Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients
Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients
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DOI：
10.1158/1078-0432.ccr-05-2603
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发表时间：
2006-05-15
影响因子：
11.5
通讯作者：
Shapiro, Charles L.
中科院分区：
文献类型：
--
作者：
Ramaswamy, Bhuvaneswari;Elias, Anthony D.;Shapiro, Charles L.
目的：为了评估贝伐单抗和每周多西他赛作为一线或二线治疗转移性乳腺癌（MBC）患者的安全性和有效性，患者和方法：27例MBC患者接受静脉注射贝伐单抗10 mg/kg，第1天和第15天，联合静脉注射多西他赛35 mg/m2，第1天，第8天和第15天，28天为一个周期。主要终点是评估毒性、总缓解率和无进展生存期。一个次要终点是评估血浆内皮细胞和细胞粘附标记物和临床outcomes.Results之间的关系：一百五十八个治疗周期的中位数为6个周期（范围1-15个周期）每例患者。每例患者最常见的4级毒性如下：2例（7%）-肺栓塞，1例（4%）-发热性中性粒细胞减少症和1例（4%）-感染; 3级毒性为4例（15%）-中性粒细胞减少症，4例（15%）-疲乏，2例（7%）-神经病变，2例（7%）-尿道闭锁，2例（7%）-口腔炎，1例（7%）-胸腔积液，高血压1例（4%）。总体缓解率为52% [95%置信区间（95% CI），32-71%]，中位缓解持续时间为6.0个月（95% CI，4.6-6.5个月），中位无进展生存期为7.5个月（95% CI，6.2-8.3个月）。在假设生成的单变量和有限的多变量分析，E-选择素是统计学上显着相关的响应combination.Conclusion：贝伐单抗与每周多西他赛的组合是积极的MBC可接受的毒性。评估E-选择素作为含贝伐珠单抗化疗反应标志物的其他研究是必要的。
Purpose: To evaluate the safety and efficacy of bevacizumab and weekly docetaxel as first- or second-line therapy in patients with metastatic breast cancer (MBC).Patients and Methods: Twenty-seven MBC patients received i.v. bevacizumab at 10 mg/kg on days 1 and 15 in combination with i.v. docetaxel 35 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. Primary end points were to assess toxicity, overall response rate, and progression-free survival. A secondary end point was to assess the relationship between plasma endothelial and cell adhesion markers and clinical outcomes.Results: One-hundred fifty-eight treatment cycles were administered with a median of six cycles (range 1-15 cycles) per patient. The most common grade 4 toxicities per patient were as follows: 2 (7%)-pulmonary embolus, 1 (4%)-febrile neutropenia, and 1 (4%)-infection; grade 3 toxicities were 4 (15%)-neutropenia, 4 (15%)-fatigue, 2 (7%)-neuropathy, 2 (7%)-athralgias, 2 (7%)-stomatitis, 1 (7%)-pleural effusion, and 1 (4%)-hypertension. The overall response rate was 52% [95% confidence interval (95% CI), 32-71%], median response duration was 6.0 months (95% Cl, 4.6-6.5 months), and the median progression-free survival was 7.5 months (95% Cl, 6.2-8.3 months). In hypothesis-generating univariate and limited multivariate analyses, E-selectin was statistically significantly associated with response to the combination.Conclusion: Bevazicumab in combination with weekly docetaxel is active with acceptable toxicities in MBC. Additional studies evaluating E-selectin as a marker of response to bevacizumab-containing chemotherapy are warranted.