A PHASE-II TRIAL OF 5-FLUOROURACIL AND HIGH-DOSE LEUCOVORIN IN PATIENTS WITH RECURRENT SQUAMOUS-CELL CARCINOMA OF THE CERVIX - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

The addition of leucovorin to 5-fluorouracil (5-FU) has been shown to improve the response rate in recurrent colon cancer. The combination o f low-dose leucovorin and 5-FU was previously tested by the Gynecologi c Oncology Group (GOG) and did not produce response rates greater than rates using 5-FU alone. From June 1990 to April 1992, 55 patients wit h unresectable recurrent squamous cervical cancer received high-dose l eucovorin at 200 mg/m(2) IV bolus, followed by 5-FU at 370 mg/m(2) IV bolus daily for 5 days every 4 weeks for the first two courses. Subseq uent courses were given every 5 weeks. The median number of courses de livered was two (range 1-15). Fifty patients were evaluable for toxici ty and 45 for response. Prior radiotherapy had been given to 43 patien ts and prior chemotherapy to 38. The overall response rate was 8.8% (9 5% confidence interval, 2.5-21.2%). There were two complete responses (4.4%) and two partial responses (4.4%). One response was in the pelvi s and three were outside the pelvis. None of the extrapelvic responses had received irradiation at the site of measurable disease. The major adverse effect was granulocytopenia, with 15/50 (30%) experiencing GO G grade 3 or 4 granulocytopenia. The median white blood count for pati ents experiencing leukopenia was 2,000 (range 400-3,800). Grade 3 or 4 gastrointestinal toxicity was seen in 12 patients (24%). In this pret reated population, patients receiving high-dose leucovorin with 5-FU h ad moderate toxicity but only minimal activity.