Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents

Individual Patient Data Analysis of Progression-Free Survival Versus Overall Survival As a First-Line End Point for Metastatic Colorectal Cancer in Modern Randomized Trials: Findings From the Analysis and Research in Cancers of the Digestive System Database

(2015) Qian Shi et al.   JOURNAL OF CLINICAL ONCOLOGY

Progression-Free Survival: Helpful Biomarker or Clinically Meaningless End Point?

(2015) Alan P. Venook et al.   JOURNAL OF CLINICAL ONCOLOGY

Failure of ELM-PC 5: An Ineffective Drug or an Unfit End Point?

(2015) Michael J. Morris   JOURNAL OF CLINICAL ONCOLOGY

Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials

(2015) James Chih-Hsin Yang et al.   LANCET ONCOLOGY

Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

(2015) Sandra M. Swain et al.   NEW ENGLAND JOURNAL OF MEDICINE

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

(2014) Patricia Cortazar et al.   LANCET

First-Line Crizotinib versus Chemotherapy in ALK-Positive Lung Cancer

(2014) Benjamin J. Solomon et al.   NEW ENGLAND JOURNAL OF MEDICINE

Preserving the Sanctity of Overall Survival for Drugs Approved on the Basis of Progression-Free Survival: Tivozanib As a Case Study

(2013) Marc B. Garnick   JOURNAL OF CLINICAL ONCOLOGY

Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial

(2013) Robert J. Motzer et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma WithEGFRMutations

(2013) Lecia V. Sequist et al.   JOURNAL OF CLINICAL ONCOLOGY

Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial

(2013) Robert J Motzer et al.   LANCET ONCOLOGY

Crizotinib versus Chemotherapy in Advanced ALK-Positive Lung Cancer

(2013) Alice T. Shaw et al.   NEW ENGLAND JOURNAL OF MEDICINE

Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

(2013) Daniel D. Von Hoff et al.   NEW ENGLAND JOURNAL OF MEDICINE

Correlation of progression-free and post-progression survival with overall survival in advanced colorectal cancer

(2012) F. Petrelli et al.   ANNALS OF ONCOLOGY

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

(2012) A. Deisseroth et al.   CLINICAL CANCER RESEARCH

Overall Survival: Patient Outcome, Therapeutic Objective, Clinical Trial End Point, or Public Health Measure?

(2012) Everardo D. Saad et al.   JOURNAL OF CLINICAL ONCOLOGY

Progression-Free Survival: Meaningful or Simply Measurable?

(2012) Christopher M. Booth et al.   JOURNAL OF CLINICAL ONCOLOGY

Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial

(2012) Rafael Rosell et al.   LANCET ONCOLOGY

Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer

(2012) Sunil Verma et al.   NEW ENGLAND JOURNAL OF MEDICINE

Postprogression survival for first-line chemotherapy of patients with advanced non-small-cell lung cancer

(2011) H. Hayashi et al.   ANNALS OF ONCOLOGY

Survival Is Not a Good Outcome for Randomized Trials With Effective Subsequent Therapies

(2011) Marc Buyse et al.   JOURNAL OF CLINICAL ONCOLOGY

Biomarker Analyses and Final Overall Survival Results From a Phase III, Randomized, Open-Label, First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients With Advanced Non–Small-Cell Lung Cancer in Asia (IPASS)

(2011) Masahiro Fukuoka et al.   JOURNAL OF CLINICAL ONCOLOGY

American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients With Advanced Non–Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy

(2011) Vicki Leigh Keedy et al.   JOURNAL OF CLINICAL ONCOLOGY

Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study

(2011) Javier Cortes et al.   LANCET

FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

(2011) Thierry Conroy et al.   NEW ENGLAND JOURNAL OF MEDICINE

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

(2011) Paul B. Chapman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy?

(2010) J. C. Soria et al.   ANNALS OF ONCOLOGY

Phase 3 trial of everolimus for metastatic renal cell carcinoma

(2010) Robert J. Motzer et al.   CANCER

Overall Survival and Post-Progression Survival in Advanced Breast Cancer: A Review of Recent Randomized Clinical Trials

(2010) Everardo D. Saad et al.   JOURNAL OF CLINICAL ONCOLOGY

Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007

(2010) R. Sridhara et al.   JNCI-Journal of the National Cancer Institute

Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial

(2010) Johann Sebastian de Bono et al.   LANCET

Biomarkers and surrogate end points—the challenge of statistical validation

(2010) Marc Buyse et al.   Nature Reviews Clinical Oncology

Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR

(2010) Makoto Maemondo et al.   NEW ENGLAND JOURNAL OF MEDICINE

Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature

(2009) E. D. Saad et al.   ANNALS OF ONCOLOGY

Issues in Using Progression-Free Survival When Evaluating Oncology Products

(2009) Thomas R. Fleming et al.   JOURNAL OF CLINICAL ONCOLOGY

Detecting an Overall Survival Benefit that Is Derived From Progression-Free Survival

(2009) Kristine R. Broglio et al.   JNCI-Journal of the National Cancer Institute

Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial

(2009) Robert Pirker et al.   LANCET

Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data

(2009) Stefan Michiels et al.   LANCET ONCOLOGY

Assessing the Measure of a New Drug: Is Survival the Only Thing That Matters?

(2008) Daniel J. Sargent et al.   JOURNAL OF CLINICAL ONCOLOGY

Evaluation of Tumor Response, Disease Control, Progression-Free Survival, and Time to Progression As Potential Surrogate End Points in Metastatic Breast Cancer

(2008) Tomasz Burzykowski et al.   JOURNAL OF CLINICAL ONCOLOGY