A phase II trial of sequential neoadjuvant chemotherapy with ifosfamide, doxorubicin, and gemcitabine (IAG), followed by cisplatin, gemcitabine and ifosfamide (CGI) in locally advanced urothelial cancer (UC): Final results from the M.D. Anderson Cancer Center
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5079 Background: Increasing evidence supports the use of neoadjuvant chemotherapy for UC. We report final results of sequential chemotherapy in patients with high risk UC. Methods: Patients with UC received 3 cycles IAG followed by 4 cycles of CGI. Patients had any of the following high-risk features: lymphovascular invasion, or cT3b-4a disease (3-D mass on exam under anesthesia, or invasion into local organs). Patients with G3 upper tract disease, or micropapillary tumors were also eligible. Using a Simon 2-stage design, 65 patients with high-risk UC were enrolled. The primary endpoint was pathologic downstaging to ≤ pT1N0M0. Results: In all, 65 patients received 166 cycles of IAG, and 196 cycles of CGI. With median follow-up of 40.7 months, the 5-year overall survival (OS) and disease-specific survival for all patients was 60% and 67%, respectively (95% CI for 5-yr OS: 0.43–0.74). Downstaging to ≤ pT1 occurred in 30 of 60 (50%) with bladder primaries, and 3 of 5 with renal pelvis primaries. Downstaging ...