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 prospectivel y treated by an intermodality approach using chemotherapy combination concomitant with split-course hyperfractionated radiation therapy (RT) . Cisplatin (CDDP) (60 mg/m(2)) was administered before radiotherapy i nitiation followed by 5-fluorouracil (5-FU)(750 mg/m(2)) for 5 days du ring the first week of irradiation. The same schedule was repeated in the last week of the RT, with 5-FU administration (1.000 mg/m(2)) 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 eq uivalent when possible: 140 cGy/fraction was administered in the morni ng and evening, with a 6-h interval. The remainder of the external bea m 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 concom itant chemotherapy had minimal toxicity and did not cause significant prolongation of the treatment program. However, a high rate of late co mplications was noted in patients who had extended-field RT due to par aaortic lymph node involvement. Thirty-two patients had complete respo nse (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 pr ognosis is effective and well tolerated, with acceptable acute toxicit y and late morbidity.