Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data

The Lancet Oncology - Tập 14 - Trang 619-626 - 2013
Audrey Mauguen1, Jean-Pierre Pignon1, Sarah Burdett2, Caroline Domerg1, David Fisher2, Rebecca Paulus3, Samithra J Mandrekar4, Chandra P Belani5, Frances A Shepherd6, Tim Eisen7, Herbert Pang8, Laurence Collette9, William T Sause10, Suzanne E Dahlberg11, Jeffrey Crawford8, Mary O'Brien12, Steven E Schild4, Mahesh Parmar2, Jayne F Tierney2, Cécile Le Pechoux13
1Meta-analysis Unit, Department of Biostatistics and Epidemiology, Gustave Roussy Institute, Villejuif, France
2MRC Clinical Trials Unit, London, UK
3RTOG Statistical Center, Philadelphia, PA, USA
4Mayo Clinic and North Central Cancer Treatment Group, Rochester, MN, USA
5Penn State Hershey Cancer Institute, Hershey, PA, USA
6Princess Margaret Hospital and NCIC Clinical Trials Group, Toronto, ON, Canada
7Cambridge Biomedical Research Centre, Cambridge, UK
8Cancer and Leukemia Group B Statistical Center, Duke University, Durham, NC, USA
9EORTC Headquarters, Brussels, Belgium
10Intermountain Medical Center, Murray, UT, USA
11Dana-Farber Cancer Institute and Harvard School of Public Health, Boston, MA, USA
12Royal Marsden Hospital, London, UK
13Radiotherapy Department, Gustave Roussy Institute, Villejuif, France

Tài liệu tham khảo

Jemal, 2011, Global cancer statistics, CA Cancer J Clin, 61, 69, 10.3322/caac.20107 D'Addario, 2010, Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up, Ann Oncol, 21, v116, 10.1093/annonc/mdq189 Siegel, 2012, Cancer statistics, 2012, CA Cancer J Clin, 62, 10, 10.3322/caac.20138 Little, 2005, Patterns of surgical care of lung cancer patients, Ann Thorac Surg, 80, 2051, 10.1016/j.athoracsur.2005.06.071 Johnson, 2011, Accelerated approval of oncology products: the food and drug administration experience, J Natl Cancer Inst, 103, 636, 10.1093/jnci/djr062 Rosell, 2012, 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, Lancet Oncol, 13, 239, 10.1016/S1470-2045(11)70393-X Mok, 2009, Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma, N Engl J Med, 361, 947, 10.1056/NEJMoa0810699 Soria, 2010, Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy?, Ann Oncol, 21, 2324, 10.1093/annonc/mdq204 Buyse, 2008, Individual- and trial-level surrogacy in colorectal cancer, Stat Methods Med Res, 17, 467, 10.1177/0962280207081864 1995, Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials, BMJ, 311, 899, 10.1136/bmj.311.7010.899 Auperin, 2010, Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer, J Clin Oncol, 28, 2181, 10.1200/JCO.2009.26.2543 2010, Adjuvant chemotherapy, with or without postoperative radiotherapy, in operable non-small-cell lung cancer: two meta-analyses of individual patient data, Lancet, 375, 1267, 10.1016/S0140-6736(10)60059-1 Le Pechoux, 2008, Individual patient data (IPD) meta-analysis (MA) of chemotherapy (CT) in locally advanced non-small cell lung cancer (NSCLC), J Thorac Oncol, 3, 35IN Mauguen, 2012, Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis, J Clin Oncol, 30, 2788, 10.1200/JCO.2012.41.6677 Burzykowski, 2001, Validation of surrogate end points in multiple randomized clinical trials with failure time end points, J R Stat Soc Ser C Appl Stat, 50, 405, 10.1111/1467-9876.00244 Buyse, 2000, The validation of surrogate endpoints in meta-analyses of randomized experiments, Biostatistics, 1, 49, 10.1093/biostatistics/1.1.49 Sargent, 2005, Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20 898 patients on 18 randomized trials, J Clin Oncol, 23, 8664, 10.1200/JCO.2005.01.6071 Michiels, 2009, Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data, Lancet Oncol, 10, 341, 10.1016/S1470-2045(09)70023-3 Lassere, 2008, Stat Methods Med Res, 17, 303, 10.1177/0962280207082719 Burzykowski, 2006, Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation, Pharm Stat, 5, 173, 10.1002/pst.207 Stone, 2011, Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group, Eur J Cancer, 47, 1763, 10.1016/j.ejca.2011.02.011 Buyse, 2007, Progression-free survival is a surrogate for survival in advanced colorectal cancer, J Clin Oncol, 25, 5218, 10.1200/JCO.2007.11.8836 Burzykowski, 2008, Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer, J Clin Oncol, 26, 1987, 10.1200/JCO.2007.10.8407 Laporte, 2013, Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: evidence from a meta-analysis of 2334 patients from 5 randomised trials, BMJ Open, 3, e001802, 10.1136/bmjopen-2012-001802 Foster, 2011, Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials, Cancer, 117, 1262, 10.1002/cncr.25526 Broglio, 2009, Detecting an overall survival benefit that is derived from progression-free survival, J Natl Cancer Inst, 101, 1642, 10.1093/jnci/djp369 Saad, 2012, Overall survival: patient outcome, therapeutic objective, clinical trial end point, or public health measure?, J Clin Oncol, 30, 1750, 10.1200/JCO.2011.38.6359 2000, Favourable and unfavourable effects on long-term survival of radiotherapy for early breast cancer: an overview of the randomised trials, Lancet, 355, 1757, 10.1016/S0140-6736(00)02263-7