FRIDAY, Sept. 20, 2024 (HealthDay News) -- Disease-free survival is significantly longer with adjuvant pembrolizumab than observation among patients with high-risk muscle-invasive urothelial carcinoma after radical surgery, according to a study published online Sept. 18 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Sept. 13 to 17 in Barcelona, Spain.
Andrea B. Apolo, M.D., from the National Institutes of Health in Bethesda, Maryland, and colleagues conducted a phase 3 trial involving patients with high-risk muscle-invasive urothelial carcinoma. Participants were randomly assigned to receive pembrolizumab (200 mg) every three weeks for one year or to undergo observation after radical surgery (354 and 348 patients, respectively). In the intention-to-treat population, the coprimary end points were disease-free and overall survival.
Patients were followed for a median of 44.8 months for disease-free survival as of July 5, 2024. The researchers found that median disease-free survival was 29.6 and 14.2 months with pembrolizumab and observation, respectively (hazard ratio for disease progression or death, 0.73). Regardless of attribution, grade 3 or higher adverse events occurred in 50.7 and 31.6 percent of patients in the pembrolizumab and observation groups, respectively.
"Taking the data in total, adjuvant checkpoint inhibitor therapy lengthens disease-free survival in certain patients with high-risk muscle-invasive urothelial cancer," the authors write.
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