S-1-based regimens and the risk of leucopenic complications; a Meta-analysis with comparison to other fluoropyrimidines and non fluoropyrimidines

Expert Opin Drug Saf. 2016;15(4):437-48. doi: 10.1517/14740338.2016.1146674. Epub 2016 Feb 16.

Abstract

Background: We performed a meta-analysis oriented at the risk of leucopenic complications associated with S-1-based regimens.

Patients and methods: The studies that were granted eligibility for inclusion include randomized phase II and III trials of patients with solid tumors on S-1; that entailed details of events of febrile neutropenia, all-grade and high-grade neutropenia and leucopenia.

Results: After rejecting ineligible studies, a total of 28 clinical trials were elected eligible for further quantitative analysis. The RR of febrile neutropenia, all-grade and high-grade neutropenia for S-1 vs.non fluoropyrimidine controls was 0.27 [95% CI 0.16, 0.46; P < 0.0001] 0.69 [95% CI 0.58, 0.81; P < 0.00001] and 0.47 [95% CI 0.32, 0.70; P = 0.0002], correspondingly; while The RR of all-grade and high-grade leucopenia for S-1 vs.non fluoropyrimidine controls was 0.60 [95% CI 0.46, 0.79; P = 0.0002] and 0.34 [95% CI 0.14, 0.79; P = 0.01], respectively.

Conclusions: The risk of febrile neutropenia, all-grade and high-grade neutropenia and leucopenia is less in S-1-based therapy than in non fluoropyrimidine regimens; yet comparable to the risk associated with infusional 5FU or capecitabine-based regimens.

Keywords: S-1; febrile neutropenia; leucopenia; neutropenia.

Publication types

  • Comparative Study
  • Meta-Analysis

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Drug Combinations
  • Humans
  • Neoplasms / drug therapy*
  • Neutropenia / chemically induced*
  • Oxonic Acid / adverse effects*
  • Oxonic Acid / therapeutic use*
  • Pyrimidines / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Risk
  • Tegafur / adverse effects*
  • Tegafur / therapeutic use*

Substances

  • Drug Combinations
  • Pyrimidines
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid