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)
- PMID: 40382877
- DOI: 10.1016/j.lungcan.2025.108580
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)
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.
Keywords: First-line; Non-small cell lung cancer; Performance status 2; Real-world; Unfit.
Copyright © 2025 Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Francesco Facchinetti declares speaker fee from Roche. Francesca Mazzoni declares advisory role for Merck Sharp & Dohme, Roche, Regeneron, AstraZeneca; travel grant from Roche. Giulio Metro declares speaker fees from Daichii-Sankyio, AstraZeneca, Takeda, Amgen. Federica Bertolini declares advisory role and speaker fees from Merck Sharp & Dohme, Regeneron, Amgen, Novartis, Astra Zeneca, Bristol Myers Squibb. Sara Pilotto declares honoraria/speaker fees from AstraZeneca, Eli Lilly, Bristol-Myers Squibb, Merck Sharp & Dohme, Takeda, Amgen, Regeneron, Pfizer, Pierre-Fabre, Boehringer Ingelheim, Novartis, and Roche. Francesco Passiglia declares consultant/advisory roles from AstraZeneca, Amgen, Johnson & Johnson, BeiGene, Pfizer, Novartis, Pharmamar, Merck Sharp & Dohme, Bristol Myers Squibb, ThermoFisher Scientific; institutional research grant from Roche. Alessandro Leonetti declares speaker fees from AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi and Takeda; advisory role for AstraZeneca, BeiGene, Novartis and Sanofi; editorial activities sponsored by Eli Lilly, Novartis and Roche; travel support from MSD, Novartis, Roche and Takeda; research funding from AstraZeneca. Giorgia Guaitoli declares advisory/editorial roles for Roche, Amgen, Novartis; speaker fee from Roche. Emilio Bria declares speaker and/or travel fees from AstraZeneca, Bristol Myers Squibb, Eli Lilly, Novartis, Pfizer and Roche; financial support as a speaker from Takeda Oncology; institutional research grants from AstraZeneca and Roche; he serves on the Data Safety and Monitoring Board of Merck Sharp & Dohme for activities outside of the submitted work. Diego Luigi Cortinovis declares advisory board compensations from Roche, Bristol Myers Squibb, AstraZeneca, Merck Sharp & Dohme, Beigene, Pfizer, Takeda, Boehringer Ingelheim, Amgen; speaker fees from Bristol Meyer Squibb, AstraZeneca, Merck Sharp & Dohme, Janssen/Johnson & Johnson. Silvia Novello declares speaker or advisory board fees from Eli Lilly, Merck Sharp & Dohme, Roche, Takeda, Pfizer, AstraZeneca, Amgen, ThermoFisher Scientific, Novartis, Sanofi, Janssen. Massimo Di Maio declares advisory board or consultancy honoraria from Amgen, AstraZeneca, GlaxoSmithKline, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Daiichi Sankyo, Ipsen and Viatris; direct research funding from Tesaro/GlaxoSmithKline; institutional funding for work in clinical trials/contracted research from BeiGene, Exelixis, Merck Sharp & Dohme, Pfizer and Roche. Marcello Tiseo declares speaker and consultant fees from AstraZeneca, Pfizer, Eli Lilly, Bristol Meyer Squibb, Novartis, Roche, Merck Sharp & Dohme, Boehringer Ingelheim, Otsuka, Takeda, Pierre Fabre, Amgen, Sanofi; institutional research grants from AstraZeneca and Boehringer Ingelheim. Other authors have no conflicts of interest to declare.