Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer |
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| Authors: | Kohei Nakachi Masaru Konishi Masafumi Ikeda Kazuaki Shimada Takuji Okusaka Akio Saiura Hiroshi Ishii Masanori Sugiyama Junji Furuse Hirohiko Sakamoto Tomotaka Shimamura Takehiro Ohta |
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| Institution: | 1.Department of Hepatobiliary and Pancreatic Oncology,National Cancer Center Hospital East,Kashiwa,Japan;2.Department of Hepatobiliary and Pancreatic Surgery,National Cancer Center Hospital East,Kashiwa,Japan;3.Department of Hepatobiliary and Pancreatic Surgery,National Cancer Center Hospital,Tokyo,Japan;4.Department of Hepatobiliary and Pancreatic Oncology,National Cancer Center Hospital,Tokyo,Japan;5.Department of Gastroenterological Surgery,Cancer Institute Hospital of the Japanese Foundation for Cancer Research,Tokyo,Japan;6.Department of Gastroenterology,Cancer Institute Hospital of the Japanese Foundation for Cancer Research,Tokyo,Japan;7.Department of Surgery,Kyorin University School of Medicine,Tokyo,Japan;8.Department of Medical Oncology,Kyorin University School of Medicine,Tokyo,Japan;9.Department of Gastroenterological Surgery,Saitama Cancer Center,Saitama,Japan;10.Department of Gastroenterology,Saitama Cancer Center,Saitama,Japan;11.Department of Surgery, Institute of Gastroenterology,Tokyo Women’s Medical University,Tokyo,Japan;12.Otaru General Hospital,Otaru,Japan |
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| Abstract: | BackgroundThe 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.MethodsPatients 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.ResultsThirty-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%.ConclusionAdjuvant 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. |
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