Endo Satoshi, Imai Hisao, Mouri Atsuto, Tsukamoto Kasumi, Masaki Kenji, Hashimoto Kosuke, Miura Yu, Shiono Ayako, Yamaguchi Ou, Nakagawa Junichi, Kaira Kyoichi, Kobayashi Kunihiko, Kagamu Hiroshi
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Gunma, Japan.
Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.
J Cancer Res Clin Oncol. 2025 Jan 23;151(1):43. doi: 10.1007/s00432-025-06089-x.
Nivolumab plus ipilimumab (Nivo-Ipi) combination therapy is an effective first-line treatment for advanced non-small cell lung cancer (NSCLC). However, its effectiveness and feasibility in elderly patients (aged ≥ 75 years) remain unclear. This study aimed to investigate the efficacy and safety of first-line Nivo-Ipi therapy in elderly patients with NSCLC.
This retrospective study included 57 patients with NSCLC (52 men and 5 women), aged ≥ 75 years (range: 75-86) who received first-line Nivo-Ipi therapy from December 2020 to November 2022 at four institutes in Japan. Patient characteristics, therapeutic efficacy, and the incidence and severity of adverse events (AE) were assessed.
The overall response rate was 42.1%, the disease control rate was 73.6%, the median progression-free survival (PFS) was 7.1 months, and the median overall survival (OS) was 14.1 months. Common Grade ≥ 3 AEs included pneumonitis, elevated aspartate transaminase, elevated alanine transaminase, adrenal insufficiency, and colitis. No treatment-related deaths were reported. PFS and OS were longer in patients who experienced treatment-related AEs. Patients with and without AEs had a median PFS of 11.7 and 2.8 months, respectively. Similarly, the median OS of patients with and without AEs was 20.4 and 9.0 months, respectively.
First-line Nivo-Ipi therapy is effective in elderly patients with NSCLC. Although there was an increased incidence of pneumonitis, the treatment was manageable and presented as a viable treatment option. Notably, the occurrence of treatment-related AEs was associated with improved clinical outcomes, suggesting a potential prognostic value of AEs in this population.
纳武利尤单抗联合伊匹木单抗（Nivo-Ipi）联合疗法是晚期非小细胞肺癌（NSCLC）的一种有效一线治疗方案。然而，其在老年患者（年龄≥75岁）中的有效性和可行性仍不明确。本研究旨在探讨一线Nivo-Ipi疗法在老年NSCLC患者中的疗效和安全性。
本回顾性研究纳入了2020年12月至2022年11月期间在日本四家机构接受一线Nivo-Ipi疗法的57例NSCLC患者（52例男性和5例女性），年龄≥75岁（范围：75 - 86岁）。评估了患者特征、治疗疗效以及不良事件（AE）的发生率和严重程度。
总缓解率为42.1%，疾病控制率为73.6%，中位无进展生存期（PFS）为7.1个月，中位总生存期（OS）为14.1个月。常见的≥3级AE包括肺炎、天冬氨酸转氨酶升高、丙氨酸转氨酶升高、肾上腺功能不全和结肠炎。未报告与治疗相关的死亡病例。发生治疗相关AE的患者的PFS和OS更长。有和没有AE的患者的中位PFS分别为11.7个月和2.8个月。同样，有和没有AE的患者的中位OS分别为20.4个月和9.0个月。
一线Nivo-Ipi疗法在老年NSCLC患者中有效。尽管肺炎的发生率有所增加，但该治疗是可控的，是一种可行的治疗选择。值得注意的是，治疗相关AE的发生与改善的临床结局相关，表明AE在该人群中具有潜在的预后价值。
