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.
journal_name
Leukemiajournal_title
Leukemiaauthors
Sakura T,Hayakawa F,Sugiura I,Murayama T,Imai K,Usui N,Fujisawa S,Yamauchi T,Yujiri T,Kakihana K,Ito Y,Kanamori H,Ueda Y,Miyata Y,Kurokawa M,Asou N,Ohnishi K,Ohtake S,Kobayashi Y,Matsuo K,Kiyoi H,Miyazaki Y,Nadoi
10.1038/leu.2017.283subject
Has Abstractpub_date
2018-03-01 00:00:00pages
626-632issue
3eissn
0887-6924issn
1476-5551pii
leu2017283journal_volume
32pub_type
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