S. Okkan et al., A RANDOMIZED STUDY OF ORNIDAZOLE AS A RADIOSENSITIZER IN CARCINOMA OFTHE CERVIX - LONG-TERM RESULTS, British Journal of Cancer, 74, 1996, pp. 282-286
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.