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Nivolumab monotherapy associated with adverse events in advanced melanoma
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Nivolumab monotherapy produced mostly low-grade adverse events in patients with advanced melanoma, according to results of a retrospective analysis.
“In nivolumab studies to date, treatment-related adverse events have included dermatologic, gastrointestinal, endocrine, hepatic, renal and pulmonary toxicities,” Jeffrey S. Weber, MD, PhD, who was senior member of H. Lee Moffitt Cancer Center and director of Donald A. Adam Comprehensive Melanoma Research Center at the time of the study but since transitioned to deputy director of Perlmutter Cancer Center at NYU Langone Medical Center and codirector of its melanoma program, and colleagues wrote. “Most adverse events have been low grade and managed successfully with supportive care.”
Researchers analyzed data from four clinical trials of patients who received 3 mg/kg nivolumab (Opdivo, Bristol-Myers Squibb) every 2 weeks (n = 576). They examined the proportion of treatment-related adverse events, time to onset and resolution of adverse events with potential immunologic etiology, as well as the effect on antitumor efficacy of certain adverse events and immune-modulating agents.
Median patient age was 61 years, and 54% had undergone ipilimumab therapy.
Median duration of treatment with nivolumab was 3.7 months, during which patients received a median nine nivolumab doses.
Median follow-up was 7.2 months.
Seventy-one percent of patients experienced treatment-related adverse events (95% CI, 67-75). These events included fatigue (25%), pruritus (17%), diarrhea (13%) and rash (13%).
Ten percent of patients experienced grade 3 or grade 4 adverse events. Nearly half (49%) of those events were gastrointestinal, endocrine, hepatic or skin-related.
Median time to onset of adverse events ranged from 5 weeks for skin-related adverse events to 15 weeks for renal adverse events.
Twenty-four percent of patients underwent treatment with immune-modulating agents to manage adverse events.
Patients who experienced any-grade treatment-related adverse events had a higher objective response rate; objective response rate was not significantly different in patients who received systemic immune-modulating agents compared with those who did not.
“An awareness of the typical timing of onset of immune-related select adverse events may aid in their early recognition and management in clinical practice,” Weber and colleagues wrote. “However, because these data were from clinical trials excluding patients with autoimmune disease, organ dysfunction and active brain metastases, safety in these contexts requires further study. Importantly, almost all grade 3 to 4 select adverse events resolved using nivolumab safety management guidelines, and use of systemic immune-modulating agents to manage high-grade adverse events did not seem to have an impact on antitumor benefit.” – by Andy Polhamus
Disclosure: Weber reports a consultant or advisory role with, as well as honoraria, research funding, travel, accommodations or other expenses from Bristol-Myers Squibb. He also reports financial relationships with several other pharmaceutical companies. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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