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Single agent epirubicin in squamous cell cervical cancer. A phase II trial.

Thirty consecutive patients with FIGO stage III-IV, squamous cell uterine cervix cancer were entered in a phase II trial evaluating activity and safety of epirubicin when given at a dose of 80 mg/m2 i.v., every 3 weeks. Two complete responses (including a pathological complete remission) plus 3 partial responses were observed among 27 evaluable patients with a response rate of 18.5% (95% confidence limits = 7.6%-36.4%). The median time to progression and median survival for all treated patients were 3 and 8 months respectively. Treatment was well tolerated. Haematological toxicity was mild. WHO grade 4 toxicity was not observed. The median total cumulative dose of epirubicin was 360 mg/m2 (80-840 mg/m2). Congestive heart failure was not noted. Further studies in cervical cancer with higher doses of epirubicin as single agent or in combination with other nonmyelotoxic drugs are indicated.