OBJECTIVES Nivolumab is now a reference treatment for patients with advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. Little data are available on treatment approaches following discontinuation of nivolumab and on the interest of a second course of immunotherapy after nivolumab discontinuation. The aims of this study were to describe treatment pathways following nivolumab discontinuation and to describe survival following retreatment with immunotherapy. MATERIALS AND METHODS The analysis includes all patients with NSCLC recorded in a national hospital database, starting nivolumab in 2015-2016. Nivolumab treatment was considered discontinued if ≥3 infusions were missed. Patients starting a second course of PD-1 inhibitor following nivolumab discontinuation were analysed according to the duration of their initial nivolumab treatment course. RESULTS 10,452 patients were included (71 % men; mean age: 63.8 ± 9.6 years; squamous histology: 44 %). Median nivolumab treatment duration was 2.8 months [IQR :1.4-6.9]. Median OS was 11.5 months [95 %CI: 11.1-11.9]; 5118 (53.4 %) patients received post nivolumab therapy lines: 1517 (29.6 %) of these received a second course of PD-1 inhibitor, either after a treatment-free interval (resumption: n = 1127) or after intervening chemotherapy (rechallenge: n = 390). Median OS after nivolumab discontinuation was 15.0 months [13.9-16.7] in the resumption group and 18.4 months [14.8-21.9] in the rechallenge group. Median OS was significantly longer in patients with an initial nivolumab treatment duration ≥3 months. CONCLUSION In this real-world setting, outcome after retreatment with a PD-1 inhibitor following a first course of nivolumab was significantly better in patients with a longer duration of initial nivolumab treatment.

中文翻译：

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在现实世界中，晚期非小细胞肺癌中尼古鲁单抗治疗后的免疫疗法挑战：国家数据库分析。

目标Nivolumab现在是先前铂类化学疗法治疗失败后的晚期非小细胞肺癌（NSCLC）患者的参考治疗。中断nivolumab后的治疗方法以及中断nivolumab后的第二疗程免疫治疗的资料很少。这项研究的目的是描述尼古拉单抗停药后的治疗途径，以及用免疫疗法再治疗后的存活率。材料与方法该分析包括记录在国家医院数据库中的所有NSCLC患者，从2015年至2016年开始使用nivolumab。如果错过了≥3次输注，则认为Nivolumab治疗已停止。根据尼古拉单抗治疗初始疗程的持续时间，分析了尼古拉单抗停用后开始第二个疗程PD-1抑制剂的患者。结果共纳入10452例患者（男性71％；平均年龄：63.8±9.6岁；鳞状组织学：44％）。nivolumab治疗中位时间为2.8个月[IQR：1.4-6.9]。OS中位数为11.5个月[95％CI：11.1-11.9]；5118（53.4％）位患者接受了尼古鲁单抗治疗后的治疗：1517位患者（29.6％）在无治疗间隔后（恢复：n = 1127）或在化疗后（干预： n = 390）。恢复组尼古鲁单抗停药后的中位OS为15.0个月[13.9-16.7]，再挑战组为18.4个月[14.8-21.9]。初始nivolumab治疗持续时间≥3个月的患者中位OS显着更长。结论在这种现实世界中，对于初始尼古鲁单抗治疗持续时间较长的患者，在尼古鲁单抗治疗的第一个疗程后用PD-1抑制剂重新治疗后的转归明显更好。