Overall survival and post-progression survival in advanced breast cancer: A review of recent randomized clinical trials

Journal of Clinical Oncology

Volumn 28, Issue 11, 2010, Pages 1958-1962

  Saad, Everardo D ^a   Katz, Artur ^a   Buyse, Marc ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADVANCED CANCER; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER HORMONE THERAPY; CANCER SURVIVAL; HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; BREAST TUMOR; DISEASE FREE SURVIVAL; FEMALE; MORTALITY; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE;

BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SURVIVAL RATE;

EID: 77951642723     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.25.5414     Document Type: Review

References (36)

1. O'Shaughnessy J, Twelves C, Aapro M: Treatment for anthracycline- pretreated metastatic breast cancer. Oncologist 7:4-12, 2002 (suppl 6) (Pubitemid 36008991)
2. Thomas ES, Gomez HL, Li RK, et al: Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25:5210-5217, 2007 (Pubitemid 350232252)
3. Bonneterre J, Buzdar A, Nabholtz JM, et al: Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer 92:2247-2258, 2001
4. Mouridsen H, Gershanovich M, Sun Y, et al: Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: Analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 21:2101-2109, 2003 (Pubitemid 46606358)
5. Slamon DJ, Leyland-Jones B, Shak S, et al: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792, 2001 (Pubitemid 32222155)
6. Marty M, Cognetti F, Maraninchi D, et al: Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: The M77001 study group. J Clin Oncol 23:4265-4274, 2005 (Pubitemid 46207001)
7. Geyer CE, Forster J, Lindquist D, et al: Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355:2733-2743, 2006 (Pubitemid 46021510)
8. Miller K, Wang M, Gralow J, et al: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357:2666-2676, 2007
9. Miles D, Chan A, Romieu G, et al: Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol 26:43s, 2008 (suppl; abstr LBA1011)
10. Robert NJ, Dieras V, Glaspy J, et al: RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab (B) for first-line treatment of HER2-negative locally recurrent or metastatic breast cancer (MBC). J Clin Oncol 27:42s, 2009 (suppl; abstr 1005)
11. Vukelja S, Rugo H, Vogel C, et al: A phase II study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer. Cancer Res 69:33, 2009 (suppl 2)
12. Burstein HJ, Sun Y, Tan AR, et al: Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: Phase 2 results in patients with advanced HER2+ breast cancer. Cancer Res 69:37, 2009 (suppl 2)
13. Bernard-Marty C, Lebrun F, Awada A, et al: Monoclonal antibody-based targeted therapy in breast cancer: Current status and future directions. Drugs 66:1577-1591, 2006 (Pubitemid 44373744)
14. Smith I: Goals of treatment for patients with metastatic breast cancer. Semin Oncol 33:S2-S5, 2006 (suppl 2)
15. Di Leo A, Bleiberg H, Buyse M: Overall survival is not a realistic end point 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 21:2045-2047, 2003
16. Saad ED, Katz A: Progression-free survival and time to progression as primary end points in advanced breast cancer: Often used, sometimes loosely defined. Ann Oncol 20:460-464, 2009
17. Bowater RJ, Bridge LJ, Lilford RJ: The relationship between progression-free and post-progression survival in treating four types of metastatic cancer. Cancer Lett 2007
18. Berruti A, Bitossi R, Gorzegno G, et al: Time to progression in metastatic breast cancer patients treated with epirubicin is not improved by the addition of either cisplatin or lonidamine: Final results of a phase III study with a factorial design. J Clin Oncol 20:4150-4159, 2002 (Pubitemid 35191017)
19. Pacini P, Rinaldini M, Algeri R, et al: FEC (5-fluorouracil, epidoxorubicin and cyclophosphamide) versus EM (epidoxorubicin and mitomycin-C) with or without lonidamine as first-line treatment for advanced breast cancer: A multicentric randomised study - Final results. Eur J Cancer 36:966-975, 2000 (Pubitemid 30316420)
20. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research: Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf
21. Wilcken N, Dear R: Chemotherapy in metastatic breast cancer: A summary of all randomised trials reported 2000-2007. Eur J Cancer 44:2218-2225, 2008
22. Reyno L, Seymour L, Tu D, et al: Phase III study of N,N-diethyl-2-[4- (phenylmethyl) phenoxy] ethanamine (BMS-217380-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA. 19. J Clin Oncol 22:269-276, 2004 (Pubitemid 41095091)
23. Yothers G: Toward progression-free survival as a primary end point in advanced colorectal cancer. J Clin Oncol 25:5153-5154, 2007
24. Buyse M, Burzykowski T, Carroll K, et al: Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 25:5218-5224, 2007 (Pubitemid 350232253)
25. Louvet C, de Gramont A, Tournigand C, et al: Correlation between progression free survival and response rate in patients with metastatic colorectal carcinoma. Cancer 91:2033-2038, 2001 (Pubitemid 32479191)
26. Harvey V, Mouridsen H, Semiglazov V, et al: Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24:4963-4970, 2006 (Pubitemid 46631397)
27. Cvitkovic E: A call for change in anticancer drug evaluation. Eur J Cancer 33:S3-S7, 1997 (suppl 2)
28. 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 26:1987-1992, 2008
29. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP): Appendix 1 to the Guideline on the Evaluation of Anticancer Medicinal Products in Man (CHMP/ewp/205/95 rev. 3): Methodological Considerations for Using Progression-free Survival (PFS) as Primary Endpoint in Confirmatory Trials for Registration. http://www.emea.europa.eu/pdfs/human/ewp/26757506en.pdf
30. Johnson JR, Williams G, Pazdur R: End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1404-1411, 2003 (Pubitemid 46606423)
31. A'Hern RP, Ebbs SR, Baum MB: Does chemotherapy improve survival in advanced breast cancer? A statistical overview. Br J Cancer 57:615-618, 1988
32. Hackshaw A, Knight A, Barrett-Lee P, et al: Surrogate markers and survival in women receiving first-line combination anthracycline chemotherapy for advanced breast cancer. Br J Cancer 93:1215-1221, 2005 (Pubitemid 41679406)
33. 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 24:371-383, 2008
34. 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 99:1572-1578, 2008
35. von Minckwitz G, du Bois A, Schmidt M, et al: Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: A German Breast Group 26/Breast International Group 03-05 study. J Clin Oncol 27:1999-2006, 2009
36. O'Shaughnessy J, Osborne C, Pippen J, et al: Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial. J Clin Oncol 27:6s, 2009 (suppl; abstr 3)