Adjuvant Pembrolizumab vs Placebo in Stage III Melanoma: Long-Term Health-Related Quality of Life

Source: The ASCO , August 2024

In an analysis from the phase III EORTC 1325-MG/KEYNOTE-054 trial reported in The Lancet Oncology, Bührer et al found that adjuvant pembrolizumab was not associated with significant differences in long-term health-related quality of life (HRQOL) compared with placebo in patients with stage III melanoma.

Study Details
In the double-blind trial, 1,019 patients with resected disease were randomly assigned to receive pembrolizumab at 200 mg (n = 514) or placebo (n = 505) every 3 weeks for up to 18 doses. Pembrolizumab treatment was associated with improvement in recurrence-free and distant metastasis–free survival. The current analysis included 481 patients in the pembrolizumab group and 467 in the placebo group who were alive 108 weeks after random assignment and had completed baseline and long-term evaluations with the EORTC Quality-of-Life Questionnaire-Core 30; assessments were performed every 6 months between 108 weeks and 48 months after random assignment. An average difference in change of ? 5 points between groups was considered clinically relevant; changes > 0 represented improvement in HRQOL.

Key Findings
The mean change from baseline to long-term HRQOL (global health status/QOL scale) was –0.56 (95% confidence interval [CI] = –2.33 to 1.22) in the pembrolizumab group and 1.63 (95% CI = –0.12 to 3.38) in the placebo group, yielding a difference between groups of –2.19 (95% CI = –4.65 to 0.27, P = .081).
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