Randomized trial to compare LSA2L2-type maintenance therapy to daily 6-mercaptopurine and weekly methotrexate with vincristine and dexamethasone pulse for children with acute lymphoblastic leukemia.

Abstract:

BACKGROUND:A total of 201 pediatric cases of acute lymphoblastic leukemia were treated with the ALL-96 protocol by the Kyushu-Yamaguchi Children's Cancer Study Group. PROCEDURE:Risk stratification was based on white cell counts, immunophenotype, the presence of central nervous system disease at diagnosis, organomegaly, and early treatment response (day 14 bone marrow status). All of the patients were classified into standard-risk (SR) or high-risk (HR) groups and were randomly assigned to receive maintenance therapy with either LSA2L2-type or 6-mercaptopurine (6-MP)/methotrexate (MTX) with vincristine (VCR) and dexamethasone (DEX) pulse in both risk groups. RESULTS:The 7-year event-free survival (EFS) and overall survival (OS) rates in the entire study population were 72.1% (95% CI: 68.0-76.2%) and 84.8% (95% CI: 79.7-89.9%), respectively, and the EFS of the SR patients (85.3% [95% CI: 78.2-92.4%]) was significantly better than HR patients (62.4% [95% CI: 52.2-72.6%]) (P = 0.0007). CONCLUSIONS:There were no differences in the EFS between the different maintenance therapies in each risk group; however, grade IV liver toxicity occurred more often in the patients receiving 6-MP/MTX with VCR and DEX therapy than in patients receiving LSA2L2.

journal_name

Pediatr Blood Cancer

journal_title

Pediatric blood & cancer

authors

Nagatoshi Y,Matsuzaki A,Suminoe A,Inada H,Ueda K,Kawakami K,Yanai F,Nakayama H,Moritake H,Itonaga N,Hotta N,Fujita K,Hidaka Y,Yamanaka T,Kawano Y,Okamura J

doi

10.1002/pbc.22528

subject

Has Abstract

pub_date

2010-08-01 00:00:00

pages

239-47

issue

2

eissn

1545-5009

issn

1545-5017

journal_volume

55

pub_type

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