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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-09-15

AUTHORS

T Sakura, F Hayakawa, I Sugiura, T Murayama, K Imai, N Usui, S Fujisawa, T Yamauchi, T Yujiri, K Kakihana, Y Ito, H Kanamori, Y Ueda, Y Miyata, M Kurokawa, N Asou, K Ohnishi, S Ohtake, Y Kobayashi, K Matsuo, H Kiyoi, Y Miyazaki, T Naoe

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. More... »

PAGES

626-632

Journal

TITLE

Leukemia

ISSUE

3

VOLUME

32

Author Affiliations

  • Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan
  • Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Division of Hematology and Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan
  • Department of Hematology, Hyogo Cancer Center, Akashi, Japan
  • Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan
  • Department of Clinical Oncology and Hematology, The Jikei University School of Medicine, Tokyo, Japan
  • Department of Hematology, Yokohama City University Medical Center, Yokohama, Japan
  • Department of Hematology and Oncology, Faculty of Medical Sciences, University of Fukui, Yoshida, Japan
  • Third Department of Internal Medicine, Yamaguchi University School of Medicine, Ube, Japan
  • Hematology Division, Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital, Tokyo, Japan
  • Department of Hematology, Tokyo Medical University, Tokyo, Japan
  • Department of Hematology, Kanagawa Cancer Center, Yokohama, Japan
  • Department of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan
  • Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan
  • Department of Hematology and Oncology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan
  • Department of Hematology, Saitama Medical University International Medical Center, Hidaka, Japan
  • Japanese Red Cross Aichi Blood Center, Seto, Japan
  • Department of Clinical Laboratory Science, Kanazawa University, Kanazawa, Japan
  • Department of Hematology and Oncology, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan
  • Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan
  • Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
  • National Hospital Organization Nagoya Medical Center, Nagoya, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/leu.2017.283

    DOI

    http://dx.doi.org/10.1038/leu.2017.283

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1091787694

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/28914260


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