|
Sub-category:
Metastatic Breast Cancer
Category:
Breast Cancer--Metastatic Breast Cancer
Meeting:
2009 ASCO Annual Meeting
Abstract No:
1020
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 1020)
Author(s):
W. Tan, J. Allred, M. Salim, P. Flynn, J. W. Kugler, P. J. Stella, M. Wiesenfeld, A. M. Bernath, T. R. Fitch, E. A. Perez; Mayo Clinic Florida, Jacksonville, FL; Mayo Clinic, Rochester, MN; Saskatchewan Cancer Foundation, Saskatchewan, SK, Canada; Metro Minnesota Community Clinical Oncology Program, St. Louis Park, MN; Illinois Oncology Research Assn, Peroia, IL; Michigan Cancer Research Consortium, Ann Arbor, MI; Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA; Geisinger Clinic & Medical Center CCOP, Danville, PA; Mayo Arizona Scottsdale, Scottsdale, AZ; Mayo Clinic, Jacksonville, FL
Abstract:
Background: Trastuzumab-containing regimes have dramatically improved outcome of patients with HER2+ breast cancer. Efforts to improve efficacy and tolerability of combination regimens with this monoclonal antibody are important for patient care. Thus, we conducted a multi-institutional phase II study of a triplet combination in patients eligible to receive either first- or second-line treatment for HER2+ metastatic breast cancer (MBC). Methods: A phase II study designed to test that the true confirmed response rate (CRR) was at most 45% versus a true CRR of at least 65% was done (March 2005-June 2008). This design required that at least 25/45 confirmed responses in evaluable patients for the treatment to be considered promising. Patients received capecitabine 825 mg/m2 po (days 1-14), vinorelbine intravenously (IV) 25 mg/m2 days 1 and 8 every 3 weeks and trastuzumab IV 8mg/kg day 1, week 1, and then 6 mg/kg q 3 weeks. Tissue and blood have been collected for future studies on biomarkers. Results: 47 women were accrued, one patient cancelled participation prior to receiving any study drug, and another had a major protocol violation. 45 patients were evaluable and 30 (67%) achieved a confirmed response, (26 patients, 58% had a confirmed partial response and 4 patients, 9% had a confrimed complete response). Median progression free survival was 11.3 months (95% CI 8.4-23.2 months), median overall survival was 27.2 months (95% CI: 26.6-NA months), and among the 30 responders, the median duration of response time was 15.5 months (95% 7.7-26.1 months). The most common grade 3 events include neutropenia 61%, fatigue 13%, skin reaction-hand-foot 11%, and leukopenia 11%. Alopecia was not noted with this regimen. Conclusions: This triplet combination is effective, safe, and is promising in patients with HER2+ MBC. A phase III study should be conducted to compare the best doublet with this triplet combination whether this would lead to better clinical outcomes.
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 W. Tan:
Presentations by W. Tan:
Educational Book Manuscripts by W. Tan:
|
