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 aclarubicin (LC-ACR) with very low-dose cytosine arabinoside (VLD-AC) in 39 consecutive untreated patients with myelodysplastic syndromes (MDS), including refractory anemia (RA), RA with excess of blasts (RAEB) and RAEB in transformation (RAEB-t). Nineteen patients received the VLD-AC therapy; 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 survival between these two groups of patients. These observations suggest that the LD-ACR therapy is effective in some patients with MDS and can be used as an alternative to the low-dose Ara-C therapy.
Harada
M
M
First Department of Internal Medicine, Faculty of Medicine, Kyushu University.
Shibuya
T
T
Teshima
T
T
Murakawa
M
M
Okamura
T
T
Niho
Y
Y
Gondo
H
H
Hayashi
S
S
Akashi
K
K
Tamura
K
K
D015250:Aclarubicin / Q000627:therapeutic use* / Q000633:toxicity*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016913:Blood Component Transfusion; D003561:Cytarabine / Q000627:therapeutic use* / Q000633:toxicity*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000401:mortality; D011336:Probability; D016019:Survival Analysis
D003561:Cytarabine; D015250:Aclarubicin