Risk-stratification Based Bladder-sparing Modalities for Muscle-invasive Bladder Cancer
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Neoadjuvant chemotherapy plus radical cystectomy is the standard if care for
cisplatin-eligible patients with MIBC. Developments in the last two decades suggest that
bladder sparing therapy may be a valuable alternative to radical cystectomy. Currently,
well-documented TMT regimens, which include complete transurethral resection of bladder tumor
(TURBT), chemotherapy, and radiation therapy, demonstrated durable oncologic control and
long-term survival in selected patients. Nevertheless, TMT has not been widely used in
clinical practice. On the one hand, due to the complexity of TMT, multiple clinical
departments are required to cooperate in the assessment, treatment and follow-up of patients.
On the other hand, concerns about tumor recurrence, lack of surgical intervention in regional
lymph nodes, and organ dysfunction due to the treatment of large doses of pelvic radiation
have reduced the clinical acceptance of TMT. In recent years, immunocheckpoint inhibitors
such as PD-1/L1, including Nivolumab, Pembrolizumab, and Tislelizumab, have proven to be
promising immunotherapy approaches for advanced urothelium cancer, leading to breakthroughs
in the treatment of advanced urothelium cancer. Immunocheckpoint inhibitors also showed
positive efficacy in patients who did not respond to BCG treatment during perioperative
period. Therefore, immunotherapy can be another means of bladder preservation after surgery,
chemotherapy and radiotherapy. However, bladder sparing target population is still unclear,
among which, the NCCN guidelines recommend patients suitable for bladder preservation:
T2-3N0M0, single lesion (longest diameter less than 6 cm), histological type of urothelial
carcinoma, no CIS, and no hydronephrosis. Therefore, the focus of bladder preservation
treatment is not only on the treatment before and during bladder preservation, but also on
maximizing the follow-up treatment of TURBT and exploring its long-term benefits based on
response to systematic treatment before maximized TURBT.