BMC Cancer (Jul 2020)

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)

  • 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

DOI
https://doi.org/10.1186/s12885-020-07185-6
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 8

Abstract

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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

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