Justeau Grégoire, Chouaid Christos, Debieuvre Didier, Audigier-Valette Clarisse, Quantin Xavier, Léna Hervé, Bosquet Lise, Girard Nicolas, Schoemaker Minouk J, Mella Marta, Pinto Correia Bárbara, Rault Caroline, Daumont Melinda J, Penrod John R, Lee Adam, Pérol Maurice
Department of Pneumology, Angers University Hospital, Angers, France.
Department of Pneumology and Thoracic Oncology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
Front Oncol. 2025 Feb 20;15:1526931. doi: 10.3389/fonc.2025.1526931. eCollection 2025.
This study describes treatment and retreatment patterns and outcomes in patients in France following nivolumab as a second-line or later (2L+) treatment in locally advanced or metastatic non-small cell lung cancer (LAM NSCLC).
This analysis included adults with tumor, node, metastasis stage IIIB-IV NSCLC (as defined in the 7th or 8th edition American Joint Committee on Cancer/Union for International Cancer Control) treated with nivolumab monotherapy in 2L+ using data from the retrospective Epidemiological-Strategy and Medical Economics Lung Cancer database. The inclusion period was from January 1, 2015, to September 30, 2020, with a follow-up until September 30, 2021. Analyses were stratified according to the duration of index nivolumab treatment and tumor programmed death ligand 1 expression levels.
In total, the study included 4,001 patients (68% male; mean age [standard deviation] at index date, 63.6 [9.7] years) with a median follow-up of 34.3 months. The median nivolumab duration was 2.5 months (interquartile range, 1.4-6.3). The median overall survival (OS) from nivolumab initiation was 10.2 months (95% confidence interval [CI], 9.6-10.8). The median real-world progression-free survival and time to treatment discontinuation or death (95% CI) were 2.2 (2.1-2.3) and 2.7 (2.5-2.8) months, respectively. In total, 2,985 (74.6%) patients discontinued index nivolumab treatment: 226 (7.6% of discontinuers) received a further immune checkpoint inhibitor (ICI; 12.3% of discontinuers receiving further systemic treatment), and 1,604 (53.7%) received chemotherapy and/or targeted therapy. The proportion of ICI-retreated patients was the highest among those with the longest index treatment duration (15.8% among discontinuers receiving ≥26 weeks' index nivolumab). The median OS from retreatment was longer in the resumption (ICI restart without another therapy for ≥6 weeks) compared with the rechallenge (ICI restart following non-ICI therapy) patient subgroup.
Few patients with LAM NSCLC in France received ICI retreatment following index nivolumab discontinuation, but the proportion increased with a longer duration of index nivolumab.
本研究描述了法国局部晚期或转移性非小细胞肺癌（LAM NSCLC）患者接受纳武利尤单抗作为二线或更晚期（2L+）治疗后的治疗和再治疗模式及结果。
本分析纳入了根据回顾性肺癌流行病学策略与医学经济学数据库的数据，接受纳武利尤单抗单药2L+治疗的肿瘤、淋巴结、转移分期为IIIB-IV期NSCLC（按照美国癌症联合委员会/国际癌症控制联盟第7版或第8版定义）的成年患者。纳入期为2015年1月1日至2020年9月30日，随访至2021年9月30日。分析根据首次纳武利尤单抗治疗时长和肿瘤程序性死亡配体1表达水平进行分层。
该研究共纳入4001例患者（68%为男性；首次纳武利尤单抗治疗时的平均年龄[标准差]为63.6[9.7]岁），中位随访时间为34.3个月。纳武利尤单抗的中位治疗时长为2.5个月（四分位间距为1.4 - 6.3）。从开始使用纳武利尤单抗起的中位总生存期（OS）为10.2个月（95%置信区间[CI]，9.6 - 10.8）。真实世界的中位无进展生存期和治疗中断或死亡时间（95%CI）分别为2.2（2.1 - 2.3）个月和2.7（2.5 - 2.8）个月。共有2985例（74.6%）患者停止了首次纳武利尤单抗治疗：226例（占停止治疗患者的7.6%）接受了进一步的免疫检查点抑制剂（ICI；占接受进一步全身治疗的停止治疗患者中的12.3%），1604例（53.7%）接受了化疗和/或靶向治疗。在首次治疗时长最长（接受≥26周首次纳武利尤单抗治疗的停止治疗患者中占15.8%）的患者中，ICI再治疗患者的比例最高。与再次挑战（在接受非ICI治疗后重启ICI）患者亚组相比，重新开始治疗（≥6周内未接受其他治疗而重启ICI）患者亚组从再治疗起的中位OS更长。
法国很少有LAM NSCLC患者在首次纳武利尤单抗停药后接受ICI再治疗，但该比例随首次纳武利尤单抗治疗时长的延长而增加。
