TY - JOUR
T1 - Managing toxicities associated with immune checkpoint inhibitors
T2 - Consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group
AU - on behalf of the Society for Immunotherapy of Cancer Toxicity Management Working Group
AU - Puzanov, I.
AU - Diab, A.
AU - Abdallah, K.
AU - Bingham, C. O.
AU - Brogdon, C.
AU - Dadu, R.
AU - Hamad, L.
AU - Kim, S.
AU - Lacouture, M. E.
AU - LeBoeuf, N. R.
AU - Lenihan, D.
AU - Onofrei, C.
AU - Shannon, V.
AU - Sharma, R.
AU - Silk, A. W.
AU - Skondra, D.
AU - Suarez-Almazor, M. E.
AU - Wang, Y.
AU - Wiley, K.
AU - Kaufman, H. L.
AU - Ernstoff, M. S.
AU - Anderson, Jeff
AU - Lehman, Kimberly
AU - Reshef, Dan
AU - Saylors, Ann
AU - Turner, Michelle
AU - Waxman, Ian
AU - Arrindell, Deborah
AU - Andrews, Stephanie
AU - Ballesteros, Joan
AU - Boyer, Janie
AU - Cotarla, Ion
AU - Dawson, Michelle
AU - Goswami, Trishna
AU - Hayreh, Vinny
AU - Holmes, William
AU - Rasheed, Zeshaan
AU - Sarkeshik, Makan
AU - Schreiber, Judy
AU - Shafer-Weaver, Kim
AU - Chen, Daniel
AU - Ley-Acosta, Sergio
AU - Chonzi, David
AU - Go, William
AU - Cunha, Renato
AU - Gulley, James L.
AU - Wood, Lauren
AU - Davies, Marianne
AU - Dicker, Adam
AU - Sharfman, William
N1 - Funding Information:
The workshop on managing toxicities associated with immune checkpoint inhibitors was made possible by sponsorship from AstraZeneca Pharmaceuticals, LP; Bristol-Myers Squibb, and Merck & Co, Inc. Contributions to the content of this white paper from representatives from these companies represent the clinical expertise of the individual authors and not the position of the corporation. Medical writing support for the development of this white paper was provided by Esther Berkowitz at the Society for Immunotherapy of Cancer; no funding support was provided for this purpose. ** The following individuals were contributing authors for the Society for Immunotherapy of Cancer Toxicity Management Working Group: Jeff Anderson, Bristol-Myers Squibb Company, New York, NY. Deborah Arrindell, Amgen, Inc., Thousand Oaks, CA. Stephanie Andrews, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL. Joan Ballesteros, Vivia Biotech S.L., Tres Cantos, Spain. Janie Boyer, AstraZeneca, Gaithersburg, MD. Daniel Chen, Genentech, Inc., San Francisco, CA. David Chonzi, Kite Pharma, Los Angeles, CA. Ion Cotarla, AstraZeneca, Gaithersburg, MD. Renato Cunha, National Cancer Institute, Bethesda, MD. Marianne Davies, Yale Cancer Center, New Haven, CT. Michelle Dawson, AstraZeneca, Gaithersburg, MD♦. Adam Dicker, Thomas Jefferson University, Philadelphia, PA. Lisa Eifler, Prometheus Therapeutics & Diagnostics, San Diego, CA. Andrew Ferguson, Gritstone Oncology, Inc., Emeryville, CA. Cristiano Ferlini, F. Hoffmann La Roche Ltd., New York, NY. Stanley Frankel, Celgene Corporation, Summit, NJ. William Go, Kite Pharma, Los Angeles, CA. Celestine Gochett, KentuckyOne Health, Louisville, KY. Jenna Goldberg, Janssen Pharmaceuticals, Inc., New York, NY. Priscila Goncalves, HIV and AIDS Malignancy Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD. Trishna Goswami, AstraZeneca, Gaithersburg, MD. Nancy Gregory, Prometheus Therapeutics & Diagnostics, San Diego, CA. James L. Gulley, National Cancer Institute, Bethesda, MD. Vinny Hayreh, AstraZeneca, Gaithersburg, MD. Nicole Helie, Johns Hopkins Department of Neurology and Neurosurgery Clinical Trials, Baltimore, MD. William Holmes, AstraZeneca, Gaithersburg, MD. Jer-Yuan Hsu, NGM Biopharmaceuticals, Inc., San Francisco, CA. Ramy Ibrahim, Parker Institute for Cancer Immunotherapy, San Francisco, CA. Cecilia Larocca, Dana Farber Cancer Institute/Brigham and Women’s Hospital, Boston, MA. Kimberly Lehman, Bristol-Myers Squibb Company, New York, NY. Sergio Ley-Acosta, Genentech, Inc., San Francisco, CA. Olivier Lambotte, Assistance Publique Hôpitaux de Paris, France. Jason Luke, University of Chicago, Chicago, IL. Joan McClure, National Comprehensive Cancer Network, Fort Washington, PA. Elisabete Michelon, Pfizer Inc., New York, NY. Mary Nakamura, University of California, San Francisco, CA. Kiran Patel, Janssen Pharmaceuticals, Inc., New York, NY. Bilal Piperdi, Merck & Co., Kenilworth, NJ. Zeshaan Rasheed, AstraZeneca, Gaithersburg, MD. Dan Reshef, Bristol-Myers Squibb Company, New York, NY. Joanne Riemer, Johns Hopkins Hospital, Baltimore, MD. Caroline Robert, Institut Gustave Roussy, Villejuif, France. Makan Sarkeshik, AstraZeneca, Gaithersburg, MD. Ann Saylors, Bristol-Myers Squibb Company, New York, NY. Judy Schreiber, AstraZeneca, Gaithersburg, MD. Kim Shafer-Weaver, AstraZeneca, Gaithersburg, MD. William Sharfman, Johns Hopkins Medicine, Baltimore, MD. Elad Sharon, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD. Richard Sherry, Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD. Cyndy Simonson, (Un)Common Sense Solutions, Raleigh, NC. Cherry Thomas, Jounce Therapeutics, Inc., Cambridge, MA. John A. Thompson, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA. Elizabeth Trehu, Jounce Therapeutics, Inc., Cambridge, MA. Dina Tresnan, Pfizer Inc., Groton, CT.
