Clinical study of tegafur-gimeracil-oteracil potassium capsule (s-1) and oxaliplatin combination chemotherapy in advanced colorectal cancer.

OBJECTIVE: The aim of this study was to evaluate the therapeutic efficacy and toxicity of a combination of tegafur-gimeracil-oteracil potassium capsules (S-1) with oxaliplatin for treatment of advanced or recurrent colorectal cancer. SUBJECTS AND METHODS: Between October 2009 and October 2011, 70 patients at our hospital with advanced or recurrent colorectal cancer were enrolled into our study and divided randomly into two groups: A treatment group (S-1 combined with oxaliplatin) and a control group (Xeloda combined with oxaliplatin). All patients received 130 mg/m(2) oxaliplatin by intravenous infusion on day 1, every three weeks. Patients in the treatment group were treated with oral administration of 30-40 mg/m(2) S-1 twice daily for 14 days. Patients in the control group were treated with oral administration of 1000 mg/m(2) Xeloda twice daily for 14 days. The efficacy and toxicity of the combination therapy were evaluated after two cycles of treatment.
RESULTS: The response rates in the treatment and control groups were 54.3% and 42.9%, respectively. The disease control rates of the two groups were 80.0% and 74.3%, respectively. The 1-year and 2-year survival rates were 73.6% and 39.1% in the treatment group, respectively, compared to 73.8% and 37.8% in the control group. No statistical difference between the two groups for any of the parameters, including toxicity, was observed (P > 0.05).
CONCLUSION: The efficacy of the S-1 and oxaliplatin combination regimen in advanced or recurrent colorectal cancer treatment is not inferior to the combination of Xeloda and oxaliplatin and does not result in additional toxicity. Therefore, S-1 could be used to substitute Xeloda in combined chemotherapy with oxaliplatin for the treatment of advanced or recurrent colorectal cancer.

RCT Entities:   Population Interventions Outcomes