Immune checkpoint inhibitors have revolutionized the treatment of multiple types of cancer, but these therapies may result in adverse events (AEs) that can be severe or even life-threatening. In order to offer clinicians much-needed guidance, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have developed new guidelines, published today in the Journal of Clinical Oncology
and at NCCN’s website
, on managing immune checkpoint inhibitor-related toxicities.
“With rapidly increasing use of immune checkpoint inhibitors, it is imperative that clinicians are knowledgeable about their unique toxicity profiles,” Clifford A. Hudis, MD, FASCO, FACP, CEO of ASCO, said in a statement. “These new guidelines from ASCO and NCCN will help our community continue to provide the highest quality of care to all patients as they incorporate these agents into routine care.”
In order to develop the guidelines, ASCO and NCCN convened multidisciplinary panels that included clinicians from a variety of therapeutic areas, nurses, and patient advocacy experts who based their clinical recommendations on a systematic review of literature and on an informal consensus process.
The guidelines cover dermatologic, gastrointestinal, hepatic, pancreatic, endocrine, pulmonary, renal, ocular, nervous system, cardiovascular, and musculoskeletal toxicities, as well as infusion-related reactions. Also addressed are the principles of immunosuppression, patient education, immunotherapy challenge, and routine monitoring.
The guidelines hold that, in general, checkpoint inhibitors can be continued with close monitoring for grade 1 toxicities, except in the case of neurologic or some hematologic toxicities. For grade 2 toxicities, checkpoint inhibitors should be held until symptoms or lab values revert to grade 1 or lower, and corticosteroids may be offered. In the case of severe (grade 3) toxicities, patients should receive high-dose corticosteroids for at least 6 weeks, and extreme caution must be exercised if immunotherapy is restarted. Very severe toxicities of grade 4 necessitate a permanent halt to checkpoint inhibitor therapy.
NCCN underscored the fact that these guidelines pertain only to immune checkpoint inhibitors, and do not apply to other types of immunotherapy. NCCN plans to continually update its guidelines as data evolve, and reports that it will include toxicities related to the new chimeric antigen receptor T-cell therapies later in 2018.
In addition to helping clinicians better identify and manage toxicities associated with immune checkpoint inhibitors as these therapies become more widely used, ASCO and NCCN hope that the guidelines can help patients to take their symptoms seriously and get the care that they need if they experience an AE.
“Some people will brush their symptoms aside, but any unusual symptom should be reported to the doctor,” said Julie Brahmer, MD, chair of the panel that developed the document. “These guidelines will help all providers who care for patients treated with immune checkpoint inhibitors, not just oncologists, but also emergency room and primary care doctors, assess and manage these side effects.”
ASCO and NCCN encourage oncologists, other practitioners, and patients to provide feedback on these guidelines via either the ASCO Guidelines Wiki
or the NCCN’s website.
Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline. Published online before print February 14, 2018. J Clin Oncol.