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Sub-category:
Metastatic Breast Cancer
Category:
Breast Cancer--Metastatic Breast Cancer
Meeting:
2009 ASCO Annual Meeting
Abstract No:
1005
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 1005)
Author(s):
N. J. Robert, V. Dieras, J. Glaspy, A. Brufsky, I. Bondarenko, O. Lipatov, E. Perez, D. Yardley, X. Zhou, S. Phan; Fairfax-Northern Virginia Hematology-Oncology, Fairfax, VA; Institut Curie, Paris, France; UCLA TORI, Los Angeles, CA; University of Pittsburgh, Pittsburgh, PA; State Medical Academy, Dnipropetrovsk, Ukraine; Bashkirian Republican Clinical Oncology, Ufa, Russian Federation; Mayo Clinic, Jacksonville, FL; Sarah Cannon Cancer Center, Nashville, TN; Genentech, Inc., South San Francisco, CA
Abstract:
Background: B in combination with weekly paclitaxel or docetaxel (D) as 1st-line therapy for MBC has improved progression-free survival (PFS) compared with the respective taxane alone in two large Phase III trials. This study investigated the addition of B to standard 1st-line chemotherapy regimens for MBC.
Methods: Patients were randomized in 2:1 ratio to receive B + chemotherapy or placebo (pl) + chemotherapy. Prior to randomization, investigators chose capecitabine (Cap) (2000 mg/m² x 14d), taxane (T) (nab-paclitaxel [260 mg/m²] or D [75 or 100 mg/m²], q3wk), or anthracycline (Ant)-based chemotherapy (q3wk). B or pl was administered at 15 mg/kg q3wk. Key eligibility criteria included MBC or locally-recurrent disease, no prior cytotoxic treatment, ECOG PS 0 or 1, HER2-negative disease and no CNS metastases. The primary endpoint was investigator-assessed PFS. Secondary endpoints included overall survival (OS), objective response rate (ORR), independent review of PFS, and safety. At progression, all patients were eligible for B with 2nd line chemotherapy. The Cap cohort and the pooled T or Ant (T + Ant) cohort were independently powered and analyzed in parallel using two-sided stratified log-rank test (Cap: 80% power to detect HR=0.75; T + Ant: 90% power to detect HR=0.7).
Results: RIBBON-1 enrolled 1237 patients (Cap, 615; T, 307; Ant, 315) from 12/05 to 8/07 in 22 countries with a median follow-up of 15.6 months in the Cap cohort and 19.2 months in the T + Ant cohort. The results are summarized below. OS data are limited with only 33% of events. Safety was consistent with results of prior B trials.
Conclusions: The addition of B to Cap, T; or Ant-based chemotherapy regimens used in 1st-line treatment of MBC resulted in statistically-significant improvement in PFS with a safety profile comparable to prior Phase III studies.
| | Cap (n=615) | | T + Ant (n=622) | | | Pl (n=206) | B (n=409) | Pl (n=207) | B (n=415) |
| | PFS, HR (95% CI) |
0.688 (0.564, 0.840) | |
0.644 (0.522, 0.795) | | | Log-rank p-value | 0.0002 | | <0.0001 | |
| Median (months) | 5.7 |
8.6 | 8.0 |
9.2 | | ORR* (%) | 38 (23.6) | 115 (35.4) | 67 (37.9) | 177 (51.3) | | p-value | 0.0097 | | 0.0054 | | | OS, HR ( 95% CI) | 0.847 (0.631, 1.138) | | 1.032 (0.774, 1.376) | | | Log-rank p-value | 0.2706 | | 0.8298 | | | Median (months) | 21.2 | 29.0 | 23.8 | 25.2 |
| | HR=hazard ratio. * Includes only patients with measurable disease at baseline. |
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by N. J. Robert:
Presentations by N. J. Robert:
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1. Discussing Costs of Care with Patients: The Community Oncology Perspective
Meeting:
2009 ASCO Annual Meeting
Speaker:
Nicholas J. Robert, MD
Session:
Discussing the Cost of Care with Patients with Cancer: What Can We Tell Them? What Is the Goal?
(Education Session)
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2. 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).
Meeting:
2009 ASCO Annual Meeting
Presenter:
Nicholas J. Robert, MD
Session:
Breast Cancer - Metastatic
(Oral Presentation)
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3. Fellows, Residents, Trainees, and Junior Faculty Breakfast
Meeting:
2008 Breast Cancer Symposium
Speaker:
Nicholas J. Robert, MD
Session:
Fellows, Residents, Trainees, and Junior Faculty Breakfast
(Special Session)
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More...
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Educational Book Manuscripts by N. J. Robert:
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