对于晚期非小细胞肺癌（NSCLC）患者使用免疫检查点抑制剂（ICI）的最佳疗程尚待确定。基石性3期临床试验中治疗持续时间在固定的2年和疾病进展之前均有所不同。因此，临床实践可能因主治医生而异。本文提供了关于2年内治疗决策及其后临床结果的实际数据。该多中心观察研究纳入了2年后病情稳定的晚期NSCLC患者，他们接受了2年的pembrolizumab或nivolumab治疗。主要观察指标是是否停用ICI治疗的决策，以及促使该决策的因素。次要观察指标包括无进展生存期（PFS）（根据是否继续治疗）和不良事件。共纳入91名患者，其中60名（66%）有过先前治疗。PD-L1表达水平≥50%的患者为43名（47%）。61名患者（67%）在2年治疗后继续ICI治疗。该决策与治疗中心显著相关（p < 0.001），但与2年内肿瘤反应（根据CT扫描或PET扫描评估）、临床状态、免疫相关不良事件或前期局部治疗下ICI的淤滞性进展无关。在2年决策之后2年，'ICI停用'组的PFS为68.5%，[95%置信区间（CI）（53.3-88.0）]，'ICI继续'组为64.1% [95% CI（51.9-79.2）]；复发风险比为1.14 [95% CI（0.54-2.30），p = 0.77]。停药后24个月的总生存率为'停用'组89.2% [95% CI（78.4-100）]，'继续'组93.1% [95% CI（85.8-100）]。由于样本数据不足，无法比较总生存。在治疗2年后，在继续ICI治疗与否的决策主要依赖于治疗中心，且似乎不影响生存。需要更大规模、随机的数据集来证实这一结果。© 作者，2023年。

The optimal duration of immune checkpoint inhibitor (ICI) treatment for patients with advanced non-small cell lung cancer (NSCLC) remains to be determined. Treatment durations in cornerstone phase 3 clinical trials vary between a fixed 2-year duration and pursuit until disease progression. Clinical practices may thus differ according to the attending physician.Here we provide real-world data about treatment decisions at 2 years, with subsequent clinical outcomes.This multicentric observational study included patients with advanced NSCLC whose disease was controlled after 2 years of pembrolizumab or nivolumab. The primary outcome was the decision to discontinue ICI treatment or not, along with factors motivating this decision. Secondary outcomes included progression-free survival (PFS) (according to treatment continuation or not) and adverse events.A total of 91 patients were included, of which 60 (66%) had been pre-treated. The programmed death-ligand 1 expression level was ⩾50% in 43 patients (47%). In 61 patients (67%), ICI was continued after 2 years of treatment. This decision was significantly associated with the care center (p < 0.001) but neither with the tumor response at 2 years, as evaluated by CT scan or PET scan, nor with clinical status, immune-related adverse events, or previous locally treated oligo-progressive disease under ICI. Two years after the 2-year decision, PFS was 68.5%, [95% confidence interval (CI) (53.3-88.0)] in the 'ICI discontinuation' group and 64.1% [95% CI (51.9-79.2)] in the 'ICI pursuit' group; hazard ratio for relapse was 1.14 [95% CI (0.54-2.30), p = 0.77]. The overall survival rate at 24 months after discontinuation was 89.2% [95% CI (78.4-100)] for the 'discontinuation' group and 93.1% [95% CI (85.8-100)] for the 'pursuit' group. Given insufficient power, overall survival could not be compared.The decision to continue ICI or not after 2 years of treatment depends mainly on the care center and does not seem to impact survival. Larger, randomized data sets are required to confirm this result.© The Author(s), 2023.