Phase II trial of S-1 in combination with oxaliplatin in previously untreated patients with recurrent or inoperable biliary tract cancer.

BACKGROUND

Biliary tract cancers are among the most aggressive tumors with a poor prognosis. We conducted a phase II study on combination chemotherapy consisting of S-1 and oxaliplatin in previously untreated patients.

METHODS

Patients were treated with S-1 40 mg/m(2) twice daily, administered orally on days 1-28, and 85 mg/m(2) of oxaliplatin, administered via an intravenous 90-min infusion on days 1, 15 and 29. Treatments were repeated every 6 weeks.

RESULTS

15 patients were enrolled: 9 patients (60%) had intrahepatic and 3 (20%) had extrahepatic cholangiocarcinoma, 2 (13.3%) had cancer of the ampulla of Vater and 1 patient had gall bladder cancer. Partial response was observed in 1 of the 15 (6.7%) patients. Stable disease was observed in 4 patients (26.7%). The median time to progression was 1.4 months (95% confidence interval, CI, 0.9-1.9), and the median overall survival was 3.1 months (95% CI, 0.0-7.0). Grade 3 hematologic toxicities included neutropenia (1, 6.7%) and thrombocytopenia (1, 6.7%). As the response rate in stage I did not justify progression to stage II (> or =2/15), this study had to be discontinued in accordance with the established protocols.

CONCLUSION

The combination chemotherapy with S-1 and oxaliplatin utilized in this study resulted in no promising antitumor activity.