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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 extrahepatic primary tumors, followed by ampullary, gallbladder, and intrahepatic. The majority of tumors were stage T2 (58%), were node negative (60%), and had clear margin R0 resection (85%). Half of patients required pancreatoduodenectomy with or without hepatectomy.
At a median follow up of 45.4 months, the primary endpoint of 3-year overall survival was significantly improved with S-1compared with observation (77.1% vs. 67.6%; hazard ratio, 0.69; one sided P = 0.0080). Three-year relapse-free survival trended better with S-1 compared with observation (62.4% vs. 50.9%; HR, 0.80; two-sided P = 0.088). No new safety signals were observed. Prespecified subset analyses indicated the greatest benefit in females, in N1 disease, and after R0 resection.
This trial provides supportive evidence for a benefit of adjuvant therapy with an oral fluorinated pyrimidine after resection of biliary cancer. The modest survival benefit indicates that further study of potentially more effective adjuvant systemic therapies is warranted.
Nakachi K et al.
Title: Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): A multicentre, open-label, randomised, controlled, phase 3 trial.
Source: Lancet 2023 Jan 21; [e-pub]. (Abstract/FREE Full Text)