Kohei Nakachi1,2, Masaru Konishi3, Masafumi Ikeda4, Kazuaki Shimada5, Takuji Okusaka6, Akio Saiura7, Hiroshi Ishii8, Masanori Sugiyama9, Junji Furuse10, Hirohiko Sakamoto11, Tomotaka Shimamura12, Takehiro Ohta13. 1. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. knakachi-gi@umin.org. 2. Otaru General Hospital, 1-1-1, Wakamatsu, Otaru, Hokkaido, 047-8550, Japan. knakachi-gi@umin.org. 3. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. 4. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. 5. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 6. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 7. Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. 8. Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan. 9. Department of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan. 10. Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan. 11. Department of Gastroenterological Surgery, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, Saitama, 362-0806, Japan. 12. Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, Saitama, 362-0806, Japan. 13. Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
Abstract
BACKGROUND: The role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer. METHODS: Patients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051. RESULTS: Thirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%. CONCLUSION: Adjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.
BACKGROUND: The role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer. METHODS:Patients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051. RESULTS: Thirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%. CONCLUSION: Adjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.
Authors: T Ebata; S Hirano; M Konishi; K Uesaka; Y Tsuchiya; M Ohtsuka; Y Kaneoka; M Yamamoto; Y Ambo; Y Shimizu; F Ozawa; A Fukutomi; M Ando; Y Nimura; M Nagino Journal: Br J Surg Date: 2018-02 Impact factor: 6.939
Authors: John P Neoptolemos; Malcolm J Moore; Trevor F Cox; Juan W Valle; Daniel H Palmer; Alexander C McDonald; Ross Carter; Niall C Tebbutt; Christos Dervenis; David Smith; Bengt Glimelius; Richard M Charnley; François Lacaine; Andrew G Scarfe; Mark R Middleton; Alan Anthoney; Paula Ghaneh; Christopher M Halloran; Markus M Lerch; Attila Oláh; Charlotte L Rawcliffe; Caroline S Verbeke; Fiona Campbell; Markus W Büchler Journal: JAMA Date: 2012-07-11 Impact factor: 56.272