Department of Respiratory Medicine, Japan Community Health Care Organization Hitoyoshi Medical Center, Hitoyoshi City, Kumamoto, Japan.
Department of Respiratory Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Kumamoto, Japan.
Clin Lung Cancer. 2024 Dec;25(8):661-671.e7. doi: 10.1016/j.cllc.2024.07.001. Epub 2024 Jul 6.
The PACIFIC trial established durvalumab administration after chemoradiotherapy as the standard of care for unresectable locally advanced nonsmall cell lung cancer (LA-NSCLC). However, the efficacy and safety of durvalumab in elderly patients aged 75 years or above remains unclear. This study aimed to investigate the real-world efficacy and safety of durvalumab for LA-NSCLC, with a specific focus on elderly patients.
We reviewed 214 patients who received durvalumab out of 278 patients with unresectable LA-NSCLC who underwent chemoradiotherapy at 7 institutions between July 2018 and March 2022. Propensity score matching (PSM) analysis was performed to evaluate the efficacy of durvalumab in elderly patients.
The 2-year progression-free survival (PFS) and 2-year overall survival (OS) rates were 42.2% (95% confidence interval [CI], 34.7%-49.5%) and 77.1% (95% CI, 70.1-82.7%), respectively. Grade ≥ 3 immune-related adverse events (irAEs) occurred in 8.2% of patients. PSM analysis revealed that OS was significantly shorter in elderly patients (≥ 75 years) than in younger patients (< 75 years) (hazard ratio [HR]; 95% CI, 1.39-8.99; P = .008), whereas PFS did not differ significantly between the 2 groups (HR: 1.50, 95% CI, 0.84-2.68, P = .169). The frequency of irAEs did not differ between these groups.
The real-world efficacy and safety of durvalumab administration following chemoradiotherapy for LA-NSCLC coincided with the PACIFIC trial's findings. Disease control achieved with this protocol did not differ significantly between elderly and younger patients but had acceptable tolerability, demonstrating its benefit even in elderly LA-NSCLC patients aged 75 years or above.
PACIFIC 试验确立了放化疗后使用度伐利尤单抗作为不可切除局部晚期非小细胞肺癌(LA-NSCLC)的标准治疗方法。然而,对于 75 岁及以上的老年患者,度伐利尤单抗的疗效和安全性尚不清楚。本研究旨在探讨度伐利尤单抗治疗 LA-NSCLC 的真实世界疗效和安全性,特别是针对老年患者。
我们回顾了 278 例接受放化疗的不可切除 LA-NSCLC 患者,其中 214 例在 7 家机构接受了度伐利尤单抗治疗。采用倾向评分匹配(PSM)分析评估度伐利尤单抗在老年患者中的疗效。
2 年无进展生存率(PFS)和 2 年总生存率(OS)分别为 42.2%(95%置信区间[CI],34.7%-49.5%)和 77.1%(95% CI,70.1-82.7%)。≥3 级免疫相关不良事件(irAEs)发生率为 8.2%。PSM 分析显示,老年患者(≥75 岁)的 OS 明显短于年轻患者(<75 岁)(风险比[HR];95%CI,1.39-8.99;P=0.008),而两组间 PFS 无显著差异(HR:1.50,95%CI,0.84-2.68,P=0.169)。两组间 irAEs 发生率无差异。
放化疗后序贯度伐利尤单抗治疗 LA-NSCLC 的真实世界疗效和安全性与 PACIFIC 试验结果一致。该方案治疗的疾病控制率在老年和年轻患者之间无显著差异,但具有可接受的耐受性,表明其在 75 岁及以上的老年 LA-NSCLC 患者中也有益处。