口服尿嘧啶替加氟加亚叶酸与氟尿嘧啶推注加利叶酸治疗晚期结直肠癌：五项随机对照临床试验的荟萃分析。

Oral uracil-tegafur plus leucovorin vs fluorouracil bolus plus leucovorin for advanced colorectal cancer: a meta-analysis of five randomized controlled 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. 2011 Aug;13(8):837-45. doi: 10.1111/j.1463-1318.2009.02184.x. Epub 2009 Dec 28.

DOI:10.1111/j.1463-1318.2009.02184.x

PMID:20050863

Abstract

AIM

The aim of this study was to evaluate systematically the efficacy and safety of oral uracil-tegafur (UFT) plus leucovorin (LV) compared with infusional fluorouracil (5-FU) plus LV for advanced colorectal cancer.

METHOD

Eligible studies were identified from Medline, Embase and the Cochrane Library. The end-points included overall survival and overall tumour response rate, and toxicity including leucopenia, febrile neutropenia, stomatitis/mucositis and diarrhoea.

RESULTS

Five randomized controlled trials were identified. Pooled data demonstrated no difference in overall survival between the oral UFT plus LV regimen and the 5-FU bolus plus LV regimen [hazard ratio 1.013; 95% confidence interval (CI) 0.911-1.127].The fixed-effect pooled estimate for overall tumour response rate showed no significant difference between the two regimens (relative risk 0.893; 0.672-1.187). Grade 3-4 leucopenia [odds ratio (OR) 0.126; 955 CI 0.048-0.326], grade 1-4 leucopenia (OR 0.089; 95% CI 0.067-0.119) and grade1-4 febrile neutropenia (OR 0.020; 95% CI 0.004-0.102) were significantly less prominent in the oral UFT regimens. For nonhaematological toxicities, grade 3-4 stomatitis/mucositis (OR 0.075; 95% CI 0.039-0.146), grade 3-4 infection (OR 0.484; 95% CI 0.310-0.758), grade 1-4 infection (OR 0.672; 95% CI 0.547-0.826, P < 0.001), grade 1-4 diarrhoea (OR 0.743; 95% CI 0.626-0.881) were also less likely to happen in patients in the oral UFT plus LV regimen, while there was no significant difference between the two treatment regimens with respect to grade 1-4 stomatitis/mucositis (OR 0.278; 95% CI 0.053-1.456) and grade 3-4 (OR 1.174; 95% CI 0.983-1.403) diarrhoea.

CONCLUSION

Oral UFT or 5-FU bolus combined with LV results in similar overall survival and tumour response rates for advanced colorectal cancer. The former treatment regimen is greatly superior in terms of toxicity, especially haematological toxicity.

摘要

目的

本研究旨在系统评估口服替加氟（UFT）联合亚叶酸（LV）与氟尿嘧啶持续输注（5-FU）联合 LV 治疗晚期结直肠癌的疗效和安全性。

方法

从 Medline、Embase 和 Cochrane 图书馆中检索合格的研究。终点包括总生存和总肿瘤反应率，以及毒性包括白细胞减少、发热性中性粒细胞减少、口腔炎/黏膜炎和腹泻。

结果

确定了 5 项随机对照试验。合并数据显示，口服 UFT 联合 LV 方案与 5-FU 推注联合 LV 方案的总生存无差异[风险比 1.013；95%置信区间（CI）0.911-1.127]。两种方案的总肿瘤反应率的固定效应合并估计值无显著差异（相对风险 0.893；95%CI 0.672-1.187）。3-4 级白细胞减少[比值比（OR）0.126；95%CI 0.048-0.326]、1-4 级白细胞减少（OR 0.089；95%CI 0.067-0.119）和 1-4 级发热性中性粒细胞减少（OR 0.020；95%CI 0.004-0.102）在口服 UFT 方案中明显较少见。对于非血液学毒性，3-4 级口腔炎/黏膜炎（OR 0.075；95%CI 0.039-0.146）、3-4 级感染（OR 0.484；95%CI 0.310-0.758）、1-4 级感染（OR 0.672；95%CI 0.547-0.826，P<0.001）、1-4 级腹泻（OR 0.743；95%CI 0.626-0.881）也较少发生在口服 UFT 联合 LV 方案的患者中，而两种治疗方案在 1-4 级口腔炎/黏膜炎（OR 0.278；95%CI 0.053-1.456）和 3-4 级（OR 1.174；95%CI 0.983-1.403）腹泻方面无显著差异。