中国循证医学杂志

中国循证医学杂志

卡培他滨联合伊立替康与联合奥沙利铂比较治疗晚期/转移性结直肠癌疗效与安全性的系统评价

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目的 系统评价卡培他滨联合伊立替康(CAPIRI 方案)与联合奥沙利铂(CAPOX 方案)比较治疗晚期/转移性结直肠癌的疗效与安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、VIP、WanFang Data 和 CNKI 数据库,搜集 CAPIRI 和 CAPOX 方案比较治疗晚期/转移性结直肠癌的随机对照试验(RCT),检索时限均从建库至 2018 年 8 月。由 2 名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 meta 分析。 结果 共纳入 12 个 RCT,包括 1 049 例患者。meta 分析结果显示:两种方案在完全缓解率、部分缓解率、疾病稳定率、疾病进展率、客观缓解率、中位无进展生存期、中位总生存期等方面,差异均无统计学意义(P>0.05),但 CAPIRI 组的疾病控制率低于 CAPOX 组[RR=0.93,95%CI(0.86,1.00),P=0.04]。CAPIRI 组腹泻发生率高于 CAPOX 组[RR=1.83,95%CI(1.37,2.45),P<0.000 1],周围神经毒性发生率低于 CAPOX 组[RR=0.13,95%CI(0.05,0.35),P<0.000 1]。但两组在恶心呕吐、手足综合征、贫血、血小板减少、白细胞减少、脱发等方面的差异均无统计学意义(P>0.05)。 结论 当前证据表明,CAPIRI 方案和 CAPOX 方案的近期疗效和远期疗效相当,但 CAPIRI 方案的腹泻发生率更高,而 CAPOX 方案周围神经毒性的风险更高。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of capecitabine combined with irinotecan (CAPIRI) versus capecitabine combined with oxaliplatin (CAPOX) for patients with advanced/metastatic colorectal cancer. Methods PubMed, EMbase, The Cochrane Library, VIP, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) about capecitabine combined with irinotecan versus capecitabine combined with oxaliplatin for patients with advanced/metastatic colorectal cancer from inception to August 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 12 RCTs involving 1 049 patients were included. The results of meta-analysis showed that: there were no significant differences in complete response (CR), partial response (PR), stable disease (SD), progression disease (PD), overall respond rate (ORR), median progression-free survival (mPFS), and median overall survival (mOS) between two groups (P>0.05). But CARIRI group was lower than CAPOX group on the disease control rate (RR=0.93, 95%CI 0.86 to 1.00,P=0.04). Incidence of diarrhea was higher in CAPIRI group (RR=1.83, 95%CI 1.37 to 2.45, P<0.000 1). However, the incidence rate of peripheral neurotoxicity in CAPOX group was higher (RR=0.13, 95%CI 0.05 to 0.35,P<0.000 1). There were no significant differences between two groups in the incidence rates of nausea and vomiting, hand-foot syndrome, anemia, thrombocytopenia, leukocytopenia and alopecia (P>0.05). Conclusion Current evidence shows that two groups are equivalent in terms of curative effect. CAPIRI has a higher incidence rate of diarrhea, while CAPOX has a higher risk of peripheral neurotoxicity. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 卡培他滨; 奥沙利铂; 伊立替康; 结直肠癌; 疗效; 安全性; Meta 分析; 系统评价; 随机对照试验

Key words: Capecitabine; Oxaliplatin; Irinotecan; Colorectal cancer; Efficacy; Safety; Meta-analysis; Systematic review; Randomized controlled trial

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