Outcomes Following Clinical Complete Response to Neoadjuvant Chemotherapy for Muscle-invasive Urothelial Carcinoma of the Bladder in Patients Refusing Radical Cystectomy.

OBJECTIVE: To investigate survival outcomes of patients with muscle-invasive bladder cancer (MIBC) that demonstrate complete clinical response (cT0) to neoadjuvant chemotherapy (NAC) and then reject subsequent radical cystectomy (RC).

METHODS: A retrospective chart review identified patients with MIBC who were cT0 after platinum-based NAC. cT0 was defined as negative cytology, cystoscopy with transurethral resection of bladder tumor, and imaging. cT0 patients refusing for RC were followed up with cytology, cystoscopy with biopsy, and cross-sectional imaging.

RESULTS: Forty-eight patients were identified with MIBC that were cT0 after NAC. Seven patients underwent immediate RC, whereas 41 elected bladder preservation with close surveillance. Of those remaining 41 patients, mean age was 68 ± 11 years with median follow-up of 35 months. NAC regimens were 46% methotrexate/vinblastine/doxorubicin/cisplatin, 39% gemcitabine/cisplatin, and 15% other platinum-based therapies. Five-year cancer-specific survival was 87%, disease-free survival was 58%, and cystectomy-free survival was 79%. A total of 19 patients (46%) relapsed with 5.4-month median recurrence time.

CONCLUSION: Bladder preservation may be a reasonable option in a highly select subset of patients with MIBC who are complete clinical responders after NAC. For those patients that were cT0 after NAC and refused or were ineligible for RC, 5-year disease-free survival was nearly 60% and cancer-specific survival was nearly 90%. Future studies should focus on identifying clinical and molecular factors associated with a durable pathologic complete response after NAC.