Bladder preservation in patients with urothelial muscle-invasive bladder cancer who refused radical cystectomy after clinical complete response to trans-urethral resection of bladder tumors and neoadjuvant systemic chemotherapy. A retrospective single-center experience.

Abstract

e16585 Background: Neoadjuvant systemic chemotherapy (NASCT) followed by radical cystectomy (RC) is widely used among the standard treatments for patients with muscle invasive bladder cancer (MIBC). RC is associated with significant morbidity and worsening of quality of life. We conducted a retrospective single-center analyses including patients with non-metastatic urothelial MIBC who refused RC after the achievement of clinical complete response to trans-urethral resection of bladder tumor (TURBT) and NASCT. Methods: Before NASCT, patients uderwent complete initial TURBT, and 4-5 weeks later to maximal restaging TURBT, random cold-cup biopsies of the bladder and prostatic urethra, and urinary cytology.. Patients with concomitant carcinoma in situ, tumors of the upper urinary tract or prostatic urethra, hydronephrosis and reduced bladder capacity were referred for RC. After NASCT patients were managed with intravesical sequential BCG and Mitomycin to prevent disease recurrence. Patients were assessed with urinary cytology, cystoscopy and imaging at 3 month intervals for 2 years, 6 month interval for 3 years and yearly thereafter. The primary endpoint was the event-free survival (EFS), defined as the absence of urothelial high grade tumor relapse or cancer-specific death . The secondary endpoints were bladder preservation rate and the overall survival (OS). Results: From July 1997 to December 2021, 237 patients with MIBC (cT2/3 - cN0 - cM0), received TURBT, restaging TURBT and platinum based NASCT (gemcitabine plus cisplatin [n = 179]; dose-dense MVAC [n = 58] with evidence of complete clinical response (pT0-Nx-MX) ; among these 159 refused RC. The median age was 57yo and 84.9% were male. All patients received susequent intravesical sequential BCG and Mitomycin. After a medial follow-up of 15.1 years, 129 (81.1%) patients had an EFS. Twenty-six patients (16.3%) had a new MIBC occurred in the bladder (n = 7), urethra (n = 6) and upper urinary tract (3 = 13); 6 patients developed distant metastases and died. The stimated 10-yr EFS and OS were 81.4% (95% CI: 74.9-88.5) AND 85.2% (95% CI: 79.2-91.6), respectively. The 10-yr bladder preservation rate was 94.5% (95 CI: 90.5-98.6). In multivariable analyses, older age, multifocal disease, and tumor larger than 5 cm were significantly associated with worse EFS (HR = 1.06, p = 0.004) and OS (HR = 1.1, p < 0.001). Conclusions: In this retrospective MIBC cohort, selected patients who refused RC had benefit from multimodal approach including maximal TURBT, NESCTand intravesical sequential ommuno-chemo-therapy to prevent disease recurrence. These results deserve future investigations in prospective bladder-sparing trials.