Three-Year Overall Survival of Patients With Advanced Non-Small-Cell Lung Cancers With ≥50% PD-L1 Expression Treated With First-Line Pembrolizumab Monotherapy in a Real-World Setting (ESCKEYP GFPC Study).
Journal
Journal of immunotherapy (Hagerstown, Md. : 1997)
ISSN: 1537-4513
Titre abrégé: J Immunother
Pays: United States
ID NLM: 9706083
Informations de publication
Date de publication:
09 Oct 2023
09 Oct 2023
Historique:
received:
03
08
2023
accepted:
16
08
2023
medline:
9
10
2023
pubmed:
9
10
2023
entrez:
9
10
2023
Statut:
aheadofprint
Résumé
Outside clinical trials, few data are available on the effect of long-term first-line pembrolizumab in patients with advanced non-small-cell lung cancers with ≥50% of tumor cells expressing programmed cell death ligand 1 (PD-L1). This French, multicenter study included consecutive advanced patients with non-small-cell lung cancer given first-line pembrolizumab alone between May 2017 (authorization date for this indication) and November 2019 (authorization date for pembrolizumab-chemotherapy combination). Information was collected from patients' medical files, with a local evaluation of the response and progression-free survival (PFS). Overall survival (OS) was calculated from pembrolizumab onset using the Kaplan-Meier method. The analysis concerned 845 patients, managed in 33 centers: median age: 65 (range: 59-72) years, 67.8% men, 78.1% Eastern Cooperative Oncology Group performance status 0/1, 38.9%/51.5%/6.6% active, ex or never-smokers, respectively, 10.9%/16.8% taking or recently took corticosteroids/antibiotics, 69.6% nonsquamous histology, 48.9% ≥75% PD-L1-positive, and 20.8% had brain metastases at diagnosis. After a median (95% CI) follow-up of 45 (44.1-45.9) months, respective median (95% CI) PFS and OS lasted 8.2 (6.9-9.2) and 22 (8.5-25.9) months; 3-year PFS and OS rates were 25.4% and 39.4%, respectively. Multivariate analysis retained never-smoker status, adenocarcinoma histology, Eastern Cooperative Oncology Group performance status ≥2, and neutrophil/lymphocyte ratio >4 as being significantly associated with shorter survival, but not brain metastases at diagnosis or <75% PD-L1 tumor-cell expression. These long-term results of pembrolizumab efficacy based on a nationwide "real-world" cohort reproduced those obtained in clinical trials.
Identifiants
pubmed: 37807621
doi: 10.1097/CJI.0000000000000490
pii: 00002371-990000000-00069
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Références
Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375:1823–1833.
Reck M, Rodríguez-Abreu D, Robinson AG, et al. Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score ≥ 50. J Clin Oncol. 2021;39:2339–2342.
Descourt R, Greillier L, Perol M, et al. First-line single-agent pembrolizumab for PD-L1-positive (tumor proportion score >/= 50%) advanced non-small cell lung cancer in the real world: impact in brain metastasis: a national French multicentric cohort (ESCKEYP GFPC study). Cancer Immunol Immunother. 2023;72:91–99.
Cortellini A, Tiseo M, Banna GL, et al. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥50. Cancer Immunol Immunother. 2020;69:2209–2222.
Velcheti V, Chandwani S, Chen X, et al. Outcomes of first-line pembrolizumab monotherapy for PD-L1-positive (TPS ≥50%) metastatic NSCLC at US oncology practices. Immunotherapy. 2019;11:1541–1554.
Pérol M, Felip E, Dafni U, et al. Effectiveness of PD-(L)1 inhibitor alone or in combination with platinum-doublet chemotherapy in first-line (1L) non-squamous non-small-cell lung cancer (Nsq-NSCLC) with PD-L1-high expression using real-world data. Ann Oncol. 2022;33:511–521.
Pons-Tostivint E, Hulo P, Guardiolle V, et al. Real-world multicentre cohort of first-line pembrolizumab alone or in combination with platinum-based chemotherapy in non-small cell lung cancer PD-L1 ≥50. J Cancer Immunol Immunother. 2023;72:1891–1892.
Roborel de Climens F, Chouaid C, Poulet C, et al. Salvage immunotherapy with pembrolizumab in patients hospitalized for life-threatening complications of NSCLC. JTO Clin Res Rep. 2021;2:100147.
Shiotsu S, Yoshimura A, Yamada T, et al. Pembrolizumab monotherapy for untreated PD-L1-positive non-small cell lung cancer in the elderly or those with poor performance status: a prospective observational study. Front Oncol. 2022;12:904644.
Velcheti V, Hu X, Yang L, et al. Long-term real-world outcomes of first-line pembrolizumab monotherapy for metastatic non-small cell lung cancer with ≥50% expression of programmed cell death-ligand 1. Front Oncol. 2022;12:83476.
Terai H, Soejima K, Shimokawa A, et al. Real-world data analysis of pembrolizumab monotherapy for NSCLC using Japanese postmarketing all-case surveillance data. JTO Clin Res Rep. 2022;3:100404.
Velcheti V, Hu X, Li Y, et al. Real-world time on treatment with first-line pembrolizumab monotherapy for advanced NSCLC with PD-L1 expression ≥50%: 3-year follow-up data. Cancers. 2022;14:1041.
Gainor JF, Rizvi H, Jimenez Aguilar E, et al. Clinical activity of programmed cell death 1 (PD-1) blockade in never, light, and heavy smokers with non-small-cell lung cancer and PD-L1 expression ≥50. Ann Oncol. 2020;31:404–411.
Chen DL, Li QY, Tan QY, et al. Smoking history and the efficacy of immune checkpoint inhibitors in patients with advanced non-small cell lung cancer: a systematic review and meta-analysis. J Thorac Dis. 2021;13:220–231.
Conforti F, Pala L, Pagan E, et al. Sex-based differences in response to anti-PD-1 or PD-L1 treatment in patients with non-small-cell lung cancer expressing high PD-L1 levels. A systematic review and meta-analysis of randomized clinical trials. ESMO Open. 2021;6:100251.
Conforti F, Pala L, Bagnardi V, et al. Sex-based heterogeneity in response to lung cancer immunotherapy: a systematic review and meta-analysis. J Natl Cancer Inst. 2019;111:772–781.
Aguilar EJ, Ricciuti B, Gainor JF, et al. Outcomes to first-line pembrolizumab in patients with non-small-cell lung cancer and very high PD-L1 expression. Ann Oncol. 2019;30:1653–1659.
Nikola N, Aleksa G, Ana R, et al. Brief report: predictive value of PD-L1 expression in non-small-cell lung cancer—should we set the bar higher for monotherapy? Clin Lung Cancer. 2023:S1525–S7304.
Cao D, Xu H, Xu X, et al. A reliable and feasible way to predict the benefits of Nivolumab in patients with non-small cell lung cancer: a pooled analysis of 14 retrospective studies. Oncoimmunology. 2018;7:e1507262.
Nichetti F, Ligorio F, Zattarin E, et al. Is there an interplay between immune checkpoint inhibitors, thromboprophylactic treatments, and thromboembolic events? Mechanisms and impact in non-small cell lung cancer patients. Cancers. 2019;12:67.