Enpower:评估重组人血管内皮抑制素联合化疗±PD-1单抗一线治疗EGFR/ALK阴性晚期非鳞状非小细胞肺癌有效性和安全性队列研究

Enpower:evaluation on the efficacy and safety of recombinant human Endostatin in combination with chemotherapy±PD-1 antibody as first line regimen for EGFR/ALK-negative advanced non-squamous non-small cell lung cancer,a cohort study

目的评估重组人血管内皮抑制素(恩度)联合化疗±PD-1单抗一线治疗EGFR/ALK阴性晚期非鳞状非小细胞肺癌(NSCLC)的有效性和安全性。方法采用全国多中心、开放、前瞻性队列研究设计。(1)诱导缓解期:队列1患者使用重组人血管内皮抑制素联合化疗加PD-1单抗治疗;队列2患者使用重组人血管内皮抑制素联合化疗,4~6个周期。(2)未疾病进展患者进入维持期治疗:队列1患者使用重组人血管内皮抑制素加PD-1单抗;队列2患者使用重组人血管内皮抑制素。主要研究终点之一客观缓解率(ORR)。结果基于43例可评价患者最佳疗效结果,队列1(15例)ORR为53%;队列2(28例)ORR为39%。50例患者纳入不良事件分析。队列1和队列2总体不良事件发生率分别为90%和86%。队列1中肝功能异常(33%)、心悸(29%)和皮肤过敏反应(10%)的发生率高于队列2。结论重组人血管内皮抑制素联合化疗加PD-1单抗一线治疗EGFR/ALK阴性晚期非鳞状NSCLC,近期疗效好,但轻度肝转氨酶升高发生率增加值得关注。

Objective To evaluate the efficacy and safety of recombinant human Endostatin(rh-Endostatin)in combination with chemotherapy with or without PD-1 antibody as the first-line regimen for EGFR/ALK-negative advanced non-squamous non-small-cell lung cancer(NSCLC).Methods An open label,multicenter,prospective cohort study was designed.(1)In induced remission,the patients in Cohort 1 received rh-Endostatin and chemotherapy plus PD-1 antibody,and those in Cohort 2 was subject to rh-Endostatin and chemotherapy for 4-6 cycles.(2)Maintenance therapy in patients with no disease progression:the patients received rh-Endostatin plus PD-1 antibody in Cohort 1 and only rh-Endostatin in Cohort 2.One of the study primary endpoints was the objective response rate(ORR).Results 43 subjects were evaluable for the best efficacy analysis,with 15 in Cohort 1 and 28 in Cohort 2.ORR was 53%in Cohort 1 and 39%in Cohort 2,respectively.50 subjects were included in safety analysis.The overall incidence of adverse events was 90%in Cohort 1 and 86%in Cohort 2.The adverse events occurred more frequently in Cohort 1,with AST/ALT abnormal(33%),palpitate(29%)and skin hypersensitivity(10%),than in Cohort 2.Conclusions rh-Endostatin in combination with chemotherapy plus PD-1 antibody for the first line treatment of EGFR/ALK-negative,advanced non-squamous NSCLC could obtain the better improvement in ORR.However,higher occurrence of AST/ALT abnormal was warranted for attention.