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Type: Artigo de periódico
Title: Benefits Of The Intermittent Use Of 6-mercaptopurine And Methotrexate In Maintenance Treatment For Low-risk Acute Lymphoblastic Leukemia In Children: Randomized Trial From The Brazilian Childhood Cooperative Group--protocol All-99.
Author: Brandalise, Silvia R
Pinheiro, Vitória R
Aguiar, Simone S
Matsuda, Eduardo I
Otubo, Rosemary
Yunes, José A
Pereira, Waldir V
Carvalho, Eny G
Cristofani, Lilian M
Souza, Marcelo S
Lee, Maria L
Dobbin, Jane A
Pombo-de-Oliveira, Maria S
Lopes, Luiz F
Melnikoff, Katharina N T
Brunetto, Algemir L
Tone, Luiz G
Scrideli, Carlos A
Morais, Vera L L
Viana, Marcos B
Abstract: PURPOSE To describe event-free survival (EFS) and toxicities in children with low-risk acute lymphoblastic leukemia (ALL) assigned to receive either continuous 6-mercaptopurine (6-MP) and weekly methotrexate (MTX) or intermittent 6-MP with intermediate-dose MTX, as maintenance treatment. PATIENTS AND METHODS Between October 1, 2000, and December 31, 2007, 635 patients with low-risk ALL were enrolled onto Brazilian Childhood Cooperative Group for ALL Treatment (GBTLI) ALL-99 protocol. Eligible children (n = 544) were randomly allocated to receive either continuous 6-MP/MTX (group 1, n = 272) or intermittent 6-MP (100 mg/m(2)/d for 10 days, with 11 days resting) and MTX (200 mg/m(2) every 3 weeks; group 2, n = 272). RESULTS The 5-year overall survival (OS) and EFS were 92.5% +/- 1.5% SE and 83.6% +/- 2.1% SE, respectively. According to maintenance regimen, the OS was 91.4% +/- 2.2% SE (group 1) and 93.6% +/- 2.1% SE (group 2; P = .28) and EFS 80.9% +/- 3.2% SE (group 1) and 86.5% +/- 2.8% SE (group 2; P = .089). Remarkably, the intermittent regimen led to significantly higher EFS among boys (85.7% v 74.9% SE; P = .027), while no difference was seen for girls (87.0% v 88.8% SE; P = .78). Toxic episodes were recorded in 226 and 237 children, respectively. Grade 3 to 4 toxic events for groups 1 and 2 were, respectively, 273 and 166 for hepatic dysfunction (P = .002), and 772 and 636 for hematologic episodes (P = .005). Deaths on maintenance were: seven (group 1) and one (group 2). CONCLUSION The intermittent use of 6-MP and MTX in maintenance is a less toxic regimen, with a trend toward better long-term EFS. Boys treated with the intermittent schedule had significantly better EFS.
Subject: 6-mercaptopurine
Antineoplastic Combined Chemotherapy Protocols
Child, Preschool
Neoplasm Staging
Precursor Cell Lymphoblastic Leukemia-lymphoma
Prospective Studies
Risk Factors
Survival Rate
Treatment Outcome
Rights: fechado
Identifier DOI: 10.1200/JCO.2009.25.6115
Date Issue: 2010
Appears in Collections:Unicamp - Artigos e Outros Documentos

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