The Adjuvant S-1 for Cholangiocarcinoma Trial (JCOG1202, [ASCOT]) was a multicenter, randomized controlled trial aimed at investigating the efficacy and safety of adjuvant chemotherapy (AC) with S-1 for resected biliary tract cancer (BTC). This trial reported that overall survival was prolonged with AC compared with observation.
With the aim of increasing enrollment, the present survey biannually recorded the number of patients eligible for enrollment into ASCOT and reasons for ineligibility among patients who had undergone surgery for BTC from April 2015 to September 2017 at 36 institutions participating in ASCOT.
Of 2039 patients who underwent surgery for BTC, 211 (10.3%) were already enrolled, 166 (8.1%) were eligible but had not been enrolled, and 1662 (81.5%) were ineligible. Among ineligible patients, the predominant reasons for ineligibility were patient refusal (n = 332, 20.0%), pathologic stage (pT1N0; n = 248, 14.9%), age (≥ 81 years; n = 196, 11.8%), and prolonged postoperative complications (n = 176, 10.6%).
Patients undergoing surgery for BTC are a heterogeneous cohort comprising patients with earlier pathologic stage, advanced age, and prolonged postoperative complications. These factors should be considered during the design of future clinical trials of perioperative treatments for resectable BTC.
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All authors deeply appreciate the participating institutions for kindly replying to the survey. Participating institutions in Japan (in decreasing latitude) were: Sapporo-Kosei General Hospital, Hokkaido University Graduate School of Medicine, Teine-Keijinkai Hospital, Tohoku University Graduate School of Medicine, Tochigi Cancer Center, Jichi Medical University, Saitama Cancer Center, National Cancer Center Hospital East, Chiba Cancer Center, Chiba University Graduate School of Medicine, National Cancer Center Hospital, Kyorin University Faculty of Medicine, National Center for Global Health and Medicine, Tokyo Women’s Medical University, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Teikyo University School of Medicine, Tokai University School of Medicine, Kanagawa Cancer Center, Kitasato University School of Medicine, Yokohama City University Medical Center, St. Marianna University School of Medicine, Niigata Cancer Center Hospital, Toyama University Hospital, Kanazawa University School of Medicine, Shizuoka Cancer Center, Aichi Cancer Center Hospital, Kinki University Faculty of Medicine, Osaka International Cancer Institute, Osaka National Hospital, Kansai Medical University Hirakata Hospital, Kobe University Graduate School of Medicine, Hyogo Cancer Center, National Hospital Organization Shikoku Cancer Center, Kochi Health Sciences Center, National Kyushu Cancer Center, and Kyushu University Hospital.
This study was supported by the National Cancer Center Research and Development Fund (23-A-22, 26-A-4, 29-A-3) and by the Practical Research for Innovative Cancer Control from the Japan Agency for Medical Research and Development, AMED (16ck0106079h0003, 17ck0106350h0001), Health and Labour Sciences Research Expenses for Commission, and Applied Research for Innovative Treatment of Cancer from the Ministry of Health, Labour, and Welfare (H26-076).
Masafumi Ikeda; honoraria, AstraZeneca, AbbVie, Abbott Japan, Bayer, Bristol-Myers Squibb, Chiome Bioscience, Chugai, EA Pharma, Eisai, Eli Lilly Japan, Fujifilm Toyama Chemical, Delta-Fly Pharma, Incyte Biosciences Japan, Invitae, J-Pharma, Merus N.V., Merck biopharma, MSD, Nippon Kayaku, Novartis, NIHON SERVIER, Otsuka, Ono, Pfizer, Syneos Health, Takeda, Taiho, Taisho Pharmaceutical, Teijin, Yakult Makoto Ueno; honoraria and research funding, Taiho Pharmaceutical, AstraZeneca, Yakult Honsha, MSD, Nihon Servier, Ono Pharmaceutical, Incyte, CHUGAI PHARMACEUTICAL, Boehringer Ingelheim, J-pharma, Daiichi Sankyo, Eisai, Takeda Pharmaceutical, Merck Biopharma, Astellas Pharma, DFP, Novartis Takuji Okusaka; honoraria, consulting and advisory role, and research funding, Taiho Pharmaceutical, AstraZeneca, Syneos Health, EP clude, Eisai, MSD, Insight Japan, Nihon Servier, Dainippon Sumitomo Pharma, Bristol-Myers, FUJIFILM Toyama Chemical, Ono Pharmaceutical, Yakult Honsha, Johnson & Johnson, Daiichi Sankyo, Chugai Pharmaceutical, Nippon Shinyaku, Eli Lilly Japan, Pfizer Japan, Novartis Pharma. Akiko Todaka; honoraria, Ono Pharmaceutical, Yakult Honsha, Taiho Pharmaceutical, and Nihon Servier. Sohei Satoi; research funding, Nihon Servier. Junji Furuse; honoraria and research funding, Ono Pharmaceutical, Chugai Pharma, Incyte Biosciences Japan, Eisai, Eli Lilly Japan, Astra Zeneca, Yakult Honsha, Servier Japan, MSD, Novartis Pharma, Takeda, Bayer, Taiho Pharmaceutical, EA Pharma, Teijin pharma, Daiichi Sankyo, Terumo, Astellas, Sanofy, J-Pharma, Sumitomo Dainippon, Taiho Pharmaceutical, Delta-Fly-Pharma. Shin Kobayashi; none to declare. Kohei Nakachi; none to declare. Akira Tomokuni; none to declare. Masaru Konishi; none to declare
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Kobayashi, S., Ikeda, M., Nakachi, K. et al. A Multicenter Survey on Eligibility for a Randomized Phase III Trial of Adjuvant Chemotherapy for Resected Biliary Tract Cancer (JCOG1202, ASCOT). Ann Surg Oncol 30, 7331–7337 (2023). https://doi.org/10.1245/s10434-023-13913-6