XELOX方案联合恩度一线治疗晚期胆系肿瘤的临床观察

目的 观察卡培他滨和奥沙利铂（XELOX方案）联合重组人血管内皮抑制素（恩度）一线治疗晚期胆系肿瘤的临床疗效及毒副反应。方法 收集2008年1月至2013年12月我院肿瘤科收治的胆系肿瘤Ⅳ期患者42例，随机分为联合组（n=18）和单纯化疗组（n=24）。单纯化疗组应用XELOX方案化疗：卡培他滨1.25 g/m2 口服，d1~d14；奥沙利铂85 mg/m2 静脉滴注，d1。联合组在应用以上药物的同时给予恩度15 mg静滴3~4 h，d1~d14。21 d为1个周期，每2个周期评价疗效、生活质量（QOL）及毒副反应，比较两组有效率（RR）、疾病控制率（DCR）、中位无疾病进展生存期（mPFS）和中位生存时间（mOS）。结果 单纯化疗组患者获CR 0例，PR 6例，SD 8例，PD 10例，RR为25.0%，DCR为58.3%；mPFS为 5个月，mOS 为9.5个月，QOL改善稳定率为66.7%。联合组患者获CR 0例，PR 5例，SD 6例，PD 7例，RR为27.8%，DCR为61.1%；mPFS为7.5个月，mOS为14个月，QOL改善稳定率为77.8%。两组mPFS、mOS和QOL改善稳定率比较，差异均有统计学意义（P均<0.05）。两组毒副反应主要为消化道反应、手足综合征、骨髓抑制、神经毒性及口腔黏膜炎，多为Ⅰ级/Ⅱ级，Ⅲ级/Ⅳ级少见，差异均无统计学意义（P均＞0.05）。结论 XELOX方案联合恩度一线治疗晚期胆系肿瘤的疗效较好，毒副反应可耐受，安全性良好，值得进一步观察及临床推广应用。

Efficacy and safety of combined XELOX and Endostar therapy as first-line treatment for patients with advanced biliary tract carcinoma

Objective  To observe the efficacy and safety of the combination of Endostar therapy with capecitabine and oxaliplatin therapy as a first-line treatment for patients with advanced biliary tract carcinoma. Methods Records were retrospectively reviewed for 42 patients with stage Ⅳ primary biliary tract carcinoma confirmed by pathology and imaging，who were treated at our hospital from January 2008 to December 2013. Eighteen patients were treated with Endostar+XELOX，while 24 were treated with XELOX alone. The XELOX regimen involved capecitabine at 1.25 g/m2， po，d1-d14 and oxaliplatin at 85 mg/m2，ivgtt， d1. Endostar was given at a dose of 15 mg，ivgtt， d1-d14，on a 21-day cycle. After 2 cycles，efficacy， quality of life（QOL），safety，median  progression-free survival （mPFS） and median overall survival（mOS） were compared between the two treatment groups. Results In the XELOX group after 2 treatment cycles，no patient was in CR，6 were in PR，8 were in SD，and 10 were in PD；the response rate（RR） was 25.0%， disease control rate （DCR） was 58.3%，mPFS was 5.0 months and mOS was 9.5 months. QOL improved as a result of treatment，and 66.7% patients were in stable condition. In the Endostar+XELOX group after 2 cycles， no patient was in CR，5 were in PR，6 were in SD，and 7 were in PD；RR was 27.7%，DCR was 61.1%，mPFS was 7.5 months and mOS was 14.0 months. QOL improved as a result of therapy，and 77.8% of patients achieved a stable condition. mPFS and mOS were significantly longer for patients who received combination therapy（P<0.05）. The two therapies were associated with similar types and rates of adverse events，the most frequent of which were gastrointestinal reactions，hand-foot syndrome，myelosuppression，neurotoxicity，and stomatitis（mainly gradeⅠ-Ⅱ）. Conclusion Endostar+XELOX shows good efficacy as a first-line treatment for advanced biliary tract carcinoma，and it is well tolerated， justifying its further study and potentially wider implementation in the clinic.