Evidence map›Paper›PMID 33677616›Full record

Trial reportCancer chemotherapy and pharmacology2021

A pharmacologically-based approach to high dose methotrexate administration to investigate nephrotoxicity and acute kidney injury biomarkers in children and adolescents with newly diagnosed osteosarcoma.

Elizabeth Fox, Christine Busch, Alexander DeBernardo, Blair Segers, Joseph Gottschalk, Richard Womer, Naomi Balamuth, Rochelle Bagatell, Frank Balis

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01848457 (Pilot Study to Prevent Nephrotoxicity of High-Dose Methotrexate by Prolonging the Infusion Duration and Prevent Nephrotoxicity and Ototoxicity of Cisplatin With Pantoprazole in Children, Adolescents and Young Adults With Osteosarcoma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT01848457 phase2completednot on this map

Pilot Study to Prevent Nephrotoxicity of High-Dose Methotrexate by Prolonging the Infusion Duration and Prevent Nephrotoxicity and Ototoxicity of Cisplatin With Pantoprazole in Children, Adolescents and Young Adults With Osteosarcoma

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2013 to 2016Enrolled13ConditionsOsteosarcoma, Nephrotoxicity, OtotoxicityArmsPantoprazole, High-dose methotrexate infusion duration
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
  5. 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

9 authors at 2 institutions in 1 country.

Elizabeth FoxChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA. elizabeth.fox@stjude.org.ORCID 0000-0002-9998-5326
Christine BuschChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Alexander DeBernardoChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Blair SegersChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Joseph GottschalkChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Richard WomerChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Naomi BalamuthChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Rochelle BagatellChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Frank BalisChildren's Hospital of Philadelphia, Philadelphia, PA, 19104, USA.
Children's Hospital of Philadelphia · USSt. Jude Children's Research Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHigh dose methotrexate (HDMTX) acute kidney injury (AKI) results in prolonged hospitalization and treatment delays. Using a pharmacologically-based approach, HDMTX was administered with standard combination therapy to patients with osteosarcoma; nephrotoxicity was assessed.

methodsPatients were randomized by cycle to 4 h or 12 h HDMTX (12 g/m

resultsPatients (n = 12), median (range) age 12.4 (5.7-19.2) years were enrolled; 73 MTX infusions were analyzed. Median (95% Confidence Interval) serum and urine [MTX] were 1309 (1190, 1400) µM and 16.4 (14.7, 19.4) mM at the end of 4 h infusion and 557 (493, 586) µM and 11.1 (9.9, 21.1) mM at the end of 12 h infusion. Time to serum [MTX] < 0.1 µM was 83 (80.7, 90.7) h and 87 (82.8, 92.4) h for 4 and 12 h infusions. GFR

conclusionsReducing peak serum and urine MTX concentration by prolonging the infusion duration did not alter risk of acute kidney injury. GFR CLINICAL TRIAL: NCT01848457.

Indexed as

Abortifacient Agents, NonsteroidalAcute Kidney InjuryAdolescentAdultBiomarkersChildChild, PreschoolFemaleHumansMaleMethotrexateOsteosarcomaYoung AdultAbortifacient Agents, NonsteroidalBiomarkersMethotrexateAcute kidney injuryMethotrexateNephrotoxicityOsteosarcoma

Identifiers

PMID33677616
OpenAlexW3135597399

What OpenQuestion holds

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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.