吉西他滨固定剂量率联合替吉奥二线解救治疗晚期胆道肿瘤的临床疗效

Clinical efficacy of gemcitabine at a fixed dose-rate combined with S-1 as second-line therapy in the treatment of advanced biliary tract cancer

目的:探讨吉西他滨固定剂量率联合替吉奥二线解救治疗晚期胆道肿瘤的疗效及安全性。方法:回顾性分析37例接受吉西他滨固定剂量率联合替吉奥二线化疗的晚期胆道肿瘤患者的临床资料。具体治疗方案为吉西他滨10 mg·m2·min-1,共1 000 mg/m2,第1天和第8天;第1～14天口服替吉奥40～60 mg/次,2次/d,每21d为1个周期。所有患者至少接受2个周期化疗。根据实体瘤疗效反应评价标准评价疗效,根据美国国立癌症研究所制定的常规不良反应判定标准(第3版)评价不良反应。结果:37例患者均可评价疗效,完全缓解0例,部分缓解6例,疾病稳定14例;客观有效率为16.2%(6/37),疾病控制率为54.1%(20/37)。中位无进展生存时间为11周(95%可信区间:9.1～12.9),中位总生存时间为7个月(95%可信区间:4.1～9.9)。主要不良反应为中性粒细胞下降、血小板下降、贫血、恶心、呕吐、疲乏、黏膜炎和厌食,对症处理后均可缓解。结论:吉西他滨固定剂量率输注联合替吉奥二线解救治疗晚期胆道肿瘤患者具有一定的疗效,不良反应发生率低,耐受性较好。

Objective： To evaluate the efficacy and safety of fixed dose-rate gemcitabine plus S-1 as second-line therapy for the advanced biliary tract cancer patients.Methods： The clinical data of 37 patients with advanced biliary tract cancer were retrospectively analyzed. The patients received second- line therapy with gerncitabine at a fixed dose-rate of 10 mg·m^-2. rnin-1 in fusion on days 1 and 8, combined with oral S-1 at a dose of 40-60 rng twice daily from days 1 to 14, repeated every 21 d. The clinical evaluation was performed by response evaluation criteria in solid tumors （RECIST）. The adverse events were analyzed by Common Terminology Criteria for Adverse Events （CTCAE） version 3.0. Results： A total of 37 patients could be evaluated, with 0 case of complete response, 6 case of partial disease, 14 case of stable disease. The objective response rate was 16.2%. The disease control rate was 54.1%. The median progression-free survival and overall survival time were 11 weeks [95% confidence interval （CI）：9.1-12.9] and 7 months （95% CI： 4.1-9.9）, respectively. The common adverse effects were neutropenia, thrombocytopenia, anemia, nausea, vomiting, fatigue, mucositis and anorexia, which were apparently relieved after symptomatic treatments. Conclusion： Gemcitabine at a fixed dose rate combined with S-1 second-line regimen has certain efficacy for advanced biliary tract cancer patients, with well tolerance and low incidence of adverse reactions.