XELOX方案联合恩度一线治疗晚期胆系肿瘤的临床观察

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

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（m PFS）和中位生存时间（m OS）。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%;m PFS为5个月,m OS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%;m PFS为7.5个月,m OS为14个月,QOL改善稳定率为77.8%。两组m PFS、m OS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。

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（m PFS）and median overall survival（m OS）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%,m PFS was 5.0 months and m OS was 9.5 months. QOL improved as a result of treatment,and66.7% 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%,m PFS was 7.5 months and m OS was 14.0 months. QOL improved as a result of therapy,and 77.8% of patients achieved a stable condition. m PFS and m OS 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 grade Ⅰ-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.