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一项针对中国转移性结直肠癌患者使用贝伐单抗作为二线化疗药物持续治疗的单臂临床研究。

A single-arm clinical study of continuous usage of bevacizumab as second-line chemotherapy for Chinese patients with metastatic colorectal cancer.

作者信息

Wang Guojun, Ye Yanwei, Zhang Xiefu, Liu Hongxiang, Song Junmin

机构信息

The Department of Gastrointestinal Surgery, First Affiliated Hospital of Zhengzhou University, 1 Jianshe East Rd, Zhengzhou, 450052, Henan Province, China,

出版信息

Med Oncol. 2015 May;32(5):163. doi: 10.1007/s12032-015-0566-2. Epub 2015 Apr 22.

DOI:10.1007/s12032-015-0566-2
PMID:25895595
Abstract

Recent studies demonstrated that second-line chemotherapy of continuous usage of bevacizumab after initial disease progression improved survivals in Caucasian patients with metastatic colorectal cancer (mCRC). We intended to examine this strategy in Chinese patients specifically. Eligible Chinese mCRC patients had disease progression up to 3 months after receiving first-line bevacizumab-included chemotherapy. They were given IV bevacizumab infusion at 5 mg/kg on day 1 every 2 weeks. The primary endpoint is progression-free survival (PFS). One hundred and fourteen eligible patients received second-line chemotherapy plus bevacizumab. Among them, 56.1 % were male patients and median age was 63.4 years (29-81 years). Median follow-up time is 12 months. Median PFS was 7.3 months (95 % CI 3.9-8.9 months), and median OS was 14.7 months (95 % CI 10.7-18.5 months). No patients had complete responses, but 17 patients had partial response and 75 had stable disease. The safety profiles showed that severe adverse events (grades 3-4), such as nausea, proteinuria and hypertension, were often experienced by Chinese mCRC patients received continuous second-line chemotherapy of bevacizumab. Continuous usage of bevacizumab as second-line chemotherapy for patients with metastatic colorectal cancer in China showed equivalent improvement on patients' survival as Caucasian counterparts.

摘要

近期研究表明,对于转移性结直肠癌(mCRC)的白种人患者,在疾病初始进展后持续使用贝伐单抗进行二线化疗可提高生存率。我们旨在专门针对中国患者研究这一策略。符合条件的中国mCRC患者在接受含贝伐单抗的一线化疗后3个月内出现疾病进展。他们每2周在第1天接受5 mg/kg的静脉注射贝伐单抗。主要终点是无进展生存期(PFS)。114例符合条件的患者接受了二线化疗加贝伐单抗治疗。其中,56.1%为男性患者,中位年龄为63.4岁(29 - 81岁)。中位随访时间为12个月。中位PFS为7.3个月(95%CI 3.9 - 8.9个月),中位总生存期(OS)为14.7个月(95%CI 10.7 - 18.5个月)。没有患者完全缓解,但有17例患者部分缓解,75例病情稳定。安全性分析显示,接受贝伐单抗持续二线化疗的中国mCRC患者经常出现严重不良事件(3 - 4级),如恶心、蛋白尿和高血压。在中国,将贝伐单抗作为转移性结直肠癌患者的二线化疗持续使用,对患者生存的改善与白种人患者相当。

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本文引用的文献

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Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings.贝伐珠单抗联合化疗在既往接受贝伐珠单抗联合化疗治疗的转移性结直肠癌患者中首次进展后继续使用:ML18147 研究 KRAS 亚组结果。
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Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial.贝伐珠单抗治疗转移性结直肠癌(ML18147)一线进展后的延续治疗:一项随机 3 期临床试验
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