High-dose Methotrexate Therapy Significantly Improved Survival of Adult Acute Lymphoblastic Leukemia: a Phase III Study by JALSG

Overview

Journal Leukemia

Specialties Hematology
Oncology

Date 2017 Sep 16

PMID 28914260

Citations 35

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

Affiliations

Soon will be listed here.

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/m) or Id-MTX (0.5 g/m). 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.

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