This can bring a paradigm shift in the treatment of muscle-invasive urothelial carcinoma, by providing a therapeutic option to patients not eligible for cisplatin or in those with pathological evidence of residual disease despite neoadjuvant cisplatin-based chemotherapy.Ĭonflicts of interest: There are no conflicts of interest. , īased on Checkmate 274 trial, FDA has granted a priority review designation to nivolumab for use as adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma. However, DFS at 2–3 years is considered a surrogate of overall survival among patients with muscle-invasive urothelial carcinoma and thus, further follow-up may consolidate these findings by providing overall survival data. The secondary end point of overall survival was not achieved at the time of analysis, for which longer follow-up is required. About 48.2% of patients in the nivolumab arm and 57.3% of patients in the placebo group had disease recurrence or died during follow-up.
The limitation of this trial is it being an interim analysis with a short follow-up of 20 months. The reason for this difference is also not clear however, this requires further analysis. Through a 1:1 randomization, nivolumab (240 mg) or placebo every 2 weeks was administered for up to 1 year or until disease recurrence or discontinuation from trial, with stratification according to tumor programmed death ligand-1 (PD-L1) expression level (≥1% vs. Patients included were those with Eastern Cooperative Oncology Group performance status score of 0 or 1 and who underwent radical surgery with pathological evidence of urothelial carcinoma (originating in the bladder, ureter, or renal pelvis) with or without neoadjuvant cisplatin-based chemotherapy with a high risk of recurrence (pT3, pT4a, or pN + and patient not eligible for, or declined, adjuvant cisplatin-based chemotherapy for patients who had not received neoadjuvant cisplatin-based chemotherapy and ypT2 to ypT4a or ypN + for patients who received neoadjuvant cisplatin. Available from: Ĭheckmate 274 is a phase 3, multicenter, double-blind, randomized controlled trial recently published in the New England Journal of Medicine, comparing nivolumab with placebo in adjuvant setting in patients with muscle-invasive urothelial carcinoma. Checkmate 274 trial: Is Nivolumab the new standard in adjuvant setting for high-risk muscle invasive urothelial carcinoma?. "Almost 200,000 people die each year of urothelial cancer worldwide, so advances like immunotherapy being used in this manner bring hope."Īuthors disclosed financial ties to Bristol Myers Squibb, which manufactures nivolumab and funded the study.How to cite this article: Kumar N. Nivolumab showing a benefit in all patients as well. "Longer-term follow-up data is important for reinforcing the initial results we published last year demonstrating for the first time that immunotherapy administered after surgery for bladder cancer and other urothelial cancer can decrease the risk of cancer recurrence," Galsky said in a statement. stated that CheckMate 274 (NCT02632409) reached its primary endpoint DFS in an interim analysis with. Nonurothelial tract recurrence-free survival and distant metastasis-free survival were also improved with nivolumab. For most subgroups, including analysis by age, sex, nodal status, use of prior cisplatin-based chemotherapy, and PD-L1 status, improvement in disease-free survival with nivolumab was maintained. At 12 months, among patients with tumor programmed death-ligand 1 (PD-L1) expression of ≥1 percent, the disease-free survival probability was 67.6 percent with nivolumab and 46.3 percent with placebo. At 12 months, disease-free survival probability was 63.5 percent with nivolumab and 46.9 percent with placebo. The researchers found that with five additional months of follow-up, the disease-free survival benefit of nivolumab was maintained. Matthew Galsky, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted longer-term follow-up among participants in the CheckMate 274 trial in which patients with high-risk muscle-invasive urothelial carcinoma (MIUC) were randomly assigned to either adjuvant nivolumab (353 patients) or placebo (356 patients) after radical surgery. TUESDAY, (HealthDay News) - Immunotherapy after surgery helps reduce cancer recurrence in patients with muscle-invasive bladder cancer, according to a study presented at the annual meeting of the American Urological Association, held from May 13 to 16 in New Orleans.
