Abstract

Purpose The aim of this phase II-III study was to determine a bladder sparing treatment in patients with invasive bladder cancer allowing a better quality of life. Objectives were to determine toxicity, disease free and overall survival of an alternated chemo-radiotherapy definitive treatment compare to patients treated with surgery in a previous randomized study. Methods and materials 76 patients with muscle invading bladder cancer stage T1G3 through T4 N0 M0 entered in the same chemotherapy regimen (Cisplatin 200 mg/mq and 5-Fluorouracil 200 mg/mq i.v. in 5 days) alternated with different radiotherapy scheduling: the first 18 patients received 2 cycles of 200 cGy/10 fr/12 d each; the second group of 58 patients received 2 cycles of 2500 cGy/10 fr/12 d each (the last 21 patients received Methotrexate 40 mg/mq instead of 5-Fluorouracil). Results A clinical complete response was observed in 57 patients (81%), partial response in 7 patients (10%), and a non response in 6 patients (9%). At a median follow-up of 45 months, 33 patients (47%) were alive and free of tumor. The 6 years overall survival and progression free survival was 42% and 40% respectively. Systemic side effects were mild, while a moderate or severe local toxicity was observed in 14 patients and 13 patients (about 20%) respectively. Conclusion Our conservative combination treatment allowed sparing in a high rate of patients and a survival comparable to that reported after radical cystectomy.

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