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Patients with melanoma treated with Keytruda had improved recurrence-free survival without an effect on their quality of life.
Keytruda (pembrolizumab) does not significantly decrease health-related quality of life in patients with resected, high-risk stage 3 melanoma compared to placebo, according to data published in The Lancet.
“Given the need for safe and effective adjuvant therapies, the assessment of (health-related quality of life) is increasingly important, in part because of serious (side effects) associated with melanoma drug therapies,” the study authors wrote.
Previously, it was reported in a phase 3 trial that recurrence-free survival (the length of time after primary treatment ends without any signs or symptoms of cancer) was improved in patients with resected stage 3 melanoma who were treated with Keytruda compared with placebo.
The trial included 1,019 patients with previously untreated stage 3 resected cutaneous melanoma. Patients received either Keytruda (514 patients) or placebo (505 patients). Factors of interest included health-related quality of life (an individual’s or group’s perceived mental and physical health over time) and overall health. Follow-up was conducted for a median of 15.1 months.
Health-related quality of life survey compliance was 93.6% at the start of the study. This decreased over time, with greater than 70% compliance during the first year and greater than 60% afterwards for both treatment groups.
When the study began, overall health/quality of life scores were similar in both groups and remained stable through time. The difference between the two groups during treatment was –1.1 points and was –2.2 points after treatment. There was also a difference of –2.2 points after two years.
“These differences are within the five-point clinical relevance threshold for the (the questionnaire used to assess the patients physical, psychological and social quality of life) and are therefore clinically non-significant,” the study authors wrote.
Researchers noted that although severe or worse side effects occurred more often in the Keytruda group versus the placebo group, this was not reflected in the health-related quality of life reports.
“The results of our exploratory (health-related quality of life) endpoint analysis demonstrated that (Keytruda) had no clinically relevant effect on the (global health/quality of life) scale compared with placebo, showing that prolonged recurrence-free survival does not necessarily come at the price of reduced (health-related quality of life),” the study authors concluded.
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