Counseling Patients and Caregivers on Immune-Related Adverse Events

Counseling Patients and Caregivers on Immune-Related Adverse Events Posted By:
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In this commentary, Alexa Basilio, PharmD, BCOP, and Jordan McPherson, PharmD, MS, BCOP, discuss important topics for pharmacists to consider when counseling patients and caregivers on the recognition of irAEs, as ensuring early recognition is a key factor for accurate and timely irAE management.

Since 2011, 11 immune checkpoint inhibitor (ICI) agents have been approved by the FDA for cancer-related indications. These agents block the immune checkpoint proteins CTLA-4, PD-1, PD-L1, and LAG3 to stimulate immune activation against cancer. ICIs increasingly are used in oncology, as for many malignancies they have led to improved survival compared with traditional cytotoxic chemotherapy and may result in long-term, durable responses. In general, ICIs have a favorable adverse event profile compared with traditional cytotoxic chemotherapy, but they do carry the risk of a highly unique and unpredictable class of toxicities—immune-related adverse events (irAEs). Counseling patients and caregivers on the recognition of irAEs is important for ensuring early recognition for accurate and timely irAE management.

Patients and caregivers should be aware that irAEs can affect any organ system. The most common irAEs include diarrhea, rash, thyroiditis, pneumonitis, and hepatitis, whereas less common, easy-to-miss irAEs include myocarditis, nephritis, mucositis, and neuropathy. The majority of nonendocrine irAEs are mild to moderate and reversible, in contrast to endocrine irAEs, which are highly treatable but permanent. irAE severity can range from asymptomatic to life-threatening, particularly if an irAE is allowed to escalate without intervention. Because symptoms vary widely and severity may worsen quickly, it is crucial for patients and caregivers to maintain a high level of suspicion for irAEs and to report any new or unusual symptoms to their healthcare professional (HCP) during or after treatment. It takes only a single dose of ICI therapy to put a patient at risk for an irAE. Even if patients switch or discontinue therapy, they are still at risk for many months. Provide patients and caregivers with a symptom checklist; this can be helpful in letting them know what they should be concerned about at home. Immunotherapy wallet cards also can assist patients in communicating their treatment to HCPs outside of their oncology team and may trigger workup of an irAE in nonspecialist settings.

When counseling patients and caregivers on irAEs, it is important to emphasize that the timing of irAEs differs from the timing of toxicities with conventional cytotoxic chemotherapies. Whereas chemotherapy toxicities often are experienced within the chemotherapy cycle and improve over time, irAEs typically emerge within a few months of ICI initiation and exponentially worsen without immunosuppressive intervention. It is important to note that irAEs can occur at any time and up to 1-2 years after discontinuation of ICI therapy. Furthermore, without prompt intervention, permanent organ damage can result.

Finally, when counseling patients and caregivers on irAEs, it is crucial to keep in mind differences in health literacy; irAEs are complex and unique, and they may differ from the expectations that patients bring to their initial treatment discussions based on past experiences of loved ones with traditional chemotherapy toxicity. Therefore, HCPs should focus on improving the health literacy of their patients by relating to these experiences and contrasting them with what to expect with ICI therapy. The reality is that irAEs are complex for everyone involved—both HCPs and patients. Thus, our challenge is to ensure that patient education on irAEs is kept simple without losing its core meaning. Minor adjustments in wording can make a huge difference in patient understanding. For example, use “inflamed gut” instead of colitis or “hormone problem” instead of endocrinopathy. Improving health literacy with easy-to-understand patient education is a key step in mitigating the risks of irAEs and optimizing patient outcomes during immunotherapy.


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Filed under: Oncology/Hematology , NPs & PAs

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