Randomized Phase III Trial of Capecitabine Compared With Bevacizumab Plus Capecitabine in Patients With Previously Treated Metastatic Breast Cancer

医学 卡培他滨 贝伐单抗 转移性乳腺癌 内科学 危险系数 不利影响 临床终点 乳腺癌 人口 随机对照试验 紫杉烷 癌症 肿瘤科 外科 化疗 置信区间 结直肠癌 环境卫生
作者
Kathy D. Miller,Linnea Chap,Frankie A. Holmes,Melody A. Cobleigh,P. Kelly Marcom,Louis Fehrenbacher,Maura N. Dickler,Beth Overmoyer,James D. Reimann,Amy P. Sing,Virginia K. Langmuir,Hope S. Rugo
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:23 (4): 792-799 被引量:1310
标识
DOI:10.1200/jco.2005.05.098
摘要

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 were randomly assigned to receive capecitabine (2,500 mg/m2/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.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.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.

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