ESMO 2018: Adjuvant Pembrolizumab and Quality of Life in Patients With High-Risk Melanoma
Posted: Wednesday, November 21, 2018
Adjuvant pembrolizumab treatment does not seem to negatively affect health-related quality of life in patients with resected, high-risk, stage III melanoma. This finding, which came from an exploratory analysis of the EORTC 1325-MG/KEYNOTE 054 trial, is of interest because pembrolizumab has been associated with severe adverse events (grade 3 or higher) in this patient population. Alexander M. M. Eggermont, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, presented their study results at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich (Abstract 1278P).
A total of 1,019 patients with stage III melanoma that had metastasized to a lymph node were enrolled in this phase III, international, double-blinded, randomized trial, which was previously published in The New England Journal of Medicine. After complete resection, 514 patients were randomly assigned to receive pembrolizumab, and 505 patients were assigned to receive placebo. Health-related quality-of-life outcomes for all patients were evaluated based on global health and quality scores (as measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire–C30). Data collected over 19 months were analyzed.
Overall, the average global health and quality score in patients treated with pembrolizumab was 2.2 points lower than in those who received placebo. During and after treatment, the average global health and quality score in patients treated with pembrolizumab was 1.1 points lower and 2.2 points lower than in those who received placebo, respectively. These differences were under the 5-point clinical relevance threshold.
“Pembrolizumab maintains health-related quality of life compared to placebo, when given as adjuvant therapy for patients with resected high-risk stage III melanoma,” concluded the investigators.