Early Stage Squamous Lung Cancer (Alliance).

Journal article J Thorac Oncol · November 2020 INTRODUCTION: Surgical resection is curative for some patients with early lung squamous cell carcinoma. Staging and clinical factors do not adequately predict recurrence risk. We sought to validate the discriminative performance of proposed prognostic gene ... Full text Link to item Cite

Randomized Study of Maintenance Pemetrexed Versus Observation for Treatment of Malignant Pleural Mesothelioma: CALGB 30901.

Journal article Clin Lung Cancer · November 2020 BACKGROUND: The role of maintenance therapy for malignant pleural mesothelioma (MPM) is unknown. We performed a randomized phase II trial to determine if continuation of pemetrexed after first-line pemetrexed and platinum would improve progression-free sur ... Full text Link to item Cite

Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment.

Journal article J Biopharm Stat · November 1, 2020 We propose a new adaptive threshold detection and enrichment design in which the biomarker threshold is adaptively estimated and updated by optimizing a trade-off between the size of the biomarker positive population and the magnitude of the treatment effe ... Full text Link to item Cite

Development and Validation of a Natural Language Processing Tool to Generate the CONSORT Reporting Checklist for Randomized Clinical Trials.

Journal article JAMA Netw Open · October 1, 2020 IMPORTANCE: Adherence to the Consolidated Standards of Reporting Trials (CONSORT) for randomized clinical trials is associated with improvingquality because inadequate reporting in randomized clinical trials may complicate the interpretation and the applic ... Full text Link to item Cite

Radiomics analysis using stability selection supervised component analysis for right-censored survival data.

Journal article Comput Biol Med · September 2020 Radiomics is a newly emerging field that involves the extraction of massive quantitative features from biomedical images by using data-characterization algorithms. Distinctive imaging features identified from biomedical images can be used for prognosis and ... Full text Open Access Link to item Cite

Predictive accuracy of markers or risk scores for interval censored survival data.

Journal article Stat Med · August 15, 2020 Methods for the evaluation of the predictive accuracy of biomarkers with respect to survival outcomes subject to right censoring have been discussed extensively in the literature. In cancer and other diseases, survival outcomes are commonly subject to inte ... Full text Link to item Cite

Endpoint surrogacy in oncology Phase 3 randomised controlled trials.

Journal article Br J Cancer · August 2020 Endpoint surrogacy is an important concept in oncology trials. Using a surrogate endpoint like progression-free survival as the primary endpoint-instead of overall survival-would lead to a potential faster drug approval and therefore more cancer patients w ... Full text Open Access Link to item Cite

Definitive Radiotherapy for Inoperable Stage IIB Non-small-cell Lung Cancer: Patterns of Care and Comparative Effectiveness.

Journal article Clinical lung cancer · May 2020 BackgroundThe purpose of this study was to analyze practice patterns and perform comparative effectiveness of definitive radiotherapy techniques for inoperable stage IIB (American Joint Committee on Cancer eighth edition) non-small-cell lung cance ... Full text Cite

Predicting risk of chemotherapy-induced severe neutropenia: A pooled analysis in individual patients data with advanced lung cancer.

Journal article Lung cancer (Amsterdam, Netherlands) · March 2020 ObjectivesNeutropenia is associated with the risk of life-threatening infections, chemotherapy dose reductions and delays that may compromise outcomes. This analysis was conducted to develop a prediction model for chemotherapy-induced severe neutr ... Full text Cite

Clinical and radiographic predictors of successful therapeutic bronchoscopy for the relief of malignant central airway obstruction.

Journal article BMC Pulm Med · November 21, 2019 BACKGROUND: Malignant central airway obstruction (CAO) occurs in approximately 20-30% of patients with lung cancer and is associated with debilitating symptoms and poor prognosis. Multimodality therapeutic bronchoscopy can relieve malignant CAO, though car ... Full text Open Access Link to item Cite

Effect of Erlotinib Plus Bevacizumab vs Erlotinib Alone on Progression-Free Survival in Patients With Advanced EGFR-Mutant Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial.

Journal article JAMA Oncol · October 1, 2019 IMPORTANCE: Erlotinib is a standard first-line therapy for patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). Median progression-free survival (PFS) with erlotinib is approximately 10 months. OBJECTIVE: To dete ... Full text Link to item Cite

Second primary malignancy in patients with esophageal adenocarcinoma and squamous cell carcinoma.

Journal article Medicine (Baltimore) · September 2019 There have been no studies on implementing effective screening models for esophageal adenocarcinoma and squamous cell carcinoma survivors. We used a proportional subdistribution hazards model to estimate second primary malignancy risks among patients with ... Full text Link to item Cite

Clinical prognostic model for older patients with advanced non-small cell lung cancer.

Journal article J Geriatr Oncol · July 2019 BACKGROUND: Older patients with non-small cell lung cancer (NSCLC) are often not prescribed standard therapy. It is important to know which older patients would be candidates for aggressive therapy based on their prognosis, and to develop a model that can ... Full text Link to item Cite

Endpoint surrogacy in oncological randomized controlled trials with immunotherapies: a systematic review of trial-level and arm-level meta-analyses.

Journal article Ann Transl Med · June 2019 Few cancer drugs or their indications achieved survival benefit in subsequent trials during postmarket period after approval based on surrogate endpoints. This causes a concern of using surrogate endpoints instead of overall survival (OS) as the primary en ... Full text Link to item Cite

Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial.

Journal article J Clin Oncol · March 10, 2019 PURPOSE: The overexpression of cyclooxygenase 2 (COX-2) gene, also known as prostaglandin-endoperoxide synthase 2 ( PTGS2), occurs in breast cancer, but whether it affects response to anticox drugs remains unclear. We investigated the relationships between ... Full text Link to item Cite

Toxicity Related to Radiotherapy Dose and Targeting Strategy: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Locally Advanced Non-Small Cell Lung Cancer.

