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. 2021 Jun;9(6):e002435.
doi: 10.1136/jitc-2021-002435.

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events

Julie R Brahmer  1 , Hamzah Abu-Sbeih  2 , Paolo Antonio Ascierto  3 , Jill Brufsky  4 , Laura C Cappelli  5 , Frank B Cortazar  6   7 , David E Gerber  8 , Lamya Hamad  9 , Eric Hansen  10 , Douglas B Johnson  11 , Mario E Lacouture  12 , Gregory A Masters  13 , Jarushka Naidoo  1   14 , Michele Nanni  10 , Miguel-Angel Perales  12 , Igor Puzanov  10 , Bianca D Santomasso  15 , Satish P Shanbhag  5   16 , Rajeev Sharma  10 , Dimitra Skondra  17 , Jeffrey A Sosman  18 , Michelle Turner  1 , Marc S Ernstoff  19
Affiliations

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events

Julie R Brahmer et al. J Immunother Cancer. 2021 Jun.

Abstract

Immune checkpoint inhibitors (ICIs) are the standard of care for the treatment of several cancers. While these immunotherapies have improved patient outcomes in many clinical settings, they bring accompanying risks of toxicity, specifically immune-related adverse events (irAEs). There is a need for clear, effective guidelines for the management of irAEs during ICI treatment, motivating the Society for Immunotherapy of Cancer (SITC) to convene an expert panel to develop a clinical practice guideline. The panel discussed the recognition and management of single and combination ICI irAEs and ultimately developed evidence- and consensus-based recommendations to assist medical professionals in clinical decision-making and to improve outcomes for patients.

Keywords: antineoplastic protocols; guidelines as topic; immunotherapy.

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Conflict of interest statement

Competing interests: PAA—Contracted research: Bristol-Myers Squibb, Roche, Array; Consulting fees: Bristol-Myers Squibb, Roche, Array, Novartis, Merck Serono, Pierre Fabre, Incyte, Medimmune, Sindax, AstraZeneca, Sun Pharma, Sanofy, Idera, Ultimovacs, Sandox, Immunocore, 4sc, Alkermes, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron; Travel support: MSD. JRB—Contracted research: AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, Merck, RAPT Therapeutics, Inc, Revolution Medicines; Consulting fees: Amgen, Bristol-Myers Squibb, Genentech/Roche, Eli Lilly, GlaxoSmithKline, Merck, Sanofi, Regeneron; Data and safety monitoring board/committees: GlaxoSmithKline, Sanofi. JB—Partner consulting fees: AstraZeneca, Merck, Roche, Pfizer, Lilly, Daiichi, Seattle Genetics, Novartis. LCC—Consulting fees: AbbVie; Contracted research: Bristol-Myers Squibb, Merck, EMD Serono, Alkermes, Iovance, Merrimack, National Cancer Institute. DEG—Consulting fees: Samsung Bioepis, Catalyst Pharmaceuticals, Bristol-Myers Squibb Steering Committee, G1 Therapeutics; Contracted research: AstraZeneca, BerGenBio, Karyopharm, Bristol-Myers Squibb Steering Committee; Ownership interest: Gilead. DBJ—Consulting fees: Bristol-Myers Squibb, Catalyst Biopharma, Iovance, Jansen, Merck, Novartis, Oncosec; Contracted research: Bristol-Myers Squibb, Incyte. MEL—Contracted research: Veloce, US Biotest, Lutris, Paxman, Novocure Inc; Grant funding: National Cancer Institute Cancer Center support grant P30 CA008748, National Institute of Arthritis and Musculoskeletal and Skin Diseases grant U01AR0775; Royalty: Legacy Healthcare Services, Apricity Health, Azitra, Inc, Deciphera, Galderma Research and Development, Johnson and Johnson, NCODA, Novocure Inc, Kyowa Kirin Inc, Loxo, Merck Sharp and Dohme Corporation, Janssen Research & Development, Menlo Therapeutics, Novartis Pharmaceuticals Corporation, QED Therapeutics, F. Hoffmann-La Roche AG, Amgen Inc, AstraZeneca Pharmceuticals, Genentech Inc, Seattle Genetics, Lutris, Paxman Coolers, OnQuality Pharmaceuticals Ltd, Takeda Millenium. JN—Consulting fees: AstraZeneca, Bristol-Myers Squibb, Merck, Roche/Genentech; Contracted research: AstraZeneca, Merck; Non-CME services: Merck, Bristol-Myers Squibb, AstraZeneca. M-AP—Consulting fees: AbbVie, Bellicum, Celgene, Bristol-Myers Squibb, Incyte, Kite/Gilead, Merck, Novartis, Nektar Therapeutics, Omeros, and Takeda; Contracted research: Incyte, Kite/Gilead and Miltenyi Biotec; Ownership interest: NexImmune Member, DSMBs for Cidara Therapeutics, Servier and Medigene. IP—Consulting fees: Merck, Amgen; Ownership interest: Celldex; Partner ownership: Celldex. BDS—Consulting fees: Kite/Gilead, Juno/Celgene; Contracted research: ADC Therapeutics; NPI: 1215164884. SPS—Consulting fees: Takeda, GSK, Kura, Celgene, Daiichi-Sankyo. DS—Scientific advisory board: Allergan, Alimera, Biogen. JAS—Consulting fees: Array, Nektar, Bristol-Myers Squibb, Iovance, Curis; Contracted research: Bristol-Myers Squibb, Corvus, Caltera. HA-S, FBC, MSE, LH, EH, GAM, MN, RS, MT—Nothing to disclose. SITC staff: SMW—Shares owned: Pacific Biosciences of California Inc, Editas Medicine. EG, AK, BL, LL—Nothing to disclose.

Figures

Figure 1
Figure 1
Manifestations of immune checkpoint inhibitor (ICI)-associated skin toxicity. (A) bullous pemphigoid rash; (B) lichenoid dermatitis; (C) vitiligo; (D) pruritus; (E) psoriaform dermatitis; (F) maculopapular rash.
Figure 2
Figure 2
Manifestations of ICI-associated pneumonitis. Radiological features of pneumonitis associated with anti-programmed cell death protein-1/programmed death-ligand 1 therapy stratified into five distinct phenotypes. (From Naidoo et al, JCO, 2017)
See this image and copyright information in PMC

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