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Leukemia. 2018 Mar;32(3):626-632. doi: 10.1038/leu.2017.283. Epub 2017 Sep 15.

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

Author information

1
Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan.
2
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
3
Division of Hematology and Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan.
4
Department of Hematology, Hyogo Cancer Center, Akashi, Japan.
5
Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
6
Department of Clinical Oncology and Hematology, The Jikei University School of Medicine, Tokyo, Japan.
7
Department of Hematology, Yokohama City University Medical Center, Yokohama, Japan.
8
Faculty of Medical Sciences, Department of Hematology and Oncology, University of Fukui, Yoshida, Japan.
9
Third Department of Internal Medicine, Yamaguchi University School of Medicine, Ube, Japan.
10
Hematology Division, Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital, Tokyo, Japan.
11
Department of Hematology, Tokyo Medical University, Tokyo, Japan.
12
Department of Hematology, Kanagawa Cancer Center, Yokohama, Japan.
13
Department of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan.
14
Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
15
Department of Hematology and Oncology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
16
Department of Hematology, Saitama Medical University International Medical Center, Hidaka, Japan.
17
Japanese Red Cross Aichi Blood Center, Seto, Japan.
18
Department of Clinical Laboratory Science, Kanazawa University, Kanazawa, Japan.
19
Department of Hematology and Oncology, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan.
20
Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan.
21
Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
22
National Hospital Organization Nagoya Medical Center, Nagoya, Japan.

Abstract

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/m2) or Id-MTX (0.5 g/m2). 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.

PMID:
28914260
DOI:
10.1038/leu.2017.283
[Indexed for MEDLINE]

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