GLX方案一线治疗晚期转移性胆系肿瘤的临床观察

Clinical observation on gemcitabine combined with xeloda and calcium folinate tablets as the first-line regimen for advanced billiary tract carcinoma

目的观察吉西他滨联合亚叶酸钙、希罗达组成的GLX方案一线治疗晚期转移性胆系肿瘤(BTCs)的有效性和安全性。方法 2008年4月至2014年10月间48例经病理组织学和影像学检查确诊的晚期BTCs患者接受GLX方案一线治疗,具体方案如下:吉西他滨1000 mg/m2静滴,d1、d8;亚叶酸钙40~60 mg/m2口服2/日,d1~d14;希罗达1250 mg/m2口服2/日,d1~d14;21天为1周期。2个周期后按照RECIST 1.1版标准评价近期疗效,参考Karnofsky体力状况评分(KPS)评价患者生活质量(Qo L),根据NCI-CTC 4.0版标准评价毒副反应,并随访疾病进展时间(TTP)和总生存期(OS)。结果全组共接受238个周期化疗,每例2~10个周期,平均4.9个周期。48例均可评价疗效和毒副反应。获CR 1例,PR 8例,SD 26例,有效率为18.7%,疾病控制率为72.9%;中位TTP为7个月,中位OS为13个月,治疗后23例Qo L改善,15例Qo L稳定,10例Qo L降低,有效率为79.2%;常见毒副反应为血液学毒性,以白细胞减少为主,发生率为52.1%,其中3级减少发生率分别为6.3%;手足综合征发生率为20.8%,3级发生率为6.3%。结论 GLX方案一线治疗晚期转移性BTCs疗效较好,可以改善或稳定Qo L,延长生存;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 gemcitabine combined with xeloda and calcium folinate tablets （GLX） as the first-line regimen for advanced billiary tract cancers （BTCs）. Methods From April 2008 to October 2014,48 patients di- agnosed as BTCs by pathologic and imaging examination were treated with GLX as the first-line regimen. Gemcitabine was administrated intravenously at the dose of 1000 mg/m2 for about 30 min on d1 and d8, and Xeloda 1250 mg/m2 and calcium folinate tablets 40-60 rag/ m2 twice daily, oral application d1-d14. Regimen was repeated every 3 weeks. The efficacy was evaluated strictly after 2 cycles according to RECIST 1.1 criteria, and quality of life （QoL）was evaluated accoding to karnofsky scores. Side effects was evaluated after 1 cycle ac- cording to NCI-CTC 4. 0 version criteria. The patients were followed-up for the time to progression （TFP） and overall survival （OS）. Re- sults All patients received 238 cycles totally and mean cylces was 4. 9 ranged from 2 to 10. All were eligible for efficacy and toxicity e- valuation. There were 1 case of CR, 8 PR and 26 SD. The overall response rate was 18.7% and disease control rate was 72. 9%. The me- dium TIP was 7 months and the medium OS was 13 months. The quality of life（QoL） were improve on 23 cases, stabled on 15 cases and decreased on 10 case with the effective rate of 72. 9%. Most common toxicity in grade 3 were leucopenia（6. 3%） and hand-foot syndrome （6. 3%）. Conclusion GLX as first-line treatment of advanced metastatic BTCs has good effect, and may improve or stabilize the patient＇s QoL with longer TIP and OS. GLX regimen is well tolerated, which is worthy of clinical use and further observation.