First-line pembrolizumab in advanced non-small cell lung cancer patients with poor performance status.
ECOG PS 2
Immune checkpoint inhibitors
Immunotherapy
NSCLC
PD-1
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
12
01
2020
revised:
20
02
2020
accepted:
20
02
2020
pubmed:
30
3
2020
medline:
24
11
2020
entrez:
30
3
2020
Statut:
ppublish
Résumé
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. 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). 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 32220780
pii: S0959-8049(20)30096-4
doi: 10.1016/j.ejca.2020.02.023
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Programmed Cell Death 1 Receptor
0
pembrolizumab
DPT0O3T46P
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
155-167Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest statement F.F. declares he has attended editorial activities sponsored by Roche and BMS. F.P. declares having attended advisory boards and having performed consultant activities from MSD. C.P. declares honoraria and travel accommodation from BMS; travel accommodation from MSD: advisory board and travel accommodation from Roche; speaker's bureau from Eli Lilly. S.P. received honoraria or speakers’ fee from AstraZeneca, BMS, Boehringer Ingelheim, MSD, Roche and Istituto Gentili. V.S. declares speakers’ fees and advisory boards from MSD. A.D.C. declares speakers’ fees from MSD. A.A. declares advisory board and research grants from BMS; advisory board from MSD; speakers' fees from Eli Lilly; advisory boards from Boehringer Ingelheim; speakers’ fees from Pfizer; research grants from Celgene. A.B. declares advisor and speaker services for Takeda, Boehringer Ingelheim, Novartis, Pfizer, MSD, travel grants from Jansen, Roche, MSD, BMS. M.C.G. declares personal financial interests with the following organizations: AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche and Takeda. S.N. declares speaker bureau/advisory boards for AstraZeneca, Boehringer Ingelheim, MSD, Pfizer, Bayer, Takeda, Abbvie, Eli Lilly, Roche, BMS. E.B. declares consulting, scientific advisory board, speaker's fees from Roche, MSD, AstraZeneca, Pfizer, Eli Lilly, BMS, Novartis; research funding from AstraZeneca and Roche. A.R. declares advisory boards and honoraria as speaker's bureau from MSD, Eli Lilly, AstraZeneca, Roche, Boehringer Ingelheim. M.D.M. received honoraria and had roles as consultant or advisor for AstraZeneca, Eli Lilly, BMS, MSD and Janssen. M.T. declares advisory boards and speakers’ fees from AstraZeneca, Pfizer, Eli Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Takeda, Pierre Fabre; research grants from AstraZeneca and Boehringer Ingelheim. All other authors declare they have no conflict of interest to disclose.