Nutrfs11/20/2023 ![]() ![]() For these reasons, there remains a need for a novel and effective perioperative therapy for MIUC. Therefore, the Japanese guidelines state that when cisplatin-based chemotherapy is used for UTUC, it should be performed as neoadjuvant therapy, but no specific chemotherapy regimen has been proposed ( 4). However, decreased renal function has been reported after nephroureterectomy ( 15) and may contraindicate chemotherapy. Adjuvant chemotherapy may prolong disease-free survival (DFS) in patients with locally advanced UTUC eligible for chemotherapy ( 14). However, compared with neoadjuvant chemotherapy, there is limited evidence supporting adjuvant chemotherapy for bladder cancer and it is not considered standard therapy in Japan ( 3). An updated analysis further confirmed a benefit of cisplatin-based adjuvant chemotherapy on OS (56.0 vs. A large retrospective study reported that the 5-year OS rate was significantly better in patients who received adjuvant chemotherapy compared with patients who underwent observation following radical cystectomy without neoadjuvant chemotherapy (37.0 vs. 31.8%), overall survival (OS) was not significantly improved with immediate chemotherapy ( 11). Although the timing of adjuvant chemotherapy (immediate/deferred) has been trialed in patients with pT3–4 or N+ M0 UC of the bladder, the results remain suboptimal although immediate chemotherapy (within 90 days after surgery) was associated with improved progression-free survival (PFS) compared with deferred chemotherapy until first recurrence (5-year PFS: 47.6 vs. 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. Of 49 patients in the Japanese subgroup, 27 and 22 patients were randomized to nivolumab and placebo, respectively. ![]()
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