Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital, Athens, Greece;
Pulmonary Department, Lung Cancer Oncology Unit, Aristotle University of Thessaloniki, G. Papanicolaou Hospital, Thessaloniki, Greece.
Anticancer Res. 2023 Jun;43(6):2799-2812. doi: 10.21873/anticanres.16449.
BACKGROUND/AIM: Nivolumab is an FDA-approved immune checkpoint inhibitor (ICI) for patients with advanced, pre-treated non-small cell lung cancer (NSCLC). However, treatment profiles and patient outcomes often differ in routine clinical practice while the financial impact of approved therapies is largely unknown. In this study, we investigated the efficacy, tolerability, and economic impact of nivolumab in real-world settings (RWS) in Greece.
Patients diagnosed with advanced pre-treated NSCLC, receiving nivolumab were recruited from October 2015 until November 2019 across 18 different clinical centers in Greece. Endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Cost analysis was conducted using a third-party public-payer perspective (National Organization for Healthcare Services Provision; EOPYY).
A total of 346 patients, median age 66.5 years, were included. With 43.4 months median follow-up, median PFS was 7.8 months and median OS 15.8 months. The 1-year OS rate was 56.5%, 2-year OS 38.8%, and 3-year OS 27.3%. The ORR was 29.5% and DCR 58.7%, with a median response duration of 26.8 months. Patients with objective response were more likely to experience long-term survival (HR=0.14, p<0.001). Only 8.4% of patients experienced grade 3-4 adverse events. The presence of immune-related adverse events was associated with improved OS (HR=0.77, p=0.043). Nivolumab-associated economic burden accounted for €2,214.10 per cycle for each patient, mainly attributed to drug-acquisition costs.
This is the first report of real-world efficacy, safety, and economic burden of nivolumab in pre-treated patients with NSCLC in Greece. Indirectly compared to clinical trials, nivolumab was associated with improved efficacy in RWS, further supporting its use in clinical practice and providing insights on clinical prognosticators. The main cost component affecting the nivolumab economic burden was drug-acquisition costs, while toxicity-associated cost was negligible.
背景/目的：纳武利尤单抗是一种获得美国食品药品监督管理局（FDA）批准的免疫检查点抑制剂（ICI），适用于晚期、预处理的非小细胞肺癌（NSCLC）患者。然而，在常规临床实践中，治疗方案和患者结局往往存在差异，而批准疗法的财务影响在很大程度上尚不清楚。在这项研究中，我们调查了纳武利尤单抗在希腊真实世界环境（RWS）中的疗效、耐受性和经济影响。
2015 年 10 月至 2019 年 11 月，从希腊的 18 个不同临床中心招募了诊断为晚期预处理 NSCLC 并接受纳武利尤单抗治疗的患者。终点包括无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）和安全性。使用第三方公共支付者视角（国家医疗保健服务提供组织；EOPYY）进行成本分析。
共纳入 346 例患者，中位年龄为 66.5 岁。中位随访时间为 43.4 个月，中位 PFS 为 7.8 个月，中位 OS 为 15.8 个月。1 年 OS 率为 56.5%，2 年 OS 率为 38.8%，3 年 OS 率为 27.3%。ORR 为 29.5%，DCR 为 58.7%，中位反应持续时间为 26.8 个月。有客观缓解的患者更有可能获得长期生存（HR=0.14，p<0.001）。只有 8.4%的患者发生 3-4 级不良事件。免疫相关不良事件的发生与 OS 改善相关（HR=0.77，p=0.043）。纳武利尤单抗相关的经济负担为每个患者每个周期 2214.10 欧元，主要归因于药物获得成本。
这是希腊首例关于纳武利尤单抗在预处理 NSCLC 患者中的真实世界疗效、安全性和经济负担的报告。与临床试验间接比较，纳武利尤单抗在 RWS 中具有更好的疗效，进一步支持其在临床实践中的应用，并提供了临床预后指标的见解。影响纳武利尤单抗经济负担的主要成本组成部分是药物获得成本，而毒性相关成本可以忽略不计。
