白蛋白结合型紫杉醇二线及以上治疗晚期非小细胞肺癌的单臂、单中心探索性临床研究

Single-arm,one-center, exploratory clinical trial of albumin-bound paclitaxel second and more line therapy for advanced non-small cell lung cancer

目的:探讨白蛋白结合型紫杉醇二线及以上治疗晚期非小细胞肺癌的疗效及安全性。方法:选取2012年10月到2015年12月入组前接受过至少一线治疗方案失败的晚期非小细胞肺癌患者63例,给予白蛋白结合型紫杉醇130 mg/m2,第1天和第8天静脉滴注治疗,21 d为一个周期。每2个周期进行疗效评价,用CTCAE4.03版本的标准评价每个周期出现的不良反应。患者疾病进展后通过电话随访获取患者的预后数据。结果:纳入研究的63例患者均可评价疗效,其中接受治疗后疗效达到完全缓解(CR)0例,部分缓解(PR)15例,疾病稳定(SD)21例,疾病进展(PD)27例。该研究的客观缓解率(ORR)为23.81%,疾病控制率(DCR)为57.14%。经过随访预后,63例患者的中位无进展生存期(mPFS)为3.9个月(95%CI:3.1-5.2),中位总生存期(mOS)为9.3个月(95%CI:7.8-10.4)。安全性方面,主要的2级以上不良反应为中性粒细胞减少,血小板减少,脱发和外周神经毒性,总体不良反应可耐受。结论:白蛋白结合型紫杉醇二线及以上治疗晚期非小细胞肺癌患者具有不错的疗效,不良事件可控,有望成为晚期非小细胞肺癌二线治疗标准。

AIM:To explore the efficacy and safety of second and more line treatment with albumin-bound paclitaxel for advanced non-small cell lung cancer.METHODS:From Oct 2012 to Dec 2015,a total of 63 patients with advanced non-small cell lung cancer who had failed previously first-line and more line treatment were enrolled in this study.The patients were treated with 130 mg/m2 intravenous infusion albumin-binding paclitaxel on day 1 and day 8,21 days one cycle.The efficacy was evaluated every 2 cycles,and adverse reactions were recorded using the CTCAE4.03 version.Patients were followed up by telephone to obtain prognostic data after disease progression.RESULTS:All of the 63 patients were available for efficacy evaluation,among them,complete remission(CR)0 case,partial remission(PR)15 case,stable disease(SD)21 case,progression disease(PD)27 case.Objective response rate(ORR)was 23.81%,disease control rate(DCR)was 57.14%,median Progression-free survival(PFS)of the 63 patients was 3.9 months(95%CI:3.1-5.2),median Overall survival(OS)was 9.3 months(95%CI:7.8-10.4).In terms of safety analysis,the major grade 2 and above adverse reactions were neutropenia,thrombocytopenia,alopecia and peripheral neurotoxicity,and the overall adverse reactions were tolerable.CONCLUSION:The second and more line treatment with albumin-bound paclitaxel in patients with advanced non-small cell lung cancer has superior efficacy and controllable adverse events,which is expected to become the second-line treatment standard regimens for advanced NSCLC.