Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study.
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
/ administration & dosage
Autoimmune Diseases
/ complications
Drug-Related Side Effects and Adverse Reactions
/ diagnosis
Female
Humans
Incidence
Male
Middle Aged
Neoplasms
/ complications
Programmed Cell Death 1 Receptor
/ antagonists & inhibitors
Progression-Free Survival
Retrospective Studies
Severity of Illness Index
Young Adult
Anti‐programmed death‐1
Autoimmune disease
Immune checkpoint inhibitors
Immunotherapy
Performance status
Sex
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
received:
22
09
2018
accepted:
07
01
2019
pubmed:
24
2
2019
medline:
21
7
2020
entrez:
24
2
2019
Statut:
ppublish
Résumé
Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors. Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups. A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive ( This study quantifies the increased risk of developing irAEs in patients with pre-existing AIDs who had to be treated with anti-PD-1 immunotherapy. Nevertheless, the incidence of grade 3/4 irAEs is not significantly higher when compared with control population. The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender-related differences in immuno-oncology. Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors but are frequent in clinical practice. This study quantifies the increased risk of developing immune-related adverse events (irAEs) in patients with pre-existing AIDs who had to be treated with anti-programmed death-1 immunotherapy. Nevertheless, their toxicities are mild and the incidence of grade 3/4 irAEs is not significantly higher compared with those of controls. These results will help clinicians in everyday practice, improving their ability to offer a proper counselling to patients, in order to offer an immunotherapy treatment even to patients with pre-existing autoimmune disease.
Sections du résumé
BACKGROUND
Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors.
MATERIALS AND METHODS
Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.
RESULTS
A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (
CONCLUSION
This study quantifies the increased risk of developing irAEs in patients with pre-existing AIDs who had to be treated with anti-PD-1 immunotherapy. Nevertheless, the incidence of grade 3/4 irAEs is not significantly higher when compared with control population. The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender-related differences in immuno-oncology.
IMPLICATIONS FOR PRACTICE
Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors but are frequent in clinical practice. This study quantifies the increased risk of developing immune-related adverse events (irAEs) in patients with pre-existing AIDs who had to be treated with anti-programmed death-1 immunotherapy. Nevertheless, their toxicities are mild and the incidence of grade 3/4 irAEs is not significantly higher compared with those of controls. These results will help clinicians in everyday practice, improving their ability to offer a proper counselling to patients, in order to offer an immunotherapy treatment even to patients with pre-existing autoimmune disease.
Identifiants
pubmed: 30796151
pii: theoncologist.2018-0618
doi: 10.1634/theoncologist.2018-0618
pmc: PMC6656514
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
PDCD1 protein, human
0
Programmed Cell Death 1 Receptor
0
Types de publication
Comparative Study
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e327-e337Informations de copyright
© AlphaMed Press 2019.
Déclaration de conflit d'intérêts
Disclosures of potential conflicts of interest may be found at the end of this article.
Références
Int J Clin Pharm. 2018 Aug;40(4):852-861
pubmed: 29860707
Control Clin Trials. 1996 Aug;17(4):343-6
pubmed: 8889347
Ann Oncol. 2017 Feb 1;28(2):368-376
pubmed: 27687304
Anticancer Res. 2012 Apr;32(4):1119-36
pubmed: 22493341
Autoimmun Rev. 2017 Oct;16(10):1049-1057
pubmed: 28778707
Oncologist. 2018 Nov;23(11):1358-1365
pubmed: 29934411
J Clin Oncol. 2018 Jul 1;36(19):1905-1912
pubmed: 29746230
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
Immunol Today. 1993 Sep;14(9):426-30
pubmed: 8216719
J Urol. 2014 Feb;191(2):323-8
pubmed: 23994371
Ann Oncol. 2018 Apr 1;29(4):1067
pubmed: 29300807
JAMA Oncol. 2016 Nov 1;2(11):1507-1508
pubmed: 27262099
JAMA Dermatol. 2013 Oct;149(10):1150-7
pubmed: 23945633
Clin Lung Cancer. 2015 Sep;16(5):325-33
pubmed: 25862554
Eur J Cancer. 2018 Mar;91:21-29
pubmed: 29331748
Eur J Cancer. 2017 Oct;84:130-140
pubmed: 28802709
JAMA Oncol. 2016 Feb;2(2):234-40
pubmed: 26633184
Lung Cancer. 2018 Jan;115:71-74
pubmed: 29290265
J Clin Oncol. 2017 Dec 1;35(34):3807-3814
pubmed: 28841387
Nat Rev Immunol. 2016 Oct;16(10):626-38
pubmed: 27546235
Ann Intern Med. 2018 Jan 16;168(2):121-130
pubmed: 29297009
Lancet Oncol. 2018 Jun;19(6):737-746
pubmed: 29778737
Acta Oncol. 2016;55 Suppl 1:79-84
pubmed: 26784139
Med Oncol. 2018 Aug 20;35(10):132
pubmed: 30128793
Ann Oncol. 2016 Apr;27(4):559-74
pubmed: 26715621
Melanoma Manag. 2018 Apr 24;5(1):MMT05
pubmed: 30190931
Crit Rev Oncol Hematol. 2017 Nov;119:1-12
pubmed: 29065979
Oncotarget. 2017 Nov 1;8(59):99336-99346
pubmed: 29245905