Abstract
Objectives. The aim of our study was to compare the efficacy and safety of S-1-based therapy (SBT) versus 5-fluorouracil-based therapy (FBT) for advanced colorectal cancer (ACRC). Methods. A meta-analysis of all eligible randomized controlled trials (RCTs) was performed using RevMan 5.1.0 software. Results. A total of 1625 patients from twelve RCTs including 820 patients in the SBT group and 805 patients in the FBT group were available for analysis. The meta-analysis of overall survival (hazards ratio HR = 0.94, 95% CI = 0.80–1.10), progression-free survival (HR = 1.03, 95% CI = 0.91–1.18), and overall response rate (odds ratio OR = 1.23, 95% CI = 1.00–1.53) showed no statistical significance between SBT group and FBT group. The statistically significant differences in the meta-analysis indicated less incidence of graded 3-4 neutropenia (OR = 0.49, 95% CI = 0.35–0.68) and nausea/vomit (OR = 0.41, 95% CI = 0.23–0.72) in the SBT group, and there was no statistically significant difference in the incidence of grade 3-4 anemia, thrombocytopenia, leucopenia, diarrhea, and treatment-related deaths between two groups. Conclusions. SBT had similar efficacy and better safety than FBT and was an attractive alternative to FBT for patients of ACRC, but further investigations in different populations would be needed to confirm it.
Highlights
Despite advances in diagnosis and treatment, colorectal cancer remains the third leading cancer, with approximated 1,233,700 new cases and 608,700 deaths worldwide each year [1]
Neutropenia in hematologic toxicity: meta-analysis of four trials [9,10,11, 16] including 541 patients in the S-1-based therapy (SBT) group and 533 patients in the fluorouracil-based therapy (FBT) group showed graded 3-4 neutropenia was less likely to happen in the SBT group (OR = 0.35, 95% confidence interval (CI) = 0.27–0.47), and yet there was significant heterogeneity across these trials (P < 0.1, I2 = 69%)
With respect to overall response rate (ORR), disease control rate (DCR), and one- or two-year survival rate (SR), our meta-analysis showed no significant difference between SBT and FBT group, which suggested that SBT was noninferior to FBT for the patients of advanced colorectal cancer (ACRC)
Summary
Despite advances in diagnosis and treatment, colorectal cancer remains the third leading cancer, with approximated 1,233,700 new cases and 608,700 deaths worldwide each year [1]. For the patients with advanced colorectal cancer (ACRC), acquiring curative therapy by surgery or radiotherapy is complex; systemic chemotherapy is the main effective treatment, which can prolong survival and enhance life quality of patients [2]. Traditional continuous-infusion 5-fluorouracil (5-FU) in combination with leucovorin (LV) has been the backbone of palliative therapy for ACRC [2], and the combination of 5-FU and LV with either oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) has been recognized as standard first-line therapies for ACRC [3]. Tegafur is a prodrug that is mainly converted by liver enzyme cytochrome P450(CYP)2A6 to 5-FU, CDHP is an inhibitor of dihydropyrimidine dehydrogenase, which can prolong the half-life of 5-FU, and Oxo can reduce the toxic effects of 5-FU by inhibiting the phosphorylation of 5FU to fluorouridine monophosphate in the gastrointestinal tract [4]. S-1-based therapy (SBT) has found to have similar efficacy and safety to 5-fluorouracil-based therapy (FBT) in the treatment of advanced gastric cancer (AGC) [5] and has Gastroenterology Research and Practice been approved for the treatment of patients with AGC in japan
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