Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer

被引:1072
作者
Miller, KD
Chap, LI
Holmes, FA
Cobleigh, MA
Marcom, PK
Fehrenbacher, L
Dickler, M
Overmoyer, BA
Reimann, JD
Sing, AP
Langmuir, V
Rugo, HS
机构
[1] Indiana Univ, Indianapolis, IN 46202 USA
[2] Univ Calif Los Angeles, Los Angeles, CA USA
[3] Kaiser No Calif, Vallejo, CA USA
[4] Genentech Inc, San Francisco, CA 94080 USA
[5] Univ Calif San Francisco, San Francisco, CA 94143 USA
[6] US Oncol, Houston, TX USA
[7] Rush Presbyterian St Lukes Med Ctr, Chicago, IL 60612 USA
[8] Duke Univ, Durham, NC USA
[9] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
[10] Case Western Univ, Cleveland, OH USA
关键词
ENDOTHELIAL GROWTH-FACTOR; TUMOR ANGIOGENESIS; CARCINOMA; THERAPY; ASSOCIATION; PAMIDRONATE; MARKER;
D O I
10.1200/JCO.2005.05.098
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This randomized phase III trial compared the efficacy and safety of capecitabine with or without bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. Patients and Methods Patients were randomly assigned to receive capecitabine (2,500 mg/m(2)/d) twice daily on day 1 through 14 every 3 weeks, alone or in combination with bevacizumab (15 mg/kg) on day 1. The primary end point was progression-free survival (PFS), as determined by an independent review facility. Results From November 2000 to March 2002, 462 patients were enrolled. Treatment arms were balanced. No significant differences were found in the incidence of diarrhea, hand-foot syndrome, thromboembolic events, or serious bleeding episodes between treatment groups. Of other grade 3 or 4 adverse events, only hypertension requiring treatment (17.9% v 0.5%) was more frequent in patients receiving bevacizumab. Combination therapy significantly increased the response rates (19.8% v 9.1% ; P = .001); however, this did not result in a longer PFS (4.86 v 4.17 months; hazard ratio = 0.98). Overall survival (15.1 v 14.5 months) and time to deterioration in quality of life as measured by the Functional Assessment Of Cancer Treatment-Breast were comparable in both treatment groups. Conclusion Bevacizumab was well tolerated in this heavily pretreated patient population. Although the addition of bevacizumab to capecitabine produced a significant increase in response rates, this did not translate into improved PFS or overall survival. (C) 2005 by American Society of Clinical Oncology
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收藏
页码:792 / 799
页数:8
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