Treatment rationale and design of the PROLONG study: safety and efficacy of pembrolizumab as first-line therapy for elderly patients with non-small cell lung cancer.
Pembrolizumab
elderly patient
non-small cell lung cancer (NSCLC)
Journal
Journal of thoracic disease
ISSN: 2072-1439
Titre abrégé: J Thorac Dis
Pays: China
ID NLM: 101533916
Informations de publication
Date de publication:
Mar 2020
Mar 2020
Historique:
entrez:
11
4
2020
pubmed:
11
4
2020
medline:
11
4
2020
Statut:
ppublish
Résumé
Pembrolizumab is recommended as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and a Programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥50% without driver mutations. However, the safety and efficacy were not investigated among patients who were ≥75 years old. This open-label single-arm phase II study is designed to evaluate pembrolizumab as first-line therapy for patients who are ≥75 years old with advanced NSCLC and a PD-L1 TPS of ≥50% without driver mutations. The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, safety, and quality of life. Recruitment started in October 2017 and is expected to continue for approximately 3 years. Given the currently poor prognosis of elderly patients with advanced NSCLC, we hope that the findings of this study will facilitate more effective treatment in this setting.
Sections du résumé
BACKGROUND
BACKGROUND
Pembrolizumab is recommended as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and a Programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥50% without driver mutations. However, the safety and efficacy were not investigated among patients who were ≥75 years old.
METHODS
METHODS
This open-label single-arm phase II study is designed to evaluate pembrolizumab as first-line therapy for patients who are ≥75 years old with advanced NSCLC and a PD-L1 TPS of ≥50% without driver mutations. The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, safety, and quality of life. Recruitment started in October 2017 and is expected to continue for approximately 3 years.
CONCLUSIONS
CONCLUSIONS
Given the currently poor prognosis of elderly patients with advanced NSCLC, we hope that the findings of this study will facilitate more effective treatment in this setting.
Identifiants
pubmed: 32274176
doi: 10.21037/jtd.2019.12.46
pii: jtd-12-03-1079
pmc: PMC7139059
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1079-1084Informations de copyright
2020 Journal of Thoracic Disease. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of Interest: The authors have no conflicts of interest to declare.
Références
N Engl J Med. 2018 Jun 14;378(24):2288-2301
pubmed: 29863955
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Cancer Immunol Immunother. 2009 Dec;58(12):1907-8
pubmed: 19787858
Cancer Immunol Immunother. 2009 Dec;58(12):1979-89
pubmed: 19238382
N Engl J Med. 2018 Nov 22;379(21):2040-2051
pubmed: 30280635
Eur J Cancer. 2018 Sep;100:126-134
pubmed: 30014881
Cancer Immunol Immunother. 2018 Oct;67(10):1571-1578
pubmed: 30056599
J Natl Cancer Inst. 2003 Mar 5;95(5):362-72
pubmed: 12618501
Lancet. 2011 Sep 17;378(9796):1079-88
pubmed: 21831418
CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30
pubmed: 26742998
PLoS One. 2018 Jul 6;13(7):e0199642
pubmed: 29979712
J Clin Oncol. 2006 Aug 1;24(22):3657-63
pubmed: 16877734
N Engl J Med. 2016 Nov 10;375(19):1823-1833
pubmed: 27718847
Ann Oncol. 2016 Sep;27(suppl 5):v1-v27
pubmed: 27664245
Semin Oncol. 2018 Aug;45(4):220-225
pubmed: 30391014
N Engl J Med. 2018 May 31;378(22):2078-2092
pubmed: 29658856