11/21/2023 0 Comments Nutrfs![]() The type of surgery depends on the location of the carcinoma: cystectomy for bladder carcinoma and nephroureterectomy for upper tract urothelial carcinomas (UTUC) ( 3, 4). The standard treatment for muscle-invasive urothelial carcinoma (MIUC) is radical surgery ( 1, 2). The changes in quality of life scores from baseline over time were similar in both groups. The most common treatment-related adverse events in the nivolumab group were lipase increased, amylase increased and diarrhea. Treatment-related adverse events of Grade 3–4 occurred in 25.9 and 13.6% of patients in the nivolumab and placebo groups, respectively. The corresponding values in patients with tumor PD-L1 expression level of 1% or more were 29.67 months (95% confidence interval 2.63–not reached) and 25.95 months (95% confidence interval 5.59–not reached) (hazard ratio 1.10, 95% confidence interval 0.31–3.92), respectively. The median disease-free survival times in the nivolumab and placebo groups were 29.67 months (95% confidence interval 7.79–not reached) and 9.72 months (95% confidence interval 4.73–not reached), respectively (hazard ratio 0.77, 95% confidence interval 0.35–1.69). Eleven and 8 patients, respectively, had tumor PD-L1 expression level of 1% or more. Clinical trial information: NCT02632409.Of 49 patients in the Japanese subgroup, 27 and 22 patients were randomized to nivolumab and placebo, respectively. These results further support adjuvant NIVO as a standard-of-care treatment for pts with high-risk MIBC after radical resection ± neoadjuvant cisplatin-based chemotherapy. The DFS benefit was observed in all prespecified subgroups. Improvement in DFS was observed with NIVO over PBO in pts with MIBC after radical resection regardless of tumor PD-L1 expression. Grade 3–4 treatment-related adverse events occurred in 17% and 6% of pts in the NIVO and PBO arms, respectively. Improvement in NUTRFS and DMFS with NIVO vs PBO was also observed (Table). DFS was improved with NIVO vs PBO across subgroups according to age, sex, ECOG performance status, nodal status, and PD-L1 expression status. DFS probability at 12 months in all MIBC pts was 66% with NIVO and 45% with PBO. With a minimum follow-up of 11.0 months, a DFS benefit was observed with NIVO vs PBO in these pts, regardless of tumor PD-L1 expression (Table). ![]() Of 709 randomized pts in the trial, 560 had MIBC (NIVO, n = 279 PBO, n = 281). This exploratory analysis focused on the subgroup of pts with muscle-invasive bladder cancer (MIBC) after radical resection. Non–urothelial tract recurrence-free survival (NUTRFS) was a secondary endpoint, and distant metastasis-free survival (DMFS) was an exploratory endpoint. Primary endpoints were DFS in ITT pts and in pts with PD-L1 ≥ 1%. Pts had radical resection ± neoadjuvant chemotherapy and were at high risk of recurrence on final pathologic staging. Pts were randomized 1:1 to NIVO 240 mg intravenously every 2 weeks or PBO for ≤ 1 year of adjuvant treatment and stratified by nodal status, prior neoadjuvant cisplatin, and tumor PD-L1 expression. We report results for the subgroup of pts with bladder cancer, the most predominant type of urothelial carcinoma.ĬheckMate 274 is a phase 3, randomized, double-blind trial of adjuvant NIVO vs PBO in high-risk muscle-invasive urothelial carcinoma (bladder, ureter, renal pelvis) after radical resection. In the CheckMate 274 trial, disease-free survival (DFS) was significantly improved with nivolumab (NIVO) vs placebo (PBO) both in intent-to-treat (ITT) patients (pts) (hazard ratio, 0.70 98.22% confidence interval, 0.55–0.90 P < 0.001) and in pts with tumor programmed death ligand 1 (PD-L1) expression ≥ 1% (HR, 0.55 98.72% CI, 0.35–0.85 P < 0.001). ![]()
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