A randomized comparison of postremission therapy in acute myelogenous
leukemia: a Southeastern Cancer Study Group trial
WR Vogler, EF Winton, DS Gordon, MR Raney, B Go and L Meyer
The Southeastern Cancer Study Group conducted a post-remission induction
randomized trial in adult acute myelogenous leukemia to assess the efficacy
of alternate drug therapy during consolidation and of immunotherapy during
maintenance. Of 508 evaluable patients entered into the study, 335 (66%)
achieved a complete remission treated with a 7-day infusion of cytosine
arabinoside at a dose of 100 mg/sq m/day and 3 days of daunorubicin at a
dose of 45 mg/sq m/day. Those in remission were randomized to receive 3
courses of 1 of 3 consolidation regimens: (A) a continuous infusion of
5-azacytidine, 150 mg/sq m/day for 5 days; (B) 5-azacytidine plus
beta-deoxythioguanosine, 300 mg/sq m/day for 5 days; or (C) cytosine
arabinoside, 100 mg/sq m/day intravenously, and thioguanine, 100 mg/sq m
orally every 12 hr, plus daunorubicin, 10 mg/sq m every 24 hr daily for 5
days. There was no difference in relapse rate among the 3 arms. Those
completing consolidation and remaining in remission were randomized to 1 of
3 maintenance regimens: (D) chemotherapy, 5-day infusion of cytosine
arabinoside and 2 days of daunorubicin (same doses as induction) given
every 13 wk for 1 yr; (E) BCG given twice weekly for 1 mo and then monthly
for 1 yr; or (F) the combination of regimens D and E. The median duration
of remission was significantly better on regimen D (17.4 versus 9.4 and 9.5
mo), and median survival was 29 mo compared to 21 mo for the other
regimens. Those given different drugs during consolidation than used for
induction (regimens A and B) and subsequent chemotherapy for maintenance
(regimen D) had the longest remission durations and survival. Immunotherapy
was not as good as intensive chemotherapy for maintenance.
Volume 63,
Issue 5,
pp. 1039-1045,
05/01/1984
Copyright © 1984 by The American Society of Hematology
