白蛋白结合型紫杉醇联合奥沙利铂治疗晚期胆系肿瘤的疗效观察

Clinical observation of albumin-bound paclitaxel plus oxaliplatin for advanced BTC

目的:观察白蛋白结合型紫杉醇联合奥沙利铂治疗晚期胆系肿瘤(biliary tract cancers,BTCs)患者的疗效和安全性。方法:回顾性分析13例晚期胆系肿瘤患者资料。予全身化疗,具体方案为:白蛋白结合型紫杉醇130mg/m^2,静脉滴注30分钟,d_(1,8);奥沙利铂85mg/m^2,静脉滴注,d_(1,8),21天为1周期。2个周期后按照RECIST 1.1标准评价近期疗效及远期疗效,KPS变化评价生活质量(QOL),每周期后根据NCI CTCAE 3.0标准评价不良反应,并观察无进展生存期(PFS)和总生存时间(OS)。结果:每例完成2~8个周期化疗,共62个周期,平均每例完成4.8个周期化疗,均可评价疗效。完全缓解(CR)0例,部分缓解(PR)3例,病情稳定(SD)5例,病情进展(PD)5例,有效率(RR)为23.1%(3/13),疾病控制率(DCR)为61.5%(8/13)。中位无进展生存期(m PFS)6.1个月,中位总生存(m OS)9.8个月。最常见的1-3级不良反应主要为中性粒细胞减少、胃肠道反应、感觉神经病变、肌肉痛/关节痛,未出现4级不良反应,无治疗相关性死亡。QOL改善稳定率为76.9%。结论:白蛋白结合型紫杉醇联合奥沙利铂治疗晚期胆系肿瘤疗效较好,可以改善或稳定QOL,延长生存时间,且耐受性较好。

Objective：To evaluate the efficacy and safety of albumin-bound paclitaxel plus oxaliplatin in the treatment of advanced biliary tract cancer.Methods：Retrospectively analyze thirteen advanced BTCs.All patients received systemic chemotherapy as follow：Albumin-bound paclitaxel 130 mg / m^2,30 minutes intravenous drip,d1,8.Oxaliplatin intravenous drip,85 mg / m^2,d1,8,21 days for 1 cycle.The short-term efficacy and long-term efficacy was evaluated after 2 cycles according to RECIST 1.1 criteria.Quality of life（ QOL） was evaluated accoding to Karnofsky scores,and safety was evaluated after 1 cycle progression-free survival（ PFS） and overall survival（ OS） were also observed.Results：Each patients completed 2 to 8 cycles chemotherapy up to total 62 cycles,with a mean of 4.8 cycles in each of the 13 patients,and all can be evaluated.No CR patients,3 cases of PR,5 cases of SD and 5 cases of PD were found.The response rate（ RR） was 23.1%（ 3 /13） and the disease control rate（ DCR） was 61.5%（ 8 /13）.QOL improved and stable rate was 76.9%.The most common grade 1-3 toxicities were neutropenia,gastrointestinal reaction,sensory neuropathy,muscle pain / joint pain,and no grade 4 toxicities were observed and no death related to therapy.Median progression-free survival（ m PFS） was 6.1 months,and the median overall survival（ m OS） was 9.8months.Conclusion：Albumin-bound paclitaxel plus oxaliplatin for advanced BTCs has good efficacy,which may improve the patients QOL and prolong survival,and the toxicities are well-tolerated.