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

被引：198

作者：

Ohtake, Shigeki ^{[1
]}

Miyawaki, Shuichi ^{[2
]}

Fujita, Hiroyuki ^{[3
]}

Kiyoi, Hitoshi ^{[4
]}

Shinagawa, Katsuji ^{[5
]}

Usui, Noriko ^{[6
]}

Okumura, Hirokazu ^{[7
]}

Miyamura, Koichi ^{[8
]}

Nakaseko, Chiaki ^{[9
]}

Miyazaki, Yasushi ^{[10
,11
]}

Fujieda, Atsushi ^{[12
]}

Nagai, Tadashi ^{[13
]}

Yamane, Takahisa ^{[14
]}

Taniwaki, Masafumi ^{[15
]}

Takahashi, Masatomo ^{[16
]}

Yagasaki, Fumiharu ^{[17
]}

Kimura, Yukihiko ^{[18
]}

Asou, Norio ^{[19
]}

Sakamaki, Hisashi ^{[20
]}

Handa, Hiroshi ^{[21
]}

Honda, Sumihisa ^{[22
]}

Ohnishi, Kazunori ^{[23
]}

Naoe, Tomoki ^{[4
]}

Ohno, Ryuzo ^{[24
]}

机构：

[1] Kanazawa Univ, Dept Clin Lab Sci, Grad Sch Med Sci, Kanazawa, Ishikawa 9200942, Japan

[2] Saiseikai Maebashi Hosp, Leukemia Res Ctr, Maebashi, Gunma, Japan

[3] Yokohama City Univ, Dept Internal Med & Clin Immunol, Grad Sch Med, Yokohama, Kanagawa 232, Japan

[4] Nagoya Univ, Grad Sch Med, Dept Hematol & Oncol, Nagoya, Aichi 4648601, Japan

[5] Okayama Univ Hosp, Div Hematol Oncol, Okayama, Japan

[6] Jikei Univ, Sch Med, Dept Internal Med, Div Hematol & Oncol, Tokyo, Japan

[7] Kanazawa Univ, Dept Hematol, Grad Sch Med Sci, Kanazawa, Ishikawa 9200942, Japan

[8] Japanese Red Cross Nagoya First Hosp, Dept Internal Med, Nagoya, Aichi, Japan

[9] Chiba Univ Hosp, Dept Hematol, Chiba, Japan

[10] Nagasaki Univ, Grad Sch Biomed Sci, Atom Bomb Dis Inst, Dept Hematol, Nagasaki 852, Japan

[11] Nagasaki Univ, Grad Sch Biomed Sci, Atom Bomb Dis Inst, Mol Med Unit, Nagasaki 852, Japan

[12] Mie Univ, Grad Sch Med, Dept Hematol & Oncol, Tsu, Mie 514, Japan

[13] Jichi Med Univ, Div Hematol, Shimotsuke, Japan

[14] Osaka City Univ, Dept Hematol, Osaka 558, Japan

[15] Kyoto Prefectural Univ Med, Dept Clin Mol Genet & Lab Med, Kyoto, Japan

[16] St Marianna Univ, Sch Med, Dept Internal Med, Div Hematol & Oncol, Kawasaki, Kanagawa, Japan

[17] Saitama Med Sch, Dept Hematol, Hidaka, Japan

[18] Tokyo Med Univ, Dept Internal Med 1, Div Hematol, Tokyo, Japan

[19] Kumamoto Univ, Sch Med, Dept Hematol, Kumamoto 860, Japan

[20] Tokyo Metropolitan Komagome Hosp, Dept Hematol, Tokyo, Japan

[21] Gunma Univ, Grad Sch Med, Dept Med & Clin Sci, Maebashi, Gunma 371, Japan

[22] Nagasaki Univ, Grad Sch Biomed Sci, Dept Publ Hlth, Nagasaki 852, Japan

[23] Hamamatsu Univ Sch Med, Ctr Oncol, Hamamatsu, Shizuoka 4313192, Japan

[24] Aichi Canc Ctr, Nagoya, Aichi 464, Japan

来源：

BLOOD | 2011年 / 117卷 / 08期

关键词：

ACUTE MYELOGENOUS LEUKEMIA; MAINTENANCE INTENSIFICATION THERAPY; CONSOLIDATION THERAPY; MARROW-TRANSPLANTATION; POSTREMISSION THERAPY; CYTOSINE-ARABINOSIDE; CHEMOTHERAPY; CYTARABINE; TRIAL; COMBINATION;

D O I：

10.1182/blood-2010-03-273243

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 standarddose 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. (Blood. 2011;117(8):2358-2365)

引用

页码：2358 / 2365

页数：8

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