The British Journal of Radiology, Vol 57, Issue 679 585-595, Copyright © 1984 by British Institute of Radiology
A study of the effect of misonidazole in conjunction with radiotherapy for the treatment of head and neck cancer. MRC working party on misonidazole in head and neck cancer
The effect of the hypoxic cell sensitiser misonidazole as an adjuvant to
radiotherapy of head and neck cancer was tested in a randomised double
blind study. Patients with squamous carcinoma of the upper alimentary and
respiratory tract, excluding those with early disease for which the
prognosis was good, who were deemed suitable for radical radiotherapy and
fit to receive the drug were entered into the study. Two radiotherapy
regimes were employed, 10 fractions in 3 weeks to a modal tumour dose of
4000-4500 cGy, and 20 fractions in 4 weeks to a modal tumour dose of
5000-5750 cGy. Participating radiotherapists opted for one of the two
schemes. Misonidazole or placebo capsules were administered 4 to 5 hours
before each fraction of radiotherapy to a total of 11 to 13 g/m2. 168
patients were treated with 10 fractions and 99 with 20 fractions, between
March 1979 and November 1981, when entry was stopped because of the high
incidence of drug toxicity and lack of benefit. The estimated hazard ratio
for local control was 0.89, indicating a slight advantage to misonidazole
which was not statistically significant (p = 0.5). Peripheral neuropathy
occurred in 56 patients who received misonidazole, and was more severe when
treatment was given in 10 fractions.