Journal article J Thorac Oncol · February 2019 OBJECTIVE: Concurrent chemoradiotherapy (CRT) was the standard treatment for locally advanced NSCLC (LA-NSCLC). This study was performed to examine thoracic radiotherapy (TRT) parameters and their impact on adverse events (AEs). METHODS: We collected indiv ... Full text Link to item Cite

A pooled analysis of individual patient data from National Clinical Trials Network clinical trials of concurrent chemoradiotherapy for limited-stage small cell lung cancer in elderly patients versus younger patients.

Journal article Cancer · February 1, 2019 BACKGROUND: Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited-stage small cell lung cancer (LS-SCLC). Many patients with LS-SCLC are elderly with comorbidities. METHODS ... Full text Link to item Cite

Impact of Esophageal Motion on Dosimetry and Toxicity With Thoracic Radiation Therapy.

Journal article Technol Cancer Res Treat · 2019 PURPOSE: To investigate the impact of intra- and inter-fractional esophageal motion on dosimetry and observed toxicity in a phase I dose escalation study of accelerated radiotherapy with concurrent chemotherapy for locally advanced lung cancer. METHODS AND ... Full text Open Access Link to item Cite

Bias-adjusted Kaplan-Meier survival curves for marginal treatment effect in observational studies.

Journal article J Biopharm Stat · 2019 For time-to-event outcomes, the Kaplan-Meier estimator is commonly used to estimate survival functions of treatment groups and to compute marginal treatment effects, such as the difference in survival rates between treatments at a landmark time. The derive ... Full text Link to item Cite

Auxiliary variable-enriched biomarker-stratified design.

Journal article Stat Med · December 30, 2018 Featured Publication Clinical trials in the era of precision medicine require assessment of biomarkers to identify appropriate subgroups of patients for targeted therapy. In a biomarker-stratified design (BSD), biomarkers are measured on all patients and used as stratification ... Full text Link to item Cite

Long-term Survival After Surgery Compared With Concurrent Chemoradiation for Node-negative Small Cell Lung Cancer.

Journal article Ann Surg · December 2018 OBJECTIVE: To determine whether surgery with adjuvant chemotherapy offers a survival advantage over concurrent chemoradiation for patients with cT1-2N0M0 small cell lung cancer (SCLC). BACKGROUND: Although surgery with adjuvant chemotherapy is the recommen ... Full text Link to item Cite

Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503).

Journal article Lancet Respir Med · December 2018 BACKGROUND: Increased detection of small-sized, peripheral, non-small-cell lung cancer has renewed interest in sublobar resection instead of lobectomy, the traditional standard of care for early-stage lung cancer. We aimed to assess morbidity and mortality ... Full text Link to item Cite

Sample size calculation for studies with grouped survival data.

Journal article Stat Med · November 30, 2018 Grouped survival data arise often in studies where the disease status is assessed at regular visits to clinic. The time to the event of interest can only be determined to be between two adjacent visits or is right censored at one visit. In data analysis, r ... Full text Open Access Link to item Cite

Predictors of Physical and Functional Loss in Advanced-Stage Lung Cancer Patients Receiving Platinum Chemotherapy.

Journal article J Thorac Oncol · September 2018 INTRODUCTION: Muscle wasting has detrimental effects, including increased mortality. Identifying patients at risk can guide treatment efforts. METHODS: POWER 1 and 2 were randomized, double-blind, placebo-controlled, multinational phase III trials that stu ... Full text Link to item Cite

Exploring Radiotherapy Targeting Strategy and Dose: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Stage III NSCLC.

Journal article J Thorac Oncol · August 2018 INTRODUCTION: Concurrent chemoradiotherapy (CRT) is standard therapy for locally advanced NSCLC (LA-NSCLC) patients. This study was performed to examine thoracic radiotherapy (TRT) parameters and their impact on patient survival. METHODS: We collected indi ... Full text Link to item Cite

Phase 1 Study of Accelerated Hypofractionated Radiation Therapy With Concurrent Chemotherapy for Stage III Non-Small Cell Lung Cancer: CALGB 31102 (Alliance).

Journal article Int J Radiat Oncol Biol Phys · May 1, 2018 PURPOSE: To investigate the safety of accelerated hypofractionated radiation therapy (AHRT) with concurrent chemotherapy (CT) for inoperable stage III non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: The primary objectives were to define the maxim ... Full text Link to item Cite

Surgical Outcomes After Neoadjuvant Chemotherapy and Ipilimumab for Non-Small Cell Lung Cancer.

Journal article Ann Thorac Surg · March 2018 BACKGROUND: The objective of this study was to evaluate the safety and feasibility of using neoadjuvant chemotherapy plus ipilimumab followed by surgery as a treatment strategy for stage II-IIIA non-small cell lung cancer. METHODS: From 2013 to 2017, posto ... Full text Link to item Cite

On Enrichment Strategies for Biomarker Stratified Clinical Trials.

Journal article J Biopharm Stat · 2018 In the era of precision medicine, drugs are increasingly developed to target subgroups of patients with certain biomarkers. In large all-comer trials using a biomarker stratified design, the cost of treating and following patients for clinical outcomes may ... Full text Open Access Link to item Cite

Immune Activation in Early-Stage Non-Small Cell Lung Cancer Patients Receiving Neoadjuvant Chemotherapy Plus Ipilimumab.

Journal article Clin Cancer Res · December 15, 2017 Purpose: To determine the immunologic effects of neoadjuvant chemotherapy plus ipilimumab in early-stage non-small cell lung cancer (NSCLC) patients.Experimental Design: This is a single-arm chemotherapy plus phased ipilimumab phase II study of 24 treatmen ... Full text Link to item Cite

Impact of Timing of Lobectomy on Survival for Clinical Stage IA Lung Squamous Cell Carcinoma.

