Evidence map›Paper›PMID 24587006›Full record

Trial reportPloS one2014

Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy.

Belen Sadaba, Anabel del Barrio, Miguel Angel Campanero, Jose Ramon Azanza, Almudena Gomez-Guiu, Jose Maria Lopez-Picazo, Salvador Martin Algarra, Francisco Guillén Grimá, Maria Blanco Prieto, Jose Luis Perez-Gracia and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01046240 (Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.8field-weighted citation impact, top 16% 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.

NCT01046240 phase1 / phase2completednot on this map

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous (SC) Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2009 to 2010Enrolled29ConditionsEmesisArmsPalonosetron
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 15 citations in OpenAlex.

  1. 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

11 authors at 2 institutions in 1 country.

Belen SadabaClinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Anabel del BarrioOncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Miguel Angel CampaneroClinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Jose Ramon AzanzaClinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Almudena Gomez-GuiuClinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Jose Maria Lopez-PicazoOncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Salvador Martin AlgarraOncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Francisco Guillén GrimáDepartment of Preventive Medicine, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Maria Blanco PrietoDepartment of Pharmacy and Pharmaceutical Technology, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Jose Luis Perez-GraciaOncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Alfonso GurpideOncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
Universidad de Navarra · ESClinica Universidad de Navarra · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPalonosetron is a potent second generation 5- hydroxytryptamine-3 selective antagonist which can be administered by either intravenous (IV) or oral routes, but subcutaneous (SC) administration of palonosetron has never been studied, even though it could have useful clinical applications. In this study, we evaluate the bioavailability of SC palonosetron. PATIENTS AND

methodsPatients treated with platinum-based chemotherapy were randomized to receive SC or IV palonosetron, followed by the alternative route in a crossover manner, during the first two cycles of chemotherapy. Blood samples were collected at baseline and 10, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 12 and 24 h after palonosetron administration. Urine was collected during 12 hours following palonosetron. We compared pharmacokinetic parameters including AUC0-24h, t1/2, and Cmax observed with each route of administration by analysis of variance (ANOVA).

resultsFrom October 2009 to July 2010, 25 evaluable patients were included. AUC0-24h for IV and SC palonosetron were respectively 14.1 and 12.7 ng × h/ml (p=0.160). Bioavalability of SC palonosetron was 118% (95% IC: 69-168). Cmax was lower with SC than with IV route and was reached 15 minutes following SC administration.

conclusionsPalonosetron bioavailability was similar when administered by either SC or IV route. This new route of administration might be specially useful for outpatient management of emesis and for administration of oral chemotherapy.

trial registrationClinicalTrials.gov NCT01046240.

Indexed as

Administration, IntravenousAdultAgedAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansInjections, SubcutaneousIsoquinolinesMaleMiddle AgedNeoplasmsPalonosetronPlatinumQuinuclidinesTreatment OutcomeAntiemeticsIsoquinolinesPalonosetronPlatinumQuinuclidines

Identifiers

PMID24587006
PMCPMC3937332
OpenAlexW1963751388

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.