Long-term results of a phase II study of S-1 plus irinotecan in metastatic colorectal cancer.

AIM

The current study aimed to assess the long-term efficacy of combination therapy with oral S-1, a fluoropyrimidine prodrug, plus irinotecan in previously untreated patients with metastatic colorectal cancer.

PATIENTS AND METHODS

Between April 2004 and February 2005, 41 patients with previously untreated advanced or recurrent colorectal cancer were enrolled in the study. Chemotherapy consisted of oral administration in S-1 at 40 mg/m(2) twice daily on days 1 to 14 and intravenous infusion of irinotecan at 150 mg/m(2) on day 1 in a 21-day cycle.

RESULTS

The median patient follow-up was 78.0 months. The median survival time was 23.7 months, and the 2-year survival rate was 50%. The median time to tumor progression was 8.3 months.

CONCLUSION

The results of this long-term update confirmed that first-line combination therapy with oral S-1 plus irinotecan was effective in patients with metastatic colorectal cancer.