Kim Y J, Im S-A, Kim H G, Oh S Y, Lee K W, Choi I S, Oh D Y, Lee S H, Kim J H, Kim D W, Kim T Y, Kim S W, Heo D S, Yoon Y B, Bang Y J
Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Ann Oncol. 2008 Jan;19(1):99-103. doi: 10.1093/annonc/mdm439. Epub 2007 Sep 9.
Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC.
Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m(2) p.o. b.i.d. from D1-14) and cisplatin (60 mg/m(2) on D1), repeated every 3 weeks.
Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31-71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3-42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3-6.3) and median overall survival was 8.7 months (95% CI, 6.0-11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles).
Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.
晚期胆管癌（BTC）的最佳化疗方案尚未确定。我们开展本研究以评估S-1与顺铂联合化疗对转移性或复发性BTC的疗效和毒性。
病理证实为BTC的患者符合条件。化疗方案包括S-1（第1 - 14天口服，40 mg/m²，每日2次）和顺铂（第1天，60 mg/m²），每3周重复一次。
2005年1月至2006年12月共纳入51例BTC患者（转移性：复发性 = 37:14，胆囊癌：肝内胆管癌：肝外胆管癌 = 16:25:10）。中位年龄为57岁（范围31 - 71岁），大多数患者的体能状态良好。总缓解率为30% [95%置信区间（CI），17.3 - 42.7]，2例患者（4%）达到完全缓解，13例（26%）部分缓解，21例（42%）病情稳定，9例（18%）病情进展。中位随访时间为12.4个月，中位疾病进展时间为4.8个月（95% CI，3.3 - 6.3），中位总生存期为8.7个月（95% CI，6.0 - 11.4）。主要毒性反应为3/4级中性粒细胞减少（占所有周期的8.9%），6个周期出现发热性中性粒细胞减少（占所有周期的2.7%）。
S-1与顺铂联合化疗是一种对BTC患者有效的基于门诊的适度化疗方案。毒性反应中等但可控制。
