Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Otaru General Hospital, 1-1-1, Wakamatsu, Otaru, Hokkaido, 047-8550, Japan.
Int J Clin Oncol. 2018 Oct;23(5):894-899. doi: 10.1007/s10147-018-1283-6. Epub 2018 Apr 28.
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.
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.
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%.
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.
辅助化疗在可切除胆管癌患者中的作用尚未确定。S-1 已被证明对晚期胆管癌具有活性。因此，我们评估了 S-1 在可切除胆管癌患者中的辅助化疗的可行性。
本研究纳入了完全行肝内/肝外胆管、胆囊或壶腹癌根治性切除术的患者。S-1 口服，每日 2 次，每 6 周为一个周期，共 4 个周期。治疗持续至 24 周或直至复发/出现不可接受的毒性。主要终点为治疗完成率，定义为接受相对剂量强度≥75%的患者比例。该试验已在 UMIN000004051 注册。
2010 年 6 月至 2011 年 3 月期间共纳入 33 例患者。27 例患者的相对剂量强度≥75%，治疗完成率为 81.8%。最常见的 3/4 级不良事件是中性粒细胞减少症（18%）。12%的患者出现 2 级恶心或腹泻。3 年无复发生存率为 39.4%。3 年生存率为 54.5%。
S-1 辅助化疗在可切除胆管癌患者中是一种可行的治疗方法。有必要开展 III 期研究以确认 S-1 辅助治疗可切除 BTC 患者的疗效。
