Between March 1980 and December 1981, 22 patients were treated with 4'(9-acridinylamino)methanesulfon-m-anisidide (
m-AMSA) and
5-azacytidine (AZA), each given by I.V. push in a dosage of 150 mg/m2 for 5 days. Seven of 12 prior-remitting,
acute nonlymphoblastic leukemia (
ANLL) patients achieved complete remission (58%). Six
ANLL patients who failed to remit on standard
daunorubicin-
cytosine arabinoside programs also failed to remit on the
m-AMSA-AZA combination. Two patients with relapsed acute lymphatic
leukemia (ALL) also failed while two patients with
chronic myelocytic leukemia (CML) in evolution were cytoreduced. The seven patients who achieved remission had additional relapse-free survival for a median of six months (range 1-23+ months). One patient obtained a second remission with
m-AMSA-AZA after relapse which followed a 9-month period of nonmaintained remission. Most patients demonstrated mild to moderate
nausea and
vomiting. Hepatic toxicity was mild to infrequent. Only four patients showed
cardiac toxicity which was not life-threatening. The most troublesome toxicity was
mucositis and was seen in 11 patients; four whom required I.V. hyperalimentation. We conclude that this combination is an effective salvage program for relapsed prior-remitting
ANLL. Future studies should be conducted in three areas. The first study might be a comparison of relapsed prior-remitting
ANLL with single-
agent m-
AMSA. The second, in untreated
ANLL, following induction with DAT, might use
m-AMSA-AZA in consolidation and maintenance arms of future protocols. The final study should explore
m-AMSA-AZA activity in evolved CML in a greater number of patients.