Guideline focuses on management of immune checkpoint inhibitor-related toxicities
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An expert panel has developed recommendations on best practices for managing clinically relevant immune-related adverse events associated with immune checkpoint inhibitor treatment.
The Society for Immunotherapy of Cancer clinical practice guideline — published in Journal for ImmunoTherapy of Cancer — focuses on common gastrointestinal and dermatologic toxicities, as well as serious but rare neurologic and cardiac events.
“With the discovery of immune checkpoint inhibitors and the development of antibodies that inhibit immune checkpoints, suddenly there was an explosion in the use of these agents. Since 2011, when the first immune checkpoint inhibitor received FDA approval, a month does not go by without another FDA indication or FDA approval for the use of immune checkpoint inhibitors,” Marc S. Ernstoff, MD, chief of the ImmunoOncology Branch at NCI, told Healio. “Agents that impact the immune system have been used for centuries. Nevertheless, immunotherapy has had a small footprint up until recently.”
Immune checkpoint inhibitors have been accompanied by a unique profile of toxicities with a timing different from that of standard treatments such as chemotherapy, targeted therapy, surgery or radiation, Ernstoff added.
“With the development of this unique safety profile, it has become increasingly important to educate health care providers on the adverse events that may develop with these agents, how to recognize the adverse events and how best to treat them,” he said.
Ernstoff and colleagues — including oncologists, rheumatologists, gastroenterologists, endocrinologists and dermatologists — convened to determine the most appropriate management of immune-related adverse events associated with single and combination immune checkpoint inhibitors. They also aimed to develop evidence- and consensus-based recommendations to assist medical professionals in clinical decision-making and ultimately improve outcomes for this population of patients.
Recommendations state that patients should:
- receive educational materials on immune-related adverse events from a medical professional;
- be encouraged to use contraception while undergoing immunotherapy, with discussion about fertility prior to treatment;
- undergo tests including complete blood count with differential, comprehensive metabolic panel, thyroid-stimulating hormone and free thyroxine before initiating an immune checkpoint inhibitor, with consideration of urinalysis to evaluate for baseline kidney disease; and
- be considered for baseline electrocardiogram if they have a higher risk for myocarditis. Baseline troponin testing also should be considered for potential evaluation of future cardiac toxicity.
“The more rare and life-threatening toxicities patients are experiencing, such as myocarditis and myasthenia, are sometimes less recognized. Clinicians need to be aware that there is a unique spectrum of toxicities,” Ernstoff said. “In addition, [although] these toxicities are frequently seen within the first few months of treatment, toxicities can be late and are not always associated with the last treatment dose. [This] is very different from targeted therapy or chemotherapy, where there is a period of time that we need to be aware of. Also, adverse events related to immune checkpoint inhibition frequently require discontinuation — at least temporarily — of the agent with immune suppression, and we do not dose-reduce these agents.”
The clinical practice guideline already has had an impact on patient care, according to Ernstoff, who said immune checkpoint inhibitors are now a foundational component of treatment.
“This will be an ongoing effort to educate providers as new agents are developed,” Ernstoff said. “The guidelines will become a resource for physicians undergoing training in oncology and who will have a personal experience with these agents throughout their training. These guidelines will have a major impact on the quality and safety of the care of patients with cancer who are receiving treatment with these agents.”
For more information:
Marc S. Ernstoff, MD, can be reached at marc.ernstoff@nih.gov.
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