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- Title
Age and high-dose methotrexate are associated to clinical acute encephalopathy in FRALLE 93 trial for acute lymphoblastic leukemia in children.
- Authors
Dufourg, M. N.; Landman-Parker, J.; Auclerc, M. F.; Schmitt, C.; Perel, Y.; Michel, G.; Levy, P.; Couillault, G.; Gandemer, V.; Tabone, M. D.; Demeocq, F.; Vannier, J. P.; Leblanc, T.; Leverger, G.; Baruchel, A.
- Abstract
The objective of the study was to assess acute neurotoxicity associated with triple intrathecal therapy (TIT)±high-dose methotrexate (HD MTX) in children with acute lymphoblastic leukemia (ALL). 1395 children were enrolled on FRALLE 93 protocol from 1993 to 1999. Lower-risk group (LR, n=182) were randomized to weekly low-dose MTX at 25 mg/m2/week (LD MTX, n=81) or HD MTX at 1.5 g/m2/2 weeks × 6 (n=77). Intermediate-risk group (IR, n=672) were randomized to LD MTX (n=290) or HD MTX at 8 g/m2/2 weeks × 4 (n=316). Higher-risk group (HR, n=541) prednisone-responder patients received LD MTX and cranial radiotherapy. HR group steroid resistant cases were grafted (autologous or allogenic). TIT (MTX, cytarabine and methylprednisolone) was given every 2 weeks during 16–18 weeks and every 3 months during maintenance therapy in LR and IR patients. 52 patients (3.7%) developed neurotoxicity. Isolated seizures: n=15 (1.1%), peripheral and spinal neuropathy: n=17 (1.2%) and encephalopathy: n=20 (1.4%). Age >10 years was significantly associated with neurotoxicity (P=0.01) and use of HD MTX is associated with encephalopathy (P=0.03). Sequels are reported respectively in 60 and 33% of spinal neuropathy and encephalopathy cases. Current strategies tailoring risk of neurological sequels has to be defined.Leukemia (2007) 21, 238–247. doi:10.1038/sj.leu.2404495; published online 14 December 2006
- Subjects
METHOTREXATE; NEUROTOXICOLOGY; LYMPHOBLASTIC leukemia in children; DRUG dosage; HEPATIC encephalopathy; RADIOTHERAPY; THERAPEUTICS
- Publication
Leukemia (08876924), 2007, Vol 21, Issue 2, p238
- ISSN
0887-6924
- Publication type
Article
- DOI
10.1038/sj.leu.2404495