However, the outcomes of neoadjuvant chemotherapy are unsatisfactory, with 5-year survival rates that ranged from 20 to 40% in patients with urothelial carcinomas (UC) graded pT2 or worse or patients with lymph node metastasis (N+) ( 10). ( 9) also demonstrated its usefulness in Japanese patients. Neoadjuvant cisplatin-based chemotherapy is now established as a standard treatment in the clinical practice guidelines for bladder cancer ( 1–3), and its survival benefit has been demonstrated in several meta-analyses ( 7, 8). Despite radical surgery, it has been estimated that ~50% of patients experience metastatic recurrence within 1 year, and 5-year survival rates of patients with pT3 or pT4 of 31–38 and 21–33%, respectively, have been reported ( 5, 6). 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. 2021 384(22):2102-2114.Of 49 patients in the Japanese subgroup, 27 and 22 patients were randomized to nivolumab and placebo, respectively. NUTRFS, non-urothelial tract recurrence-free survival OS, overall survival PD-L1, programmed death ligand 1 Q2W, every 2 weeks R, randomized.īajorin DF, et al. OS and DSS data are not presented.ĭFS, disease-free survival DMFS, distant metastasis-free survival DSS, disease-specific survival HRQoL, health-related quality of life IHC, immunohistochemistry ITT, intent-to-treat Median follow-up in ITT population, 20.9 months (NIVO) and randomized patients with tumor PD-L1 ≥ 1%ġ9.5 months (PBO) Secondary endpoints: NUTRFS, DSS, and OS bĮxploratory endpoints included: DMFS, safety, HRQoLĪ Defined by the percent of positive tumor cell membrane staining in a minimum of 100 evaluable tumor cells using the PD-L1 IHC 28-8 PharmDx immunohistochemistry assay.ī OS data were not mature at the time of the first planned interim analysis. Minimum follow-up, 5.9 months Primary endpoints: DFS in ITT population and DFS in all Disease-free status within 4 weeks of dosing.Radical surgery within the past 120 days Q2W.Patients with pT3-pT4a or pN+ MIUC without prior neoadjuvant R Treat for up toĬisplatin chemotherapy and not eligible/refuse adjuvant cisplatin 1:1 1 year of adjuvant.Patients with ypT2-ypT4a or ypN+ MIUC who had neoadjuvant cisplatin.Phase 3, randomized, double-blind, multicenter study of adjuvant nivolumab vs placebo in patients
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