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Management of Immune-Related Adverse Events and Kinetics of Response With Ipilimumab
Abstract
Monoclonal antibodies directed against the immune checkpoint protein cytotoxic T-lymphocyte antigen-4 (CTLA-4; CD152)—ipilimumab and tremelimumab—have been investigated in metastatic melanoma and other cancers and have shown promising results. Recently, ipilimumab was approved by the US Food and Drug Administration for the treatment of metastatic melanoma. We review the literature on managing the adverse effects and kinetics of tumor regression with ipilimumab and provide guidelines on their management. During treatment with these antibodies, a unique set of adverse effects may occur, called immune-related adverse events (irAEs). These include rashes, which may rarely progress to life-threatening toxic epidermal necrolysis, and colitis, characterized by a mild to moderate, but occasionally also severe and persistent diarrhea. Hypophysitis, hepatitis, pancreatitis, iridocyclitis, lymphadenopathy, neuropathies, and nephritis have also been reported with ipilimumab. Early recognition of irAEs and initiation of treatment are critical to reduce the risk of sequelae. Interestingly, irAEs correlated with treatment response in some studies. Unique kinetics of response have been observed with CTLA-4 blockade with at least four patterns: (1) response in baseline lesions by week 12, with no new lesions seen; (2) stable disease, followed by a slow, steady decline in total tumor burden; (3) regression of tumor after initial increase in total tumor burden; and (4) reduction in total tumor burden during or after the appearance of new lesion(s) after week 12. We provide a detailed description of irAEs and recommendations for practicing oncologists who are managing them, along with the unusual kinetics of response associated with ipilimumab therapy.
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“We observed an association between irAEs and improved PFS using a landmark analysis, in agreement with previous studies58–60, and uncovered that baseline gut microbiome composition segregated PD-1-treated patients who developed irAEs from those who did not.”
From Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1 (2022) · cites this paper as [60]
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“One patient showed asymptomatic grade 4 hepatic and pancreatic toxicity after the first dose, while two patients manifested grade 3 gastrointestinal adverse events after the first or third dose, but these side effects resolved completely after steroid treatment, confirming efficacy using steroid treatment as control o…”
BackgroundPD-1/PD-L1 immune checkpoint blockade in non-small cell lung cancer.
Bagley, S. J., Bauml, J. M., & Langer, C. J. (2015) · PubMed · Cited by 25
Kee, D., & McArthur, G. A. (2016) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2016.07.014 · Cited by 26
“Early recognition and treatment may help to mitigate the severity of any irAE’s and comprehensive management guidelines have been developed based on expert consensus.(58,59) Basic principals involve symptomatic management for lower-grade events and temporary immunosuppression with corticosteroids, tumor necrosis facto…”
Komaki, Y., Komaki, F., Yamada, A., Micić, D., Ido, A., & Sakuraba, A. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.633 · Cited by 26
“Recent studies reported that the most common immunerelated adverse events with both anti-CTLA4 and -PD1 therapy involve dermatologic toxicity.(35,36) We separately assessed the risk of pruritus and rash.”
BackgroundManagement of adverse events related to checkpoint inhibition therapy
Rudzki, J. D. (2018) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-018-0416-y · Cited by 25
“aging patients receiving IO (immuno-oncology) treatment [8].”
Immunotherapy a New Hope for Cancer Treatment: A Review
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“Although ICPis have markedly changed lung cancer treatment, they may cause irAEs, including rash, pruritus, colitis, hepatitis, hypothyroidism and hypophysitis (1).”
Management of immune-related adverse events resulting from immune checkpoint blockade
Baroudjian, B., Arangalage, D., Cuzzubbo, S., Hervier, B., Lebbé, C., Lorillon, G., Tazi, A., Zalcman, G., Bouattour, M., Lioté, F., et al. (2018) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2019.1562342 · Cited by 28
Myasthenia gravis following human papillomavirus vaccination: a case report
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Meta-Analysis of Quality of Life in Cancer Patients Treated With Immune Checkpoint Inhibitors
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Immune-mediated enteropathies: From bench to bedside
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Kubo, T., Hirohashi, Y., Tsukahara, T., Kanaseki, T., Murata, K., Morita, R., & Torigoe, T. (2021) · Immunological Medicine · doi:10.1080/25785826.2021.1976942 · Cited by 25
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“Compared to anticancer therapies, the ICIs may cause immune-related adverse events (irAEs) because of nonspecific immune activation [4].”
