随机对照试验(RCT)产生了令人信服的结果，这导致在真实世界(RW)情景下，免疫检查点抑制剂(ICI)作为标准治疗的一部分的使用越来越多。然而，与RCT人群相比，RW患者在临床上有所差异，可能存在较低的长期生存率。目前，关于接受ICI治疗的晚期非小细胞肺癌(NSCLC) RW患者的3-5年生存率的数据非常有限。进行了一项多中心研究，包括729名接受单药ICI治疗的晚期NSCLC患者(回顾性数据n = 566和前瞻性数据n = 163)。详细记录了基线临床特征、PD-L1肿瘤比例评分(TPS)和基线血液计数。采用Kaplan-Meier估计和log-rank检验进行生存分析，Cox回归确定预后因素。随访中位时间(FU)为48.7个月(四分位范围37.2-54.3)。一线治疗的中位总生存(OS)为20.4个月(四分位范围8.5-45.0)，而≥2线的为11.4个月(四分位范围4.6-27.1)(HR 1.48，95%CI 1.25-1.75)。在一线治疗中，3年、4年和5年的OS估计概率分别为30%、23%和13%，而≥2线中分别为17%、13%和11%。对于那些有2级病情评分(PS 2)的患者，2年OS率为32%(95%CI 0.22-0.43)，而PD-L1≥50%与<50%的患者分别为5%(95%CI 0.01-0.15)。与RCT相比，在一线使用ICI治疗的真实世界患者的长期OS和PFS率较低，但与化疗历史率相比有显著改善。令人鼓舞的是，OS和进展无病生存(PFS)曲线的趋平反映了一部分真实世界患者也可以获得长期缓解。PS 2和PD-L1≥50%的患者可能获得临床意义的2年PFS和OS率。

Convincing results from randomized controlled trials (RCTs) have led to increasing use of immune checkpoint inhibitors (ICI) as part of standard therapies in real-world (RW) scenarios. However, RW patients differ clinically from RCT populations and might have reduced long-term survival. Currently, only sparse data on 3-5-year survival rate for RW patients with advanced non-small cell lung cancer (NSCLC) treated with ICI exist.A multicenter study was performed including 729 patients with advanced NSCLC receiving monotherapy with ICI (retrospective data (n = 566) and prospective data (n = 163)). Detailed baseline clinical characteristics, programmed death-ligand 1 (PD-L1) tumor proportion score (TPS), and baseline haematological count were registered. Kaplan-Meier estimates and log-rank test were used for survival analyses, Cox regression for determination of prognostic factors.Median time of follow-up (FU) was 48.7 months (IQR 37.2-54.3). Median overall survival (OS) in first line treatment was 20.4 months (IQR 8.5-45.0) compared to 11.4 months (IQR 4.6-27.1) in ≥2nd line (HR 1.48, 95% CI 1.25-1.75). Estimated probability of OS was 30% at 3 years, 23% at 4 years, and 13% at 5 years in first line compared to 17, 13, and 11% in ≥2nd line, respectively. For those with performance status (PS) 2, the 2-year OS rate was 32% (95% CI 0.22-0.43) compared to 5% (95% CI 0.01-0.15) in patients with PD-L1 ≥ 50% versus <50%, respectively.Compared to RCTs, long-term OS and PFS rates are lower in real-world patients treated with ICI in first line but much improved compared to historic rates on chemotherapy. A promising flattening of both the OS and progression free survival curves illustrates that also a subset of real-world patients obtain long-term remission. Patients with PS 2 and PD-L1 ≥ 50% may obtain clinically meaningful 2-year PFS and OS rates.