Comparison of 5-FU-based and Capecitabine-based Neoadjuvant Chemoradiotherapy in Patients With Rectal Cancer: A Meta-analysis.

INTRODUCTION

The inconvenience of using infusion therapies resulted in the development of capecitabine (CA), an oral fluoropyrimidine. In this meta-analysis, we evaluated 10 studies that compared the efficacy and safety of an oral CA-based regimen with those of a continuous infusion 5-fluorouracil (5-FU) regimen for neoadjuvant chemoradiotherapy in patients with rectal cancer.

MATERIALS AND METHODS

The databases searched included Medline, Cochrane, EMBASE, and Google Scholar (until August 31, 2016). The primary outcome assessed was the rate of postoperative down-staging of the tumor and pathologic complete response. The secondary outcomes were disease-free survival (DFS) and overall survival (OS).

RESULTS

This meta-analysis (5 retrospective studies, 3 prospective studies, and 2 randomized controlled trials [RCTs]) compared the efficacy of the 5-FU arm (n = 757) to that of the CA arm (n = 719). There was no significant difference in tumor down-staging rate between the 2 regimens (RCTs/prospective studies: odds ratio [OR], 0.88; 95% confidence interval [CI], 0.65-1.20; P = .416; retrospective studies: OR, 0.84; 95% CI, 0.50-1.44; P = .534). There was also no significant difference in pathologic complete response (RCTs/prospective studies: OR, 0.80; 95% CI, 0.52-1.23; P = .304; retrospective studies: OR, 0.73; 95% CI, 0.48-1.12; P = .149), or survival rates (3-year, 5-year DFS, and 5-year OS rate) between the 2 groups. The CA group had a higher number of patients reporting diarrhea and hand-foot syndrome compared with the 5-FU group. The 5-FU group had a higher number of patients reporting mucositis compared with the CA group.

CONCLUSIONS

Our data suggested that oral CA was equivalent to continuous infusion 5-FU in the curative setting of rectal cancer during neoadjuvant chemoradiotherapy.