RESUMO
Patients with T2 grade III and T3 bladder cancer were treated in a Phase II trial of radical irradiation plus Misonidazole (MISO). Forty Gy in 2 Gy fractions (5 per week) to the whole pelvis were followed by 12 Gy in 6 Gy fractions (1 per week) plus oral and intravesical MISO to a coned down volume. Twenty-two patients were treated and the results compared with historical controls. The cystoscopic complete tumor response between 6 and 12 months post therapy were 73 and 43%, respectively. The patient two year survival was 81 and 51%, respectively, and the patient 2 year survival with bladder preservation was 61 and 48%, respectively--4 patients in the MISO study having undergone salvage cystectomy. Complications that may be radiation related in the MISO study are wound sepsis after salvage cystectomy in 2 patients, rectal stenosis requiring colostomy 16 months after salvage cystectomy in 1 patient and the development of a contracted bladder in 1 patient with a history of prior extensive endoscopic therapy. No misonidazole neurotoxicity seen. These findings are being further evaluated in a prospective randomized trial.
