Abstract
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.
Original language | English (US) |
---|---|
Article number | 95 |
Journal | Journal for immunotherapy of cancer |
Volume | 5 |
Issue number | 1 |
DOIs | |
State | Published - Nov 21 2017 |
Keywords
- Immune checkpoint inhibitor
- Immune-related adverse events
- Toxicity
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Molecular Medicine
- Oncology
- Pharmacology
- Cancer Research
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Managing toxicities associated with immune checkpoint inhibitors : Consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. / on behalf of the Society for Immunotherapy of Cancer Toxicity Management Working Group.
In: Journal for immunotherapy of cancer, Vol. 5, No. 1, 95, 21.11.2017.Research output: Contribution to journal › Article › peer-review
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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. Funding Information: AF declared that he is an employee of Gritstone Oncology, Inc. BP declared that he is an employee and shareholder of Merck & Co., Inc. CS declared that she is a member of Genentech, Inc. Tecentriq Speakers Bureau. CR declared that she received personal fees through service on the advisory boards at Bristol-Myers Squibb Co., GlaxoSmithKline Pharmaceuticals Ltd., Novartis International AG, Amgen, Inc., Merck & Co., Inc., and F. Hoffmann-La Roche, Ltd. DC declared that he was employed by Genentech, Inc., until June 2016. DJL declared that he has received personal compensation as a consultant for F. Hoffmann-La Roche, Ltd., Bristol-Myers Squibb Co., and Amgen, Inc., and research support from Takeda Pharmaceuticals U.S.A., Inc. DT declared that she is an employee and shareholder of Pfizer, Inc. DW declared that he has been an employee and shareholder of Janssen Research & Development, LLC, from May 2016, to present, and an employee of Bayer Healthcare Pharmaceuticals, Inc., from June 2012, to May 2016. IP declared that he received consulting fees from Amgen, Inc., and F. Hoffmann-La Roche, Ltd. JR declared that she is a research nurse at Johns Hopkins University and works with patients receiving IO agents from multiple sponsors and investigator-initiated studies; JR has also participated in Institute for Clinical Immuno-Oncology Immunotherapy Workshops, has participated in reviewing educational materials developed by AstraZeneca committee and an advisory board meeting sponsored by Merck EMD. JS declared that she is an employee of AstraZeneca Pharmaceuticals. KA declared that he was an employee of AstraZeneca Pharmaceuticals until May 2015, is currently an employee and shareholder of Merck & Co., Inc., and is a shareholder of Sanofi. KS-W declared that she is an employee of AstraZeneca Pharmaceuticals. MD declared that she has a financial relationship with Speakers Bureau: AstraZeneca Pharmaceuticals; Genentech, Inc.; Merck & Co., Inc.; Bristol-Myers Squibb Co. ML declared that he has received personal fees from Quintiles Inc., Janssen Research & Development, LLC, AstraZeneca Pharmaceuticals, Genentech, Inc., Foamix Pharmaceuticals Inc., Infinity Pharmaceuticals, Adgero Biopharmaceuticals Holdings, Inc., Bristol-Myers Squibb Co., and Berg LLC. MS declared that he is an employee of AstraZeneca Pharmaceuticals. MS-A declared that she participated in the Bristol-Myers Squibb Co Advisory Board. OL declared that he has financial relationships with Bristol-Myers Squibb Co, MSD (Merck & Co., Inc.) and Janssen Research & Development, LLC. RD Declared that she receives personal fees from serving on the advisory board at Bristol-Myers Squibb Co. SA declared that she has a financial relationship with Genentech, Inc. Speaker’s Bureau. SL declared that he was an employee of Janssen Research & Development, LLC until January 2016, and is currently an employee of Genentech, Inc. VH declared that she is an employee of AstraZeneca Pharmaceuticals. WS declared that he received consulting fees and general funding from Merck & Co., Inc., Bristol-Myers Squibb Co, and Novartis International AG. ZR declared that he is an employee of AstraZeneca Pharmaceuticals. All remaining authors declared no competing interests.
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
UR - http://www.scopus.com/inward/record.url?scp=85034749402&partnerID=8YFLogxK
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
VL - 5
JO - Journal for ImmunoTherapy of Cancer
JF - Journal for ImmunoTherapy of Cancer
SN - 2051-1426
IS - 1
M1 - 95
ER -