[Effect of etoposide added to individualized induction therapy of adult acute myeloid leukemia--the JALSG-AML-92 Study. Japan Adult Leukemia Study Group].
A multicenter prospective randomized study was undertaken to assess the efficacy of etoposide added to the standard remission induction therapy for acute myeloid leukemia (AML). Consecutively registered newly diagnosed adult AML patients were randomized to receive either daunorubicin (40 mg/m2/day x 4 or more), behenoyl cytarabine (200 mg/m2/day x 10 or more) and 6-mercaptopurine (70 mg/m2/day x 10 or more) (BH-AC-DM), or the same three drugs plus etoposide (100 mg/m2/day x 5) (BH-AC-EDM) for response-oriented individualized induction therapy. The patients achieving complete remission (CR) received the same 3 courses of consolidation therapy followed by 6 courses of maintenance/intensification therapy. M3 was excluded and M0 was included. Of 667 patients registered, 655 were evaluable. The median age was 49 years (range, 15 to 85). CR rates were 77% in the BH-AC-DM group and 75% in the BH-AC-EDM group. In M4 patients, CR rates were 86% and 69% (p = 0.009), and, in M5, 80% and 77% (p = 0.810) in the BH-AC-DM and BH-AC-EDM groups, respectively. The predicted 6-year overall survival rates were 30% and 38% for BH-AC-DM and BH-AC-EDM groups, and the disease-free survival (DFS) rates of CR patients were 25% and 35% (p = 0.925), respectively. In conclusion, the present study failed to show any advantage of the addition of etoposide to the standard individualized induction therapy in adult AML, even among M4 and M5. These above data have already been published in the Int J Hematol (70: 87-104, 1999).
Miyawaki
S
S
Dept. of Medicine, Saiseikai Maebashi Hospital.
Tanimoto
M
M
Kobayashi
T
T
Minami
S
S
Tamura
J
J
Omoto
E
E
Kuriyama
K
K
Hatake
K
K
Saito
K
K
Ohno
R
R
D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D015122:Mercaptopurine / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies
D000972:Antineoplastic Agents, Phytogenic; D003561:Cytarabine; D005047:Etoposide; D015122:Mercaptopurine; D003630:Daunorubicin