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Immune-Related Adverse Events and Recurrence-Free Survival in Melanoma

By: Joshua Swore
Posted: Wednesday, February 12, 2020

A secondary analysis of the EORTC 1325/KEYNOTE-054 trial published in JAMA Oncology has revealed a relationship between immune-related adverse effects and outcomes in patients with melanoma treated with pembrolizumab. According to Alexander M.M. Eggermont, MD, PhD, of University of Paris-Saclay, Villejuif, and colleagues, “The occurrence of an immune-related adverse event was associated with longer recurrence-free survival among both men and women in the pembrolizumab arm.”

A total of 1,019 patients—622 men and 389 women—with stage III melanoma were enrolled in the study. In the experimental arm, 509 patients received a 200-mg dose of pembrolizumab, and 502 patients in the control arm received a placebo. Immune-related adverse events were recorded from the beginning of treatment to 1 month after treatment ended.

Through this study, the authors identified 190 incidences of immune-related adverse effects in the pembrolizumab arm and 45 adverse effects in the control arm. Endocrine disorders were reported in about one-quarter of both men and women treated with pembrolizumab; other disorders observed in those treated with pembrolizumab were respiratory/thoracic, skin, and gastrointestinal.

The researchers found that the occurrence of an immune-related adverse event was associated with a longer recurrence-free survival in the pembrolizumab arm (hazard ratio = 0.61; P = .03) but was insignificant in the placebo arm (hazard ratio = 1.37; P = .21). The authors noted that the reduction in the hazard of recurrence in the pembrolizumab arm was greater after the onset of an immune-related adverse event than without or before adverse events. These results indicate that immune-related adverse events are an indication of immune checkpoint inhibitor activity, which may result in a longer recurrence-free survival.

Disclosure: For full disclosures of study authors, visit jamanetwork.com.



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