Schematic representation of the design of HCRN GU16-257.
MFS, muscle-invasive urothelial cancer of the bladder
BLADDER TUMOR
Patients with muscle-invasive urothelial cancer of the bladder diagnosed based on standard of care TURBT (transurethral resection of bladder tumor) received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging consisting of cystoscopy with biopsies, urine cytology, and imaging including MRI (magnetic resonance imaging) of the bladder (or computed tomography scan if MRI was contraindicated). Patients achieving a clinical complete response (cCR) were offered the option to proceed with immediate cystectomy versus proceed without cystectomy and receive an additional 4 months of single-agent nivolumab followed by surveillance. Patients without a cCR were recommended to undergo immediate cystectomy. The primary objectives were to estimate the cCR rate and to assess the positive predictive value (PPV) of cCR for a composite outcome measure (MFS, metastasis-free survival). *Patients achieving a clinical CR were offered the option to forgo cystectomy or proceed with immediate cystectomy.
