Treatment of Acute Myelocytic Leukemia: A Study by Cancer and Leukemia Group B

• Published in: Blood Vol. 58; no. 6; pp. 1203 - 1212
• Main Authors: Rai, Kanti R., Holland, James F., Glidewell, Oliver J., Weinberg, Vivian, Brunner, Kurt, Obrecht, J.P., Preisler, Harvey D., Nawabi, Ismat W., Prager, David, Carey, Robert W., Cooper, M. Robert, Haurani, Farid, Hutchison, J.L., Silver, Richard T., Falkson, Geoffrey, Wiernik, Peter, Hoagland, H. Clark, Bloomfield, Clara D., James, G. Watson, Gottlieb, Arlan, Ramanan, S.V., Blom, Johannes, Nissen, Nis I., Bank, Arthur, Ellison, Rose Ruth, Kung, Faith, Henry, Patrick, McIntyre, O. Ross, Kaan, Sze K.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-12-1981
• Subjects: Acute Disease; Adolescent; Adult; Cytarabine - therapeutic use; Daunorubicin - therapeutic use; Female; Humans; Leukemia, Erythroblastic, Acute - diagnosis; Leukemia, Erythroblastic, Acute - drug therapy; Leukemia, Erythroblastic, Acute - mortality; Leukemia, Myeloid, Acute - diagnosis; Leukemia, Myeloid, Acute - drug therapy; Leukemia, Myeloid, Acute - mortality; Male; Middle Aged; Random Allocation; Time Factors
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V58.6.1203.1203

In a randomized study of acute myelocytic leukemia (AML), 352 patients of all ages were treated for remission induction by one of the four regimens: 7 days of cytosine arabinoside (ara-C) by continuous intravenous (i.v.) infusion or bolus injection every 12 hr, together with daunorubicin (DNR) by rapid i.v. injection on days 1, 2, 3; or 5 days of ara-C by infusion or bolus injection and DNR for 2 days only. The regimen of 7 and 3 infusion was significantly superior to the other 3 regimens, resulting in 56% complete remission (CR). For remission maintenance, ara-C was given for 5 days every month and each month one of the following four drugs added on a cyclic rotational basis: thioguanine, cyclophosphamide, CCNU, or DNR. Although ara-C dosage each month was the same, the route of ara-C administration by random allocation was either rapid i.v. bolus or subcutaneous (s.c.) injection. The median duration of CR was significantly longer for s.c. ara-C group: 14 mo for patients less than 60 yr old (versus 8 mo for i.v.) and 31 mo for 60 or older age group (versus 9 mo for i.v.). Patients who received a combination of the best of the four induction regimens (7 and 3 infusion) and the better of the two maintenance schedules (s.c. ara-C) had a median remission duration of 22 mo and a median survival of 35 mo (the longest reported in a prospective randomized trial of therapy for AML). These results establish the validity of an intensive chemotherapy to produce rapid marrow aplasia followed by a sequential maintenance therapy for achieving prolonged disease-free survival in AML.