NATIONWIDE RANDOMIZED COMPARATIVE-STUDY OF DAUNORUBICIN AND ACLARUBICIN IN COMBINATION WITH BEHENOYL CYTOSINE-ARABINOSIDE, 6-MERCAPTOPURINE, AND PREDNISOLONE FOR PREVIOUSLY UNTREATED ACUTE MYELOID-LEUKEMIA
E. Nagura et al., NATIONWIDE RANDOMIZED COMPARATIVE-STUDY OF DAUNORUBICIN AND ACLARUBICIN IN COMBINATION WITH BEHENOYL CYTOSINE-ARABINOSIDE, 6-MERCAPTOPURINE, AND PREDNISOLONE FOR PREVIOUSLY UNTREATED ACUTE MYELOID-LEUKEMIA, Cancer chemotherapy and pharmacology, 34(1), 1994, pp. 23-29
Aclarubicin was evaluated in combination chemotherapy for adult acute
myeloid leukemia in a randomized trial involving 58 institutions throu
ghout Japan. Behenoyl cytosine arabinoside (BH-AC).daunorubicin, 6-mer
captopurine, and prednisolone (DMP) was compared with BH-AC.aclarubici
n, 6-mercaptopurine, and prednisolone (AMP). In the 360 evaluable case
s among the 433 cases enrolled, complete remission (CR) rates were 63.
7% (116/182) for BH-AC.DMP and 53.9% (96/178) for BH-AC.AMP (P = 0.058
7). Median survival periods and 7-year survival rates were 15.8 months
and 19.3% for BH-AC.DMP and 9.5 months and 20.2% for BH-AC.AMP (P = 0
.0091 according to the generalized Wilcoxon test [GW], P = 0.196 accor
ding the log-rank test [LR]). Median disease-free survival periods wer
e 15.4 months for BH-AC.DMP and 14.1 months for BH-AC.AMP (P = 0.851 b
y GW, P = 0.439 by LR). Among the 346 cases of extra-murally confirmed
FAB subtypes, CR rates were 67.9% (19/28) with BH-AC.DMP and 31.8% (7
/22) with BH-AC.AMP for subtype M3 (P = 0.011) and 63.3% (93/147) with
BH-AC.AMP and 56.8% (84/148) with BH-AC.AMP (P = 0.254) for subtypes
M1, M2, M4, and M5. Diarrhea, ileus, pneumonia, and renal failure were
more frequent with BH-AC.AMP than with BH-AC.DMP. The results indicat
e, at least on the basis of the long-term outcome, that BH-AC.AMP has
antileukemic effects on subtypes M1, M2, M4, and M5 that are comparabl
e with those of BH-AC.DMP.