S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis.

We set out to evaluate the efficacy and safety of S-1-based therapy versus fluorouracil (5-FU)-based therapy in advanced gastric cancer (AGC). Eligible studies were identified from Pubmed, EMBASE, and Cochrane Library. Additionally, abstracts presented at American Society of Clinical Oncology (ASCO) conferences held between January 2000 and November 2009 were searched to identify relevant clinical trials. The outcome included overall survival (OS), overall response rate (ORR), and grade 3/4 advent events. Four randomized controlled trials (one full text and three abstracts) with 2,115 participants in AGC were identified in our analysis(1,065 patients were in the S-1-based group, 1,050 patients were in the 5-FU-based group). Meta-analysis showed there was significant OS benefit in favor of S-1-based therapy (hazard ratio [HR]=0.87, 95% confidence interval [CI]: 0.79 to 0.96). Pooled estimate for ORR showed no significant difference between S-1-based group and 5-FU-based group (OR=1.25, 95%CI: 0.31 to 5.09). Lower incidence of grade 3/4 neutropenia was observed in patients with S-1-based therapy (OR=0.33, 95%CI: 0.25 to 0.44). With regard to grade 3/4 anemia (OR=1.20, 95%CI: 0.74 to 1.96), leucopenia (OR=1.09, 95%CI: 0.43 to 2.74), stomatitis (OR=2.65, 95%CI: 0.12 to 58.89), diarrhea (OR=0.53, 95% CI: 0.00 to 229.10), nausea (OR=1.36, 95%CI: 0.68 to 2.72), and treatment-related deaths (OR=1.84, 95%CI: 0.95 to 3.54), equivalent frequencies were found between groups. S-1-based therapy significantly improved OS in relation to 5-FU-based therapy. ORR and safety profile were considerable between two groups. These results needed to be confirmed by high-quality trials and further studies in the West.