A sequential treatment approach to muscle-invasive urothelial cancer: A phase II Southwest Oncology Group Trial (S0219) of neoadjuvant paclitaxel, carboplatin, and gemcitabine (PCG)

5022 Background: S8710 demonstrated a survival benefit for neoadjuvant MVAC prior to a radical cystectomy for patients (pts) with myoinvasive bladder cancer (Grossman, NEJM 2003). In S8710, 38% of pts achieved a pathologic complete response (pT0) to chemotherapy. A phase II trial of neoadjuvant PCG was conducted to evaluate the clinical T0 (cT0) rate with PCG & to pilot a sequential approach of either cystoscopic surveillance or immediate cystectomy for pts with cT0 status following chemotherapy. Tumor tissue was collected pre/post-PCG & at cystectomy for biomarker studies. Methods: Pts with T2-T4a chemo- & radiation-naive urothelial cancer with adequate end- organ function & Zubrod performance status 0–2 were eligible. T2+ tumor must be diagnosed by a transurethral resection of bladder tumor (TURBT) followed by another TURBT to confirm persistent disease (dz) w/in 16 weeks of the first TURBT and 2–8 weeks pre-study. Chemo: 3 cycles of P 80 mg/m2 + G 800 mg/m2 on days 1&8, and C (AUC=5) on day 1. Pts with...