纳武利尤单抗联合重组人血管内皮抑素用于既往治疗过的晚期非小细胞肺癌的安全性和疗效
Safety and efficacy of nivolumab plus recombinant human endostatin in previously treated advanced non-small-cell lung cancer.
作者信息
Lv Weize, Pei Xiaofeng, Zhao Wenhua, Cong Yunyan, Wei Yajun, Li Ting, Zhang Hongyu, Lin Zhong, Saito Yuichi, Kim Jae Jun, Liang Zibin, Zhong Beilong, Wang Zhihui
机构信息
Department of Interventional Medicine, The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, China.
Guangdong Provincial Key Laboratory of Biomedical Imaging, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.
出版信息
Transl Lung Cancer Res. 2022 Feb;11(2):201-212. doi: 10.21037/tlcr-22-49.
BACKGROUND
Evidence of the efficacy of immune checkpoint inhibitors (ICIs) plus antiangiogenic drugs in previously treated patients with advanced non-small-cell lung cancer (NSCLC) is still insufficient, so we investigated the safety and efficacy of nivolumab plus recombinant human (rh)-endostatin in such patients.
METHODS
Patients without epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) targetable mutations in advanced NSCLC who did not respond to previous treatment were enrolled. Eligible patients received nivolumab (3 mg/kg, i.v. drip, day 1) every 2 weeks and rh-endostatin (210 mg, continuous i.v. infusion for 168 h) every 4 weeks until disease progression or discontinuation. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), duration of response (DOR), clinical benefit response rate (CBR), progression-free survival (PFS), overall survival (OS) and safety.
RESULTS
A total of 34 patients received a median of 4 cycles of therapy. In all, 14 patients achieved confirmed partial response (PR) with an ORR of 41.2% [14/34; 95% confidence interval (CI): 23.7-58.6%], DCR of 64.7% (22/34; 95% CI: 47.8-81.6%), CBR of 44.1% (95% CI: 26.5-61.7%), and a DOR of 6.9 (95% CI: 4.4-9.4) months. Median follow-up was 12.2 (range, 2.3-18.1) months. Median PFS (mPFS) was 6.8 (95% CI: 1.1-12.1) months, median OS (mOS) was 17.1 (95% CI: 6.6-27.6) months, and 12-month survival rate of 64.4% (95% CI: 46.2-82.6%). In all, 18 (18/34, 52.9%) patients experienced at least one treatment-related adverse event (TRAE), and Grade 3 TRAEs occurred in 4 (4/34, 11.8%) of them.
CONCLUSIONS
This study is first to assess nivolumab plus rh-endostatin in previously treated patients with advanced NSCLC. In view of its favorable efficacy and safety profile, this combination represents a promising treatment regimen in this patient population.
背景
免疫检查点抑制剂（ICI）联合抗血管生成药物用于既往治疗过的晚期非小细胞肺癌（NSCLC）患者的疗效证据仍不充分，因此我们研究了纳武利尤单抗联合重组人（rh）内皮抑素在此类患者中的安全性和疗效。
方法
纳入既往治疗无效的晚期NSCLC患者，这些患者不存在上皮生长因子受体（EGFR）或间变性淋巴瘤激酶（ALK）可靶向突变。符合条件的患者每2周接受一次纳武利尤单抗（3mg/kg，静脉滴注，第1天），每4周接受一次rh内皮抑素（210mg，持续静脉输注168小时），直至疾病进展或停药。主要终点为客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、缓解持续时间（DOR）、临床获益缓解率（CBR）、无进展生存期（PFS）、总生存期（OS）和安全性。
结果
共有34例患者接受了中位4个周期的治疗。总体而言，14例患者获得确认的部分缓解（PR），ORR为41.2%[14/34；95%置信区间（CI）：23.7 - 58.6%]，DCR为64.7%（22/34；95%CI：47.8 - 81.6%），CBR为44.1%（95%CI：26.5 - 61.7%），DOR为6.9（95%CI：4.4 - 9.4）个月。中位随访时间为12.2（范围：2.3 - 18.1）个月。中位PFS（mPFS）为6.8（95%CI：1.1 - 12.1）个月，中位OS（mOS）为17.1（95%CI：6.6 - 27.6）个月，12个月生存率为64.4%（95%CI：46.2 - 82.6%）。总体而言，18例（18/34，52.9%）患者发生至少1次治疗相关不良事件（TRAE），其中3级TRAE发生在4例（4/34，11.8%）患者中。
结论
本研究首次评估了纳武利尤单抗联合rh内皮抑素用于既往治疗过的晚期NSCLC患者。鉴于其良好的疗效和安全性，这种联合方案在此类患者群体中代表了一种有前景的治疗方案。
Zotero 插件