Evidence map›Paper›PMID 18294323›Full record

Trial reportBritish journal of clinical pharmacology2008

Population pharmacokinetics and exploratory pharmacodynamics of ifosfamide according to continuous or short infusion schedules: an n = 1 randomized study.

Etienne G C Brain, Kevan Rezai, François Lokiec, Maya Gutierrez, Saïk Urien

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Article
  2. Article
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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

5 authors.

Etienne G C BrainDepartment of Medical Oncology, René Huguenin Cancer Centre, 35, rue Dailly, 92210 Saint-Cloud, France. e.brain@stcloud-huguenin.org
Kevan Rezai
François Lokiec
Maya Gutierrez
Saïk Urien

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

what is already known about this subject* The optimal infusion duration for ifosfamide remains to be determined. * No differences according to time of infusion have been identified in traditional pharmacokinetic endpoints, such as area under the curve. * The impact on pharmacodynamics has never been modelled or correlated with pharmacokinetics. WHAT THIS STUDY ADDS: * The pharmacokinetics and pharmacodynamics of ifosfamide and its main metabolites can both be modelled with no influence of infusion duration. * Pharmacodynamic modelling (renal and haematological toxicity) allows further simulations of new schedules with favourable toxicity profiles.

aimsTo model the pharmacokinetics and pharmacodynamics of ifosfamide and its key metabolites. The pharmacodynamic parameters included were renal toxicity and myelosuppression measured using urinary beta(2)-microglobulin (BMG) and absolute neutrophil count (ANC), respectively.

methodsSeventeen patients were enrolled into an n = 1 randomized trial during two consecutive cycles of ifosfamide 9 g m(-2) during each cycle given by a 3 h or 72 h infusion. Data were analyzed using NONMEM.

resultsIfosfamide and metabolite concentration-time profiles were described by a one-compartment open-model with auto-induction of clearance. BMG and ANC time-courses were related to ifosfamide concentration via indirect response models.

conclusionsThis modelling allowed the simulation of weekly schedules of flat doses with favourable myelotoxic profiles.

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingDose-Response Relationship, DrugDrug Administration ScheduleEpidemiologic MethodsFemaleHumansIfosfamideLinear ModelsMaleMiddle AgedNeoplasms, Multiple PrimaryAntineoplastic Agents, AlkylatingIfosfamide

Identifiers

PMID18294323
PMCPMC2291389

What OpenQuestion holds

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Registered trials

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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.