A Controlled Trial of Misonidazole in the Curative Treatment of Infiltrating Bladder Cancer

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Abstract
Between 1980 and 1983 a total of 89 patients with infiltrating transitional cell carcinoma of the bladder were entered in a multi centre randomised controlled clinical trial with either misonidazole or placebo added to the first 40.00 Gy of radiotherapy. Depending on their referring clinican, patients then completed treatment with either further radiotherapy to a radical dose, or surgery four weeks later. All patients have been followed up for a minimum of three years, and no significant difference has been found in local control, survival, or pathological downstaging of the tumour. The neurotoxicity was considerable, with 43% of patients receiving misonidazole developing a peripheral neuropathy, starting five weeks on average after beginning treatment, and with a mean duration of 27 months. Eighty per cent of patients affected still had peripheral neuropathy at three years or their prior death. There is a suggestion that alcohol may predispose to the neuropathy. This study failed to show any benefit of misonidazole in tumour control and produced unacceptably high levels of toxicity.