Journal article Chest · December 2017 BACKGROUND: Because the relationship between the timing of surgery following diagnosis of lung cancer and survival has not been precisely described, guidelines on what constitutes a clinically meaningful delay of resection of early-stage lung cancer do not ... Full text Link to item Cite

Pooled Analysis of Individual Patient Data on Concurrent Chemoradiotherapy for Stage III Non-Small-Cell Lung Cancer in Elderly Patients Compared With Younger Patients Who Participated in US National Cancer Institute Cooperative Group Studies.

Journal article J Clin Oncol · September 1, 2017 Purpose Concurrent chemoradiotherapy is standard treatment for patients with stage III non-small-cell lung cancer. Elderly patients may experience increased rates of adverse events (AEs) or less benefit from concurrent chemoradiotherapy. Patients and Metho ... Full text Link to item Cite

Reporting and Guidelines in Propensity Score Analysis: A Systematic Review of Cancer and Cancer Surgical Studies.

Journal article J Natl Cancer Inst · August 1, 2017 BACKGROUND: : Propensity score (PS) analysis is increasingly being used in observational studies, especially in some cancer studies where random assignment is not feasible. This systematic review evaluates the use and reporting quality of PS analysis in on ... Full text Link to item Cite

A national analysis of wedge resection versus stereotactic body radiation therapy for stage IA non-small cell lung cancer.

Journal article J Thorac Cardiovasc Surg · August 2017 OBJECTIVE: Lobectomy is considered optimal therapy for early-stage non-small cell lung cancer, but sublobar wedge resection and stereotactic body radiation therapy are alternative treatments. This study compared outcomes between wedge resection and stereot ... Full text Link to item Cite

Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for Advanced Non-Small-Cell Lung Cancer With Cyclooxygenase-2 Overexpression: CALGB 30801 (Alliance).

Journal article J Clin Oncol · July 1, 2017 Purpose Tumor overexpression of cyclooxygenase-2 (COX-2) has been associated with worse outcome in non-small-cell lung cancer (NSCLC). In Cancer and Leukemia Group B (CALGB) 30203, we found that the selective COX-2 inhibitor celecoxib in addition to chemot ... Full text Link to item Cite

Biopsy first: Lessons learned from Cancer and Leukemia Group B (CALGB) 140503.

Journal article J Thorac Cardiovasc Surg · June 2017 OBJECTIVE: Cancer and Leukemia Group B 140503 is an ongoing, multicenter randomized trial assessing whether sublobar resection is equivalent to lobectomy for the treatment of stage I A non-small cell lung cancer (NSCLC) ≤2 cm in diameter. The objective of ... Full text Link to item Cite

Maintenance Sunitinib following Initial Platinum-Based Combination Chemotherapy in Advanced-Stage IIIB/IV Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study-CALGB 30607 (Alliance).

Journal article J Thorac Oncol · May 2017 INTRODUCTION: The aim of this study was to evaluate efficacy of maintenance sunitinib after first-line chemotherapy for stage IIIB/IV NSCLC. METHODS: Cancer and Leukemia Group B 30607 trial was a randomized, double-blind, placebo-controlled, phase III stud ... Full text Link to item Cite

Small Cell Lung Cancer Exhibits Frequent Inactivating Mutations in the Histone Methyltransferase KMT2D/MLL2: CALGB 151111 (Alliance).

Journal article J Thorac Oncol · April 2017 INTRODUCTION: SCLC is a lethal neuroendocrine tumor type that is highly prone to metastasis. There is an urgency to understand the mutated genes that promote SCLC, as there are no approved targeted therapies yet available. SCLC is rarely resected, limiting ... Full text Link to item Cite

The Role of Extent of Surgical Resection and Lymph Node Assessment for Clinical Stage I Pulmonary Lepidic Adenocarcinoma: An Analysis of 1991 Patients.

Journal article J Thorac Oncol · April 2017 BACKGROUND: This study examined the association of extent of lung resection, pathologic nodal evaluation, and survival for patients with clinical stage I (cT1-2N0M0) adenocarcinoma with lepidic histologic features in the National Cancer Data Base. METHODS: ... Full text Link to item Cite

Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials.

Journal article Oncologist · February 2017 Featured Publication PURPOSE: The aim of this study was to investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in malignant mesothelioma. MATERIALS AND METHODS: Individual data were collected from 15 Cancer and L ... Full text Link to item Cite

Patterns of Distant Metastases After Surgical Management of Non-Small-cell Lung Cancer.

Journal article Clin Lung Cancer · January 2017 BACKGROUND: Patients with limited metastases, oligometastases (OMs), might have improved outcomes compared with patients with widespread distant metastases (DMs). The incidence and behavior of OMs from non-small-cell lung cancer (NSCLC) need further charac ... Full text Link to item Cite

Reply to T.-H. Wang et al.

Journal article J Clin Oncol · January 2017 Full text Link to item Cite

The prognostic value of interleukin-17 in lung cancer: A systematic review with meta-analysis based on Chinese patients.

Journal article PLoS One · 2017 BACKGROUND: Interleukin-17 (IL-17) plays an important role in cancer progression. Previous studies remained controversial regarding the correlation between IL-17 expression and lung cancer (LC) prognosis. To comprehensively and quantitatively summarize the ... Full text Link to item Cite

Spectral methods for learning discrete latent tree models

Journal article Statistics and Its Interface · 2017 Full text Cite

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

Journal article J Clin Oncol · November 20, 2016 Purpose Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung ... Full text Link to item Cite

Impact of thoracic radiotherapy timing in limited-stage small-cell lung cancer: usefulness of the individual patient data meta-analysis.

Journal article Ann Oncol · October 2016 BACKGROUND: Chemotherapy (CT) combined with radiotherapy is the standard treatment of 'limited-stage' small-cell lung cancer. However, controversy persists over the optimal timing of thoracic radiotherapy and CT. MATERIALS AND METHODS: We carried out a met ... Full text Link to item Cite

Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors combined with chemotherapy in first-line treatment in an advanced non-small cell lung cancer patient with EGFR sensitive mutation.

