Cited by 3,713Cancer Immunotherapy and BiomarkersPharmacovigilance and Adverse Drug ReactionsImmunotherapy and Immune Responses

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline

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Brahmer, Julie R., Lacchetti, Christina, Schneider, Bryan J., Atkins, Michael B., Brassil, Kelly J., Caterino, Jeffrey M., Chau, Ian, Ernstoff, Marc S. +22 more·2018·Journal of Clinical Oncology

Abstract

Purpose: To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods: A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process. The systematic review focused on guidelines, systematic reviews and meta-analyses, randomized controlled trials, and case series published from 2000 through 2017. Results: The systematic review identified 204 eligible publications. Much of the evidence consisted of systematic reviews of observational data, consensus guidelines, case series, and case reports. Due to the paucity of high-quality evidence on management of immune-related adverse events, recommendations are based on expert consensus. Recommendations: Recommendations for specific organ system–based toxicity diagnosis and management are presented. While management varies according to organ system affected, in general, ICPi therapy should be continued with close monitoring for grade 1 toxicities, with the exception of some neurologic, hematologic, and cardiac toxicities. ICPi therapy may be suspended for most grade 2 toxicities, with consideration of resuming when symptoms revert to grade 1 or less. Corticosteroids may be administered. Grade 3 toxicities generally warrant suspension of ICPis and the initiation of high-dose corticosteroids (prednisone 1 to 2 mg/kg/d or methylprednisolone 1 to 2 mg/kg/d). Corticosteroids should be tapered over the course of at least 4 to 6 weeks. Some refractory cases may require infliximab or other immunosuppressive therapy. In general, permanent discontinuation of ICPis is recommended with grade 4 toxicities, with the exception of endocrinopathies that have been controlled by hormone replacement. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

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Crossref · 10.1200/jco.2017.77.6385

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  • Corticosteroids may be safely administered without compromising outcomes.

    “and may be safely administered without compromising outcomes [16,64].”

    From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [64]

    The Recommendations (page unavailable) endorse corticosteroids for several immune-related adverse events, supporting their administration in that setting. They do not establish that corticosteroids leave cancer outcomes unaffected; the passage reporting no negative effect on overall survival concerns stronger immunosuppressive agents used for corticosteroid-refractory colitis. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • Most international guidelines recommend higher doses of corticosteroids (from 0.5 to 2 mg/kg/day) for other irAEs.

    “Although most international guidelines recommend higher doses of corticosteroids (from 0.5 to 2 mg/kg/day) for other irAEs,5,32,33”
  • Patients with pre-existing anti-thyroid antibodies have a much higher risk of thyroid dysfunction; three studies reported 20-50% versus 1-2.5% in antibody-negative patients.

    “three studies showed that patients with antithyroglobulin or anti-thyroid peroxidase antibodies had a much higher risk of thyroid dysfunction compared with patients negative for these antibodies (20-50% vs. 1-2.5%).41–43”

    From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [42]

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  1. [157]Ramalingam SS: Lung cancer: Disparities and implications for immunotherapy. 8th AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, Atlanta, GA, November 13–16, 2015

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Authors
Brahmer, J. R., Lacchetti, C., Schneider, B. J., Atkins, M. B., Brassil, K. J., Caterino, J. M., Chau, I., Ernstoff, M. S., Gardner, J. M., Ginex, P., Hallmeyer, S., Holter Chakrabarty, J., Leighl, N. B., Mammen, J. S., McDermott, D. F., Naing, A., Nastoupil, L. J., Phillips, T., Porter, L. D., Puzanov, I., Reichner, C. A., Santomasso, B. D., Seigel, C., Spira, A., Suarez-Almazor, M. E., Wang, Y., Weber, J. S., Wolchok, J. D., Thompson, J. A., & in collaboration with the National Comprehensive Cancer Network
Affiliations
  • American Society of Clinical Oncology (US)
  • Julie R. Brahmer, Johns Hopkins Kimmel Cancer Center; Jennifer S. Mammen, Johns Hopkins University, Baltimore, MD; Christina Lacchetti, American Society of Clinical Oncology, Alexandria; Alexander Spira, Virginia Cancer Specialists and US Oncology Research, Fairfax, VA; Bryan J. Schneider, University of Michigan Health System, Ann Arbor, MI; Michael B. Atkins, Georgetown Lombardi Comprehensive Cancer Center; Cristina A. Reichner, Georgetown University; Laura D. Porter, Colon Cancer Alliance; Washington,...
Venue
Journal of Clinical Oncology
Published
2018-06-10
Volume
36
Issue
17
Pages
1714-1768
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2786816161
Cited by
3,713
References
159
Citations by year
2026: 264 · 2025: 333 · 2024: 373 · 2023: 421 · 2022: 550 · 2021: 663 · 2020: 614 · 2019: 356 · 2018: 130 · 2017: 2 · 2015: 1 · 2014: 1
FWCI
165.67
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Cancer Institute (P30CA006973)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords
immune-related adverse events, immune checkpoint inhibitors, corticosteroid therapy, infliximab, immunosuppressive therapy, endocrine disorders, neurologic toxicity, hematologic toxicity, cardiotoxicity, skin toxicity, supportive care
MeSH terms
Antineoplastic Agents, Immunological, Adult, Antibodies, Monoclonal, Humans, Neoplasms, Practice Guidelines as Topic, B7-H1 Antigen, CTLA-4 Antigen, Programmed Cell Death 1 Receptor

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