Aim: Evaluation of trans-retinoic acid (ATRA) in combination with cytostatic drugs in treatment of acute promyelocytic leukemia (APL).
Materials and methods: In a multicenter study APL was 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 (cytosine-arabinoside 100 mg/m2 twice a day v.v. day 1-7, daunorubicin 60 mg/m2 v.v. day 1-3) induced a complete remission in 25 patients (90%). Early lethality was 10% (3 patients died). Resistant APL was not registered. Retinoid syndrome was diagnosed in 15 patients, one patient died. 2-year overall and recurrence-free survival made up 72 and 82%, respectively.
Conclusion: ATRA combination with cytosine-arabinoside and daunorubicin is a novel treatment of acute promyelocytic leukemia providing a high rate of complete remission and long-term survival.