A trial of Ro 03-8799 (pimonidazole) in carcinoma of the uterine cervix: an interim report from the Medical Research Council Working Party on advanced carcinoma of the cervix.

A randomised controlled clinical trial of Ro 03-8799 (pimonidazole) was performed in advanced stage II and stage III squamous cell carcinoma of the uterine cervix. A total of 183 patients were contributed by 15 centres in Western Europe and coordinated by the Medical Research Council Trials Office in Cambridge. Analysis has shown poorer local tumour control with a hazard ratio (HR) of 2.1 [95% confidence interval (CI) 1.2 to 3.7] and survival with a HR of 1.6 (95% CI 1.0 to 2.5) in the group given the Ro 03-8799. These results were not materially affected after adjustment of stage or haemoglobin levels in stratified analysis or to inadequate radiotherapy being given to the sensitiser group. A true adverse effect caused by the drug is a possible cause and this might be related to a drug-induced impairment of blood supply to the tumour. When compared with results recorded previously for advanced cervical carcinoma treated by radiotherapy, it was apparent that the tumour control and survival in the sensitiser arm was similar, but the control arm showed results superior to those previously recorded. Whatever is the explantation it can certainly be concluded that the radiosensitising drug, pimonidazole, gave no benefit in the radiotherapy of advanced cervical cancer.