Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study
Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI and fluoropyrimidines in metastatic colorectal cancer: the BEAT study
复制标题
DOI：
10.1093/annonc/mdp233
复制
发表时间：
2009-11-01
影响因子：
50.5
通讯作者：
Cunningham, D.
中科院分区：
文献类型：
--
作者：
Van Cutsem, E.;Rivera, F.;Cunningham, D.
患者和方法：不可切除的mCRC患者接受化疗（医生选择）加贝伐珠单抗[5 mg/kg每2周一次（5-氟尿嘧啶方案）或7.5 mg/kg每3周一次（卡培他滨方案）]。主要终点是安全性，包括在研究期间接受非预期手术的患者的前瞻性数据收集。次要目标是无进展生存期（PFS）和总生存期（OS）。结果：最终分析包括1914名可评估患者（男性58%;中位年龄59岁）。化疗包括5-氟尿嘧啶/亚叶酸（5-FU/LV）+奥沙利铂（29%）、伊立替康+5-FU/LV（26%）、卡培他滨+奥沙利铂（18%）和单药治疗（16%）。贝伐珠单抗关注的严重/3-5级不良事件包括出血（3%）、胃肠道穿孔（2%）、动脉血栓栓塞（1%）、高血压（5.3%）、蛋白尿（1%）和伤口愈合并发症（1%）。60天死亡率为3%。中位PFS为10.8个月[95%置信区间（CI）10.4-11.3个月]，中位OS达到22.7个月（95% CI 21.7-23.8个月）。BEAT研究表明，贝伐珠单抗在常规临床实践中的疗效和安全性特征与前瞻性随机临床试验和另一项大型观察性研究中观察到的结果一致。美国（BRite研究）。
Patients and methods: Patients with unresectable mCRC received chemotherapy (physician's choice) plus bevacizumab [5 mg/kg every 2 weeks (5-fluorouracil regimens) or 7.5 mg/kg every 3 weeks (capecitabine regimens)]. The primary end point was safety, including prospective data collection in patients receiving unanticipated surgery during the study. Secondary objectives were progression-free survival (PFS) and overall survival (OS).Results: The final analysis comprised 1914 assessable patients (male 58%; median age 59 years). Chemotherapy included 5-fluorouracil/leucovorin (5-FU/LV) + oxaliplatin (29%), irinotecan plus 5-FU/LV (26%), capecitabine plus oxaliplatin (18%) and monotherapy (16%). Serious/grade 3-5 adverse events of interest for bevacizumab included bleeding (3%), gastrointestinal perforation (2%), arterial thromboembolism (1%), hypertension (5.3%), proteinuria (1%) and wound-healing complications (1%). Sixty-day mortality was 3%. Median PFS was 10.8 months [95% confidence interval (CI) 10.4-11.3 months] and median OS reached 22.7 months (95% CI 21.7-23.8 months).Conclusions: The BEAT study shows that the efficacy and safety profile of bevacizumab in routine clinical practice is consistent with results observed in prospective randomised clinical trials and another large observational study in the United States (BRiTE study).