Phase I-II study of combined 5-fluorouracil and cisplatin chemotherapy and altered fractionation radiotherapy for advanced squamous cell carcinoma of the cervix.

Forty patients with advanced carcinoma of the cervix were prospectively treated by an intermodality approach using chemotherapy combination concomitant with split-course hyperfractionated radiation therapy (RT). Cisplatin (CDDP) (60 mg/m2) was administered before radiotherapy initiation followed by 5-fluorouracil (5-FU) (750 mg/m2) for 5 days during the first week of irradiation. The same schedule was repeated in the last week of the RT, with 5-FU administration (1,000 mg/m2) for only 3 days. RT consisted of 5,020 cGy to the pelvis, followed by two intracavitary applications for a total of 5,000-5,500 mg/h radium equivalent when possible: 140 cGy/fraction was administered in the morning and evening, with a 6-h interval. The remainder of the external beam radiation was delivered at a standard daily fractionation of 180 cGy/fraction to a total dose of 5,020 cGy. This regimen of RT with concomitant chemotherapy had minimal toxicity and did not cause significant prolongation of the treatment program. However, a high rate of late complications was noted in patients who had extended-field RT due to paraaortic lymph node involvement. Thirty-two patients had complete response (CR) (80%). 24 (75%) of whom have no evidence disease (NED), with a median follow-up of 24 months. Our study suggests that this regimen of combined chemotherapy and RT in this group of patients with poor prognosis is effective and well tolerated, with acceptable acute toxicity and late morbidity.