First-line Chemotherapy with 5-FU and Platinum for Advanced and Recurrent Cancer of the Cervix: a Phase II Study

This study was designed to assess the role of first-line chemotherapy with 5-fluorouracil (5-FU) and platinum in the treatment of advanced or recurrent cervical cancer. Ten patients with advanced or recurrent cancer of the cervix with no prior chemotherapy were entered in a phase II trial from October 2000 to November 2001. Eight patients were treated with Cis-platinum (50 mg/m2 over 60 minutes on the first day) followed by 5-FU (1 g/m2 over 24 hours for 4 days) and two patients with impaired renal function were treated with carboplatin (300 mg/m2 over 15 minutes on the first day) followed by 5-FU (1 g/m2 over 24 hours for 4 days) every 3 weeks until progression of disease or prohibitive toxicity had been observed. Median age was 52 years (range 28-70 years). Ten patients received a total of 42 cycles of chemotherapy. The mean number of chemotherapy cycles was 4.2 (median 4, range 3-7). Three patients had a partial response (30%, 95% CI, 1.7-58.5%). Mean duration of response was 198 days (range 122-273 days). Four patients required red blood cell transfusions; three of them had Grade II and one of the Grade III nausea and vomiting. Two had fever and neutropenia (one developed acute renal insufficiency), and there were no treatment related mortalities. First-line chemotherapy with platinum and 5-FU for advanced and recurrent cervical cancer is promising and deserves consideration for a larger phase III trial.