GEMOX方案联合重组人血管内皮抑素一线治疗晚期胆系肿瘤的初步观察

Observation of GEMOX regimen combined with endostar as the first-line treatment for patients with advanced biliary tract carcinoma

目的：观察吉西他滨（ GEM）、奥沙利铂（ OXA）联合重组人血管内皮抑素（恩度）一线治疗晚期胆系肿瘤（BTCs）的疗效及安全性。方法回顾性分析2009年1月至2013年8月ⅣB期BTCs患者48例，分为联合组（n＝20）和单纯化疗组（ n＝28）。联合组：吉西他滨1000mg／m2静滴，d1、d8；奥沙利铂100mg／m2静滴 d2，3周为1周期；恩度15mg 静滴 d1～d14，3周为1周期。单纯化疗组仅给予GEMOX方案化疗，剂量与使用方法同联合组。2个周期后按照RECIST1.1标准评价近期疗效，参考KPS变化评价生活质量（QoL），根据NCI CTC3.0标准评价不良反应，并观察疾病进展时间（TTP）和总生存时间（ OS）。结果联合组获CR 1例、PR 3例、SD 12例、PD 4例，有效率（ RR）为20.0％，疾病控制率（ DCR）为80.0％；中位TTP为8.6个月，中位OS为14.0个月；QoL改善稳定率为80.0％。单纯化疗组获 CR 1例、PR 5例、SD 15例、PD 7例，RR 为21.5％，DCR 为75.0％；中位TTP为6.0个月，中位OS为10.0个月；QoL改善稳定率为71.4％。两组中位TTP和OS的差异有统计学意义（ P＜0.05）。两组最常见的不良反应为骨髓抑制，其他不良反应包括恶心呕吐、肝功能损害、外周神经炎、皮肤过敏反应等，以1～2级为主，两组比较差异无统计学意义（ P＞0.05）。化疗联合恩度组仅2例出现心电图T波改变，1例出现房性早搏，1例出现轻度血压升高。结论 GEMOX联合恩度方案一线治疗转移性BTCs疗效较好，可以改善或稳定QoL，延长生存时间，且耐受性较好，值得临床推广使用和进一步深入观察。

Objective To observe the efficacy and safety of endostar combined with gemcitabine and oxaliplatin as the first-line treatment for patients with advanced biliary tract carcinoma. Methods Forty-eight patients from Jan. 2009 to Aug. 2013 confirmed with pathologic and imaging examination as stage ⅣB primary biliary tract carcinoma were reviewed. Twenty cases received endostar＋GEMOX regimen and 28 cases were applied with GEMOX regimen alone. GEMOX regimen was given as follow：gemcitabine 1000mg/m2 iv, d1 ,d8;oxaliplatin 100mg/m2 iv, d2 , 21 days was a cycle. Endostar was given 15mg iv d1-d14 , 21 days was a cycle. The effica-cy was evaluated strictly after 2 cycles according to RECIST 1.1 criteria, quality of life（QoL）was evaluated accoding to karnofsky scores,safety was evaluated after 1 cycle according to NCI CTC 3.0 version criteria. The time to progress（TTP）and overall survival （ OS） were also observed. Results In GEMOX＋endostar group, 1 was in CR,3 in PR,12 in SD, and 4 in PD; the response rate （RR）was 20.0%, disease control rate（DCR）was 80.0%; median TTP was 8.6 months and the median OS was 14.0 months; the QoL improved and stable rate was 80.0%. In GEMOX group, 1 was in CR,5 in PR,15 in SD, and 7 in PD; RR was 21.5%, and DCR was 75.0%; the median TTP was 6.0 months and the median OS was 10.0 months; the QoL improved and stable rate was 71.4%. There was statistical difference in TTP and OS between the two groups（ P〈0.05） . The most common toxicity in the two groups were myelosuppression, other main toxicities included nause/vommiting, liver dysfaction, peripheral nearitis, skin allergy reaction and etc, mainly in grade 1-2, and there were no sugnificant differences between the two groups（ P〈0.05） . In GEMOX＋endostar group, on- ly 2 case of non-specific T wave changed. One case was of auricular flutter, and 1 case with mild hypertension. Conclusion GEMOX＋endostar as the first-line treatment for advanced BTCs has good efficacy, may improve or stabilize the patient.s QoL and prolong surviv-al, and the toxicities are well-tolerated, which worth clinical use and further observation.