Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American society of clinical oncology clinical practice guideline

Julie Brahmer, Christina Lacchetti, Bryan J. Schneider, Michael B. Atkins, Kelly J. Brassil, Jeffrey M. Caterino, Ian Chau, Marc S. Ernstoff, Jennifer M. Gardner, Pamela Ginex, Sigrun Hallmeyer, Jennifer Holter Chakrabarty, Natasha B. Leighl, Jennifer S Mammen, David F. McDermott, Aung Naing, Loretta J. Nastoupil, Tanyanika Phillips, Laura D. Porter, Igor PuzanovCristina A. Reichner, Bianca D. Santomasso, Carole Seigel, Alexander Spira, Maria E. Suarez-Almazor, Yinghong Wang, Jeffrey S. Weber, Jedd D. Wolchok, John A. Thompson

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1714-1768
Number of pages55
JournalJournal of Clinical Oncology
Volume36
Issue number17
DOIs
StatePublished - Jun 10 2018

Fingerprint

Medical Oncology
Practice Guidelines
Adrenal Cortex Hormones
Guidelines
Emergency Nursing
Pulmonary Medicine
Emergency Medicine
Endocrinology
Methylprednisolone
Urology
Rheumatology
Hematology
Gastroenterology
Therapeutics
Immunosuppressive Agents
Neurology
Dermatology
Prednisone
Nervous System
Publications

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy : American society of clinical oncology clinical practice guideline. / Brahmer, Julie; Lacchetti, Christina; Schneider, Bryan J.; Atkins, Michael B.; Brassil, Kelly J.; Caterino, Jeffrey M.; Chau, Ian; Ernstoff, Marc S.; Gardner, Jennifer M.; Ginex, Pamela; Hallmeyer, Sigrun; Chakrabarty, Jennifer Holter; Leighl, Natasha B.; Mammen, Jennifer S; McDermott, David F.; Naing, Aung; Nastoupil, Loretta J.; Phillips, Tanyanika; Porter, Laura D.; Puzanov, Igor; Reichner, Cristina A.; Santomasso, Bianca D.; Seigel, Carole; Spira, Alexander; Suarez-Almazor, Maria E.; Wang, Yinghong; Weber, Jeffrey S.; Wolchok, Jedd D.; Thompson, John A.

In: Journal of Clinical Oncology, Vol. 36, No. 17, 10.06.2018, p. 1714-1768.

Research output: Contribution to journalArticle

Brahmer, J, Lacchetti, C, Schneider, BJ, Atkins, MB, Brassil, KJ, Caterino, JM, Chau, I, Ernstoff, MS, Gardner, JM, Ginex, P, Hallmeyer, S, Chakrabarty, JH, Leighl, NB, Mammen, JS, McDermott, DF, Naing, A, Nastoupil, LJ, Phillips, T, Porter, LD, Puzanov, I, Reichner, CA, Santomasso, BD, Seigel, C, Spira, A, Suarez-Almazor, ME, Wang, Y, Weber, JS, Wolchok, JD & Thompson, JA 2018, 'Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American society of clinical oncology clinical practice guideline', Journal of Clinical Oncology, vol. 36, no. 17, pp. 1714-1768. https://doi.org/10.1200/JCO.2017.77.6385
Brahmer, Julie ; Lacchetti, Christina ; Schneider, Bryan J. ; Atkins, Michael B. ; Brassil, Kelly J. ; Caterino, Jeffrey M. ; Chau, Ian ; Ernstoff, Marc S. ; Gardner, Jennifer M. ; Ginex, Pamela ; Hallmeyer, Sigrun ; Chakrabarty, Jennifer Holter ; Leighl, Natasha B. ; Mammen, Jennifer S ; McDermott, David F. ; Naing, Aung ; Nastoupil, Loretta J. ; Phillips, Tanyanika ; Porter, Laura D. ; Puzanov, Igor ; Reichner, Cristina A. ; Santomasso, Bianca D. ; Seigel, Carole ; Spira, Alexander ; Suarez-Almazor, Maria E. ; Wang, Yinghong ; Weber, Jeffrey S. ; Wolchok, Jedd D. ; Thompson, John A. / Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy : American society of clinical oncology clinical practice guideline. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 17. pp. 1714-1768.
@article{9764502cc1e1490ba4565435668a06cd,
title = "Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American society of clinical oncology clinical practice guideline",
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.",
author = "Julie Brahmer and Christina Lacchetti and Schneider, {Bryan J.} and Atkins, {Michael B.} and Brassil, {Kelly J.} and Caterino, {Jeffrey M.} and Ian Chau and Ernstoff, {Marc S.} and Gardner, {Jennifer M.} and Pamela Ginex and Sigrun Hallmeyer and Chakrabarty, {Jennifer Holter} and Leighl, {Natasha B.} and Mammen, {Jennifer S} and McDermott, {David F.} and Aung Naing and Nastoupil, {Loretta J.} and Tanyanika Phillips and Porter, {Laura D.} and Igor Puzanov and Reichner, {Cristina A.} and Santomasso, {Bianca D.} and Carole Seigel and Alexander Spira and Suarez-Almazor, {Maria E.} and Yinghong Wang and Weber, {Jeffrey S.} and Wolchok, {Jedd D.} and Thompson, {John A.}",
year = "2018",
month = "6",
day = "10",
doi = "10.1200/JCO.2017.77.6385",
language = "English (US)",
volume = "36",
pages = "1714--1768",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "17",

}

TY - JOUR

T1 - Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy

T2 - American society of clinical oncology clinical practice guideline

AU - Brahmer, Julie

AU - Lacchetti, Christina

AU - Schneider, Bryan J.

AU - Atkins, Michael B.

AU - Brassil, Kelly J.

AU - Caterino, Jeffrey M.

AU - Chau, Ian

AU - Ernstoff, Marc S.

AU - Gardner, Jennifer M.

AU - Ginex, Pamela

AU - Hallmeyer, Sigrun

AU - Chakrabarty, Jennifer Holter

AU - Leighl, Natasha B.

AU - Mammen, Jennifer S

AU - McDermott, David F.

AU - Naing, Aung

AU - Nastoupil, Loretta J.

AU - Phillips, Tanyanika

AU - Porter, Laura D.

AU - Puzanov, Igor

AU - Reichner, Cristina A.

AU - Santomasso, Bianca D.

AU - Seigel, Carole

AU - Spira, Alexander

AU - Suarez-Almazor, Maria E.

AU - Wang, Yinghong

AU - Weber, Jeffrey S.

AU - Wolchok, Jedd D.

AU - Thompson, John A.

PY - 2018/6/10

Y1 - 2018/6/10

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85048283183&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85048283183&partnerID=8YFLogxK

U2 - 10.1200/JCO.2017.77.6385

DO - 10.1200/JCO.2017.77.6385

M3 - Article

C2 - 29442540

AN - SCOPUS:85048283183

VL - 36

SP - 1714

EP - 1768

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 17

ER -