Evidence map›Paper›PMID 27796539›Full record

ArticleCancer chemotherapy and pharmacology2016

A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function.

Analía Azaro, Jordi Rodón, Jean-Pascal Machiels, Sylvie Rottey, Silvia Damian, Richard Baird, Javier Garcia-Corbacho, Ron H J Mathijssen, Pierre-François Clot, Claudine Wack and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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

12 authors.

Analía AzaroMolecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain. aazaro@vhio.net.
Jordi RodónMolecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Jean-Pascal MachielsDepartment of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Brussels, Belgium.
Sylvie RotteyDepartment of Medical Oncology, University Hospital of Ghent and Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium.
Silvia DamianDepartment of Medical Oncology, Fondazione IRCCS National Cancer Institute of Milan, Milan, Italy.
Richard BairdEarly Phase Clinical Trials Team, Department of Oncology, University of Cambridge, Cambridge, UK.
Javier Garcia-CorbachoEarly Phase Clinical Trials Team, Department of Oncology, University of Cambridge, Cambridge, UK.
Ron H J MathijssenErasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands.
Pierre-François ClotSanofi, Chilly-Mazarin, France.
Claudine WackSanofi, Chilly-Mazarin, France.
Liji ShenSanofi, Bridgewater, NJ, USA.
Maja J A de JongeErasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLimited data are available on cabazitaxel pharmacokinetics in patients with renal impairment. This open-label, multicenter study assessed cabazitaxel in patients with advanced solid tumors and normal or impaired renal function.

methodsCohorts A (normal renal function: creatinine clearance [CrCL] >80 mL/min/1.73 m

resultsOverall, 25 patients received cabazitaxel (median cycles: 3 [range 1-20]; Cohort A: 5 [2-13]; Cohort B: 3 [1-15]; and Cohort C: 5 [1-20]), of which 24 were eligible for pharmacokinetic analysis (eight in each cohort). For moderate and severe renal impairment versus normal renal function, GMR estimates were: clearance normalized to body surface area (CL/BSA) 0.95 (90% CI 0.80-1.13) and 0.89 (0.61-1.32); area under the curve normalized to dose (AUC/dose) 1.06 (0.88-1.27) and 1.14 (0.76-1.71); and F

conclusionsRenal impairment had no clinically meaningful effect on cabazitaxel pharmacokinetics.

Indexed as

AdultAgedAntineoplastic AgentsFemaleHumansMaleMiddle AgedNeoplasmsRenal InsufficiencyTaxoidsAntineoplastic AgentscabazitaxelTaxoidsAdvanced solid tumorsCabazitaxelPharmacokineticsPhase IRenal impairment

Identifiers

PMID27796539
PMCPMC5114328

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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.