白蛋白结合型紫杉醇联合卡铂治疗晚期初治非小细胞肺癌的临床观察

Clinical observation of albumin-bound paclitaxel plus carboplatin as first-line therapy in patients with ad-vanced non-small cell lung cancer

目的 比较白蛋白结合型紫杉醇联合卡铂（nab-PC）方案和紫杉醇联合卡铂（PC）方案一线治疗晚期非小细胞肺癌（NSCLC）的疗效及毒副反应.方法 将经病理组织学或细胞学检查确诊的60例晚期初治NSCLC患者随机分为nab-PC组（白蛋白结合型紫杉醇130mg/m2,d1、d8;卡铂AUC=6,d1）和PC组（紫杉醇175mg/m2,d1;卡铂AUC=6,d1）,每3周为1周期.采用RECIST 1.1标准评价近期客观疗效,WHO急性及亚急性毒性分级标准评价毒性反应.结果 全组60例均可评价疗效.nab-PC组的总有效率（RR）和疾病控制率（DCR）分别为40.0％和80.0％,均高于PC组的23.3％和60.0％,差异均有统计学意义（P＜0.05）.在鳞癌中,nab-PC组和PC组的RR分别为57.1％ （8/14）和23.1％ （3/13）,差异有统计学意义（P＜0.05）;非鳞癌中,两组的RR分别为25.0％ （4/16）和23.3％ （4/17）,差异无统计学意义（P＞0.05）.nab-PC组和PC组的中位无进展生存期分别为6.5个月和5.9个月,差异无统计学意义（P＞0.05）.两组3～4级毒副反应发生率的差异均无统计学意义（P＞0.05）,nab-PC组中性粒细胞减少的发生率高于PC组（P＜0.05）.结论 白蛋白结合型紫杉醇联合卡铂—线治疗晚期NSCLC的疗效较好,对鳞癌效果更佳,毒副反应能耐受,值得临床上推广.

Objective To compare the efficacy and safety of nab-paclitaxel plus carboplatin （nab-PC） versus paclitaxel plus carboplatin （PC） in the treatment of patients with advanced non-small cell lung cancer （NSCLC）.Methods Sixty patients with advanced NSCLC diagnosed by histological or cytological examination were randomly divided into nab-PC group （n =30 ; albumin-bound paclitaxel 130 mg/m2,d1,d8; carboplatin AUC =6,d1） and PC group （n =30; paclitaxel 175mg/m2,d1; carboplatin AUC =6,d1）.Three weeks were a cycle.The WHO grading system for acute and subacute toxicity was used to evaluate the adverse reaction and the version 1.1 of Response Evaluation Criteria in Solid Tumors （RECIST） guideline was employed to evaluate the objective response.Results All patients can be evaluated.The response rate （RR） and disease control rate （DCR） in nab-PC group were 40.0% and 80.0%,higher than 23.3% and 60.0% in PC group with significant difference （P 〈0.05）.The RR of squamous cell carcinoma and non-squamous cell carcinoma were 57.1% （8/14） and 25.0% （4/16） in nab-PC group and 23.1% （3/13） and 23.3% （4/17） in PC group.There was significant difference in the RR of squamous cell carcinoma between both groups.The median progression-free survival were 6.5 months and 5.9 months in nab-PC and PC group without statistical significance （P 〉 0.05）.No significant difference was observed in grade 3-4 toxicities between both groups,but the incidence of neutropenia of nab-PC group was higher than that of PC group （P 〈 0.05）.Conclusion The albumin-bound paclitaxel plus carboplatin as first-line therapy shows favorable benefits and can be well tolerated in patients with advanced NSCLC.