A prospective study on clinicians’ attitudes and survival outcomes for patients with advanced NSCLC and poor performance status in the immunotherapy era: PICASO (GOIRC-04-2020)

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2025-05-08 DOI:10.1016/j.lungcan.2025.108580

Francesco Facchinetti , Andrea Camerini , Chiara Bennati , Paola Bordi , Elisa De Carlo , Francesca Mazzoni , Giulio Metro , Federica Bertolini , Lucia Longo , Serena Ricciardi , Sara Pilotto , Donatella Giardina , Francesco Passiglia , Vieri Scotti , Paolo Piacentini , Stefano Frega , Luana Calabrò , Annalisa Guida , Maria Antonietta Grosso , Jenny Longobardi , Marcello Tiseo

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Abstract

Background

Therapeutic strategies for patients with advanced NSCLC and an ECOG performance status (PS) 2 at diagnosis are supported by limited evidence.

Patients and methods

We led a prospective, observational study in 20 Italian centers on patients with advanced NSCLC and ECOG PS 2. Patients with EGFR mutations, ALK fusions or receiving first-line targeted treatments were excluded. We recorded physicians’ attitudes in addressing first-line treatments and clinical outcomes. The primary endpoint was progression-free rate at six months.

Results

From March 2022 to October 2023, 198 consecutive patients were included. Median age was 73 years (range 43–91). Forty-four patients (22%) were candidate to best supportive care, 49 (25%) to single agent chemotherapy, 14 (7%) to platinum doublet, 40 (20%) to mono-immunotherapy, 52 (26%) to chemo-immunotherapy. At a median follow-up of 9.4 months (95 % CI 7.2 – 11.7), 6-month progression-free rate was 15.3%, with a median progression-free survival of 1.6 months (95 % CI 1.3 – 1.9). Six-months overall survival (OS) rate was 27.7%, with a median OS of 2.8 months (95 % CI 2.0 – 3.6). Patients receiving chemo-immunotherapy (PD-L1 < 50%) had 6-month progression-free and OS rates of 22.9% and 29.1% respectively, with median PFS 1.9 months and median OS 3.7 months; mono-immunotherapy for patients with PD-L1 ≥ 50% led to slightly better outcomes. Among 155 patients receiving active treatment, no clinical-pathological characteristic harbored a prognostic role. One third of patients receiving immunotherapy-containing regimens encountered early clinical progression or death before the first radiological evaluation. No relevant safety signals emerged across treatments.

Conclusions

Less than half of patients with NSCLC and ECOG PS 2 were candidates to the regimens recommended for fit pts, i.e. mono-immunotherapy or chemo-immunotherapy according to PD-L1. Even with immunotherapy, most of these patients have dismal outcomes, suggesting that trials dedicating to PS 2 perform an intrinsic patient selection.

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免疫治疗时代临床医生对晚期非小细胞肺癌治疗态度及预后的前瞻性研究：PICASO （GOIRC-04-2020）

背景：对于诊断时ECOG表现状态（PS） 2的晚期非小细胞肺癌患者的治疗策略得到有限证据的支持。患者和方法我们在意大利20个中心对晚期NSCLC和ECOG ps2患者进行了一项前瞻性观察性研究。排除了EGFR突变、ALK融合或接受一线靶向治疗的患者。我们记录了医生对解决一线治疗和临床结果的态度。主要终点是6个月时的无进展率。结果从2022年3月至2023年10月，连续纳入198例患者。中位年龄为73岁（43-91岁）。最佳支持治疗44例（22%），单药化疗49例（25%），铂双药化疗14例（7%），单免疫治疗40例（20%），化疗免疫治疗52例（26%）。中位随访9.4个月（95% CI 7.2 - 11.7）， 6个月无进展率为15.3%，中位无进展生存期为1.6个月（95% CI 1.3 - 1.9）。6个月总生存率（OS）为27.7%，中位OS为2.8个月（95% CI 2.0 - 3.6）。接受化疗免疫治疗(PD-L1 <；50%) 6个月无进展和OS率分别为22.9%和29.1%，中位PFS为1.9个月，中位OS为3.7个月；对于PD-L1≥50%的患者，单免疫治疗的效果略好。在接受积极治疗的155例患者中，没有临床病理特征具有预后作用。三分之一接受含免疫疗法方案的患者在第一次放射学评估前出现早期临床进展或死亡。在治疗过程中没有出现相关的安全信号。结论：不到一半的非小细胞肺癌和ECOG ps2患者适合推荐的方案，即根据PD-L1进行单免疫治疗或化学免疫治疗。即使使用免疫疗法，大多数患者的预后也很差，这表明针对ps2的试验进行了一种内在的患者选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.