Report of an early stopped randomized trial comparing cisplatin vs. cisplatin/ifosfamide/ 5-fluorouracil in recurrent cervical cancer

Abstract

This paper reports on an early stopped prospective randomized phase III trial comparing cisplatin, ifosfamide and 5-fluorouracil (PIF) with cisplatin monotherapy in the treatment of recurrent cervical cancer. The aim of the study was to compare response rates, survival, side effects and quality of life. Cisplatin monotherapy was given in a dose of 37.5 mg/m(2) on days 1 + 2 of 4-week schedules. In the PIF regimen, cisplatin was given in the same manner, ifosfamide in a dose of 2 g/m(2) on days 1 + 2 together with mesna 0.5 g/m(2), 5-fluorouracil 500 mg/m(2) on days 1 + 2, and folinic acid 30 mg/m(2) also on days 1 + 2. This regimen was also given in 4-week schedules. The intention had been to include 200 patients in the trial but because of poor accrual the trial was stopped prematurely. Twenty-four patients were included, 3 of which not eligible, and of the remaining 21 patients, 11 were randomized to the cisplatin group and 10 to the PIF group. Median survival for the cisplatin group amounted to 13 months and for the PIF regimen to 12.3 months. The most important side effects were hematologic, with more thrombocytopenia and leukopenia in the PIF regimen. The response rate for the PIF regimen was 40% (4 partial remissions) and 9% for the cisplatin group (1 complete remission). No firm conclusions can be drawn from this trial due to the low number of participants. Still, we believe that the response and survival rates observed with PIF are interesting and that it is important to report all trials, even if they are stopped earlier than intended.