Evidence map›Paper›PMID 11986955›Full record

Trial reportLeukemia2002

Pharmacokinetic interactions of cyclosporine with etoposide and mitoxantrone in children with acute myeloid leukemia.

N J Lacayo, B L Lum, D L Becton, H Weinstein, Y Ravindranath, M N Chang, L Bomgaars, S J Lauer, B I Sikic, G V Dahl

Abstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Interactions Between Inflammatory Bowel Disease Drugs and Chemotherapy.Current treatment options in gastroenterology · 2016
    Review
  6. Review
  7. Article
  8. Review
  9. Review
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

10 authors at 6 institutions in 2 countries.

N J LacayoDivisions of Pediatric Hematology Oncology, Stanford University School of Medicine, Palo Alto, CA, USA.
B L Lum
D L Becton
H Weinstein
Y Ravindranath
M N Chang
L Bomgaars
S J Lauer
B I Sikic
G V Dahl
Stanford University · USPediatric Oncology Group · CAArkansas Children's Hospital · USBaylor College of Medicine · USBoston University · USChildren's Hospital of Michigan · US

Funding

XOLAIR IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH FOOD ALLERGYM01RR000070 · NCRR · STANFORD UNIVERSITY · PI RASGON, NATALIE L · 1985 to 2008
$32.4M
PEDIATRIC ONCOLOGY GROUP-OPERATIONS OFFICEU10CA030969 · NCI · WASHINGTON UNIVERSITY · PI REAMAN, GREGORY H · 1985 to 2002
$24.8M
PEDIATRIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA029139 · NCI · UNIVERSITY OF FLORIDA · PI DEVIDAS, MEENAKSHI · 1985 to 2002
$7.3M
POG9153--RHABDOMYOSARCOMA STUDY/LABORATORY EVALUATION OF TUMORU10CA003161 · NCI · BAYLOR COLLEGE OF MEDICINE · PI STEUBER, C P · 1985 to 2002
$1.0M
PEDIATRIC ONCOLOGY GROUPU10CA033603 · NCI · STANFORD UNIVERSITY · PI LINK, MICHAEL P. · 1985 to 2002
$979k
MODULATION OF MULTIDRUG RESISTANCE MECHANISMSR01CA052168 · NCI · STANFORD UNIVERSITY · PI SIKIC, BRANIMIR I · 1990 to 2002
$813k
PEDIATRIC ONCOLOGY GROUP PARTICIPATIONU10CA031566 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI PUI, CHING-HON · 1985 to 2002
$668k
PEDIATRIC ONCOLOGY GROUPU10CA041573 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRIER, HOLCOMBE E · 1986 to 2002
$610k
POG9153--RHABDOMYOSARCOMA STUDY/LABORATORY EVALUATION OF TUMORU10CA032053 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI CAMITTA, BRUCE M · 1985 to 2002
$539k
POG9153--RHABDOMYOSARCOMA STUDY/LABORATORY EVALUATION OF TUMORU10CA033625 · NCI · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI WINICK, NAOMI J · 1985 to 2002
$511k
PEDIATRIC ONCOLOGY GROUPU10CA007431 · NCI · CHILDREN'S MEMORIAL HOSPITAL (CHICAGO) · PI COHN, SUSAN L · 1985 to 2002
$499k
PEDIATRIC ONCOLOGY STUDY GROUPU10CA025408 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CASTLEBERRY, ROBERT P · 1985 to 2002
$498k
NCI NIH HHS CA 03161NCI NIH HHS CA 05587NCI NIH HHS CA 07431NCI NIH HHS CA 11233NCI NIH HHS CA 15525NCI NIH HHS CA 15898NCI NIH HHS CA 20543NCI NIH HHS CA 25408NCI NIH HHS CA 28383NCI NIH HHS CA 28439NCI NIH HHS CA 28473NCI NIH HHS CA 29139NCI NIH HHS CA 29293NCI NIH HHS CA 29691NCI NIH HHS CA 30969NCI NIH HHS CA 31566NCI NIH HHS CA 32053NCI NIH HHS CA 33587NCI NIH HHS CA 33603NCI NIH HHS CA 33625NCI NIH HHS CA 41573NCI NIH HHS CA 69177NCI NIH HHS CA 69428NCI NIH HHS R01 CA 52168NCRR NIH HHS M01 RR 00070
6 · The paper itself

Abstract

The purpose of this study was to assess the effect of the multidrug resistance modulator cyclosporine (CsA) on the pharmacokinetics of etoposide and mitoxantrone in children with de novo acute myeloid leukemia (AML). Serial blood samples for pharmacokinetic studies were obtained in 38 children over a 24-h period following cytotoxin treatment with or without CsA on days 1 and 4. Drug concentrations were quantitated using validated HPLC methods, and pharmacokinetic parameters were determined using compartmental modeling with an iterative two-stage approach, implemented on ADAPT II software. Etoposide displayed a greater degree of interindividual variability in clearance and systemic exposure than mitoxantrone. With CsA treatment, etoposide and mitoxantrone mean clearance declined by 71% and 42%, respectively. These effects on clearance, in combination with the empiric 40% dose reduction for either cytotoxin, resulted in a 47% and 12% increases in the mean AUC for etoposide and mitoxantrone, respectively. There were no differences in the rates of stomatitis or infection between the two groups. CsA treatment resulted in an increased incidence of hyperbilrubinemia, which rapidly reversed upon conclusion of drug therapy. The variability observed in clearance, combined with the empiric 40% dose reduction of the cytotoxins, resulted in statistically similar systemic exposure and similar toxicity.

Indexed as

Acute DiseaseAdolescentAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveChildChild, PreschoolChromatography, High Pressure LiquidCyclosporineDrug InteractionsDrug Resistance, MultipleEtoposideFemaleHumansInfantLeukemia, MyeloidMaleCyclosporineEtoposideMitoxantrone

Identifiers

PMID11986955
OpenAlexW1986093701

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.