卡培他滨治疗晚期/转移性结直肠癌的Meta分析

Capecitabine for Advance/Metastatic Colorectal Cancer: A Meta Analysis

目的:系统评价卡培他滨单药治疗晚期/转移性结直肠癌的疗效与安全性。方法:检索Pubmed、CENTRAL、Embase、Medline、中国知网期刊全文数据库(CNKI)、维普(VIP)和万方数据(Wan Fang)等文献数据库,选取随机对照试验(RCT),试验组为卡培他滨单药治疗,对照组为氟尿嘧啶/亚叶酸钙(5-FU/LV)联合治疗。利用RevMan5.2软件对数据进行分析。结果:共纳入5个RCT研究,包括3 490例患者,分析结果显示在治疗晚期/转移性结直肠癌疗效方面,卡培他滨组的客观缓解(OR)和部分缓解(PR)均优于5-FU/LV组(P<0.05或0.000 1);两组完全缓解(CR)、疾病稳定(SD)、疾病进展(PD)的差异均无统计学意义(P>0.05)。安全性评价方面,卡培他滨组手足综合征的发生率高于5-FU/LV组(P<0.000 01);而5-FU/LV组口腔炎的发生率高于卡培他滨组(P<0.000 01);腹泻、败血症、中性粒细胞减少的发生率两组差异均无统计学意义(P≥0.05)。结论:与5-FU/LV组相比,卡培他滨治疗晚期/转移性结直肠癌方面不良反应较少且反应较轻,疾病进展方面两组结局至少相当,具有较好的临床价值。但由于本研究存在样本量较少、限定检索语言等局限性,该结论有待进一步加大样本量进行证实。

Objective： To evaluate oral capecitabine on treatment of advanced/metastatic colorectal cancer in terms of efficacy and safety. Methods： The seven databases as follow： Pubmed, CENTRAL, Embase, Medline, CNKI , Vip and WanFang, were systematically retrieved, of which randomized controlled trials （RCTs） were screened. Capecitabine monotherapy as experimental group and fluorouracil/leucovorin （5-FU/LV） combination therapy as control group were ana- lyzed by Cochrane Collaboration Review Manager 5.2. Results： Five RCTs and 3 490 patients were included in the Meta-a- nalysis. In the treatment of advanced/metastatic colorectal cancer, capecitabine was more efficacy than 5-FU/LV in terms of objective response （OR） （P 〈 0. 000 1 ） and partial response （PR） （P 〈 0.05 ） with statistically significant. In terms of complete response （CR）, stable disease （SD）, progression disease （PD）, there were no statistically significant differ- ences in two groups （ P 〉 0.05 ）. As for safety evaluation, capecitabine group was significantly higher than 5-FU/LV group on the incidence rate of hand-foot syndrome （ P 〈 0. 000 01 ）. However, the incidence rate of stomatitis in 5-FU/LV group was obviously higher than capecitabine group （P 〈 0. 000 01 ）. The incidence rates of diarrhea, sepsis, neutropenia were of no significant difference（P≥0.05）. Conclusion：Compared with 5-FU/LV group, capecitabine group has tess adverse re- actions. The two groups are equivalent in terms of efficacy. As a result, capecitabine has better clinical value. But this study has limitions, such as language was limited and patients were fewer, so the conclusion remains to be confirmed with higher qualitity RCTs.