Journal article Thorac Cancer · September 2016 This article demonstrates a case of a lung adenocarcinoma patient in stage IV harboring an epidermal growth factor receptor (EGFR) 19 exon deletion mutation treated with 500 mg/m2 pemetrexed and 75 mg/m2 cisplatin on day 1, sequenced with 250 mg gefitinib ... Full text Link to item Cite

Toxicity of definitive and post-operative radiation following ipilimumab in non-small cell lung cancer.

Journal article Lung Cancer · August 2016 To determine the feasibility and toxicity of radiation therapy, delivered either as definitive treatment or following surgery, following neo-adjuvant immune checkpoint inhibition for locally advanced NSCLC sixteen patients who received neo-adjuvant chemoth ... Full text Link to item Cite

Time-dependent classification accuracy curve under marker-dependent sampling.

Journal article Biom J · July 2016 Evaluating the classification accuracy of a candidate biomarker signaling the onset of disease or disease status is essential for medical decision making. A good biomarker would accurately identify the patients who are likely to progress or die at a partic ... Full text Link to item Cite

Long-term outcomes after lobectomy for non-small cell lung cancer when unsuspected pN2 disease is found: A National Cancer Data Base analysis.

Journal article J Thorac Cardiovasc Surg · May 2016 OBJECTIVE: There are few studies evaluating whether to proceed with planned resection when a patient with non-small cell lung cancer (NSCLC) unexpectedly is found to have N2 disease at the time of thoracoscopy or thoracotomy. To help guide management of th ... Full text Link to item Cite

Detection of Occult Micrometastases in Patients With Clinical Stage I Non-Small-Cell Lung Cancer: A Prospective Analysis of Mature Results of CALGB 9761 (Alliance).

Journal article J Clin Oncol · May 1, 2016 PURPOSE: Outcomes after resection of stage I non-small-cell lung cancer (NSCLC) are variable, potentially due to undetected occult micrometastases (OM). Cancer and Leukemia Group B 9761 was a prospectively designed study aimed at determining the prognostic ... Full text Link to item Cite

Role of Adjuvant Therapy in a Population-Based Cohort of Patients With Early-Stage Small-Cell Lung Cancer.

Journal article J Clin Oncol · April 1, 2016 PURPOSE: Data on optimal adjuvant therapy after complete resection of small-cell lung cancer (SCLC) are limited, and in particular, there have been no studies evaluating the role of adjuvant chemotherapy, with or without prophylactic cranial irradiation, r ... Full text Link to item Cite

Traveling to a High-volume Center is Associated With Improved Survival for Patients With Esophageal Cancer.

Journal article Ann Surg · March 15, 2016 BACKGROUND: An association between volume and outcomes has been observed for esophagectomy, though little is known about why or how patients choose low- or high-volume centers. The purpose of this study was to evaluate how travel burden and hospital volume ... Full text Link to item Cite

Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE).

Journal article J Thorac Oncol · March 2016 BACKGROUND: Prophylactic cranial irradiation (PCI) has become a standard option for patients with extensive-stage small cell lung cancer (ES-SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized phase II study of the effect of sunitinib versu ... Full text Link to item Cite

Risk calculators are useful but...

Journal article J Thorac Cardiovasc Surg · March 2016 Full text Link to item Cite

Statistical aspect of translational and correlative studies in clinical trials.

Journal article Chin Clin Oncol · February 2016 In this article, we describe statistical issues related to the conduct of translational and correlative studies in cancer clinical trials. In the era of personalized medicine, proper biomarker discovery and validation is crucial for producing groundbreakin ... Full text Link to item Cite

Sublobar Resection for Clinical Stage IA Non-small-cell Lung Cancer in the United States.

Journal article Clin Lung Cancer · January 2016 BACKGROUND: This study evaluated the use of lobectomy and sublobar resection for clinical stage IA non-small-cell lung cancer (NSCLC) in the National Cancer Data Base (NCDB). METHODS: The NCDB from 2003 to 2011 was analyzed to determine factors associated ... Full text Link to item Cite

A Multi-state Model for Designing Clinical Trials for Testing Overall Survival Allowing for Crossover after Progression.

Journal article Stat Biopharm Res · 2016 In designing a clinical trial for comparing two or more treatments with respect to overall survival (OS), a proportional hazards assumption is commonly made. However, in many cancer clinical trials, patients pass through various disease states prior to dea ... Full text Link to item Cite

Precise casting of biomorphic La 0.9 K 0.1 CoO 3 catalysts derived from pinewood for diesel soot combustion

Journal article RSC Advances · 2016 A biomorphic perovskite-type oxide, possessing a large surface area, was successfully fabricated using pinewood as a template. The porous structure prompted catalytic activity towards soot combustion under low temperature. ... Full text Cite

HMGB1 level in cerebrospinal fluid as a complimentary biomarker for the diagnosis of tuberculous meningitis.

Journal article Springerplus · 2016 PURPOSE: High mobility group box-1 (HMGB1) is a proinflammatory, DAMP protein that participates in many pathological conditions. In this study, we evaluated the usability of CSF HMGB1 as a biomarker for the diagnosis of tuberculous meningitis (TBM). METHOD ... Full text Link to item Cite

Adding radiation to induction chemotherapy does not improve survival of patients with operable clinical N2 non-small cell lung cancer.

Journal article J Thorac Cardiovasc Surg · December 2015 OBJECTIVE: Radiotherapy is commonly used in induction regimens for patients with non-small cell lung cancer with operable mediastinal nodal disease, although evidence has not shown a benefit over induction chemotherapy alone. We compared outcomes between i ... Full text Link to item Cite

The impact of tumor size on the association of the extent of lymph node resection and survival in clinical stage I non-small cell lung cancer.

Journal article Lung Cancer · December 2015 INTRODUCTION: Lymph node evaluation for node-negative non-small cell lung cancer (NSCLC) is associated with long-term survival but it is not clear if smaller tumors require as extensive a pathologic nodal assessment as larger tumors. This study evaluated t ... Full text Link to item Cite

Surrogate clinical endpoints to predict overall survival in non-small cell lung cancer trials-are we in a new era?

