A phase II study of 5-fluorouracil/cisplatinum in recurrent cervical cancer.

Thirty-seven patients with recurrent cervical carcinoma entered a phase II study of cisplatinum and 5-fluorouracil (5-FU). They were divided into patients with recurrent lesions outside previously irradiated area (group 1) and those with at least one recurrent lesion inside this volume (group 2). The treatment schedule consisted of 5-FU 1,000 mg/m2 i.v. days 1 to 5 and cisplatinum 100 mg/m2 i.v. day 1. Thirty-two patients were evaluable for response and toxicity. In group 1, 4 out of 19 patients had complete response with a median duration of 18 months, 9 out of 19 had partial response with a median duration of 10 months. Only 2 out of 13 patients in group 2 achieved partial response. All patients suffered from nausea and vomiting. The dose limiting factor was bone marrow suppression. The response rate in group 1 (68%) is impressive and higher than previously reported after other chemotherapy regimens. We found, however, the regimen too toxic for patients with central recurrences in previously irradiated areas, though some of these patients achieved substantial pain relief.