Luján Mauricio, Lema Mauricio, Preciado Beatriz, Lema Camila, Egurrola Jorge, Cardona Andrés, González Diego, Mantilla William, Pino Luis, Rojas Gustavo, Gómez Diego, Munevar Isabel, Manneh Raimundo, Manneh Ray, Lobatón José, Calle Esteban, Borras Mariana, Triana Iván, Londoño Paula, Aruachán Sandra, Pineda Mateo, Morán Diego
Clínica de Oncología Astorga, Medellín, Colombia.
Universidad Pontificia Bolivariana, Medellín, Colombia.
J Investig Med. 2023 Jun;71(5):502-510. doi: 10.1177/10815589221147897. Epub 2023 Feb 9.
Nivolumab is a human programmed death receptor-1 blocking antibody, used as treatment option in patients with advanced non-small-cell lung cancer (NSCLC). We assessed the nivolumab efficacy in terms of survival and response to treatment as second-line (2L) or third-line (3L) therapy in patients with advanced NSCLC. This is a multicentric observational study. Data of patients with advanced NSCLC who received nivolumab as 2L or 3L treatment were analyzed retrospectively. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness, and safety of nivolumab treatment were collected. The outcomes evaluated were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) to treatment. OS and PFS were estimated with the Kaplan-Meier method and the differences were evaluated through the log-rank test. Data of 178 patients were included. The median follow-up was 26.8 months (interquartile range (IQR): 20.3-40.4). Nivolumab was commonly used as a 2L treatment (77.5%). The outcomes in this setting (2L) were as follows: ORR was 21.0%, and the median PFS and OS were 5.5 months (95% confidence interval (CI): 4.5-6.5) and 12.4 months (95% CI: 10.8-14.0), respectively. In 3L, the ORR with nivolumab was 15.0%, the median PFS and OS were 4.1 months (95% CI: 3.1-5.1) and 10.1 months (95% CI: 9.4-10.6), respectively. Three patients (1.7%) required discontinuation due to toxicity. Nivolumab effectiveness and safety in this scenario was consistent with that reported by previous trials and other real-world data.
纳武利尤单抗是一种人程序性死亡受体-1阻断抗体，用于晚期非小细胞肺癌（NSCLC）患者的治疗选择。我们评估了纳武利尤单抗作为晚期NSCLC患者二线（2L）或三线（3L）治疗的生存疗效和治疗反应。这是一项多中心观察性研究。对接受纳武利尤单抗作为2L或3L治疗的晚期NSCLC患者的数据进行回顾性分析。收集了患者人口统计学和临床背景、从诊断到纳武利尤单抗治疗后的治疗模式、纳武利尤单抗治疗的有效性和安全性等信息。评估的结局指标为总生存期（OS）、无进展生存期（PFS）和治疗的客观缓解率（ORR）。采用Kaplan-Meier方法估计OS和PFS，并通过对数秩检验评估差异。纳入了178例患者的数据。中位随访时间为26.8个月（四分位间距（IQR）：20.3 - 40.4）。纳武利尤单抗常用作2L治疗（77.5%）。在此情况下（2L）的结局如下：ORR为21.0%，中位PFS和OS分别为5.5个月（95%置信区间（CI）：4.5 - 6.5）和12.4个月（95% CI：10.8 - 14.0）。在3L治疗中，纳武利尤单抗的ORR为15.0%，中位PFS和OS分别为4.1个月（95% CI：3.1 - 5.1）和10.1个月（95% CI：9.4 - 10.6）。3例患者（1.7%）因毒性需要停药。纳武利尤单抗在这种情况下的有效性和安全性与先前试验及其他真实世界数据报道的一致。
