Evidence map›Paper›PMID 23166343›Full record

Trial reportPediatrics2012

Continuous Versus Bolus Infusion of Doxorubicin in Children With ALL: Long-term Cardiac Outcomes.

Steven E Lipshultz, Tracie L Miller, Stuart R Lipsitz, Donna S Neuberg, Suzanne E Dahlberg, Steven D Colan, Lewis B Silverman, Jacqueline M Henkel, Vivian I Franco, Laura L Cushman and 10 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 174 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Cardioprotection of High-Risk Individuals.Heart failure clinics · 2022
    Review
  15. Mitochondrial-Targeted Therapy for Doxorubicin-Induced Cardiotoxicity.International journal of molecular sciences · 2022
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Novel Therapeutics for Anthracycline Induced Cardiotoxicity.Frontiers in cardiovascular medicine · 2022
    Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 11 institutions in 2 countries.

Steven E LipshultzDepartment of Pediatrics, University of Miami Miller School of Medicine, Miami, FL 33101. slipshultz@med.miami.edu
Tracie L Miller
Stuart R Lipsitz
Donna S Neuberg
Suzanne E Dahlberg
Steven D Colan
Lewis B Silverman
Jacqueline M Henkel
Vivian I Franco
Laura L Cushman
Barbara L Asselin
Luis A Clavell
Uma Athale
Bruno Michon
Caroline Laverdière
Marshall A Schorin
Eric Larsen
Naheed Usmani
Stephen E Sallan
Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia Consortium
University of Miami · USDana-Farber Cancer Institute · USHarvard University Press · USBoston Children's Hospital · USCentre hospitalier universitaire de Québec · CACentre Hospitalier Universitaire Sainte-Justine · CAInova Children's Hospital · USJackson Memorial Hospital · USMcMaster University · CAUniversity of Massachusetts Chan Medical School · USUniversity of Rochester · US

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Zebrafish Screens for Genetic Modifiers and Human Application in T-ALLP01CA068484 · NCI · DANA-FARBER CANCER INSTITUTE · PI SILVERMAN, LEWIS B · 1995 to 2010
$31.9M
Pediatric HIV/AIDS Cohort Study (PHACS): Understanding Maternal HIV Disease through Pregnancy and the Postpartum Period and its Role in Child Health OutcomesU01HD052104 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI VAN DYKE, RUSSELL B. · 2005 to 2019
$15.7M
PEDIATRIC CARDIOMYOPATHY REGISTRYR01HL053392 · NHLBI · UNIVERSITY OF ROCHESTER · PI LIPSHULTZ, STEVEN EDWARD · 1995 to 2009
$8.3M
Cardiovascular Status of HAART-Exposed Infants/ChildrenR01HL072705 · NHLBI · UNIVERSITY OF ROCHESTER · PI LIPSHULTZ, STEVEN EDWARD · 2002 to 2006
$5.6M
TRAINING PROGRAMS IN CARDIOVASCULAR PHARMACOLOGYT32HL007188 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI SZCZESNA-CORDARY, DANUTA · 1985 to 2011
$3.8M
Women and Infants Transmission Study IVU01AI050274 · NIAID · UNIVERSITY OF ILLINOIS AT CHICAGO · PI RICH, KENNETH C · 2001 to 2005
$3.6M
Pediatric Cardiomyopathy Specimen RepositoryR01HL087000 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI TOWBIN, JEFFREY ALLEN · 2007 to 2010
$2.2M
HAART Associated Cardiotoxicity in HIV-Infected ChildrenR01HL078522 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI LIPSHULTZ, STEVEN EDWARD · 2004 to 2008
$2.0M
Atherosclerotic Risk and Response to Exercise Intervention in HIV+ ChildrenR01HL095127 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI MILLER, TRACIE L · 2008 to 2010
$1.1M
FELLOWSHIP IN CLINICAL RESEARCHK30HL004537 · NHLBI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI SCOTT, GWENDOLYN BARBARA · 2000 to 2004
$1.0M
Genetic Mechanisms of Anthracycline Cardiotoxicity in Pediatric Cancer SurvivorsR01CA127642 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI LIPSHULTZ, STEVEN EDWARD · 2007 to 2009
$997k
NCI NIH HHS CA068484NCI NIH HHS CA127642NCI NIH HHS P01 CA068484NCI NIH HHS R01 CA127642NHLBI NIH HHS F31 HL094100NHLBI NIH HHS HL004537NHLBI NIH HHS HL007188NHLBI NIH HHS HL053392NHLBI NIH HHS HL072705NHLBI NIH HHS HL078522NHLBI NIH HHS HL079233NHLBI NIH HHS HL087000NHLBI NIH HHS HL087708NHLBI NIH HHS HL094100NHLBI NIH HHS HL095127NHLBI NIH HHS K30 HL004537NHLBI NIH HHS R01 HL053392NHLBI NIH HHS R01 HL072705NHLBI NIH HHS R01 HL078522NHLBI NIH HHS R01 HL087000NHLBI NIH HHS R01 HL095127NHLBI NIH HHS R13 HL087708NHLBI NIH HHS T32 HL007188NIAID NIH HHS AI50274NIAID NIH HHS U01 AI050274NICHD NIH HHS HD052102NICHD NIH HHS HD052104NICHD NIH HHS HD80002NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDoxorubicin, effective against many malignancies, is limited by cardiotoxicity. Continuous-infusion doxorubicin, compared with bolus-infusion, reduces early cardiotoxicity in adults. Its effectiveness in reducing late cardiotoxicity in children remains uncertain. We determined continuous-infusion doxorubicin cardioprotective efficacy in long-term survivors of childhood acute lymphoblastic leukemia (ALL).

methodsThe Dana-Farber Cancer Institute ALL Consortium Protocol 91-01 enrolled pediatric patients between 1991 and 1995. Newly diagnosed high-risk patients were randomly assigned to receive a total of 360 mg/m(2) of doxorubicin in 30 mg/m(2) doses every 3 weeks, by either continuous (over 48 hours) or bolus-infusion (within 15 minutes). Echocardiograms at baseline, during, and after doxorubicin therapy were blindly remeasured centrally. Primary outcomes were late left ventricular (LV) structure and function.

resultsA total of 102 children were randomized to each treatment group. We analyzed 484 serial echocardiograms from 92 patients (n = 49 continuous; n = 43 bolus) with ≥1 echocardiogram ≥3 years after assignment. Both groups had similar demographics and normal baseline LV characteristics. Cardiac follow-up after randomization (median, 8 years) showed changes from baseline within the randomized groups (depressed systolic function, systolic dilation, reduced wall thickness, and reduced mass) at 3, 6, and 8 years; there were no statistically significant differences between randomized groups. Ten-year ALL event-free survival rates did not differ between the 2 groups (continuous-infusion, 83% versus bolus-infusion, 78%; P = .24).

conclusionsIn survivors of childhood high-risk ALL, continuous-infusion doxorubicin, compared with bolus-infusion, provided no long-term cardioprotection or improvement in ALL event-free survival, hence provided no benefit over bolus-infusion.

Indexed as

AdolescentAntibiotics, AntineoplasticCancer Care FacilitiesCardiomyopathiesCardiotoxinsChildChild, PreschoolDisease-Free SurvivalDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleEchocardiographyFemaleFollow-Up StudiesHeart VentriclesHumansAntibiotics, AntineoplasticCardiotoxinsDoxorubicin

Identifiers

PMID23166343
PMCPMC3507254
OpenAlexW2125027592

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.