AN INTENSIVE TREATMENT WITH MITOXANTRONE AND IFOSFAMIDE IN 2ND-LINE THERAPY OF EPITHELIAL OVARIAN-CANCER

Aims and Background: Both mitoxantrone (DHAD) and ifosfamide (IFO) hav e:given promising results when administered as single agents in advanc ed ovarian cancer pretreated with platinum compounds. The aim of this I.T.M.O.group pilot trial was to evaluate, in a selected population of ovarian cancer patients, the efficacy and tolerability of the followi ng intensive second-line regimen: DHAD, 12 mg/m(2) i.v., day 1; IFO, 4 ,000 mg/m(2) i.v., days 1 and 2; Mesna, 800 mg/m(2) i.v. t.i.d., days 1 and 2. Filgrastim (5 mu g/kg/day i.m.) was given from day 6 to day 1 9 to reduce the expected neutropenia. Cycles were repeated every 21 da ys. Methods: Nineteen platinum-pretreated patients were enrolled and 1 4 were evaluated for tumor response; the disease of 5 patients was not measurable clinically or radiologically. Results: Seven responses wer e observed (3 CRs), with a median response duration of 5 months. The m edian time to treatment failure and overall survival for all 19 patien ts,was respectively 8 and 13 months. Anemia was observed in all of the treated patients (grade 3-4 in 9 cases). Only 6 of the 19 patients en ded the five planned cycles of chemotherapy without any delay. Conclus ions: Although DHAD plus IFO induced a considerable number of objectiv e responses, the limited response duration time to treatment failure, and overall survival as well as the reported side effects suggest that this is not a recommended regimen for the palliative treatment of ova rian cancer patients undergoing second-line chemotherapy.