High-dose methotrexate therapy significantly improved survival of adult acute lymphoblastic leukemia: a phase III study by JALSG

被引：67

作者：

Sakura, T. ^{[1
]}

Hayakawa, F. ^{[2
]}

Sugiura, I. ^{[3
]}

Murayama, T. ^{[4
]}

Imai, K. ^{[5
]}

Usui, N. ^{[6
]}

Fujisawa, S. ^{[7
]}

Yamauchi, T. ^{[8
]}

Yujiri, T. ^{[9
]}

Kakihana, K. ^{[10
]}

Ito, Y. ^{[11
]}

Kanamori, H. ^{[12
]}

Ueda, Y. ^{[13
]}

Miyata, Y. ^{[14
]}

Kurokawa, M. ^{[15
,16
]}

Asou, N. ^{[17
]}

Ohnishi, K. ^{[18
]}

Ohtake, S. ^{[19
]}

Kobayashi, Y. ^{[20
]}

Matsuo, K. ^{[21
]}

Kiyoi, H. ^{[2
]}

Miyazaki, Y. ^{[22
,23
]}

Naoe, T. ^{[24
]}

机构：

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

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

[3] Toyohashi Municipal Hosp, Div Hematol & Oncol, Toyohashi, Aichi, Japan

[4] Hyogo Canc Ctr, Dept Hematol, Akashi, Hyogo, Japan

[5] Sapporo Hokuyu Hosp, Dept Hematol, Sapporo, Hokkaido, Japan

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

[7] Yokohama City Univ, Med Ctr, Dept Hematol, Yokohama, Kanagawa, Japan

[8] Univ Fukui, Fac Med Sci, Dept Hematol & Oncol, Yoshida, Japan

[9] Yamaguchi Univ, Sch Med, Dept Internal Med 3, Ube, Yamaguchi, Japan

[10] Komagome Hosp, Tokyo Metropolitan Canc & Infect Dis Ctr, Hematol Div, Tokyo, Japan

[11] Tokyo Med Univ, Dept Hematol, Tokyo, Japan

[12] Kanagawa Canc Ctr, Dept Hematol, Yokohama, Kanagawa, Japan

[13] Kurashiki Cent Hosp, Dept Hematol Oncol, Kurashiki, Okayama, Japan

[14] Nagoya Med Ctr, Natl Hosp Org, Dept Hematol, Nagoya, Aichi, Japan

[15] Univ Tokyo, Grad Sch Med, Dept Hematol & Oncol, Tokyo, Japan

[16] Univ Tokyo, Fac Med, Tokyo, Japan

[17] Saitama Med Univ, Int Med Ctr, Dept Hematol, Hidaka, Japan

[18] Japanese Red Cross Aichi Blood Ctr, Seto, Japan

[19] Kanazawa Univ, Dept Clin Lab Sci, Kanazawa, Ishikawa, Japan

[20] Natl Canc Ctr, Natl Canc Ctr, Dept Hematol & Oncol, Tokyo, Japan

[21] Aichi Canc Ctr, Res Inst, Div Mol Med, Nagoya, Aichi, Japan

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

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

[24] Nagoya Med Ctr, Natl Hosp Org, Nagoya, Aichi, Japan

来源：

LEUKEMIA | 2018年 / 32卷 / 03期

关键词：

ACUTE LYMPHOCYTIC-LEUKEMIA; YOUNG-ADULTS; PEDIATRIC PROTOCOL; COMPLETE REMISSION; INDUCTION THERAPY; FOLLOW-UP; ADOLESCENTS; CHEMOTHERAPY; CHILDREN; INTENSIFICATION;

D O I：

10.1038/leu.2017.283

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

High-dose methotrexate (Hd-MTX) therapy has recently been applied to the treatment of adult acute lymphoblastic leukemia (ALL) based on pediatric protocols; however, its effectiveness for adult ALL has not yet been confirmed in a rigorous manner. We herein conducted a randomized phase III trial comparing Hd-MTX therapy with intermediate-dose (Id)-MTX therapy. This study was registered at UMIN-CTR (ID: C000000063). Philadelphia chromosome (Ph)-negative ALL patients aged between 25 and 64 years of age were enrolled. Patients who achieved complete remission (CR) were randomly assigned to receive therapy containing Hd-MTX (3 g/m(2)) or Id-MTX (0.5 g/m(2)). A total of 360 patients were enrolled. The CR rate was 86%. A total of 115 and 114 patients were assigned to the Hd-MTX and Id-MTX groups, respectively. The estimated 5-year disease-free survival rate of the Hd-MTX group was 58%, which was significantly better than that of the Id-MTX group at 32% (P = 0.0218). The frequencies of severe adverse events were not significantly different. We herein demonstrated the effectiveness and safety of Hd-MTX therapy for adult Ph-negative ALL. Our results provide a strong rationale for protocols containing Hd-MTX therapy being applied to the treatment of adult ALL.

引用

页码：626 / 632

页数：7

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