Progression-free survival as a potential surrogate for overall survival in metastatic breast cancer

OncoTargets and Therapy

Volumn 7, Issue , 2014, Pages 1101-1110

  Beauchemin, Catherine ^a   Cooper, Dan ^b   Lapierre, Marie Ève ^a   Yelle, Louise ^c   Lachaine, Jean ^a  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

^b Institut National d'Excellence en Sante et en Services Sociaux INESSS   (Canada)

^c CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

Metastatic breast cancer; Progression free survival; Surrogate endpoint; Time to progression

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER SURVIVAL; DISEASE COURSE; HUMAN; INCIDENCE; LIFE EXPECTANCY; OVERALL SURVIVAL; POST PROGRESSION SURVIVAL; PROGRESSION FREE SURVIVAL; QUALITY ADJUSTED LIFE YEAR; SYSTEMATIC REVIEW; TIME TO PROGRESSION; TREATMENT OUTCOME;

EID: 84902997548     PISSN: 11786930     EISSN: None     Source Type: Journal    
DOI: 10.2147/OTT.S63302     Document Type: Article

References (25)

1. Zhuang SH, Xiu L, Elsayed YA. Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Cancer J. 2009;15(5): 395-400.
2. Driscoll JJ, Rixe O. Overall survival: still the gold standard: why overall survival remains the definitive end point in cancer clinical trials. Cancer J. 2009;15(5):401-405.
3. Lebwohl D, Kay A, Berg W, Baladi JF, Zheng J. Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development. Cancer J. 2009;15(5):386-394.
4. Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010;28(11):1958-1962.
5. Saad ED. Endpoints in advanced breast cancer: methodological aspects and clinical implications. Indian J Med Res. 2011;134:413-418.
6. Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst. 2010;102(4):230-243.
7. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21(7):1404-1411.
8. US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evalation and Research (CBER). Guidance for Industry. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Rockville (MD): Food and Drug Administration (FDA); 2007. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. Accessed March 30, 2012.
9. Hughes MD. Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer. Stat Methods Med Res. 2008;17(5):487-495.
10. Sherrill B, Kaye JA, Sandin R, Cappelleri JC, Chen C. Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology. Onco Targets Ther. 2012;5:287-296.
11. Davis S, Tappenden P, Cantrell A. A Review of Studies Examining the Relationship between Progression-Free Survival and Overall Survival in Advanced or Metastatic Cancer. Sheffield: Decision Support Unit, ScHARR, University of Sheffield; 2012. Available from: http://www.nicedsu.org.uk/PFSOS%20Report.FINAL.06.08.12.pdf. Accessed March 30, 2012.
12. Saad ED, Katz A, Hoff PM, Buyse M. Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature. Ann Oncol. 2010;21(1):7-12.
13. Olivo SA, Macedo LG, Gadotti IC, Fuentes J, Stanton T, Magee DJ. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther. 2008;88(2):156-175.
14. Swinscow TDV, Campbell MJ. Statistics at Square One, ninth edition. Section 11. Correlations and regressions [webpage on the Internet]. London: BMJ Publishing Group Ltd; 1997. Available from: http://www.bmj.com/about-bmj/resources-readers/publications/statistics-square one/11-correlation-and-regression. Accessed November 30, 2011.
15. Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst. 2009;101(23):1642-1649.
16. Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E; ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23 Suppl 7:vii11-vii19.
17. Hackshaw A, Knight A, Barrett-Lee P, Leonard R. Surrogate markers and survival in women receiving first-line combination anthracycline chemotherapy for advanced breast cancer. Br J Cancer. 2005;93(11): 1215-1221.
18. Sherrill B, Amonkar M, Wu Y, et al. Relationship between effects on time-to-disease progression and overall survival in studies of metastatic breast cancer. Br J Cancer. 2008;99(10):1572-1578.
19. Miksad RA, Zietemann V, Gothe R, et al. Progression-free survival as a surrogate endpoint in advanced breast cancer. Int J Technol Assess Health Care. 2008;24(4):371-383.
20. Burzykowski T, Buyse M, Piccart-Gebhart MJ, et al. 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. 2008;26(12):1987-1992.
21. Matsubara Y, Sakabayashi S, Nishimura T, et al. Surrogacy of tumor response and progression-free survival for overall survival in metastatic breast cancer resistant to both anthracyclines and taxanes. Int J Clin Oncol. 2011;16(6):623-629.
22. Daniels MJ, Hughes MD. Meta-analysis for the evaluation of potential surrogate markers. Stat Med. 1997;16(17):1965-1982.
23. Gail MH, Pfeiffer R, Van Houwelingen HC, Carroll RJ. On meta analytic assessment of surrogate outcomes. Biostatistics. 2000;1(3): 231-246.
24. Buyse M. Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials. Cancer J. 2009;15(5): 421-425.
25. Buyse M, Molenberghs G, Burzykowski T, Renard D, Geys H. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics. 2000;1(1):49-67.