A series of randomized controlled trials (RCTs) comparing S-1 with 5-FU or capecitabine in mono or combined therapy for colorectal cancer (CRC). The meta-analysis aims to compare the efficacy and safety profile of S-1-based versus non- S-1-based chemotherapy as first-line treatment in CRC.
Relevant RCTs were obtained from PubMed, Embase, Ovid databases and the Cochrane library from database set up to May 2018. The included studies were selected according to eligibility criteria. The study design, participant characteristics, interventions, and outcomes were abstracted after the assessment of methodological quality of the trials. All data were analyzed by Review Manager 5.3.
10 RCTs were included in meta-analysis, involving 1356 and 1365 patients in S-1 and non- S-1-based chemotherapy. Meta-analysis showed that S-1-based chemotherapy significantly improved progression-free survival (PFS) (HR 0.90, 95% CI: 0.84-0.97, P = 0.006). In subgroup analysis, there was statistically significant increase in PFS when S-1-based chemotherapy was compared to 5-FU-based (HR 0.92, 95% CI 0.84–1.00, P = 0.04) or capecitabine-based chemotherapy (HR 0.85, 95% CI 0.73–0.99, P = 0.04). The meta-analysis of overall survival (OS) (P = 0.36), overall response rate (ORR) (P = 0.90), disease control rate (DCR) (P = 0.13) showed no statistical significance between S-1-based and non- S-1-based chemotherapy. The statistically significant differences in the meta-analysis indicated less incidence of graded 3-4 leucopenia(OR = 0.30, 95% CI: 0.13-0.71, P = 0.006) and hand-foot syndrome (HFS)(OR = 0.24, 95% CI: 0.10-0.58, P = 0.001) in the S-1-based chemotherapy, and there was no statistically significant difference in the incidence of grade 3-4 diarrhea, nausea/vomit, fatigue, stomatitis, sensory neuropathy, gastrointestinal perforation between two groups.
S-1-based chemotherapy had longer PFS and better safety than 5-FU-based or capecitabine-based chemotherapy, and S-1-based chemotherapy in mono or combined therapy was an attractive alternative to standard ﬁrst-line regimen for patients of CRC, but further investigations in larger populations would be needed to confirm it.
Clinical trial identification
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All authors have declared no conflicts of interest.