Medical Oncology Department, University Hospital Complex of Ourense, Ourense, Spain.
Medical Oncology Department, University Hospital Complex of Ourense, Ourense, Spain.
J Geriatr Oncol. 2021 Apr;12(3):410-415. doi: 10.1016/j.jgo.2020.11.010. Epub 2020 Dec 21.
Nivolumab is an anti PD1 immunotherapy drug approved for advanced Non-Small Cell Lung Cancer (NSCLC) patients who previously received at least one prior line of treatment. Older patients are often not represented in clinical trials and drugs with acceptable safety profiles are necessary. We aim to report the efficacy and safety profile of Nivolumab in the real-world older subgroup of the Galician lung cancer group study.
We retrospectively reviewed 188 advanced NSCLC patients treated with at least one prior therapy. We collected data from patients who were ≥70 years old treated with Nivolumab in second or subsequent lines. Patient characteristics, treatment efficacy (overall survival, progression-free survival, and response rate), and safety profile were reported.
Thirty-eight patients aged ≥70 years were included in the subgroup analysis. The median age was 74.5 years, a high percentage of patients were males (95%), most had a Performance Status of 1 (79%) and only 13% were non-smokers. The predominant histology was adenocarcinoma (53%), and 18% of patients received 2 or more lines. The median Progression-Free Survival was 7.53 months (CI 4.3-17.3, p = 0.15) and the median Overall Survival was 14.85 months (CI 10.5-20.7, p = 0.44). The objective response rate was 42%. No new adverse events were reported in comparison to a global population.
The efficacy and safety profile of Nivolumab in advanced NSCLC patients treated with at least one prior therapy and age ≥70 years old can be overlapped to a global population. Further prospective trials are needed to define and confirm these results.
Nivolumab 是一种抗 PD1 免疫疗法药物，适用于至少接受过一线治疗的晚期非小细胞肺癌（NSCLC）患者。老年患者通常在临床试验中没有代表性，需要具有可接受安全性特征的药物。我们旨在报告加利西亚肺癌组研究中真实世界的老年亚组中 Nivolumab 的疗效和安全性概况。
我们回顾性分析了 188 名接受至少一线治疗的晚期 NSCLC 患者。我们收集了在二线或后续线接受 Nivolumab 治疗且年龄≥70 岁的患者的数据。报告了患者特征、治疗疗效（总生存期、无进展生存期和缓解率）和安全性概况。
亚组分析纳入了 38 名年龄≥70 岁的患者。中位年龄为 74.5 岁，大多数患者为男性（95%），大多数患者的体能状态为 1 级（79%），仅有 13%为非吸烟者。主要组织学类型为腺癌（53%），18%的患者接受了 2 线或更多线治疗。无进展生存期的中位值为 7.53 个月（95%CI 4.3-17.3，p=0.15），总生存期的中位值为 14.85 个月（95%CI 10.5-20.7，p=0.44）。客观缓解率为 42%。与全球人群相比，未报告新的不良反应事件。
在至少接受过一线治疗且年龄≥70 岁的晚期 NSCLC 患者中，Nivolumab 的疗效和安全性概况与全球人群重叠。需要进一步的前瞻性试验来确定和证实这些结果。
