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Adjuvant Nivolumab for Patients With High-Risk Muscle-Invasive Urothelial Carcinoma

By: Joshua Swore
Posted: Friday, July 9, 2021

The PD-1 inhibitor nivolumab may prove to be a successful treatment for patients with high-risk muscle-invasive urothelial carcinoma who have undergone radical surgery, according to the phase III CheckMate 274 trial, published in The New England Journal of Medicine. Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, and colleagues observed longer disease-free survival with adjuvant nivolumab than with placebo in patients with urothelial carcinoma and in patients with a PD-L1 expression level of more than 1%.

“These clinical trial results promise to impact standard treatment of patients with urothelial cancer of the kidney, ureter, or bladder by reducing the risk of metastatic recurrence after surgery,” concluded Dr. Galsky and colleagues.

The clinical trial recruited patients from 29 countries in North and South America. A total of 709 patients with urothelial bladder cancer who had undergone radical surgery within 120 days of randomization were enrolled. Patients were treated with intravenous nivolumab at 240 mg every 2 weeks (n = 353) or a placebo (n = 356). Each group included patients with a PD-L1 expression of 1% or more (140 in the nivolumab group, and 142 in the placebo group).

The median disease-free survival was 20.8 months for the nivolumab group and 10.8 months for the placebo group. A total of 74.9% of patients treated with nivolumab and 60.3% of patients treated with the placebo were alive and disease free at 6 months. Approximately three-quarters of patients with a PD-L1 expression level of 1% or more were alive and disease-free after 6 months when given nivolumab versus 55.7% of patients given a placebo. Distant metastasis–free survival was also longer with nivolumab than placebo (40.5 months vs. 29.5 months, respectively).

Disclosure: For full disclosures of the study authors, visit nejm.org.



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