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Infectious Colitis Associated With Ipilimumab Therapy
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Two Cases of Sinusitis Induced by Immune Checkpoint Inhibition
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Reporting of late-onset immune-related adverse events with immune checkpoint inhibitors in VigiBase
Noseda, R., Bedussi, F., Giunchi, V., Fusaroli, M., Raschi, E., & Ceschi, A. (2024) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2024-009902 · Cited by 28
“This will allow a better understanding and evaluation of the actual spectrum of late-onset irAEs with ICIs and drug-related and patient-related characteristics associated with their reporting, thus finally supporting optimal management.”
Emerging Immunotherapy Strategies in Breast Cancer
Page, D. B., Naidoo, J., & McArthur, H. L. (2014) · Immunotherapy · doi:10.2217/imt.13.166 · Cited by 24
CTLA-4 antibodies: new directions, new combinations.
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Inflammatory bowel disease and cancer response due to anti-CTLA-4: is it in the flora?
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“26 These unexpected kinetics of response to CTLA-4 treatment have in turn spurred investigation into specific approaches to evaluate responses to immunotherapy and to develop biomarkers that can predict responsiveness.”
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Non-invasive Detection of Immunotherapy-Induced Adverse Events
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Lu, J., Ding, J., Liu, Z., & Chen, T. (2022) · International Journal of Oncology · doi:10.3892/ijo.2022.5302 · Cited by 24
Immune-Related Adverse Events of the Gastrointestinal System
Nicolaides, S., & Boussioutas, A. (2023) · Cancers · doi:10.3390/cancers15030691 · Cited by 24
“It is recommended that anti-motility agents are used with caution, as they can mask disease severity and often the diarrhea is not severe enough to warrant their use [13].”
BackgroundZhao, Z., Zhang, W., Pang, L., Zeng, L., Liu, S., & Liu, J. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1166299 · Cited by 25
“Immunohistochemical staining demonstrated a large infiltration of CD3+ T lymphocytes in the non-tumor regions of the pancreas from patients with immunerelated pancreatitis (92, 93), which suggested that the potential asscociation of immune-related pancreatitis with autoimmune pancreatitis (AIP) (94).”
Background
Metadata
- Authors
- Weber, J. S., Kähler, K. C., & Hauschild, A.
- Affiliations
- Moffitt Cancer Center (US)
- Venue
- Journal of Clinical Oncology
- Published
- 2012-07-20
- Volume
- 30
- Issue
- 21
- Pages
- 2691-2697
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2109653150
- Cited by
- 1,415
- References
- 33
- Citations by year
- 2026: 24 · 2025: 35 · 2024: 59 · 2023: 79 · 2022: 84 · 2021: 117 · 2020: 129 · 2019: 123 · 2018: 146 · 2017: 153 · 2016: 152 · 2015: 145 · 2014: 94 · 2013: 65 · 2012: 9
- FWCI
- 10.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Keywords
- ipilimumab, immune-related adverse events, CTLA-4 blockade, metastatic melanoma, immune checkpoint inhibitors, toxic epidermal necrolysis, colitis, hypophysitis, hepatitis, iridocyclitis, neuropathy, nephritis, adverse event management
- MeSH terms
- Ipilimumab, Antibodies, Monoclonal, Antineoplastic Agents, Colitis, Drug Eruptions, Diarrhea, Humans, Liver, Lymphatic Diseases, Melanoma, Mucous Membrane, Pancreatitis, Peripheral Nervous System Diseases, Pituitary Gland, Skin, Skin Neoplasms, Stevens-Johnson Syndrome, Uveitis, Scleritis, Chemical and Drug Induced Liver Injury, CTLA-4 Antigen, Antibodies, Monoclonal, Humanized
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