摘要
目的评价贝伐单抗在晚期结直肠癌患者维持治疗中的有效性和安全性,并根据现有证据优选出最佳维持治疗方案.方法电子检索Cochrane图书馆临床对照试验资料库、MEDLINE(1994/2016-08)、中国生物医学文献数据库(CBM,1978/2016.08)、中文科技期刊全文数据库(CNKI,1994/2016-08)根据纳入排除标准进一步筛选文献,纳入文献均为随机对照试验,试验组贝伐单抗联用化疗或其他靶向药,对照组单用化疗加或不加安慰剂,单用贝伐单抗;或贝伐单抗联用不同药物之间疗效比较.按照Cochrane系统评价员手册5.0版推荐的质量评价标准对纳入研究进行质量学评价.并应用RevMan5.0软件进行统计分析.结果共纳入8篇文献,均为平行随机对照试验,均未提及实施分配隐藏.1篇报道采用了盲法.均报道了脱落失访,并行意向性分析,所有文献对生存期及安全性进行比较,化疗联合贝伐单抗组对比化疗组中位无进展生存期(progression free survival,PFS)、中位总生存期(overall survival,OS)均有延长,PFS(HR=0.76,95%CI:0.64-0.90),OS(HR=0.82,95%CI:0.74-0.89);XELOX方案(卡培他滨、5-氟尿嘧啶、奥沙利铂)联合贝伐单抗化疗6 wk后,分为XELOX联合贝伐单抗组、卡培他滨联合贝伐单抗组,PFS(HR=1.68,95%CI:1.21-2.35)、OS(HR=1.38,95%CI:0.91-2.08);应用标准一线化疗方案联合贝伐单抗进展后,二线化疗方案联合贝伐单抗维持治疗对比化疗维持组更具生存优势,PFS(HR=0.76,95%CI:0.69-0.83)、OS(HR=0.83,95%CI:0.72-0.95).化疗联合贝伐单抗3-4级不良反应增加(RR=1.19,95%CI:1.11-1.28).结论贝伐单抗联合化疗在转移性结直肠癌维持治疗中可以提高患者PFS、OS,但同时3-4级不良反应增加.
AIM To perform a meta-analysis to evaluate the efficacy and safety of bevacizumab in the maintenance treatment of colorectal cancer.METHODS Literature retrieval was conducted by searching Cochrane Controlled Trials Register （CCTR）, MEDLINE （1994-August 2016）, Chinese Biomedical database （1978-August 2016） and CNKI （1994-August 2016）. The quality of included articles was assessed based on the approach commended by the International Cochrane Collaboration. Statistical analysis was performed using RevMan5.0 software.Eight randomized controlled clinical trials were included, but concealed allocation was not mentioned in all of them. Although loss to follow-up was reported and intention-to- treat analysis was conducted in all the included articles, blinding method was covered only in one paper. Compared with chemotherapy alone, chemotherapy combined with bevacizumab was associated with prolonged progression free survival （PFS; HR = 0.76, 95%CI： 0.64-0.90） and median overall survival （OS; HR = 0.82, 95%CI： 0.74-0.89）. After six cycles of XELOX （capecitabine, oxaliplatin, and fluorouracil） ＋ bevacizumab, the patients received maintenance therapy comprising either XELOX ＋ bevacizumab or capecitabine ＋ bevacizumab （PFS： HR = 1.68, 95%CI： 1.21-2.35; OS： HR = 1.38, 95%CI： 0.91-2.08）. In patients who had disease progression after first-line chemotherapy combined with bevacizumab, bevacizumab combined with second-line maintenance chemotherapy provided survival advantage （PFS： HR = 0.76, 95%CI： 0.69-0.83; OS： HR = 0.83, 95%CI： 0.72-0.95）. Chemotherapy plus bevacizumab increased the incidence of grade 34 toxicities （RR = 1.19, 95%CI： 1.11-1.28）.CONCLUSION Bevacizumab combined with chemotherapy can improve the PFS and OS in the treatment of metastatic colorectal cancer, but increases the incidence of grade 3-4 toxicities.
出处
《世界华人消化杂志》
CAS
2017年第4期340-350,共11页
World Chinese Journal of Digestology
关键词
临床试验
贝伐单抗
转移性结直肠癌
维持治疗
Clinical trials
Bevacizumab
Metastatic colorectal cancer
Maintenance treatment
