Evidence map›Paper›PMID 19884541›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Comparison of neurocognitive functioning in children previously randomly assigned to intrathecal methotrexate compared with triple intrathecal therapy for the treatment of childhood acute lymphoblastic leukemia.

Nina S Kadan-Lottick, Pim Brouwers, David Breiger, Thomas Kaleita, James Dziura, Veronika Northrup, Lu Chen, Megan Nicoletti, Bruce Bostrom, Linda Stork and 1 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00002744 (Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00002744 phase3completednot on this map

Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia

TypeinterventionalSponsorChildren's Oncology GroupRan1996 to 2007Enrolled1,970ConditionsLeukemiaArmsasparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Feasibility of baseline neurocognitive assessment using Cogstate during the first month of therapy for childhood leukemia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Feasibility of serial neurocognitive assessment using Cogstate during and after therapy for childhood leukemia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  13. Article
  14. Article
  15. Chemotherapy Pharmacodynamics and Neuroimaging and Neurocognitive Outcomes in Long-Term Survivors of Childhood Acute Lymphoblastic Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Milestones in the curability of pediatric cancers.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Nina S Kadan-LottickSection of Pediatric Hematology-Oncology, Yale University School of Medicine, New Haven, CT, USA. Nina.Kadan-Lottick@Yale.Edu
Pim Brouwers
David Breiger
Thomas Kaleita
James Dziura
Veronika Northrup
Lu Chen
Megan Nicoletti
Bruce Bostrom
Linda Stork
Joseph P Neglia
Children's Oncology Group · CH

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI DEVIDAS, MEENAKSHI · 2003 to 2013
$67.5M
Community Clinical Oncology Program Research BaseU10CA095861 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI POLLOCK, BRAD H · 2002 to 2013
$19.5M
Yale University Clinical and Translational Science Award ProgramKL2RR024138 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$4.8M
NCI NIH HHS U10 CA095861NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA95861NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543NCRR NIH HHS KL2 RR024138
6 · The paper itself

Abstract

purposeFor the majority of children with acute lymphoblastic leukemia (ALL), CNS prophylaxis consists of either intrathecal (IT) methotrexate or triple IT therapy (ie, methotrexate with both cytarabine and hydrocortisone). The long-term neurotoxicities of these two IT strategies have not yet been directly compared. PATIENTS AND

methodsIn this multisite study, 171 children with standard-risk ALL, age 1 to 9.99 years at diagnosis, previously randomly assigned to IT methotrexate (n = 82) or to triple IT therapy (n = 89) on CCG 1952, underwent neurocognitive evaluation by a licensed psychologist at a mean of 5.9 years after random assignment.

resultsPatients who received IT methotrexate had a mean Processing Speed Index that was 3.6 points lower, about one fourth of a standard deviation, than those who received triple IT therapy (P = .04) after analysis was adjusted for age, sex, and time since diagnosis. Likewise, 19.5% of children in the IT methotrexate group had a Processing Speed Index score in the below-average range compared with 6.9% in the triple IT therapy group (P = .02). Otherwise, the groups performed similarly on tests of full-scale intelligence quotient, academic achievement, attention/concentration, memory, and visual motor integration. The association of treatment with measures of cognitive functioning was not modified by sex or age at diagnosis. In the post-therapy period, there were no group differences in special education services, neurologic events, or use of psychotropic medications.

conclusionThis study did not show any clinically meaningful differences in neurocognitive functioning between patients previously randomly assigned to IT methotrexate or triple IT therapy except for a small difference in processing speed in the IT methotrexate group.

Indexed as

Antimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsAttentionChildChild, PreschoolCognitionCross-Sectional StudiesCytarabineFemaleHumansHydrocortisoneInfantInjections, SpinalIntelligence TestsLinear ModelsMaleAntimetabolites, AntineoplasticCytarabineHydrocortisoneMethotrexate

Identifiers

PMID19884541
PMCPMC2793042
OpenAlexW2116883551

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.