Long-Term Health-Related Quality of Life With Adjuvant Pembrolizumab in Stage III Melanoma

By: Julia Cipriano, MS
Posted: Friday, September 6, 2024

Adjuvant therapy with the PD-1 inhibitor pembrolizumab did not appear to significantly impact the long-term health-related quality of life of patients with resected stage III melanoma, based on an exploratory analysis of the multinational phase III European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 trial, published in The Lancet Oncology. Emanuel Bührer, MD, of the EORTC Headquarters, Brussels, and colleagues highlighted that, together with earlier results on efficacy and health-related quality of life, these findings support the use of pembrolizumab in this setting.

“When discussing adjuvant immunotherapy with patients, we must balance efficacy with toxicity, particularly long-term toxicity that might affect long-term health-related quality of life,” the investigators commented. “This balance is important for patients in the adjuvant setting because they have a relatively high chance of cure.”

The investigators used a stage- and geographic region–stratified minimization technique; patients with previously untreated stage IIIA, IIIB, or IIIC resected cutaneous melanoma and an Eastern Cooperative Oncology Group performance status score of 1 or 0 were randomly assigned to receive 200 mg of pembrolizumab intravenously (n = 514) or a placebo (n = 505) every 3 weeks for up to 18 doses. A total of 94% and 92% of these arms, respectively, completed the EORTC Quality-of-Life Questionnaire-Core 30 assessment at baseline. For each postbaseline time points (every 6 months between 108 weeks and 48 months after randomization), the completion rate among those survivors ranged from 60% to 90%.

The mean changes from the baseline score to the average of the long-term scores for global health status/quality of life were –0.56 and 1.63 with pembrolizumab and the placebo, respectively, with values greater than 0 indicating an improvement; the difference between the groups was –2.19 (P = .081). Similarly, for all other scales, the differences were less than the threshold for clinical relevance (defined as an average change of 5 points) and were not found to be statistically significant.

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

The Lancet Oncology