The DOI matches its Crossref record; 21 of the 23 references it cites were found in a registry or an index.
Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab
Open accessAbstract
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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“Possible risk factors for ICI-related hepatotoxicity include organ transplantation, comorbidity with autoimmune disease, history of ICI-induced irAEs, high doses of ICIs (particularly cytotoxic T-lymphocyte antigen 4 inhibitors), combination therapy with multiple ICIs, or a combination of an ICI with targeted therapy [165][166][167].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [166]
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“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]
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“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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Metadata
- 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)
- 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
- FWCI
- 49.91
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- 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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