A RANDOMIZED STUDY OF ORNIDAZOLE AS A RADIOSENSITIZER IN CARCINOMA OFTHE CERVIX - LONG-TERM RESULTS

This paper presents long-term results of a randomised study of ornidaz ole as a radiosensitiser in locally advanced carcinoma of the cervix. A total of 76 patients were randomised and followed-up with a median o f 85 months. All patients were treated with external and intracavitary irradiation. The 10 year actuarial local control rate was 61% in pati ents receiving ornidazole, compared with 50% for placebo group. This d ifference was not statistically significant. Ten year actuarial overal l and disease-free survival rates were also similar in the two treatme nt groups. Although, when analysed by stage, there was a significant a dvantage in the local control (54% vs 15%; P=0.044) and disease-free s urvival rates (37% vs 8%; P=0.047) in ornidazole group for stage IIIB cases, its implication is obscure because of the small number of patie nts. In this study moderate and severe complication rates were found t o be 30%. These results suggest that ornidazole seems to have relative ly weak sensitisation and it may show a possibility of a marginal bene fit with unconventional irradiation using relatively large radiation d oses. However, the results are insufficient for a real gain in the pro bability of local tumour control and survival.