TY - JOUR
T1 - 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)
AU - Itano, Osamu
AU - Takemura, Yusuke
AU - Kishida, Norihiro
AU - Tamagawa, Eiji
AU - Shinozaki, Hiroharu
AU - Ikeda, Ken
AU - Urakami, Hidejiro
AU - Ei, Shigenori
AU - Hayatsu, Shigeo
AU - Suzuki, Keiichi
AU - Sakuragawa, Tadayuki
AU - Ishii, Masatsugu
AU - Shito, Masaya
AU - Aiura, Koichi
AU - Fujisaki, Hiroto
AU - Takano, Kiminori
AU - Matsui, Junichi
AU - Minagawa, Takuya
AU - Shinoda, Masahiro
AU - Kitago, Minoru
AU - Abe, Yuta
AU - Yagi, Hiroshi
AU - Oshima, Go
AU - Hori, Shutaro
AU - Kitagawa, Yuko
N1 - Funding Information:
Y. Kitagawa and M. Shinoda received designated donation for research funding from Taiho Pharmaceutical. Y. Kitagawa and O. Itano has an endowed chair of Taiho Pharmaceutical. Other authors have no conflict of interest.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/7/23
Y1 - 2020/7/23
N2 - 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
AB - 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
KW - 1-year administration of S-1
KW - Adjuvant chemotherapy
KW - Biliary tract cancer
KW - Feasibility study
UR - http://www.scopus.com/inward/record.url?scp=85088526988&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088526988&partnerID=8YFLogxK
U2 - 10.1186/s12885-020-07185-6
DO - 10.1186/s12885-020-07185-6
M3 - Article
C2 - 32703191
AN - SCOPUS:85088526988
SN - 1471-2407
VL - 20
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 688
ER -
