Assessment of progression-free survival as a surrogate end-point for overall survival in patients with metastatic renal cell carcinoma

European Journal of Cancer

Volumn 50, Issue 10, 2014, Pages 1766-1771

  Negrier S ^a   Bushmakin, A G ^b   Cappelleri, J C ^b   Korytowsky, B ^b   Sandin, R ^b   Charbonneau, C ^b   Michaelson, M D ^c   Figlin, R A ^d   Motzer, R J ^e  

^a UNIVERSITÉ DE LYON   (France)

^b PFIZER INC   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^d CEDARS SINAI MEDICAL CENTER   (United States)

^e MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Overall survival; Progression free survival; Renal cell carcinoma; Sunitinib; Surrogate end point

Indexed keywords

ALPHA INTERFERON; SUNITINIB;

ARTICLE; CANCER SURVIVAL; CANCER THERAPY; DISEASE MARKER; HUMAN; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SENSITIVITY ANALYSIS; TREATMENT DURATION;

OVERALL SURVIVAL; PROGRESSION-FREE SURVIVAL; RENAL CELL CARCINOMA; SUNITINIB; SURROGATE END-POINT;

ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; ENDPOINT DETERMINATION; HUMANS; INDOLES; INTERFERON-ALPHA; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MULTICENTER STUDIES AS TOPIC; PYRROLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84901797987     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2014.03.012     Document Type: Article

References (30)

1. K.R. Broglio, and D.A. Berry Detecting an overall survival benefit that is derived from progression-free survival J Natl Cancer Inst 101 2009 1642 1649
2. A. Di Leo, H. Bleiberg, and M. Buyse Overall survival is not a realistic endpoint for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer J Clin Oncol 21 2003 2045 2047
3. F. Fleischer, B. Gaschler-Markefski, and E. Bulhmki A statistical model for the dependence between progression-free survival and overall survival Stat Med 28 2009 2669 2686
4. K. Shitara, J. Ikeda, T. Yokota, D. Takahari, T. Ura, and K. Muro et al. Progression-free survival and time to progression as surrogate markers of overall survival in patients with advanced gastric cancer: analysis of 36 randomized trials Invest New Drugs 30 2012 1224 1231
5. N.R. Foster, Y. Qi, and Q. Shi et al. 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 2011 1262 1271
6. R.A. Miksad, V. Zietemann, and R. Gothe et al. Progression-free survival as a surrogate endpoint in advanced breast cancer Int J Technol Assess Health Care 24 2008 371 383
7. M. Buyse, T. Burzykowski, and K. Carroll et al. Progression-free survival is a surrogate for survival in advanced colorectal cancer J Clin Oncol 25 2007 5218 5224
8. C. Giessen, R.P. Laubender, and D.P. Ankerst et al. Progression-free survival as a surrogate endpoint for median overall survival in mCRC: literature-based analysis from 50 randomized first-line trials Clin Cancer Res 19 2013 225 235
9. P.A. Tang, S.M. Bentzen, E.X. Chen, and L.L. Siu 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 25 2007 4562 4568
10. T.E. Delea, A. Khuu, D.Y.C. Heng, T. Haas, and D. Soulières Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma Br J Cancer 107 2012 1059 1068
11. D.Y.C. Heng, W. Xie, and G.A. Bjarnason et al. Progression-free survival as a predictor of overall survival in metastatic renal cell carcinoma treated with contemporary targeted therapy Cancer 117 2011 2637 2642
12. B. Escudier, A. Pluzanska, and P. Koralewski et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial Lancet 370 2007 2103 2111
13. R.J. Motzer, T.E. Hutson, and P. Tomczak et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma N Engl J Med 356 2007 115 124
14. R.J. Motzer, B. Escudier, and S. Oudard et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial Lancet 372 2008 449 456
15. B.I. Rini, S. Halabi, and J.E. Rosenberg et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206 J Clin Oncol 26 2008 5422 5428
16. B.J. Escudier, J. Bellmunt, and S. Negrier et al. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival J Clin Oncol 28 2010 2144 2150
17. C.N. Sternberg, I.D. Davis, and J. Mardiak et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial J Clin Oncol 28 2010 1061 1068
18. A. de Gramont, J. Hubbard, and Q. Shi et al. Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set J Clin Oncol 28 2010 460 465
19. R.J. Motzer, T.E. Hutson, and P. Tomczak et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma J Clin Oncol 27 2009 3584 3590
20. D.G. Kleinbaum, and M. Klein Survival analysis: a self-learning text 3rd ed. 2012 Springer Science+Business Media New York, NY
21. D.-G. Chen, J. Sun, and K.E. Peace Interval-censored time-to-event data: methods and applications 2013 Chapman & Hall/CRC Press Boca Raton, Florida
22. E.L. Kaplan, and P. Meier Non-parametric estimation from incomplete observations J Am Stat Assoc 53 1958 457 481
23. M. Milella, F. Massari, and F. LaRussa et al. PFS to predict long-term OS after first-line treatment for advanced renal cell carcinoma (aRCC): correlation and power analysis of randomized trials (RCT) J Clin Oncol 30 Suppl.; abstr. 4541 2012
24. P.G. Rose, C. Tian, and M.A. Bookman Assessment of tumor response as a surrogate endpoint of survival in recurrent/platinum-resistant ovarian carcinoma: a Gynecologic Oncology Group study Gynecol Oncol 117 2010 324 329
25. R.L. Prentice Surrogate endpoints in clinical trials: definition and operational criteria Stat Med 8 1989 431 440
26. B. Sherrill, J.A. Kaye, R. Sandin, J.C. Cappelleri, and C. Chen Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology Onco Targets Ther 5 2012 287 296
27. L. Zhang, C.-W. Ko, S. Tang, and R. Sridhara Relationship between progression-free survival and overall survival benefit: a simulation study Ther Innov Regul Sci 47 2013 95 100
28. C. Ferté, S. Koscielny, and L. Albiges et al. Tumor growth rate provides useful information to evaluate sorafenib and everolimus treatment in metastatic renal cell carcinoma patients: an integrated analysis of the TARGET and RECORD phase 3 trial data Eur Urol 2013 [Epub ahead of print]
29. G. Hudes, M. Carducci, and P. Tomczak et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma N Engl J Med 356 2007 2271 2281
30. R.J. Motzer, C.H. Barrios, and T.M. Kim et al. Record-3: phase II randomized trial comparing sequential first-line everolimus (EVE) and second-line sunitinib (SUN) versus first-line SUN and second-line EVE in patients with metastatic renal cell carcinoma (mRCC) J Clin Oncol 31 Suppl.; abstr. 4504 2013