Radical radiation and oral and intra-vesical misonidazole for bladder cancer.

Patients with T2 grade 3 and T3 bladder cancer were entered into studies to evaluate the efficacy of 40 Gy in 2 Gy fractions (5/week) to the whole pelvis followed by 12 Gy in 6 Gy fractions (1/week) to a coned down volume plus oral and intravesical misonidazole (MISO). In a pilot study of 22 patients the complete response rate at cystoscopy at 6 months was 73% and the 5-year survival rate (life-table) with and without bladder preservation was 48% and 54% respectively. The 5-year bowel major complication rate (life-table method) was 8%. These results are statistically significantly improved over that seen in a series of historical controls. A prospective randomized trial has been completed comparing the above regimen with 40 Gy to the whole pelvis followed by 20 Gy to the coned down volume in 2 Gy fractions (5/week). Fifty-eight patients were entered and 53 are evaluable. The complete response rate at cystoscopy at 6 months is 69% (18/26) in the patients treated with MISO and 63% (17/27) in those treated without MISO. As this is an important prognostic indicator, it is unlikely that there will be an advantage in either group and this is supported by the initial follow-up data. The complete response rate at cystoscopy at 6 months is higher in both arms of this study than in the historical series.