Phase I-II study of oral idarubicin, tegafur and levo-folinate in patientswith pretreated advanced breast cancer

Thirty patients with pretreated advanced breast cancer were enrolled in a s tudy aimed to establish the maximum tolerated dose and to evaluate the effi cacy of oral idarubicin (12 mg/m(2)/day for 3 days every 4 weeks) with tega fur and levo-folinate (200 mg/m(2)/day and 50 mg/day, respectively, for a m inimum of 6 days, increasing the dose and duration according to a modified Fibonacci scheme), The maximum tolerated doses identified were 200 mg/m(2) days 1-30 for tegafur and 50 mg days 1-30 for levo-folinate. We obtained 2 partial remissions (7%) and 12 stable disease (45%) in 27 objectively evalu able patients. The main toxicity was gastrointestinal, with no hematologic toxicity. Median time to progression was 4 months (range 2-14), median surv ival was 10 months (3-30), A median number of 4 cycles (1-13) was administe red. The results seem to support the use of this combination in elderly and pretreated patients.