Adjuvant S-1 Therapy After Resection of Biliary Cancer

After resection of biliary cancer, standard adjuvant therapy is 6 months of postoperative capecitabine. Investigators now report results of a trial evaluating adjuvant therapy with the oral agent S-1, which combines the fluorinated pyrimidine tegafur with gimeracil, a dihydropyrimidine dehydrogenase inhibitor to enhance absorption, and oteracil to reduce bowel toxicity.

In this multicenter, open-label, phase 3 trial, 440 patients in Japan with resected biliary cancer were randomized to either observation or treatment with S-1 dosed at 40, 50, or 60 mg, depending on body surface area, and given twice daily for 4 weeks followed by a 2-week rest period for 4 cycles. Median age was 69 and most patients (71%) were male. Most (56%) had extrahepati…