Evidence map›Paper›PMID 34286354›Full record

Trial reportCancer chemotherapy and pharmacology2021

Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy.

Fanny Leenhardt, Marie Alexandre, Severine Guiu, Stephane Pouderoux, Melanie Beaujouin, Gerald Lossaint, Laurent Philibert, Alexandre Evrard, William Jacot

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04025541 (Analysis of Circulating Tumor Markers in Blood), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 35% 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.

NCT04025541 narecruitingnot on this map

Analysis of Circulating Tumor Markers in Blood

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2018 to 2029Enrolled992ConditionsCancer, Breast Cancer, Sarcoma, Lung CancersArmsBlood sampling, Blood sampling C3, Blood sampling C4/7/10/13, Blood sampling C5, Blood sampling C6
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Evaluation of a decentralized investigational drug service pharmacist in a cancer clinical trial infusion unit.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2024
    Article
  5. Article
  6. Article
  7. Article
  8. Article
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 3 institutions in 1 country.

Fanny LeenhardtLaboratoire de Pharmacocinétique, Faculté de Pharmacie, Université de Montpellier, Montpellier, France. fanny.leenhardt@icm.unicancer.fr.ORCID 0000-0002-9404-5044
Marie AlexandreDépartement d'oncologie Médicale, Institut du Cancer de Montpellier, Université de Montpellier, 208 rue des Apothicaires, 34298, Montpellier, France.
Severine GuiuInstitut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Université de Montpellier, Montpellier, France.
Stephane PouderouxDépartement d'oncologie Médicale, Institut du Cancer de Montpellier, Université de Montpellier, 208 rue des Apothicaires, 34298, Montpellier, France.
Melanie BeaujouinCentre de Recherche Clinique, Institut du Cancer de Montpellier, 208 rue des Apothicaires, 34298, Montpellier, France.
Gerald LossaintDépartement de Recherche Clinique, Institut du Cancer de Montpellier, Université de Montpellier, 208 rue des Apothicaires, 34298, Montpellier, France.
Laurent PhilibertService Pharmacie, Institut du Cancer de Montpellier, Université de Montpellier, 208 rue des Apothicaires, 34298, Montpellier, France.
Alexandre EvrardLaboratoire de Pharmacocinétique, Faculté de Pharmacie, Université de Montpellier, Montpellier, France.
William JacotInstitut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Université de Montpellier, Montpellier, France.
Inserm · FRUniversité de Montpellier · FRInstitut de Recherche en Cancérologie de Montpellier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePharmacist consultation is unfrequently performed in oncology clinical trials that include patients who often have many co-treatments increasing the risk of drug-drug interactions (DDI). The aim of this study was to determine whether best possible medication history (BPMH) by hospital pharmacist at inclusion and therapeutic drug monitoring could be used for DDI risk evaluation and for current oral targeted therapy management.

methodsA prospective clinical trial (ALCINA 2, NCT04025541) was carried out in metastatic breast cancer cohort treated by palbociclib to conduct pharmacokinetics-toxicity correlation study. BPMH was prospectively performed by the hospital pharmacist at each trial inclusion, followed by a contact to the patient's community pharmacy to complete the collected data. Pharmacokinetic analysis was performed on blood samples collected at day 15 of cycle 1 of palbociclib treatment.

resultsPharmacist interventions indicated that at inclusion, current medications were incomplete for 63% of the enrolled patients (32/51). It allowed the real-time management of high-risk DDI detected in third of patients. The palbociclib C

conclusionThis is the first prospective study evaluating the relevance of proactive BPMH by pharmacist with contact to the community pharmacy during the inclusion step of a clinical trial to ensure the efficacy and safety of the investigated drug. This investigation was thus able to highlight the statistically significant impact of these DDI on palbociclib plasma concentration variation during the clinical trial.

trial registrationClinicaltrials.gov identifier NCT04025541.

Indexed as

Administration, OralAntineoplastic AgentsBreast NeoplasmsDrug InteractionsDrug MonitoringFemaleHumansMolecular Targeted TherapyPharmacistsPharmacy Service, HospitalPiperazinesProfessional RoleProspective StudiesPyridinesAntineoplastic AgentspalbociclibPiperazinesPyridinesClinical pharmacyClinical trialDrug–drug interactionOncology breast cancer

Identifiers

PMID34286354
OpenAlexW3184627852

What OpenQuestion holds

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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.