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/11/21
Y1 - 2017/11/21
N2 - Cancer immunotherapy has transformed the treatment of cancer. However, increasing use of immune-based therapies, including the widely used class of agents known as immune checkpoint inhibitors, has exposed a discrete group of immune-related adverse events (irAEs). Many of these are driven by the same immunologic mechanisms responsible for the drugs' therapeutic effects, namely blockade of inhibitory mechanisms that suppress the immune system and protect body tissues from an unconstrained acute or chronic immune response. Skin, gut, endocrine, lung and musculoskeletal irAEs are relatively common, whereas cardiovascular, hematologic, renal, neurologic and ophthalmologic irAEs occur much less frequently. The majority of irAEs are mild to moderate in severity; however, serious and occasionally life-threatening irAEs are reported in the literature, and treatment-related deaths occur in up to 2% of patients, varying by ICI. Immunotherapy-related irAEs typically have a delayed onset and prolonged duration compared to adverse events from chemotherapy, and effective management depends on early recognition and prompt intervention with immune suppression and/or immunomodulatory strategies. There is an urgent need for multidisciplinary guidance reflecting broad-based perspectives on how to recognize, report and manage organ-specific toxicities until evidence-based data are available to inform clinical decision-making. The Society for Immunotherapy of Cancer (SITC) established a multidisciplinary Toxicity Management Working Group, which met for a full-day workshop to develop recommendations to standardize management of irAEs. Here we present their consensus recommendations on managing toxicities associated with immune checkpoint inhibitor therapy.
AB - Cancer immunotherapy has transformed the treatment of cancer. However, increasing use of immune-based therapies, including the widely used class of agents known as immune checkpoint inhibitors, has exposed a discrete group of immune-related adverse events (irAEs). Many of these are driven by the same immunologic mechanisms responsible for the drugs' therapeutic effects, namely blockade of inhibitory mechanisms that suppress the immune system and protect body tissues from an unconstrained acute or chronic immune response. Skin, gut, endocrine, lung and musculoskeletal irAEs are relatively common, whereas cardiovascular, hematologic, renal, neurologic and ophthalmologic irAEs occur much less frequently. The majority of irAEs are mild to moderate in severity; however, serious and occasionally life-threatening irAEs are reported in the literature, and treatment-related deaths occur in up to 2% of patients, varying by ICI. Immunotherapy-related irAEs typically have a delayed onset and prolonged duration compared to adverse events from chemotherapy, and effective management depends on early recognition and prompt intervention with immune suppression and/or immunomodulatory strategies. There is an urgent need for multidisciplinary guidance reflecting broad-based perspectives on how to recognize, report and manage organ-specific toxicities until evidence-based data are available to inform clinical decision-making. The Society for Immunotherapy of Cancer (SITC) established a multidisciplinary Toxicity Management Working Group, which met for a full-day workshop to develop recommendations to standardize management of irAEs. Here we present their consensus recommendations on managing toxicities associated with immune checkpoint inhibitor therapy.
KW - Immune checkpoint inhibitor
KW - Immune-related adverse events
KW - Toxicity
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UR - http://www.scopus.com/inward/citedby.url?scp=85034749402&partnerID=8YFLogxK
U2 - 10.1186/s40425-017-0300-z
DO - 10.1186/s40425-017-0300-z
M3 - Article
C2 - 29162153
AN - SCOPUS:85034749402
SN - 2051-1426
VL - 5
JO - Journal for immunotherapy of cancer
JF - Journal for immunotherapy of cancer
IS - 1
M1 - 95
ER -