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).
Differences between the pembrolizumab group vs the placebo group in all other scales were < 5 points and not statistically significant: –0.46 vs 0.10, difference = –0.56, P = .53, for physical functioning; 4.23 vs 5.62, difference = –1.39, P = .42, for role functioning; 1.92 vs 3.87, difference = –1.95, P = .12, for emotional functioning; –2.47 vs –1.61, difference = –0.86, P = .44, for cognitive functioning; 4.19 vs 5.94, difference = –1.75, P = .23, for social functioning; and 1.52 vs –0.64, difference = 2.16, P = .12, for fatigue.
The investigators concluded: “Adjuvant pembrolizumab did not have a significant impact on long-term HRQOL compared with placebo in patients with resected stage III melanoma. These findings, together with earlier results on efficacy and HRQOL, support the use of pembrolizumab in this setting.”
Emanuel Bührer, MD, of EORTC Headquarters, Brussels, is the corresponding author of The Lancet Oncology article.
Disclosure: The study was funded by Merck Sharp & Dohme. For full disclosures of the study authors, visit thelancet.com.
