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Soo Park, MD
Soo Park, MD
Posted: Thursday, January 2, 2025
A recent study conducted by Eva Ellebaek, MD, PhD, of the Center for Cancer Immunotherapy, Copenhagen University Hospital-Herlev and Gentofte, and colleagues recommends that real-world and clinical trial data are necessary to evaluate the risk vs benefit of immune checkpoint inhibitors and their associated adverse events in clinical decision-making. The results of this trial, published in the European Journal of Cancer, suggest that the incidence of immune-related adverse events is comparable among real-world and clinical trial patients with melanoma.
“Our study contributes vital real-world evidence, fostering a deeper understanding of immune-related adverse event patterns, their impact on outcomes, thereby enhancing the framework for optimized patient care and therapeutic decision-making in melanoma management,” concluded the study authors. “... Even though not directly comparable, [this study] gives insight that can be used across other cancers, especially in an adjuvant setting.”
This study enrolled 792 patients with resected stage III to IV melanoma who received adjuvant anti–PD-1 therapy, primarily nivolumab. National databases such as the IMMUNOTOX and the Danish Metastatic Melanoma databases were queried for patient data. Immune-related adverse events were categorized using the Common Terminology Criteria for Adverse Events version 5.0.
The median patient age was 62 years, and just over half of individuals were male (55%). Of the total, 697 patients experienced at least one immune-related adverse event (88%). Severe events of grade 3 or 4 were reported in 116 patients, 5 of whom died because of toxicity. Of note, participants who experienced at least one immune-related adverse event before the 90-day evaluation demonstrated significantly prolonged overall (P = .0071) and progression-free (P = .032) survival.
Melanoma relapse was reported in 271 patients; 58 of these individuals did not experience adverse events, and 61 of them had multisystem toxicity. Further, patients who experienced immune-related adverse events exhibited a lower risk of relapse. In addition, there was a higher incidence of immune-related adverse events during the summer.
Disclosure: For full disclosures of the study authors, visit ejcancer.com.
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