A RANDOMIZED PHASE-II TRIAL OF LOW-DOSE ACLARUBICIN VS VERY LOW-DOSE CYTOSINE-ARABINOSIDE FOR TREATMENT OF MYELODYSPLASTIC SYNDROMES

We performed a randomized phase II trial comparing low-dose aclarubici n (LC-ACR) with very low-dose cytosine arabinoside (VLD-AC) in 39 cons ecutive untreated patients with myelodysplastic syndromes (MDS), inclu ding refractory anemia (RA), RA with excess of blasts (RAEB) and RAEB in transformation (RAEB-t). Nineteen patients received the VLD-AC ther apy; 2 good responses (GR) and 2 partial responses (PR) were obtained in 11 patients with RAEB and RAEB-t, while 2 PR were obtained in 8 RA patients. Eighteen patients received the LD-ACR therapy; 2 GR and 4 PR were obtained in 11 RAEB/RAEB-t patients while 2 PR in 7 RA patients. There was no significant difference in the therapeutic effects and su rvival between these two groups of patients. These observations sugges t that the LD-ACR therapy is effective in some patients with MDS and c an be used as an alternative to the low-dose Ara-C therapy.