[A randomized trial of conventional dose vs reduced dose in BHAC-DM therapy for acute myelogenous leukemia in elderly patients].
Twenty-nine patients aged 60-75 years with newly diagnosed acute myelogenous leukemia (AML) were randomized to receive BHAC-DM either at a reduced dose (S-1 group, n = 13; BHAC 150 mg/m2 1-7 day, DNR 30 mg/m2 1-3 day, 6MP 70 mg/m2 1-7 day) or the conventional dose (S-2 group, n = 16; BHAC 200 mg/m2 1-7 day, DNR 40 mg/m2 1-3 day, 6MP 70 mg/m2 1-7 day). On day 7, patients were given therapy for 2 more days if the ratio of blasts in their bone marrow was more than 15%. Granulocyte-colony stimulating factor was injected when the leukocyte count decreased below 1,000/microliter. The rates of complete remission were 46.2% in the S-1 group and 43.8% in the S-2 group. No significant differences in response distinguished the 2 groups. The mortality rate during myelosuppression was 1/13 in the S-1 group and 1/16 in the S-2 group. The rate of treatment-related death was 10.1% for all patients. Grade-4 adverse effects were not seen in any of the patients. We concluded that the conventional dose of BHAC-DM was as acceptable as the reduced dose in elderly patients with AML.
Mori
M
M
Tokyo Metropolitan Geriatric Hospital.
Nisimura
H
H
Urabe
A
A
Tamura
K
K
Makino
S
S
Okabe
K
K
Tomiyama
J
J
Hara
M
M
Tanimoto
M
M
Kikuchi
M
M
Hamaguchi
H
H
Sato
H
H
Saburi
Y
Y
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003630:Daunorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage / Q000009:adverse effects; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects
D003561:Cytarabine; D014750:Vincristine; D011239:Prednisolone; D015122:Mercaptopurine; D003630:Daunorubicin