Systemic Corticosteroids Resolve Immune-related AEs in Ipilimumab-treated Metastatic Melanoma Patients
(CHICAGO, IL) – Systemic corticosteroids resolve immune-mediated adverse reactions associated with ipilimumab treatment, according to a study presented at the 2012 American Society of Clinical Oncology Annual Meeting.
Results from a previously published Phase 3 trial demonstrated that patients with previously untreated metastatic melanoma who received ipilimumab at 10mg/kg plus dacarbazine (DTIC) have improved overall survival. In these previously published ipilimumab studies, the most common drug-related adverse events (AEs) were immune-related, which were generally reversible using treatment guidelines involving prompt recognition, intervention (corticosteroids, and rarely, alternative immunosuppressive agents), and possible discontinuation of therapy, according to lead study author Jean-Francois Baurain, MD, PhD, Medical Oncologist, Cliniques Universitaires Saint-Luc Cancer Centre, Brussels, Belgium.
Ipilimumab is a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to augment antitumor immune responses. In the current study, Baurain and colleagues aimed to evaluate outcomes of ipilimumab treatment-related AEs with use of systemic corticosteroids, reporting AEs from the first ipilimumab dose up to 70 days after the last dose. This analysis included AEs characterized as immune-mediated adverse reactions (imARs), which fell into the following categories: hepatitis, dermatitis, enterocolitis, and endocrinopathies.
The investigators reported that more than 70% of patients who received corticosteroids had complete resolution of the imAR, ie, the last reported AE had a grade of 0. By the time the final data were collected for analysis, high-grade imARs that had not been completely resolved improved to Grade 1 in ≥50% of patients.
Dr. Baurain and colleagues concluded that “in the majority of ipilimumab-DTIC-treated patients who received corticosteroids for the management of imARs, the most common imARs had completely resolved or improved to Grade 1.”