Systematic review and non-inferiority meta-analysis of randomised phase II/III trials on S-1-based therapy versus 5-fluorouracil- or capecitabine-based therapy in the treatment of patients with metastatic colorectal cancer

S-1 is an oral fluoropyrimidine that is increasingly used in Western countries for the treatment of metastatic colorectal cancer (mCRC). We conducted a non-inferiority meta-analysis on the efficacy of S-1-based therapy versus 5-fluorouracil (5-FU)- or capecitabine-based therapy in the treatment of p...

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Published in:European journal of cancer (1990) 2022-05, Vol.166, p.73-86
Main Authors: Derksen, Jeroen W.G., Smit, Karel C., May, Anne M., Punt, Cornelis J.A.
Format: Article
Language:English
Subjects:
5-Fluorouracil
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Cancer
Capecitabine - adverse effects
Clinical trials
Colorectal cancer
Colorectal carcinoma
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Confidence intervals
Fluoropyrimidines
Fluorouracil - adverse effects
Humans
Meta-analysis
Metastases
Metastasis
Metastatic colorectal cancer
Non-inferiority
Patients
S-1
Survival
Therapy
Treatment
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Summary:S-1 is an oral fluoropyrimidine that is increasingly used in Western countries for the treatment of metastatic colorectal cancer (mCRC). We conducted a non-inferiority meta-analysis on the efficacy of S-1-based therapy versus 5-fluorouracil (5-FU)- or capecitabine-based therapy in the treatment of patients with mCRC. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Opengrey were searched for randomised clinical trials until May 2021. Data were extracted for progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and adverse events. Pooled effect estimates, stratified by treatment line, with corresponding 99% confidence intervals (CI) were presented. For PFS, a pre-defined non-inferiority margin (ΔNI) of 1.25 was selected. Ten studies (n = 2117) were included, of which six studies reported PFS and OS data and 10 studies reported ORR data. S-1-based therapy was shown to be non-inferior to 5-FU/capecitabine-based therapy in terms of PFS (HRtotal 0.95, 99% CI 0.83–1.08) with its CI upper limit well below ΔNI, and at least as efficacious in terms of OS (HRtotal 0.93, 99% CI 0.81–1.07), and ORR (RRtotal 1.06, 99% CI 0.90–1.24). S-1-based therapy is non-inferior to 5-FU/capecitabine-based therapy in the treatment of mCRC regarding PFS and at least as efficacious as 5-FU/capecitabine-based therapy in terms of ORR and OS. These data support the use of S-1 in mCRC patients who are intolerant to 5-FU/capecitabine-based treatment. •In Asian countries, S-1 is standard of care for patients with unresectable mCRC.•S-1 has lower incidence of hand–foot syndrome and cardiac toxicities in Western mCRC.•S-1-based therapy is non-inferior to 5-FU/capecitabine-based therapy in mCRC.•Replacement of 5-FU or capecitabine by S-1 does not compromise efficacy in mCRC.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2022.02.004