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一线化疗联合贝伐单抗治疗转移性结直肠癌患者的根治性手术——首项BEAT研究及随机III期NO16966试验

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.

作者信息

Okines A, Puerto O Del, Cunningham D, Chau I, Van Cutsem E, Saltz L, Cassidy J

机构信息

Department of Medicine, The Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, UK.

出版信息

Br J Cancer. 2009 Oct 6;101(7):1033-8. doi: 10.1038/sj.bjc.6605259.

Abstract

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.

摘要

背景

对部分转移性结直肠癌患者而言,完整切除转移灶可实现治愈。

方法

首先,BEAT研究评估了1914例患者使用贝伐单抗联合一线化疗的安全性。对前瞻性收集的225例行根治性手术患者的数据进行分析,包括对接受不同治疗方案患者的切除率进行探索性比较。NO16966研究比较了1400例患者使用含奥沙利铂化疗联合贝伐单抗或安慰剂的疗效。对切除率进行回顾性分析。

结果

在BEAT研究中,1914例患者中有225例(11.8%)在最后一剂贝伐单抗后中位64天(范围42 - 100天)接受了根治性手术。225例患者中有173例(76.9%)实现了R0切除。无手术相关死亡,严重术后并发症不常见,3/4级出血和伤口愈合事件的报告率分别为0.4%和1.8%。接受含奥沙利铂联合化疗的患者切除率最高(P = 0.002),可能受患者选择因素影响。在NO16966研究中,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转移灶切除术(P = 0.24)。

结论

BEAT研究中严重术后并发症发生率与未使用贝伐单抗的历史对照相当。在NO16966研究中,接受贝伐单抗与安慰剂治疗的患者在切除率或总生存方面无统计学显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc88/2768086/dacd4d628f7a/6605259f1.jpg

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