A RANDOMIZED TRIAL OF CONCURRENT CHEMORADIOTHERAPY VERSUS RADIOTHERAPY IN ADVANCED-CARCINOMA OF THE UTERINE CERVIX

The purpose of our study was to determine whether the chemoradiation i s better than radiotherapy alone with respect to survival and treatmen t toxicity in patients with advanced carcinoma of the cervix. From Oct ober 1990 to April 1995, a total of 122 patients with advanced cervica l carcinoma were included in this study and randomly assigned to eithe r radiotherapy or concurrent chemotherapy and radiotherapy. The patien ts in the concurrent group received cisplatin, vincristine, and bleomy cin every 3 weeks for a total of four courses, in combination with rad iotherapy concurrently. Sixty patients were randomized to the concurre nt chemoradiotherapy, and 62 were randomized to the radiotherapy alone . A tumor response was observed in 88.3% of the patients in concurrent group and in 74.2% of the patients in radiotherapy group (P = 0.04). After a median follow-up of 46.8 months, the overall disease-free surv ival and actuarial survival rate at 3 years were 51.7 and 61.7% in the concurrent group, and 53.2 and 64.5% in the radiotherapy group, respe ctively. Treatment-related toxicity appears to be higher with the comb ination of radiotherapy and chemotherapy compared with radiotherapy al one (36.7% versus 17.7%, P = 0.02). However, analysis by Kaplan-Meier method showed that the actuarial survival was not statistically differ ent between the chemoradiotherapy and radiotherapy groups (mean surviv al time: 38.1 months versus 41.5 months, P = 0.27). In conclusion, thi s study showed that concurrent multiagent chemoradiotherapy did not pr ove to be a superior definitive therapy over radiotherapy alone for pa tients with advanced cervical carcinoma. (C) 1997 Academic Press.