BACKGROUND Pembrolizumab is the first-line standard of care for advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite the absence of sustaining evidence. PATIENTS AND METHODS GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2 NSCLC patients with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December 2018 at 21 Italian institutions were included. Clinical-pathological characteristics were correlated with disease response and survival outcomes; adverse events were recorded. The primary objective was 6-months progression-free rate (6-months PFR). RESULTS One hundred fifty-three patients (median age 70 years) were enrolled. At a median follow-up of 18.2 months, median progression-free survival (PFS) and overall survival (OS) were 2.4 (95% confidence interval, 95% CI, 1.6-2.5) and 3.0 months (95% CI 2.4-3.5), respectively. 6-months PFR was 27% (95% CI 21-35%). Patients with a PS 2 determined by comorbidities (n = 41) had significantly better outcomes compared with disease burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS 5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab) correlated with clinical outcomes. The determinant of PS 2 resulted the only factor independently impacting on both PFS and OS. No toxicity issues emerged. CONCLUSIONS Outcomes of PS 2 NSCLC patients with PD-L1 TPS ≥50% receiving first-line pembrolizumab were globally dismal but strongly dependent on the reason conditioning the poor PS itself.

中文翻译：

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一线pembrolizumab在晚期非小细胞肺癌患者中表现不佳。

背景派姆单抗是PD-L1肿瘤比例评分（TPS）≥50％的晚期非小细胞肺癌（NSCLC）的一线治疗标准。东部合作肿瘤小组的表现状态（PS）2例患者可能接受pembrolizumab，尽管没有持续的证据。患者和方法GOIRC-2018-01是一项多中心，回顾性，观察性研究。纳入2017年6月至2018年12月在意大利21家机构接受一线派姆单抗治疗的PD-L1 TPS≥50％的PS 2 NSCLC患者。临床病理特征与疾病反应和生存结果相关。记录不良事件。主要目标是6个月无进展率（6个月PFR）。结果153例患者（中位年龄70岁）入组。中位随访期为18.2个月，中位无进展生存期（PFS）和总体生存期（OS）分别为2.4（95％置信区间，95％CI，1.6-2.5）和3.0个月（95％CI 2.4-3.5）。6个月的PFR为27％（95％CI 21-35％）。由合并症确定的PS 2患者（n = 41）与疾病负担诱发的PS 2（n = 112）相比，结局显着更好。实际上，六个月的病死率分别为49％和19％，中位病死率分别为5.6和1.8个月，分别为5.6和1.8个月和2.8个月。其他潜在的预后因素（放射治疗，抗生素，在派姆单抗前接受类固醇激素）与临床预后相关。PS 2的决定因素是唯一独立影响PFS和OS的因素。没有出现毒性问题。