Trial reportLeukemia2007
Age and high-dose methotrexate are associated to clinical acute encephalopathy in FRALLE 93 trial for acute lymphoblastic leukemia in children.
Trial report in Leukemia, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Pooled it
- Neurocognitive outcomes among children who experienced seizures during treatment for acute lymphoblastic leukemia.Pediatric blood & cancer · 2017Trial
- Excellent prognosis of late relapses of ETV6/RUNX1-positive childhood acute lymphoblastic leukemia: lessons from the FRALLE 93 protocol.Haematologica · 2012Trial
- Choroid plexus-CSF-targeted antioxidant therapy protects the brain from toxicity of cancer chemotherapy.Neuron · 2022Article
- Predictors of Chemotherapy Induced Adverse Events in Pediatric Osteosarcoma Patients.Asian Pacific journal of cancer prevention : APJCP · 2022Article
- Methotrexate-induced Transient Encephalopathy in an Adolescent and Young Adult Patient with Acute Lymphoblastic Leukemia.Internal medicine (Tokyo, Japan) · 2021Article
- Disparities in Neurotoxicity Risk and Outcomes among Pediatric Acute Lymphoblastic Leukemia Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018Article
- Utility and Safety of Intrathecal Methotrexate Treatment in Severe Anti-N-methyl-D-aspartate Receptor Encephalitis: A Pilot Study.Chinese medical journal · 2018Article
- Effect of methotrexate/vitamin BEpigenomics · 2017Article
- Posterior reversible encephalopathy syndrome after intrathecal methotrexate infusion: a case report and literature update.Quantitative imaging in medicine and surgery · 2016Article
- Methotrexate-induced neurotoxicity and leukoencephalopathy in childhood acute lymphoblastic leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014Article
- [Hemiparesis in acute lymphoblastic leukemia].Der Radiologe · 2010Article
- Recurrent intrathecal methotrexate induced neurotoxicity in an adolescent with acute lymphoblastic leukemia: Serial clinical and radiologic findings.Pediatric blood & cancer · 2009Article
- Outcomes of a modified CALGB 19802 regimen in adult acute lymphoblastic leukemia.Journal of Korean medical science · 2008Article
- Neurotoxicity of chemotherapeutic and biologic agents in children with cancer.Current neurology and neuroscience reports · 2008Review
- Stroke-like encephalopathy following high-dose intravenous methotrexate in an adolescent with osteosarcoma: a case report.Revista brasileira de hematologia e hemoterapiaArticle
- Magnetization transfer imaging provides no evidence of demyelination in methotrexate-induced encephalopathy.AJNR. American journal of neuroradiologyArticle
- Post-intrathecal chemotherapy-related paraplegia syndrome in hematological cancer patients: A systematic review.Neuro-oncology advancesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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/m(2)/week (LD MTX, n=81) or HD MTX at 1.5 g/m(2)/2 weeks x 6 (n=77). Intermediate-risk group (IR, n=672) were randomized to LD MTX (n=290) or HD MTX at 8 g/m(2)/2 weeks x 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.