Adjuvant S-1 versus observation in curatively resected biliary tract cancer: A phase III trial (JCOG1202: ASCOT).

• DOI: 10.1200/jco.2022.40.4_suppl.382
• Publication Date: 2022-01-19T20:44:02Z
• Authors: Masafumi Ikeda; Kohei Nakachi; Masaru Konishi; Shogo Nomura; Hiroshi Katayama; Tomoko Kataoka; Katsuhiko Uesaka; Hiroaki Yanagimoto; Soichiro Morinaga; Hiroshi Wada; Kazuaki Shimada; Yu Takahashi; Toshio Nakagohri; Kunihito Gotoh; Ken Kamata; Yasuhiro Shimizu; Makoto Ueno; Hiroshi Ishii; Takuji Okusaka; Junji Furuse
• Keywords: Gallbladder Cancer; Ampulla of Vater; Clinical endpoint; Adjuvant Therapy; Bile duct cancer

382 Background: Capecitabine is usually used for patients with curatively resected biliary tract cancer (BTC) in EU and US, but no clear survival benefit has been shown phase III trials. S-1, an oral fluoropyrimidine derivative, promising efficacy, a mild toxicity profile, advanced BTC. The aim of this trial was to confirm whether adjuvant S-1 therapy might improve the overall (OS) Methods: This open-label, multicenter, randomized conducted 38 Japanese hospitals. Eligible were aged 20 80 years old, had undergone R0/R1 resection histologically confirmed adeno(squamous) carcinoma extrahepatic bile duct, gallbladder or ampulla Vater (T2-4, N0, M0 T1-4, N1, M0) intrahepatic duct (T1-4, N0-1, (7th UICC classification), ECOG performance status (PS) 0 1.The calculated sample size 440 detect hazard ratio OS 0.74 one-sided alpha 5% power 80%. Patients surgery-alone arm received further anti-cancer treatment, while those 4 cycles chemotherapy at dose 40 mg/m 2 twice daily weeks, followed by weeks rest. Primary endpoint OS, secondary endpoints relapse-free (RFS), incidence adverse events, proportion treatment completion. Results: A total (surgery-alone, n = 222; 218) enrolled from September 2013 June 2018. data cutoff date 23, 2021, median follow-up duration 45.4 months. Of all patients, significantly longer than (hazard [HR] 0.694, 95%CI, 0.514-0.935; p 0.008; 3-year 67.6% [surgery-alone; 61.0-73.3%] 77.1% [adjuvant S-1; 70.9-82.1%]). Adjuvant also better RFS (HR 0.797 [95%CI, 0.613-1.035], RFS, 50.9% 44.1-57.2%] 62.4% 55.6-68.4%]). All preplanned subgroup analyses (PS, age, type, stage, R factor, serum CA19-9) revealed favorable arm. main grade 3-4 events infection (7.2%), diarrhea (2.9%), appetite loss fatigue well-tolerated. Conclusions: led surgery alone becomes standard care Clinical information: UMIN000011688.