Journal article Transl Lung Cancer Res · December 2015 Surrogate endpoints for clinical trials in oncology offer an alternative metric for measuring clinical benefit, allowing for shorter trial duration, smaller patient cohorts, and single arm design. The correlation of surrogate endpoints with overall surviva ... Full text Link to item Cite

Quality of life and survival after II stage nonsmall cell carcinoma surgery: Video-assisted thoracic surgery versus thoracotomy lobectomy.

Journal article Indian J Cancer · December 2015 PURPOSE: Due to the improvement of thoracoscopic technology and surgeon's ability, plenty of nonsmall cell lung cancer (NSCLC) was treated by video-assisted thoracic surgery (VATS). This study was designed to evaluate the quality of life (QOL) and survival ... Full text Link to item Cite

Validation of survival prognostic models for non-small-cell lung cancer in stage- and age-specific groups.

Journal article Lung Cancer · November 2015 PURPOSE: Prognostic models have been proposed to predict survival for non-small-cell lung cancer (NSCLC). It is important to evaluate whether these models perform better than performance status (PS) alone in stage- and age-specific subgroups. PATIENTS AND ... Full text Link to item Cite

Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.

Journal article J Thorac Oncol · July 2015 INTRODUCTION: We previously reported that progression-free survival (PFS) may be a candidate surrogate end point for overall survival (OS) in first-line extensive-stage small-cell lung cancer (ES-SCLC) using data from three randomized trials (Foster, Cance ... Full text Link to item Cite

Adjuvant Chemotherapy After Lobectomy for T1-2N0 Non-Small Cell Lung Cancer: Are the Guidelines Supported?

Journal article J Natl Compr Canc Netw · June 2015 BACKGROUND: Evidence guiding adjuvant chemotherapy (AC) use after lobectomy for stage I non-small cell lung cancer (NSCLC) is limited. This study evaluated the impact of AC use and tumor size on outcomes using a large, nationwide cancer database. METHODS: ... Full text Link to item Cite

VATS lobectomy has better perioperative outcomes than open lobectomy: CALGB 31001, an ancillary analysis of CALGB 140202 (Alliance).

Journal article Ann Thorac Surg · February 2015 BACKGROUND: The short-term superiority of video-assisted thoracoscopic surgery lobectomy compared with open lobectomy for early-stage lung cancer has been suggested by single-institution studies. Lack of equipoise limits the feasibility of a randomized stu ... Full text Link to item Cite

Induction chemoradiation therapy prior to esophagectomy is associated with superior long-term survival for esophageal cancer.

Journal article Dis Esophagus · 2015 The purpose of this study was to examine the role of induction chemoradiation in the treatment of potentially resectable locally advanced (T2-3N0 and T1-3N+) esophageal cancer utilizing a large national database. The National Cancer Data Base (NCDB) was qu ... Full text Link to item Cite

A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer: results of CALGB 30605 (Alliance)/RTOG 0972 (NRG).

Journal article J Thorac Oncol · January 2015 INTRODUCTION: Patients with stage III non-small-cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radia ... Full text Link to item Cite

Synthesis, characterization, and sintering behavior of Yb3Al5O12 powders

Journal article Ceramics International · January 2015 Full text Cite

CALGB 30704 (Alliance): A randomized phase II study to assess the efficacy of pemetrexed or sunitinib or pemetrexed plus sunitinib in the second-line treatment of advanced non-small-cell lung cancer.

Journal article J Thorac Oncol · February 2014 BACKGROUND: Second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) improves survival modestly but new strategies are needed. This trial was designed to evaluate an antivascular endothelial growth factor strategy with or without standard c ... Full text Link to item Cite

Video-assisted thoracoscopic left upper lobe sleeve lobectomy combined with pulmonary arterioplasty via two-port approach

Journal article Journal of Thoracic Disease · January 1, 2014 Here we report a case of left upper lobe sleeve lobectomy with pulmonary arterioplasty via videoassisted thoracoscopy surgery (VATS) two-port approach. A squamous cell carcinoma with stage T3N1M0 was identified on pathological examination. The bronchial an ... Full text Cite

Microwave coagulation therapy and drug injection to treat splenic injury.

Journal article J Surg Res · January 2014 BACKGROUND: The present study compares the efficacy of 915- and 2450-MHz contrast-enhanced ultrasound (CEUS)-guided percutaneous microwave coagulation with that of CEUS-guided thrombin injection for the treatment of trauma-induced spleen hemorrhage. MATERI ... Full text Link to item Cite

Sleeve lobectomy for non-small cell lung cancer with N1 nodal disease does not compromise survival.

Journal article Ann Thorac Surg · January 2014 BACKGROUND: We evaluated if sleeve lobectomy had worse survival compared with pneumonectomy for non-small cell lung cancer (NSCLC) with N1 disease, which may be a risk factor for locoregional recurrence. METHODS: Patients who underwent pneumonectomy or sle ... Full text Link to item Cite

Surgical techniques and results of the pulmonary artery reconstruction for patients with central non-small cell lung cancer.

Journal article J Cardiothorac Surg · December 1, 2013 BACKGROUND: It is difficult to achieve a margin-negative resection (R0) for non-small cell lung cancer (NSCLC) patients with infiltration of the pulmonary artery. We report our experience of the pulmonary artery reconstruction with regard to long-term surv ... Full text Link to item Cite

Detection of human telomerase reverse transcriptase mRNA in cells obtained by lavage of the pleura is not associated with worse outcome in patients with stage I/II non-small cell lung cancer: results from Cancer and Leukemia Group B 159902.

Journal article J Thorac Cardiovasc Surg · July 2013 OBJECTIVE: Previous studies suggest that cytologic analysis of cells obtained by lavage of the pleural surfaces at the time of resection of non-small cell lung cancer can identify patients at risk for recurrence. Because telomerase gene expression has been ... Full text Link to item Cite

Prospective phase II trial of preresection thoracoscopic mediastinal restaging after neoadjuvant therapy for IIIA (N2) non-small cell lung cancer: results of CALGB Protocol 39803.

