A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study

被引：149

作者：

Miyawaki, Shuichi ^{[1
]}

Ohtake, Shigeki ^{[2
]}

Fujisawa, Shin ^{[3
]}

Kiyoi, Hitoshi ^{[4
]}

Shinagawa, Katsuji ^{[5
]}

Usui, Noriko ^{[6
]}

Sakura, Toru ^{[1
]}

Miyamura, Koichi ^{[7
]}

Nakaseko, Chiaki ^{[8
]}

Miyazaki, Yasushi ^{[9
,10
]}

Fujieda, Atsushi ^{[11
]}

Nagai, Tadashi ^{[12
]}

Yamane, Takahisa ^{[13
]}

Taniwaki, Masafumi ^{[14
]}

Takahashi, Masatomo ^{[15
]}

Yagasaki, Fumiharu ^{[16
]}

Kimura, Yukihiko ^{[17
]}

Asou, Norio ^{[18
]}

Sakamaki, Hisashi ^{[19
]}

Handa, Hiroshi ^{[20
]}

Honda, Sumihisa ^{[21
]}

Ohnishi, Kazunori ^{[22
]}

Naoe, Tomoki ^{[4
]}

Ohno, Ryuzo ^{[23
]}

机构：

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

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

[3] Yokohama City Univ, Dept Hematol, Med Ctr, 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] Japanese Red Cross Nagoya First Hosp, Dept Internal Med, Nagoya, Aichi, Japan

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

来源：

BLOOD | 2011年 / 117卷 / 08期

关键词：

MAINTENANCE INTENSIFICATION THERAPY; INDIVIDUALIZED INDUCTION THERAPY; CONSOLIDATION THERAPY; CYTOSINE-ARABINOSIDE; REMISSION DURATION; KIT MUTATIONS; DAUNORUBICIN; IDARUBICIN; TRIAL; CANCER;

D O I：

10.1182/blood-2010-07-295279

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m(2) twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study. Five-year disease-free survival was 43% for the HiDAC group and 39% for the multiagent CT group (P = .724), and 5-year overall survival was 58% and 56%, respectively (P = .954). Among the favorable cytogenetic risk group (n = 218), 5-year diseasefree survival was 57% for HiDAC and 39% for multiagent CT (P = .050), and 5-year overall survival was 75% and 66%, respectively (P = .174). In the HiDAC group, the nadir of leukocyte counts was lower, and the duration of leukocyte less than 1.0 x 10(9)/L longer, and the frequency of documented infections higher. The present study demonstrated that the multiagent CT regimen is as effective as our HiDAC regimen for consolidation. Our HiDAC regimen resulted in a beneficial effect on disease-free survival only in the favorable cytogenetic leukemia group. This trial was registered at www.umin.ac.jp/ctr/as #C000000157. (Blood. 2011;117(8):2366-2372)

引用

页码：2366 / 2372

页数：7

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