International journal of clinical oncology · 2018
Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer.
СтатьяНазвание и аннотация: Перевод в очереди
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Nakachi Kohei, Konishi Masaru, Ikeda Masafumi, Shimada Kazuaki, Okusaka Takuji, Saiura Akio, Ishii Hiroshi, Sugiyama Masanori, Furuse Junji, Sakamoto Hirohiko, Shimamura Tomotaka, Ohta Takehiro
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedAntimetabolites, AntineoplasticBiliary Tract NeoplasmsCarcinoma, PapillaryCarcinoma, Signet Ring CellChemotherapy, AdjuvantDrug CombinationsFeasibility StudiesFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalNeutropeniaOxonic AcidPostoperative PeriodPrognosisSurvival RateTegafurYoung Adult