A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder

IntroductionNeoadjuvant cisplatin-based combination chemotherapy improves survival in muscle-invasive bladder cancer. However, response rates and remain suboptimal. We evaluated the efficacy, safety, tolerability of cisplatin plus cabazitaxel.MethodsA phase II single-arm trial was designed to recruit at least 26 evaluable patients. This would give 80% power detect primary endpoint, an objective rate defined as a pathologic complete partial (pathologic downstaging), measured by staging cystectomy (p0 = 0.35 p1 0.60, α 0.05).ResultsObjective seen 15 patients (57.7%) more than one- third achieved (9/26; 34.6%). Seventy-eight percent (21/27) completed all cycles treatment, with only 6.7% reported adverse events being graded 3 or 4. There were 6 treatment-related serious event reported, but no suspected unexpected reactions. In who response, median progression-free overall not reached (median follow-up 41.5 months). contrast, (7.2 months) (16.9 significantly worse (P .001, log-rank) did achieve response.ConclusionCabazitaxel for neoadjuvant treatment cancer can be considered well-tolerated effective regimen before definitive therapy higher comparing favorably that cisplatin/gemcitabine (23%–26%). These results warrant further evaluation III study.