丹麦晚期非小细胞肺癌患者接受免疫检查点抑制剂单药治疗的 5 年生存率。
5-Year survival in Danish patients with advanced non-small cell lung cancer treated with immune checkpoint inhibitor monotherapy.
机构信息
Department of Oncology, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
出版信息
Acta Oncol. 2023 Aug;62(8):861-870. doi: 10.1080/0284186X.2023.2238544. Epub 2023 Aug 3.
BACKGROUND
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.
MATERIALS AND METHODS
A multicenter study was performed including 729 patients with advanced NSCLC receiving monotherapy with ICI (retrospective data ( = 566) and prospective data ( = 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.
RESULTS
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.
CONCLUSIONS
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.
背景
随机对照试验（RCT）的令人信服的结果导致免疫检查点抑制剂（ICI）越来越多地被用作真实世界（RW）环境中标准治疗的一部分。然而，RW 患者在临床上与 RCT 人群不同，可能长期生存率降低。目前，关于接受 ICI 治疗的晚期非小细胞肺癌（NSCLC）RW 患者 3-5 年生存率的稀疏数据仅存在。
材料和方法
进行了一项多中心研究，纳入 729 名接受 ICI 单药治疗的晚期 NSCLC 患者（回顾性数据（ = 566）和前瞻性数据（ = 163））。详细登记了基线临床特征、程序性死亡配体 1（PD-L1）肿瘤比例评分（TPS）和基线血液学计数。使用 Kaplan-Meier 估计和对数秩检验进行生存分析，使用 Cox 回归确定预后因素。
结果
中位随访（FU）时间为 48.7 个月（IQR 37.2-54.3）。一线治疗的中位总生存期（OS）为 20.4 个月（IQR 8.5-45.0），而≥2 线治疗的中位 OS 为 11.4 个月（IQR 4.6-27.1）（HR 1.48，95%CI 1.25-1.75）。在一线治疗中，估计的 3 年 OS 概率为 30%，4 年 OS 概率为 23%，5 年 OS 概率为 13%，而≥2 线治疗的相应概率分别为 17%、13%和 11%。对于 PS 2 的患者，2 年 OS 率为 32%（95%CI 0.22-0.43），而 PD-L1≥50%的患者为 5%（95%CI 0.01-0.15），分别。
结论
与 RCT 相比，接受 ICI 一线治疗的 RW 患者的长期 OS 和 PFS 率较低，但与化疗的历史数据相比有很大改善。OS 和无进展生存期曲线的显著平坦化表明，也有一部分 RW 患者获得了长期缓解。PS 2 和 PD-L1≥50%的患者可能获得具有临床意义的 2 年 PFS 和 OS 率。
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