Safety and Clinical Outcomes of Immune Checkpoint Inhibitors in Patients With Cancer and Preexisting Autoimmune Diseases.
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:
Historique:
received:
15
04
2021
accepted:
14
05
2021
pubmed:
15
6
2021
medline:
12
2
2022
entrez:
14
6
2021
Statut:
ppublish
Résumé
Immunotherapy has revolutionized treatment outcomes in numerous cancers. However, clinical trials have largely excluded patients with autoimmune diseases (ADs) due to the risk of AD flares or predilection for developing organ-specific inflammation. The objective of this study was to evaluate the safety and efficacy of immunotherapy in patients with cancer and preexisting ADs. A retrospective, single-center study of patients with cancer initiated on immune checkpoint inhibitors between 2012 and 2019 was conducted. The primary outcome was the development of immune-related adverse events (irAEs) with respect to the presence of AD at baseline. Associations were assessed using Kaplan-Meier curves, bivariate and multivariable analyses. Of the 417 patients included in this study, 63 patients (15%) had preexisting ADs. A total of 218 patients (53%) developed at least 1 irAE. There was no association between the presence of baseline AD on the development, grade, or number of irAEs; time to irAE or irAE recovery; systemic corticosteroid or additional immunosuppressant treatment for irAEs; permanent treatment discontinuation; or overall response rate. Two smaller cohorts were studied, melanoma and non-small cell lung cancer, and there was no effect of baseline AD on overall survival on either cohort. However, a greater proportion of patients with baseline ADs had full recovery from their irAE (P=0.037). Furthermore, age below 65, baseline steroid use, and single-agent immunotherapy regimens were protective in terms of the development of irAEs. Our study suggests that immune checkpoint inhibitors have similar safety and efficacy profiles in patients with preexisting ADs.
Identifiants
pubmed: 34121061
doi: 10.1097/CJI.0000000000000377
pii: 00002371-202111000-00005
doi:
Substances chimiques
Immune Checkpoint Inhibitors
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
362-370Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Références
Postow MA, Sidlow R, Hellmann MD. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med. 2018;378:158–168.
Menzies AM, Johnson DB, Ramanujam S, et al. Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab. Ann Oncol. 2017;28:368–376.
Tison A, Quere G, Misery L, et al. Safety and efficacy of immune checkpoint inhibitors in patients with cancer and preexisting autoimmune disease: a nationwide, multicenter cohort study. Arthritis Rheumatol. 2019;71:2100–2111.
Cortellini A, Buti S, Santini D, et al. Clinical outcomes of patients with advanced cancer and pre-existing autoimmune diseases treated with anti-programmed death-1 immunotherapy: a real-world transverse study. Oncologist. 2019;24:e327–e337.
Khan SA, Pruitt SL, Xuan L, et al. Prevalence of autoimmune disease among patients with lung cancer: implications for immunotherapy treatment options. JAMA Oncol. 2016;2:1507–1508.
Ma Q, Shilkrut M, Zhao Z, et al. Autoimmune comorbidities in patients with metastatic melanoma: a retrospective analysis of us claims data. BMC Cancer. 2018;18:145.
van der Kooij MK, Suijkerbuijk KPM, Aarts MJB, et al. Safety and efficacy of checkpoint inhibition in patients with melanoma and preexisting autoimmune disease: a cohort study. Ann Intern Med. 2021. [Epub ahead of print].
US Department of Health and Human Services, National Institutes of Health. Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0; 2017. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf . Accessed February 7, 2021.
Leonardi GC, Gainor JF, Altan M, et al. Safety of programmed death-1 pathway inhibitors among patients with non-small-cell lung cancer and preexisting autoimmune disorders. J Clin Oncol. 2018;36:1905–1912.
Donia M, Kimper-Karl ML, Hoyer KL, et al. The majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials. Eur J Cancer. 2017;74:89–95.
Khozin S, Walker MS, Jun M, et al. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs). J Clin Oncol. 2019;37(suppl):110.
Abdel-Wahab N, Shah M, Lopez-Olivo MA, et al. Use of immune checkpoint inhibitors in the treatment of patients with cancer and preexisting autoimmune disease: a systematic review. Ann Intern Med. 2018;168:121–130.
Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377:1345–1356.
Postow MA, Chesney J, Pavlick AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372:2006–2017.
Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373:23–34.
Tajmir-Riahi A, Bergmann T, Schmid M, et al. Life-threatening autoimmune cardiomyopathy reproducibly induced in a patient by checkpoint inhibitor therapy. J Immunother. 2018;41:35–38.
Abu-Sbeih H, Faleck DM, Ricciuti B, et al. Immune checkpoint inhibitor therapy in patients with preexisting inflammatory bowel disease. J Clin Oncol. 2020;38:576–583.
Danlos FX, Voisin AL, Dyevre V, et al. Safety and efficacy of anti-programmed death 1 antibodies in patients with cancer and pre-existing autoimmune or inflammatory disease. Eur J Cancer. 2018;91:21–29.
Richter MD, Pinkston O, Kottschade LA, et al. Brief report: cancer immunotherapy in patients with preexisting rheumatic disease: the Mayo Clinic experience. Arthritis Rheumatol. 2018;70:356–360.
Johnson DB, Sullivan RJ, Ott PA, et al. Ipilimumab therapy in patients with advanced melanoma and preexisting autoimmune disorders. JAMA Oncol. 2016;2:234–240.
Kahler KC, Eigentler TK, Gesierich A, et al. Ipilimumab in metastatic melanoma patients with pre-existing autoimmune disorders. Cancer Immunol Immunother. 2018;67:825–834.
Mitchell EL, Lau PKH, Khoo C, et al. Rheumatic immune-related adverse events secondary to anti-programmed death-1 antibodies and preliminary analysis on the impact of corticosteroids on anti-tumour response: a case series. Eur J Cancer. 2018;105:88–102.
Hoa S, Laaouad L, Roberts J, et al. Preexisting autoimmune disease and immune-related adverse events associated with anti-PD-1 cancer immunotherapy: a national case series from the Canadian Research Group of Rheumatology in Immuno-Oncology. Cancer Immunol Immunother. 2021. [Epub ahead of print].
Haanen J, Ernstoff MS, Wang Y, et al. Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: review of the literature and personalized risk-based prevention strategy. Ann Oncol. 2020;31:724–744.
Toi Y, Sugawara S, Sugisaka J, et al. Profiling preexisting antibodies in patients treated with anti-PD-1 therapy for advanced non-small cell lung cancer. JAMA Oncol. 2019;5:376–383.
Chaker L, Bianco AC, Jonklaas J, et al. Hypothyroidism. Lancet. 2017;390:1550–1562.
Maul LV, Weichenthal M, Kahler KC, et al. Successful anti-PD-1 antibody treatment in a metastatic melanoma patient with known severe autoimmune disease. J Immunother. 2016;39:188–190.