Evidence map›Paper›PMID 19295506›Full record

Trial reportClinical pharmacology and therapeutics2009

Personalized dosing of cyclophosphamide in the total body irradiation-cyclophosphamide conditioning regimen: a phase II trial in patients with hematologic malignancy.

J S McCune, A Batchelder, K A Guthrie, R Witherspoon, F R Appelbaum, B Phillips, P Vicini, D H Salinger, G B McDonald

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Association of Antiepileptic Medications with Outcomes after Allogeneic Hematopoietic Cell Transplantation with Busulfan/Cyclophosphamide Conditioning.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
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  6. Cyclophosphamide followed by intravenous targeted busulfan for allogeneic hematopoietic cell transplantation: pharmacokinetics and clinical outcomes.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2013
    Trial
  7. Accurate targeting of daily intravenous busulfan with 8-hour blood sampling in hospitalized adult hematopoietic cell transplant recipients.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2012
    Trial
  8. Trial
  9. Trial
  10. Defibrotide for the treatment of severe hepatic veno-occlusive disease and multiorgan failure after stem cell transplantation: a multicenter, randomized, dose-finding trial.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2010
    Trial
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  14. Review
  15. Article
  16. Article
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  19. Observational
  20. 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

9 authors at 4 institutions in 1 country.

J S McCuneClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. jmccune@u.washington.edu
A Batchelder
K A Guthrie
R Witherspoon
F R Appelbaum
B Phillips
P Vicini
D H Salinger
G B McDonald
Fred Hutch Cancer Center · USUniversity of Washington · USAmgen (United States) · USPfizer (United States) · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Geoffrey Roger HILL · 1985 to 2026
$128.4M
NCI NIH HHS CA 15704NCI NIH HHS CA 18029NCI NIH HHS P01 CA018029NCI NIH HHS P30 CA015704
6 · The paper itself

Abstract

This study investigates the efficacy and safety of personalized cyclophosphamide (CY) dosing in 50 patients receiving CY along with total body irradiation (TBI). Participants received CY 45 mg/kg with subsequent therapeutic drug monitoring using Bayesian parameter estimation to personalize the second CY dose to a target area under the curve (AUC) for carboxyethylphosphoramide mustard (CEPM) (a reporter molecule for CY-derived toxins) and for hydroxycyclophosphamide (to ensure engraftment). The mean second CY dose was 66 mg/kg; the total dose ranged from 45 to 145 mg/kg. After completion of this phase II study, we compared participants' clinical outcomes with those of concurrent controls (n = 100) who received TBI along with standard CY doses of 120 mg/kg. Patients receiving personalized CY dosing had significantly lower postconditioning peak total serum bilirubin (P = 0.03); a 38% reduction in the hazard of acute kidney injury (AKI) (P = 0.03); and nonrelapse and overall survival rates similar to those in the controls (P = 0.70 and 0.63, respectively) despite the lower doses of CY administered to most of the patients in the personalized dosage group.

Indexed as

Hematopoietic Stem Cell TransplantationTransplantation ConditioningAcute DiseaseAdolescentAdultAge FactorsAntineoplastic Agents, AlkylatingBayes TheoremBilirubinChemical and Drug Induced Liver InjuryCombined Modality TherapyCyclophosphamideDose-Response Relationship, DrugFemaleHematologic NeoplasmsHumansAntineoplastic Agents, AlkylatingBilirubinCyclophosphamide

Identifiers

PMID19295506
PMCPMC2718578
OpenAlexW2166589975

What OpenQuestion holds

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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.