A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01)

• Main Authors: Osamu Itano, Yusuke Takemura, Norihiro Kishida, Eiji Tamagawa, Hiroharu Shinozaki, Ken Ikeda, Hidejiro Urakami, Shigenori Ei, Shigeo Hayatsu, Keiichi Suzuki, Tadayuki Sakuragawa, Masatsugu Ishii, Masaya Shito, Koichi Aiura, Hiroto Fujisaki, Kiminori Takano, Junichi Matsui, Takuya Minagawa, Masahiro Shinoda, Minoru Kitago, Yuta Abe, Hiroshi Yagi, Go Oshima, Shutaro Hori, Yuko Kitagawa
• Format: Article
• Language: English
• Published: BMC 2020-07-01
• Series: BMC Cancer
• Subjects: Biliary tract cancer; Adjuvant chemotherapy; 1-year administration of S-1; Feasibility study
• Online Access: http://link.springer.com/article/10.1186/s12885-020-07185-6
• ISSN: 1471-2407

Abstract Background Although surgery is the definitive curative treatment for biliary tract cancer (BTC), outcomes after surgery alone have not been satisfactory. Adjuvant therapy with S-1 may improve survival in patients with BTC. This study examined the safety and efficacy of 1 year adjuvant S-1 therapy for BTC in a multi-institutional trial. Methods The inclusion criteria were as follows: histologically proven BTC, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, R0 or R1 surgery performed, cancer classified as Stage IB to III. Within 10 weeks post-surgery, a 42-day cycle of treatment with S-1 (80 mg/m2/day orally twice daily on days 1–28 of each cycle) was initiated and continued up to 1 year post surgery. The primary endpoint was adjuvant therapy completion rate. The secondary endpoints were toxicities, disease-free survival (DFS), and overall survival (OS). Results Forty-six patients met the inclusion criteria of whom 19 had extrahepatic cholangiocarcinoma, 10 had gallbladder carcinoma, 9 had ampullary carcinoma, and 8 had intrahepatic cholangiocarcinoma. Overall, 25 patients completed adjuvant chemotherapy, with a 54.3% completion rate while the completion rate without recurrence during the 1 year administration was 62.5%. Seven patients (15%) experienced adverse events (grade 3/4). The median number of courses administered was 7.5. Thirteen patients needed dose reduction or temporary therapy withdrawal. OS and DFS rates at 1/2 years were 91.2/80.0% and 84.3/77.2%, respectively. Among patients who were administered more than 3 courses of S-1, only one patient discontinued because of adverse events. Conclusions One-year administration of adjuvant S-1 therapy for resected BTC was feasible and may be a promising treatment for those with resected BTC. Now, a randomized trial to determine the optimal duration of S-1 is ongoing. Trial registration UMIN-CTR, UMIN000009029. Registered 5 October 2012-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347