Phase II study of conformal hypofractionated radiotherapy with concurrent @entity136 in muscle-invasive XXXX .

@entity1 @entity137 @entity5 @entity189 @entity150 @entity204 @entity136
PURPOSE: The aim of this prospective, phase II trial was to determine the response of muscle-invasive @entity150 (MIBC) to concurrent chemoradiotherapy of weekly @entity136 with 4 weeks of radiotherapy (RT; GemX). @entity1 AND METHODS: Fifty @entity1 with transitional cell @entity189 , stage T2-3, N0, M0 after transurethral resection and magnetic resonance imaging, were recruited. @entity136 was given intravenously at 100 mg/m(2) on days 1, 8, 15, and 22 of a 28-day RT schedule that delivered 52.5 Gy in 20 fractions. Chemotherapy was stopped for Radiation Therapy Oncology Group (RTOG) grade 3 bladder or bowel @entity137 . The primary end points were @entity5 response, @entity137 , and survival. RESULTS: All @entity1 completed RT; 46 tolerated all four cycles of @entity136 . Two @entity1 stopped after two cycles, and two stopped after three cycles, because of bowel @entity137 . Forty-seven @entity1 had a post-treatment cystoscopy; 44 (88%) achieved a complete endoscopic response. At a median follow-up of 36 months (range, 15 to 62 months), 36 @entity1 were alive, and 32 of these had a functional and intact bladder. Fourteen @entity1 died; seven died as a result of metastatic MIBC, five died as a result of intercurrent disease, and two died as a result of treatment-associated @entity204 . Four @entity1 underwent cystectomy; three because of recurrent disease and one because of @entity137 . One @entity1 required a bowel resection for late @entity137 . By using Kaplan-Meier analyses, 3-year cancer-specific survival was 82%, and overall survival was 75%. CONCLUSION: Concurrent @entity136 -based chemoradiotherapy (ie, GemX) produces a high response rate in MIBC and has durable local control and acceptable @entity137 , which allows @entity1 to preserve their own bladder. This treatment modality warrants additional investigation in a phase III setting.
