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Cited by 817Cancer Immunotherapy and BiomarkersCutaneous Melanoma Detection and ManagementImmunotherapy and Immune Responses

Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab

Open access
Menzies, A.M., Johnson, D.B., Ramanujam, S., Atkinson, V.G., Wong, A.N.M., Park, J.J., McQuade, J.L., Shoushtari, A.N. +12 more·2017·Annals of Oncology
DOI 10.1093/annonc/mdw443PMC PMC12080753
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Abstract

Background Anti-PD-1 antibodies (anti-PD-1) have clinical activity in a number of malignancies. All clinical trials have excluded patients with significant preexisting autoimmune disorders (ADs) and only one has included patients with immune-related adverse events (irAEs) with ipilimumab. We sought to explore the safety and efficacy of anti-PD-1 in such patients.Patients and methods Patients with advanced melanoma and preexisting ADs and/or major immune-related adverse events (irAEs) with ipilimumab (requiring systemic immunosuppression) that were treated with anti-PD-1 between 1 July 2012 and 30 September 2015 were retrospectively identified.Results One hundred and nineteen patients from 13 academic tertiary referral centers were treated with anti-PD-1. In patients with preexisting AD (N = 52), the response rate was 33%. 20 (38%) patients had a flare of AD requiring immunosuppression, including 7/13 with rheumatoid arthritis, 3/3 with polymyalgia rheumatica, 2/2 with Sjogren's syndrome, 2/2 with immune thrombocytopaenic purpura and 3/8 with psoriasis. No patients with gastrointestinal (N = 6) or neurological disorders (N = 5) flared. Only 2 (4%) patients discontinued treatment due to flare, but 15 (29%) developed other irAEs and 4 (8%) discontinued treatment. In patients with prior ipilimumab irAEs requiring immunosuppression (N = 67) the response rate was 40%. Two (3%) patients had a recurrence of the same ipilimumab irAEs, but 23 (34%) developed new irAEs (14, 21% grade 3-4) and 8 (12%) discontinued treatment. There were no treatment-related deaths.Conclusions In melanoma patients with preexisting ADs or major irAEs with ipilimumab, anti-PD-1 induced relatively frequent immune toxicities, but these were often mild, easily managed and did not necessitate discontinuation of therapy, and a significant proportion of patients achieved clinical responses. The results support that anti-PD-1 can be administered safely and can achieve clinical benefit in patients with preexisting ADs or prior major irAEs with ipilimumab.

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Crossref · 10.1093/annonc/mdw443

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  • Endocrine events are among the most common toxicities from ICI, affecting up to 40% of treated patients depending on the drugs used.

    “Endocrine events are among the most common toxicities experienced from ICI, affecting up to 40% of treated patients37, depending on the drugs used.”

    From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [37]

  • The response rate was lower among participants on nonselective immunosuppressants at the start of treatment (3/20, 15%) than among those not on immunosuppressants (14/32, 44%).

    “The response rate was lower among participants on nonselective immunosuppressants (nSIs) [e.g.corticosteroids (CS) or others] at the start of treatment (3/20, 15%) than among those not on immunosuppressants (14/32, 44%).12”

    From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [12]

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Authors
Menzies, A. M., Johnson, D. B., Ramanujam, S., Atkinson, V. G., Wong, A. N. M., Park, J. J., McQuade, J. L., Shoushtari, A. N., Tsai, K. K., Eroglu, Z., Klein, O., Hassel, J. C., Sosman, J. A., Guminski, A., Sullivan, R. J., Ribas, A., Carlino, M. S., Davies, M. A., Sandhu, S. K., & Long, G. V.
Affiliations
  • The University of Sydney (AU)
  • Vanderbilt University Medical Center (US)
  • The University of Queensland (AU)
  • Peter MacCallum Cancer Centre (AU)
  • The University of Texas MD Anderson Cancer Center (US)
  • Memorial Sloan Kettering Cancer Center (US)
  • University of California, San Francisco (US)
  • Moffitt Cancer Center (US)
  • Austin Hospital (AU)
  • Heidelberg University (DE)
  • Massachusetts General Hospital (US)
  • University of California, Los Angeles (US)
Corresponding author
Menzies, A.M.
ORCID
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2017-02
Volume
28
Issue
2
Pages
368-376
ISSN
0923-7534 (ISSN-L)
DOI
10.1093/annonc/mdw443
PMC
PMC12080753
OpenAlex
W2525217971
Cited by
817
References
23
Citations by year
2026: 30 · 2025: 43 · 2024: 57 · 2023: 62 · 2022: 94 · 2021: 116 · 2020: 134 · 2019: 119 · 2018: 88 · 2017: 68 · 2016: 3
FWCI
49.91
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Cancer Institute NSW
  • University of Hong Kong
  • National Cancer Institute (K12CA090625)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords
anti-PD-1 therapy, advanced melanoma, immune-related adverse events, ipilimumab, immune checkpoint inhibitors, immunosuppression, immunotoxicity, treatment efficacy and safety, rheumatoid arthritis, psoriasis, Sjögren's syndrome, polymyalgia rheumatica
MeSH terms
Antineoplastic Agents, Immunological, Ipilimumab, Nivolumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Autoimmune Diseases, Brain Neoplasms, Female, Humans, Male, Melanoma, Middle Aged, Retrospective Studies, Skin Neoplasms, Disease-Free Survival, Young Adult, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized

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