Background 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. Objectives Here we provide real-world data about treatment decisions at 2 years, with subsequent clinical outcomes. Design and Methods 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. Results 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. Conclusion 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.

中文翻译：

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非小细胞肺癌长期缓解患者治疗 2 年后继续或停止抗 PD1 治疗。

背景 晚期非小细胞肺癌（NSCLC）患者免疫检查点抑制剂（ICI）治疗的最佳持续时间仍有待确定。基石 3 期临床试验的治疗持续时间各不相同，有固定的 2 年持续时间和持续治疗直至疾病进展。因此，临床实践可能会因主治医生的不同而有所不同。目标 在此，我们提供有关 2 年治疗决策的真实数据以及随后的临床结果。设计和方法 这项多中心观察性研究纳入了接受帕博利珠单抗或纳武单抗治疗 2 年后疾病得到控制的晚期 NSCLC 患者。主要结局是是否决定停止 ICI 治疗，以及促使该决定的因素。次要结局包括无进展生存期（PFS）（根据是否继续治疗）和不良事件。结果共纳入91例患者，其中60例（66%）已接受过治疗。43 名患者 (47%) 的程序性死亡配体 1 表达水平≥50%。61 名患者 (67%) 在治疗 2 年后继续进行 ICI。这一决定与护理中心显着相关 (p < 0.001)，但与通过 CT 扫描或 PET 扫描评估的 2 年肿瘤反应无关，也与临床状态、免疫相关不良事件或既往局部治疗寡核苷酸相关。 ICI 下的进展性疾病。两年决策后两年，“ICI 停药”组的 PFS 为 68.5%，[95% 置信区间 (CI) (53.3-88.0)]，而“ICI 停药”组的 PFS 为 64.1% [95% CI (51.9-79.2)]。 “ICI追求”团体；复发的风险比为 1.14 [95% CI (0.54-2.30), p = 0.77]。停药后 24 个月的总生存率，“停药”组为 89.2% [95% CI (78.4-100)]，“继续”组为 93.1% [95% CI (85.8-100)]。由于功率不足，无法比较总体生存率。结论 治疗 2 年后是否继续 ICI 的决定主要取决于护理中心，似乎并不影响生存。需要更大的随机数据集来证实这一结果。