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卡培他滨联合奥沙利铂与氟尿嘧啶联合奥沙利铂一线治疗转移性结直肠癌的疗效比较:六项随机试验的荟萃分析。

Capecitabine plus oxaliplatin vs fluorouracil plus oxaliplatin as first line treatment for metastatic colorectal caner - meta-analysis of six randomized trials.

机构信息

Department of Colorectal and Anal Surgery, First Affiliated Hospital, Guangxi Medical University, Nanning, Guangxi, China.

出版信息

Colorectal Dis. 2010 Jan;12(1):16-23. doi: 10.1111/j.1463-1318.2009.01803.x.

Abstract

OBJECTIVE

This meta-analysis was performed to evaluate the efficacy and safety of capecitabine plus oxaliplatin vs fluorouracil (FU) plus oxaliplatin as first line treatment for metastatic or advanced colorectal cancer.

METHOD

A total of 2196 patients from six randomized controlled trials were available for analysis, which included 1105 patients in capecitabine plus oxaliplatin group and 1091 patients in FU plus oxaliplatin group. The efficacy data included overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), overall response rate (ORR), and the safety data contained specific grade 3 and 4 toxicity such as anaemia, thrombocytopenia, neutropenia, diarrhoea, nausea, asthenia, vomiting, abdominal pain, hand foot syndrome, neuropathy and stomatitis were evaluated.

RESULTS

Pooled analysis of OS (hazards ratio HR = 1.04, 95%CI: 0.95-1.14), PFS (1.08, 0.98-1.18), ORR (odds ratio OR = 0.87, 0.73-1.03) in the capecitabine plus oxaliplatin group shows no statistical significance when compared with those in the FU plus oxaliplatin group. The statistically significant differences in pooled estimates suggest a higher incidence of grade 3/4 thrombocytopenia (OR = 1.87, 1.24-2.81), grade 3/4 hand-foot syndrome (3.90, 2.13-7.12) in the capecitabine plus oxaliplatin group and grade 3/4 neutropenia (0.20, 0.07-0.53) in the FU plus oxaliplatin group. No statistically significant difference was noted in the incidence of grade 3/4 anaemia, asthenia, diarrhoea, nausea, vomiting, abdominal pain, neuropathy and stomatitis.

CONCLUSION

The effect of capecitabine plus oxaliplatin regimen is similar to FU plus oxaliplatin regimen as first line treatment for metastatic colorectal cancer, but it offers advantages of simplicity and convenience to administer.

摘要

目的

本荟萃分析旨在评估卡培他滨联合奥沙利铂与氟尿嘧啶(FU)联合奥沙利铂作为转移性或晚期结直肠癌一线治疗的疗效和安全性。

方法

共有六项随机对照试验的 2196 名患者可供分析,其中卡培他滨联合奥沙利铂组 1105 例,FU 联合奥沙利铂组 1091 例。疗效数据包括总生存期(OS)、无进展生存期(PFS)、治疗失败时间(TTF)、总缓解率(ORR),安全性数据包含特定的 3 级和 4 级毒性,如贫血、血小板减少、中性粒细胞减少、腹泻、恶心、乏力、呕吐、腹痛、手足综合征、周围神经病变和口腔炎等。

结果

卡培他滨联合奥沙利铂组 OS(风险比 HR = 1.04,95%CI:0.95-1.14)、PFS(1.08,0.98-1.18)和 ORR(优势比 OR = 0.87,0.73-1.03)的汇总分析与 FU 联合奥沙利铂组相比无统计学意义。卡培他滨联合奥沙利铂组 3 级/4 级血小板减少症(OR = 1.87,1.24-2.81)、3 级/4 级手足综合征(OR = 3.90,2.13-7.12)和 FU 联合奥沙利铂组 3 级/4 级中性粒细胞减少症(OR = 0.20,0.07-0.53)的汇总估计值差异有统计学意义。两组 3 级/4 级贫血、乏力、腹泻、恶心、呕吐、腹痛、周围神经病变和口腔炎的发生率无统计学差异。

结论

卡培他滨联合奥沙利铂方案作为转移性结直肠癌的一线治疗方案与 FU 联合奥沙利铂方案的疗效相似,但具有更简便的给药优势。

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