Journal article J Thorac Cardiovasc Surg · July 2013 OBJECTIVE: Accurate pathologic restaging of N2 stations after neoadjuvant therapy in stage IIIA (N2) non-small cell lung cancer is needed. METHODS: A prospective multi-institutional trial was designed to judge the feasibility of videothoracoscopy to restag ... Full text Link to item Cite

ROC curve estimation under test-result-dependent sampling.

Journal article Biostatistics · January 2013 The receiver operating characteristic (ROC) curve is often used to evaluate the performance of a biomarker measured on continuous scale to predict the disease status or a clinical condition. Motivated by the need for novel study designs with better estimat ... Full text Link to item Cite

The effects of sorafenib on liver regeneration in a model of partial hepatectomy.

Journal article J Surg Res · November 2012 BACKGROUND: Sorafenib is currently approved for advanced hepatocellular carcinoma (HCC) and is presently being studied as an adjuvant treatment for HCC following resection. The effects of sorafenib on liver regeneration have not been clearly defined. Our o ... Full text Link to item Cite

Optimal management of malignant pleural effusions (results of CALGB 30102).

Journal article J Natl Compr Canc Netw · August 2012 The optimal strategy to achieve palliation of malignant pleural effusions (MPEs) is unknown. This multi-institutional, prospective, randomized trial compares 2 established methods for controlling symptomatic unilateral MPEs. Patients with unilateral MPEs w ... Full text Link to item Cite

Nonparametric modeling auxiliary covariates in random coefficient models

Journal article Communications in Statistics Simulation and Computation · July 2, 2012 Random coefficient model (RCM) is a powerful statistical tool in analyzing correlated data collected from studies with different clusters or from longitudinal studies. In practice, there is a need for statistical methods that allow biomedical researchers t ... Full text Cite

Randomized phase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial.

Journal article J Clin Oncol · June 10, 2012 PURPOSE: Erlotinib is clinically effective in patients with non-small-cell lung cancer (NSCLC) who have adenocarcinoma, are never or limited former smokers, or have EGFR mutant tumors. We investigated the efficacy of erlotinib alone or in combination with ... Full text Link to item Cite

Vatalanib in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 30107).

Journal article Lung Cancer · June 2012 INTRODUCTION: The Cancer and Leukemia Group B (CALGB) conducted a multi-center phase II trial to evaluate the efficacy and safety of vatalanib in previously untreated patients with malignant mesothelioma and to evaluate potential biomarkers of disease resp ... Full text Link to item Cite

CYFRA 21-1 as a prognostic and predictive marker in advanced non-small-cell lung cancer in a prospective trial: CALGB 150304.

Journal article J Thorac Oncol · April 2012 BACKGROUND: Cytokeratin 19 and its soluble fragment CYFRA have been studied as markers that may be associated with response to therapy and survival in non-small-cell lung cancer (NSCLC). As a prospective correlative study of Cancer and Leukemia Group B 302 ... Full text Link to item Cite

Estimation of AUC or Partial AUC under Test-Result-Dependent Sampling.

Journal article Stat Biopharm Res · January 1, 2012 The area under the ROC curve (AUC) and partial area under the ROC curve (pAUC) are summary measures used to assess the accuracy of a biomarker in discriminating true disease status. The standard sampling approach used in biomarker validation studies is oft ... Full text Link to item Cite

Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.

Journal article Clin Cancer Res · January 1, 2012 PURPOSE: Assessing impact of poor accrual on premature trial closure requires a relevant metric. We propose defining accrual sufficiency on apparent ability to address primary endpoints (PE) rather than attaining accrual targets. EXPERIMENTAL DESIGN: All p ... Full text Link to item Cite

Stratified multivariate Mann-Whitney estimators for the comparison of two treatments with randomization based covariance adjustment

Journal article Statistics in Biopharmaceutical Research · December 1, 2011 Methodology for comparing two randomly assigned treatments for strictly ordinal response variables has been discussed throughout the literature on multivariate Mann-Whitney estimators with stratification adjustment. Although such estimators can be computed ... Full text Cite

Pulmonary toxicity in Stage III non-small cell lung cancer patients treated with high-dose (74 Gy) 3-dimensional conformal thoracic radiotherapy and concurrent chemotherapy following induction chemotherapy: a secondary analysis of Cancer and Leukemia Group B (CALGB) trial 30105.

Journal article Int J Radiat Oncol Biol Phys · November 15, 2011 PURPOSE: Cancer and Leukemia Group B (CALGB) 30105 tested two different concurrent chemoradiotherapy platforms with high-dose (74 Gy) three-dimensional conformal radiotherapy (3D-CRT) after two cycles of induction chemotherapy for Stage IIIA/IIIB non-small ... Full text Link to item Cite

Serum vascular endothelial growth factor and COX-2/5-LOX inhibition in advanced non-small cell lung cancer: Cancer and Leukemia Group B 150304.

Journal article J Thorac Oncol · November 2011 INTRODUCTION: Eicosanoids, including PGE-2 and 5-HETE, can increase levels of plasma vascular endothelial growth factor (VEGF). Overexpression of COX-2 or 5-LOX increases levels of PGE-2 and 5-HETE, respectively. Elevated levels of VEGF are common in patie ... Full text Link to item Cite

A phase II trial of high dose carboplatin and paclitaxel with G-CSF and peripheral blood stem cell support followed by surgery and/or chest radiation in patients with stage III non-small cell lung cancer: CALGB 9531.

Journal article Lung Cancer · November 2011 PURPOSE: We designed a phase II trial to evaluate the efficacy and tolerability of high dose induction chemotherapy with carboplatin and paclitaxel with G-CSF and stem cell support followed by surgical resection and/or chest radiotherapy in patients with s ... Full text Link to item Cite

Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

Journal article Clin Trials · October 2011 BACKGROUND: Research on barriers to accrual has typically emphasized factors influencing participation after trial activation. PURPOSE: We sought to identify factors influencing trial design and accrual predictions prior to trial activation associated with ... Full text Link to item Cite

Optimal weight in estimating and comparing areas under the receiver operating characteristic curve using longitudinal data.

