Phase II study of cisplatin, 5-fluorouracil and interferon-alpha in recurrent carcinoma of the cervix.

Standard cytotoxic regimens have failed to prolong survival in patients with recurrent cervical cancer; therefore, new agents or combinations of agents are necessary to improve outcome. Cisplatin and 5-fluorouracil are one of the most active regimens currently available for recurrent cervical cancer. Interferon-alpha and potentiate the in vitro and in vivo activity of both agents. Therefore, we sought to define the feasibility and activity of adding interferon-alpha to the cisplatin-5-fluorouracil regimen. Patients with histologically proven recurrent cervical carcinoma received interferon-alpha (5 x 10(6) units/m2/day for 5 days) combined with cisplatin (75 mg/m2 on day 1) plus 5-fluorouracil (500 mg/m2/day for 5 days) in recurrent cervical cancer. Twenty-six patients were included in this study and received a total of 95 courses of therapy. All 26 had prior radiotherapy and five had prior chemotherapy. This regimen was relatively well tolerated as toxicity was comparable to that of cisplatin plus 5-fluorouracil alone. Major response occurred in 8 patients (31%) and 5 (19%) had complete responses. The median response duration was 6 months (range, 2-34 months) and the median survival duration was 9 months (range, 2-38 months). The addition of interferon-alpha to cisplatin plus 5-fluorouracil is feasible. Further studies will be necessary to determine if the addition of interferon-alpha to this regimen is superior to cisplatin plus 5-fluorouracil alone.