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Surgery with curative-intent in patients treated with first-line chemotherapy plus bevacizumab for metastatic colorectal cancer First BEAT and the randomised phase-III NO16966 trial

机译:一线化疗加贝伐单抗治疗转移性结直肠癌患者的根治性手术First BEAT和III期随机试验

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摘要

BACKGROUND: Complete resection of metastases can result in cure for selected patients with metastatic colorectal cancer. METHODS: First BEAT evaluated the safety of bevacizumab with first-line chemotherapy in 1914 patients. Prospectively collected data from 225 patients who underwent curative-intent surgery were analysed, including an exploratory comparison of resection rate in patients treated with different regimens. NO16966 compared efficacy of oxaliplatin-based chemotherapy plus bevacizumab or placebo in 1400 patients. A retrospective analysis of resection rate was undertaken. RESULTS: In First BEAT, 225 out of 1914 patients (11.8%) underwent curative-intent surgery at median 64 days (range 42-100) after the last dose of bevacizumab. R0 resection was achieved in 173 out of 225 patients (76.9%). There were no surgery-related deaths and serious post-operative complications were uncommon, with grade 3/4 bleeding and wound-healing events reported in 0.4% and 1.8%, respectively. Resection rates were highest in patients receiving oxaliplatin-based combination chemotherapy (P=0.002), possibly confounded by patient selection. In NO16966, 44 out of 699 patients treated with bevacizumab (6.3%) and 34 out of 701 patients treated with placebo (4.9%) underwent R0 metastasectomy (P=0.24). CONCLUSIONS: The rate of serious post-operative complications in First BEAT was comparable to historical controls without bevacizumab. In NO16966, there were no statistically significant differences in resection rates or overall survival in patients treated with bevacizumab vs placebo.
机译:背景:转移瘤的完全切除可以治愈部分转移性结直肠癌患者。方法:First BEAT在1914例患者中评估了贝伐单抗联合一线化疗的安全性。分析了从225例接受根治性手术的患者中收集的前瞻性数据,包括对采用不同方案治疗的患者的切除率进行的探索性比较。 NO16966比较了以奥沙利铂为基础的化疗加贝伐单抗或安慰剂治疗1400例患者的疗效。对切​​除率进行回顾性分析。结果:在First BEAT中,1914名患者中的225名(11.8%)在最后一次服用贝伐单抗后的中位数64天(范围42-100)进行了根治性手术。 225例患者中有173例(76.9%)达到了R0切除。没有与手术相关的死亡,严重的术后并发症也很少见,报道的3/4级出血和伤口愈合事件分别为0.4%和1.8%。在接受以奥沙利铂为基础的联合化疗的患者中,切除率最高(P = 0.002),可能与患者选择混淆。在NO16966中,接受贝伐单抗治疗的699例患者中有44例(6.3%),接受安慰剂治疗的701例患者中有34例(4.9%)接受了R0转移切除术(P = 0.24)。结论:First BEAT术后严重并发症的发生率与无贝伐单抗的历史对照组相当。在NO16966中,接受贝伐单抗和安慰剂治疗的患者在切除率或总生存率上无统计学差异。

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