Weekly Paclitaxel, Capecitabine, and Bevacizumab With Maintenance Capecitabine and Bevacizumab as First-Line Therapy for Triple-Negative, Metastatic, or Locally Advanced Breast Cancer: Results From the GINECO A-TaXel Phase 2 Study
Weekly Paclitaxel, Capecitabine, and Bevacizumab With Maintenance Capecitabine and Bevacizumab as First-Line Therapy for Triple-Negative, Metastatic, or Locally Advanced Breast Cancer: Results From the GINECO A-TaXel Phase 2 Study
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DOI：
10.1002/cncr.30170
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发表时间：
2016-10-15
期刊：
影响因子：
6.2
通讯作者：
Largillier, Remy
中科院分区：
文献类型：
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作者：
Ferrero, Jean-Marc;Hardy-Bessard, Anne-Claire;Largillier, Remy
背景技术背景：本研究旨在确定贝伐珠单抗、紫杉醇和卡培他滨一线联合治疗三阴性局部晚期/转移性乳腺癌（LA/MBC）的疗效和安全性。方法：患有可测量的三阴性LA/MBC且既往未接受过化疗的患者接受4周一周期的紫杉醇治疗（80 mg/m2，第1、8和15天，最多6个周期）联合卡培他滨（800 mg/m2，每日两次，第1 - 5、8 - 12和1-5 - 19天）和贝伐单抗（10 mg/kg，第1和14天），每4周重复一次，直至疾病进展或出现不可接受的毒性。主要终点是客观缓解率;次要终点是无进展生存期、缓解持续时间、总生存期和安全性。结果：2010年4月至2012年3月，62例合格患者入组。患者的中位年龄为57岁，74%接受过辅助化疗，65%有内脏转移。患者接受了中位6个周期（范围，1 - 45个周期）。客观缓解率为77%（95%置信区间[95% CI] 66%-88%），包括19%的患者完全缓解。中位缓解持续时间为5.6个月（范围：1.3 - 27.6个月）。中位无进展生存期为7.6个月（95% CI，6.3 - 9.0个月），中位总生存期为19.2个月（95% CI，17.4 - 20.9个月）。最常见的≥ 3级不良事件是高血压（35%的患者）和中性粒细胞减少症（23%的患者）; 5%的患者发生发热性中性粒细胞减少症。>= 2级手足综合征、脱发和指甲毒性各有40%的患者发生（在每个周期前记录不良事件，并根据不良事件通用术语标准[4.0版]分级）。22%的患者因毒性而中断治疗。结论：紫杉醇、卡培他滨和贝伐珠单抗三联治疗方案，随后卡培他滨和贝伐珠单抗维持治疗，在该难治性人群中显示出高活性和可管理的安全性。(C)2016美国癌症协会
BACKGROUND: The current study was performed to determine the efficacy and safety of first-line combination therapy with bevacizumab, paclitaxel, and capecitabine for triple-negative, locally advanced/metastatic breast cancer (LA/MBC). METHODS: Patients with measurable triple-negative LA/MBC who had received no prior chemotherapy for their disease received 4-weekly cycles of paclitaxel (80 mg/m(2) on days 1, 8, and 15 for up to 6 cycles) combined with capecitabine (800 mg/m(2) twice daily on days 1-5, 8-12, and 15-19) and bevacizumab (10 mg/kg on days 1 and 14) repeated every 4 weeks until disease progression or unacceptable toxicity occurred. The primary endpoint was the objective response rate; secondary endpoints were progression-free survival, duration of response, overall survival, and safety. RESULTS: Between April 2010 and March 2012, 62 eligible patients were enrolled. The median age of the patients was 57 years, 74% had received adjuvant chemotherapy, and 65% had visceral metastases. Patients received a median of 6 cycles (range, 1-45 cycles). The objective response rate was 77% (95% confidence interval [95% CI] 66%-88%), including complete response in 19% of patients. The median duration of response was 5.6 months (range, 1.3-27.6 months). The median progression-free survival was 7.6 months (95% CI, 6.3-9.0 months) and the median overall survival was 19.2 months (95% CI, 17.4-20.9 months). The most common grade >= 3 adverse events were hypertension (35% of patients) and neutropenia (23% of patients); 5% of patients experienced febrile neutropenia. Grade >= 2 hand-foot syndrome, alopecia, and nail toxicity each occurred in 40% of patients (adverse events were recorded before every cycle and graded according to Common Terminology Criteria for Adverse Events [version 4.0]). Treatment was interrupted because of toxicity in 22% of patients. CONCLUSIONS: A triplet regimen of paclitaxel, capecitabine, and bevacizumab followed by maintenance therapy with capecitabine and bevacizumab demonstrated high activity and manageable safety in this difficult-to-treat population. (C) 2016 American Cancer Society.