Journal article Biom J · September 2011 In the setting of longitudinal study, subjects are followed for the occurrence of some dichotomous outcome. In many of these studies, some markers are also obtained repeatedly during the study period. Emir et al. introduced a non-parametric approach to the ... Full text Link to item Cite

Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407.

Journal article J Clin Oncol · August 10, 2011 PURPOSE: Cancer and Leukemia Group B conducted a randomized phase II trial to investigate two novel chemotherapy regimens in combination with concurrent thoracic radiation therapy (TRT). PATIENTS AND METHODS: Patients with unresectable stage III non-small- ... Full text Link to item Cite

A phase II study of sorafenib in malignant mesothelioma: results of Cancer and Leukemia Group B 30307.

Journal article J Thorac Oncol · October 2010 HYPOTHESIS: Malignant mesotheliomas (MMs) express vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, and cKIT. Sorafenib is a potent inhibitor of the ras/raf/MEK pathway and also targets VEGFR and cKIT. We evaluat ... Full text Link to item Cite

Chemoradiotherapy and gefitinib in stage III non-small cell lung cancer with epidermal growth factor receptor and KRAS mutation analysis: cancer and leukemia group B (CALEB) 30106, a CALGB-stratified phase II trial.

Journal article J Thorac Oncol · September 2010 INTRODUCTION: This study evaluated the addition of gefitinib to sequential or concurrent chemoradiotherapy (CRT) in unresectable stage III non-small cell lung cancer. METHODS: Between May 2002 and April 2005, 63 patients were entered before the study closi ... Full text Link to item Cite

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

Journal article Clin Trials · August 2010 BACKGROUND: A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. PURPOSE: We conducted a pilot study to determine the extent of ... Full text Link to item Cite

Prognostic significance of mucin and p53 expression in stage IB non-small cell lung cancer: a laboratory companion study to CALGB 9633.

Journal article J Thorac Oncol · June 2010 INTRODUCTION: Cancer and Leukemia Group B 9633 was a phase III trial that randomized patients with stage IB non-small cell lung cancer to observation or four cycles of carboplatin and paclitaxel. A statistically significant effect in favor of adjuvant chem ... Full text Link to item Cite

Design and inference for cancer biomarker study with an outcome and auxiliary-dependent subsampling.

Journal article Biometrics · June 2010 Featured Publication In cancer research, it is important to evaluate the performance of a biomarker (e.g., molecular, genetic, or imaging) that correlates patients' prognosis or predicts patients' response to treatment in a large prospective study. Due to overall budget constr ... Full text Link to item Cite

Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104.

Journal article J Clin Oncol · May 10, 2010 PURPOSE: Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. PATIENTS AND METHODS: Cancer a ... Full text Link to item Cite

Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer.

Journal article J Clin Oncol · May 1, 2010 PURPOSE: The previous individual patient data meta-analyses of chemotherapy in locally advanced non-small-cell lung cancer (NSCLC) showed that adding sequential or concomitant chemotherapy to radiotherapy improved survival. The NSCLC Collaborative Group pe ... Full text Link to item Cite

Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904.

Journal article J Clin Oncol · January 10, 2010 PURPOSE: The optimal treatment for medically inoperable stage I non-small-cell lung cancer (NSCLC) has not been defined. PATIENTS AND METHODS: Cancer and Leukemia Group B trial 39904 prospectively assessed accelerated, once-daily, three-dimensional radioth ... Full text Link to item Cite

Outcome- and auxiliary-dependent subsampling and its statistical inference.

Journal article J Biopharm Stat · November 2009 The performance of a biomarker predicting clinical outcome is often evaluated in a large prospective study. Due to high costs associated with bioassay, investigators need to select a subset from all available patients for biomarker assessment. We consider ... Full text Link to item Cite

Randomized phase II trial of docetaxel plus cetuximab or docetaxel plus bortezomib in patients with advanced non-small-cell lung cancer and a performance status of 2: CALGB 30402.

Journal article J Clin Oncol · September 20, 2009 PURPOSE: A randomized phase II trial of two novel treatment strategies in the first-line management of advanced non-small-cell lung cancer patients with performance status (PS) 2. PATIENTS AND METHODS: Patients were assigned to docetaxel 30 mg/m(2) on days ... Full text Link to item Cite

A novel rat model with obesity-associated retinal degeneration.

Journal article Invest Ophthalmol Vis Sci · July 2009 PURPOSE: A strong association between retinal degeneration and obesity has been shown in humans. However, the molecular basis of increased risk for retinal degeneration in obesity is unknown. Thus, an animal model with obesity and retinal degeneration woul ... Full text Link to item Cite

Intraoperative sentinel node mapping with technitium-99 in lung cancer: results of CALGB 140203 multicenter phase II trial.

Journal article J Thorac Oncol · February 2009 INTRODUCTION: Sentinel node mapping with radioactive technetium in non-small cell lung cancer has been shown to be feasible in several single institution reports. The Cancer and Leukemia Group B designed a phase II trial to test a standardized method of th ... Full text Link to item Cite

A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer: CALGB 30104.

Journal article J Thorac Oncol · February 2009 PURPOSE: To assess the efficacy and toxicity of carboplatin, etoposide, and exisulind as initial therapy for extensive stage small cell lung cancer. PATIENTS AND METHODS: The Cancer and Leukemia Group B conducted a phase II study of carboplatin (area under ... Full text Link to item Cite

Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303).

Journal article J Thorac Oncol · October 2008 INTRODUCTION: We investigated dose-dense docetaxel and cisplatin in patients with measurable non-small cell lung cancer in a randomized phase II study without [A] or with [B] a putative chemoprotective agent, BNP7787. PATIENTS AND METHODS: Chemotherapy-nai ... Full text Link to item Cite

Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105.

