二线卡瑞利珠单抗联合阿帕替尼和化疗治疗晚期肺腺癌的疗效和安全性:一项前瞻性、开放标签、多中心研究。
Efficacy and safety of second-line camrelizumab combined with apatinib and chemotherapy in patients with advanced lung adenocarcinoma: A prospective, open-label, multicentric study.
发表日期:2023 Nov 11
作者:
Yiwei Yao, Yong Wang, Yingying Du, Fengshou Jiang, Hui Liang, Minghong Bi, Hua Xie, Wanren Peng, Yueyin Pan
来源:
INTERNATIONAL IMMUNOPHARMACOLOGY
摘要:
卡瑞利珠单抗(一种程序性细胞死亡蛋白 1 抑制剂)和阿帕替尼(一种血管生成抑制剂)被认为是晚期肺腺癌 (LUAD) 的潜在治疗方法。本研究旨在评价二线卡瑞利珠单抗联合阿帕替尼和化疗(白蛋白结合型紫杉醇、多西他赛或培美曲塞)治疗晚期 LUAD 患者的疗效和安全性。 29 例晚期 LUAD 患者接受了二线卡瑞珠单抗联合化疗阿帕替尼和化疗被纳入这项前瞻性、开放标签、多中心研究。进行中位随访时间为 18.0 个月的随访。有 0 名(0.0%)、11 名(37.9%)、14 名(48.4%)和 3 名(10.3%)患者获得完全缓解、部分缓解、疾病稳定、和进行性疾病。与此同时,1 名 (3.4%) 患者的治疗反应未得到评估。客观缓解率和疾病控制率分别为 37.9% 和 86.3%。就生存而言,中位无进展生存期 (PFS)(95% 置信区间)为 11.1 (5.2-17.0) 个月,1 年和 2 年 PFS 率分别为 40.4% 和 20.5%。未达到中位总生存期(OS); 1 年和 2 年 OS 率分别为 72.0% 和 64.8%。当前治疗周期 ≥ 8 与更好的 PFS 和 OS 相关(P < 0.001)。此外,21 名 (72.4%) 患者经历了至少一种治疗引起的不良事件 (TEAE),其中大部分为 I 级和 II 级。最常见的 TEAE 是白细胞减少 (17.2%)、肝功能障碍 (17.2%)、甲状腺功能减退 (13.8%)、手足综合征 (13.8%) 和血小板减少 (13.8%)。二线卡瑞利珠单抗联合阿帕替尼和化疗可能作为晚期 LUAD 患者安全性可接受的潜在治疗方法。版权所有 © 2023。由 Elsevier B.V. 出版。
Camrelizumab (a programmed cell death protein 1 inhibitor) and apatinib (an angiogenesis inhibitor) are considered as potential treatments for advanced lung adenocarcinoma (LUAD). This study aimed to evaluate the efficacy and safety of second-line camrelizumab combined with apatinib and chemotherapy (albumin-bound paclitaxel, docetaxel, or pemetrexed) in patients with advanced LUAD.Twenty-nine patients with advanced LUAD underwent second-line camrelizumab combined with apatinib and chemotherapy were enrolled in this prospective, open-label, multicentric study. Follow-up with a median duration of 18.0 months was conducted.There were 0 (0.0 %), 11 (37.9 %), 14 (48.4 %), and 3 (10.3 %) patients achieving complete response, partial response, stable disease, and progressive disease, respectively. Meanwhile, treatment response was not evaluated in 1 (3.4 %) patient. The objective response and disease control rates were 37.9 % and 86.3 %, respectively. In terms of survival, the median (95 % confidence interval) progression-free survival (PFS) was 11.1 (5.2-17.0) months, with 1-year and 2-year PFS rates of 40.4 % and 20.5 %, respectively. The median overall survival (OS) was not reached; the 1-year and 2-year OS rates were 72.0 % and 64.8 %, respectively. Current treatment cycles ≥ 8 were associated with better PFS and OS (both P < 0.001). In addition, 21 (72.4 %) patients experienced at least one treatment-emergent adverse event (TEAE), which was mostly of grade I and II. The most commonly occurring TEAE was leukopenia (17.2 %), liver dysfunction (17.2 %), hypothyroidism (13.8 %), hand-foot syndrome (13.8 %), and thrombocytopenia (13.8 %).Second-line camrelizumab combined apatinib and chemotherapy might serve as a potential treatment with acceptable safety in patients with advanced LUAD.Copyright © 2023. Published by Elsevier B.V.