A phase II trial of induction and consolidation therapy of acute myeloid leukemia with weekly oral idarubicin alone in poor risk elderly patients

We have conducted a phase II outpatient trial testing weekly oral administr ation of idarubicin (ZAVEDOS-ZVD) alone to determine the rate of objective response and toxicity in poor risk acute myeloid leukemia (AML) patients ov er 60 years of age. The treatment consisted of three phases: induction, wit h 20 mg/m(2) of ZVD on days 1, 8, 15 and 22; consolidation with 20 mg/m(2) of ZVD for 4 weeks; and maintenance with six cycles lasting 3 months and co nsisting of oral 6 mercapto-purine 2 mg/kg/day, 4 days a week for 2 months; subcutaneous cytarabine 1 mg/kg, once a week for 2 months; and oral ZVD 20 mg/m(2) on day 1 and day 8 of the third month. In case of failure after in duction course, patients received salvage treatment with 4 weekly oral dose s of 40 mg/m(2) ZVD. Fifty-one patients with a median age of 76 years were enrolled and could receive induction course. Of these 51 patients, 37 could receive subsequent courses, which consisted either of consolidation, or sa lvage. Only 11 patients underwent maintenance treatment. Sixty-three percen t of patients had to be hospitalized during induction, for a median duratio n of 14.5 days, and 87% required hospitalization during salvage for a media n duration of 17.5 days. Only five patients (38%) required hospitalization during consolidation. There were three toxic deaths (6%), two from hemorrha ge and one from pulmonary embolism. The overall response rate was 29%, with 12 patients in complete response (25%) and two in partial response (4%). T he median overall survival rate is 4 months for the whole population, and t he median DFS is 9.6 months among the 14 responding patients. The results o f this trial show that this new weekly schedule of oral ZVD chemotherapy is feasible and effective in poor risk elderly patients with AML. This regime n may be helpful for patients unable to tolerate intensive intravenous regi mens, and is a real alternative to palliative treatments.