Journal article J Clin Oncol · May 20, 2008 PURPOSE: To evaluate 74 Gy thoracic radiation therapy (TRT) with induction and concurrent chemotherapy in stage IIIA/B non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with stage IIIA/B NSCLC were randomly assigned to induction chemothera ... Full text Link to item Cite

Response to the methylation inhibitor dihydro-5-azacytidine in mesothelioma is not associated with methylation of p16INK4a: results of cancer and leukemia group B 159904.

Journal article J Thorac Oncol · April 2008 INTRODUCTION: The molecular mechanisms of oncogenesis in mesothelioma involve the loss of negative regulators of cell growth including p16INK4a. Absence of expression of the p16INK4a gene product is exhibited in virtually all mesothelioma tumors and cell l ... Full text Link to item Cite

Randomized phase II Study of carboplatin and etoposide with or without the bcl-2 antisense oligonucleotide oblimersen for extensive-stage small-cell lung cancer: CALGB 30103.

Journal article J Clin Oncol · February 20, 2008 PURPOSE: To assess the efficacy and toxicity of carboplatin, etoposide, and the bcl-2 antisense oligonucleotide oblimersen as initial therapy for extensive-stage small-cell lung cancer (ES-SCLC). bcl-2 has been implicated as a key factor in SCLC oncogenesi ... Full text Link to item Cite

Eicosanoid modulation in advanced lung cancer: cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy--Cancer and Leukemia Group B Trial 30203.

Journal article J Clin Oncol · February 20, 2008 PURPOSE: Increased expression of eicosanoids in cancer has been associated with adverse prognosis. We performed a randomized phase II trial to test the hypothesis that inhibitors of two eicosanoid pathways (cyclooxygenase-2 [COX-2], celecoxib and 5-lipoxyg ... Full text Link to item Cite

Phase II trial of weekly dose-dense paclitaxel in extensive-stage small cell lung cancer: cancer and leukemia group B study 39901.

Journal article J Thorac Oncol · February 2008 INTRODUCTION: Paclitaxel is an active agent in extensive-stage (ES) small cell lung cancer (SCLC). Nevertheless, the optimal schedule is uncertain. A dose-dense schedule was previously evaluated in a Cancer and Leukemia Group B study of patients with non-S ... Full text Link to item Cite

Phase II trial of paclitaxel-topotecan-etoposide followed by consolidation chemoradiotherapy for limited-stage small cell lung cancer: CALGB 30002.

Journal article J Thorac Oncol · July 2007 PURPOSE: We sought to evaluate the activity and tolerance of the rationally designed sequence of paclitaxel-topotecan-etoposide, a nonplatinum regimen, as induction therapy for limited-stage small-cell lung cancer before combined chemo- and radiotherapy. P ... Full text Link to item Cite

A phase III study of surgical resection and paclitaxel/carboplatin chemotherapy with or without adjuvant radiation therapy for resected stage III non-small-cell lung cancer: Cancer and Leukemia Group B 9734.

Journal article Clin Lung Cancer · January 2007 PURPOSE: Patients with completely resected stage IIIA (N2) non-small-cell lung cancer (NSCLC) are at substantial risk for locoregional and systemic recurrence. Adjuvant chemotherapy has recently improved overall control for these patients. We added adjuvan ... Full text Link to item Cite

A semiparametric empirical likelihood method for biased sampling schemes with auxiliary covariates.

Journal article Biometrics · December 2006 We consider a semiparametric inference procedure for data from epidemiologic studies conducted with a two-component sampling scheme where both a simple random sample and multiple outcome- or outcome-/auxiliary-dependent samples are observed. This sampling ... Full text Link to item Cite

Impact of a multidisciplinary thoracic oncology clinic on the timeliness of care.

Journal article J Thorac Oncol · September 2006 BACKGROUND: Multidisciplinary clinics have been recommended for the evaluation of patients with lung cancer. Evidence to support this recommendation, however, is limited. A single-center, retrospective review of lung cancer patients at a Veterans Affairs h ... Link to item Cite

Patient preference in a crossover clinical trial of patients with osteoarthritis of the knee or hip: face validity of self-report questionnaire ratings.

Journal article J Rheumatol · March 2005 OBJECTIVE: To analyze correlational validity of self-report responses regarding patient preference between 2 drugs at the conclusion of a crossover double-blind clinical trial in patients with osteoarthritis (OA) of the knee or hip. METHODS: Patients were ... Link to item Cite

How do statistical properties influence findings of tracking (maintenance) in epidemiologic studies? An example of research in tracking of obesity.

Journal article Eur J Epidemiol · 2003 There is great interest in studying the tracking (maintenance) of health conditions and risk factors over the life span. Tracking is often defined as the maintenance of a distribution position (e.g., quintile or percentile) in a study population over time. ... Full text Link to item Cite

A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee.

Journal article Arthritis Rheum · July 2001 OBJECTIVE: To perform a randomized, double-blind, crossover clinical trial of diclofenac + misoprostol versus acetaminophen in ambulatory patients with osteoarthritis of the hip or knee. METHODS: Patients in 12 ambulatory care settings were eligible if the ... Full text Link to item Cite

Scaled medial axis representation: evidence from position discrimination task.

Journal article Vision Res · June 1998 Previous experimental studies (e.g. Kovacs I, Julesz B. Nature (London) 1994; 370:644-646) have found enhanced contrast sensitivity at medial locations, supporting theoretical speculations that the visual system represents simple spatial regions by their m ... Full text Link to item Cite

Enhanced position sensitivity at scaled medial loci

Journal article Investigative Ophthalmology and Visual Science · February 15, 1996 Purpose: Kovacs and Julesz (Nature, 1994) found enhanced contrast sensitivity at medial locations, supporting theoretical speculations that the visual system represents regions by medial axes. Burbeck and Pizer's core model (Vis. Res., 1995) hypothesizes t ... Cite