Efficacy of trans-retinoic acid in therapy of acute promyelocytic leukemia: Pilot results of multicenter trial

Aim. Evaluation of trans-retinoic acid (ATRA) in combination with cytostati c drugs in treatment of acute promyelocytic leukemia (APL). Materials and methods. In a multicenter study APL,vas treated according to protocols APL 01.97 and APL 06.87 in 28 patients (14 males and 14 females, median age 36 years). Results. Administration of ATRA in combination with standard program 7+3 (c ytosine-arabinoside 100 mg/m(2) twice a day v.v. day 1-7, daunorubicin 60 m g/m(2) v.v. day 1-3) induced a complete remission in 25 patients (90%). Ear ly lethality was 10% (3 patients died). Resistant APL was not registered. R etinoid syndrome was diagnosed in 15 patients, one patient died. 2-year ove rall and recurrence-free survival made up 72 and 82%, respectively. Conclusion. ATRA combination,vith cytosine-arabinoside and daunorubicine is a novel treatment of acute promyelocytic leukemia providing a high rate of complete remission and long-term survival.