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Randomized Study of Induction Therapy Comparing Standard-Dose Idarubicin With High-Dose Daunorubicin in Adult Patients With Previously Untreated Acute Myeloid Leukemia: The JALSG AML201 Study

Randomized Study of Induction Therapy Comparing Standard-Dose Idarubicin With High-Dose Daunorubicin in Adult Patients With Previously Untreated Acute Myeloid Leukemia: The JALSG AML201 Study

Shigeki Ohtake, Shuichi Miyawaki, Hiroyuki Fujita, Hitoshi Kiyoi, Katsuji Shinagawa, Noriko Usui, Hirokazu Okumura, Koichi Miyamura, Chiaki Nakaseko, Yasushi Miyazaki, Atsushi Fujieda, Tadashi Nagai, Takahisa Yamane, etc.

Blood. 2011 Feb 24;117(8):2358-65.

PMID: 20693429

Abstract:

We conducted a multi-institutional randomized study to determine whether high-dose daunorubicin would be as effective as standard-dose idarubicin in remission-induction therapy for newly diagnosed adult patients younger than 65 years of age with acute myeloid leukemia. Of 1064 patients registered, 1057 were evaluable. They were randomly assigned to receive either daunorubicin (50 mg/m(2) daily for 5 days) or idarubicin (12 mg/m(2) daily for 3 days) in combination with 100 mg/m(2) of cytarabine by continuous infusion daily for 7 days as induction therapy. Complete remission was achieved in 407 (77.5%) of 525 patients in the daunorubicin group and 416 (78.2%) of 532 in the idarubicin group (P = .79). Patients achieving complete remission received intensive postremission therapy that consisted of either 3 courses of high-dose cytarabine or 4 courses of standard-dose therapy. Overall survival rates at 5 years were 48% for the daunorubicin group and 48% for the idarubicin group (P = .54), and relapse-free survival rates at 5 years were 41% and 41% (P = .97), respectively. Thus, high-dose daunorubicin and standard-dose idarubicin were equally effective for the treatment of adult acute myeloid leukemia, achieving a high rate of complete remission and good long-term efficacy. This study is registered at http://www.umin.ac.jp/ctrj/ as C000000157.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP57852570-A	Idarubicin		57852-57-0	Price

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