Accès gratuit
Numéro
Therapie
Volume 65, Numéro 4, Juillet-Août 2010
Page(s) 367 - 372
Section Pharmacoéconomie / Pharmacoeconomics
DOI https://doi.org/10.2515/therapie/20010041
Publié en ligne 21 septembre 2010
  1. EMEA. Guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 Rev.3/Corr.2, Dec 2005) http://www.ema.europa.eu/pdfs/human/ewp/020595en.pdf [Google Scholar]
  2. FDA. Guidance for industry, clinical trial endpoints for the approval of cancer drugs and biologics (May 2007) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf [Google Scholar]
  3. Mathoulin-Pelissier S, Gourgou-Bourgade S, Bonnetain F, et al. Survival end point reporting in randomized cancer clinical trials: a review of major journals. J Clin Oncol 2008; 26: 3721-6 [CrossRef] [PubMed] [Google Scholar]
  4. Pazdur R. Endpoints for assessing durg activity in clinical trials. Oncologist 2008; 13(suppl2): 19-21 [CrossRef] [PubMed] [Google Scholar]
  5. Pignatti F, Aronso B, Vamvakas S, et al. Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology. Critical Reviews in Oncology/Hematology 2002; 42: 123-35 [CrossRef] [PubMed] [Google Scholar]
  6. Eisenhauer A, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised REGIST guideline (version 1.1). European Journal of Cancer 2009; 45: 228-47 [Google Scholar]
  7. Cheson B, Pfistner B, Juweid ME, et al. Revised response criteria for malignat lymphoma. J Clin Oncol 25: 579-86 [Google Scholar]
  8. Buyse M, Burzykowski T, Caroll K, et al. Progression-free survual is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 2007; 25: 5218-24 [CrossRef] [PubMed] [Google Scholar]
  9. Punt CJ, Buyse M, Köhne CH, et al. Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials. J Natl Cancer Inst 2007; 99: 998-1003 [CrossRef] [PubMed] [Google Scholar]
  10. Sargent D, Wieand H, Haller D, et al. 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 2005; 23: 8664-70 [CrossRef] [PubMed] [Google Scholar]
  11. Tang P, Bentzen S, Chen E, et al. Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 2007; 25: 4562-8 [CrossRef] [PubMed] [Google Scholar]
  12. Hudis C, Barlow W, Costantino J, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: The STEEP system. J Clin Oncol 2007; 25: 2127-32 [CrossRef] [PubMed] [Google Scholar]
  13. Miksad R, Zietemann V, Gothe R, et al. Progression-free survival as a surrogate endpoint in advanced breast cancer. Int J of Technol Assess Health Care 2008; 24 (4): 371-83 [Google Scholar]
  14. Knox J. Progression-free survival as endpoint in metastatic RCC? Comment n°559157 The Lancet Vol 372 August 9, 2008 [Google Scholar]
  15. Freidlin B, Korn E, Hunsberger S, et al. Proposal for the use of progression-free survival in unblinded randomized trial. J Clin Oncol 2007; 25: 2122-6 [CrossRef] [PubMed] [Google Scholar]
  16. Fleming T, Rothman M, Lu H. Issues in using progression-free survival when evaluating oncology product. J Clin Oncol 2009; 27: 2874-80 [CrossRef] [PubMed] [Google Scholar]
  17. Dodd L, Freidlin B, Jaffe C, et al. Blinded independent central review of progression-free srvival in Phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008; 26: 3791-6 [CrossRef] [PubMed] [Google Scholar]