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Type: Artigo
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: 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. 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/m2/d for 10 days, with 11 days resting) and MTX (200 mg/m2 every 3 weeks; group 2, n = 272). 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). 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: Metotrexato
Country: Estados Unidos
Editor: American Society of Clinical Oncology
Rights: Fechado
Identifier DOI: 10.1200/JCO.2009.25.6115
Date Issue: 2010
Appears in Collections:FCM - Artigos e Outros Documentos

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