Evidence map›Paper›PMID 38963459›Full record

Trial reportClinical pharmacokinetics2024

Intra-individual Dose Escalation of Abiraterone According to Its Plasma Exposure in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer: Results of the OPTIMABI Trial.

Jérôme Alexandre, Stephane Oudard, Lisa Golmard, Luca Campedel, Mourad Mseddi, Sylvain Ladoire, Ahmed Khalil, Denis Maillet, Christophe Tournigand, Blaise Pasquiers and 15 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03458247 (Intra-individual Dose Escalation of Abiraterone Acetate According to Its Plasma Concentration in Patients With Progressive Castration-resistant Metastatic Prostate Cancer), which is not on this 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.

NCT03458247 phase2completednot on this map

Intra-individual Dose Escalation of Abiraterone Acetate According to Its Plasma Concentration in Patients With Progressive Castration-resistant Metastatic Prostate Cancer

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2021Enrolled94ConditionsProstate CancerArmsAbiraterone acetate standard dose, Abiraterone acetate escalated dose
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

25 authors.

Jérôme AlexandreMedical Oncology Department, Université Paris Cité, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin-Port Royal, 75014, Paris, France.
Stephane OudardMedical Oncology Department, Université Paris Cité, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Européen George Pompidou, 75015, Paris, France.
Lisa GolmardDepartment of Genetics, Institut Curie, 75005, Paris, France.
Luca CampedelDepartment of Medical Oncology, AP-HP, Hôpital Pitié-Salpêtrière, 75013, Paris, France.
Mourad MseddiBiologie du Médicament-Toxicologie, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin, 75014, Paris, France.
Sylvain LadoireDepartment of Medical Oncology, Centre Georges François Leclerc, 21000, Dijon, France.
Ahmed KhalilDepartment of Medical Oncology, AP-HP, Hopital Tenon, 75020, Paris, France.
Denis MailletDepartment of Medical Oncology, Université de Lyon, Hôpital Lyon-Sud, 69495, Pierre-Bénite, France.
Christophe TournigandDepartment of Medical Oncology, AP-HP, Hôpital Henri Mondor, 94000, Créteil, France.
Blaise PasquiersBiologie du Médicament-Toxicologie, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin, 75014, Paris, France.
Françoise GoirandHôpital Universitaire Dijon Bourgogne, Laboratoire de Pharmacologie-Toxicologie, 21000, Dijon, France.
Joseph BerthierHôpital Universitaire Dijon Bourgogne, Laboratoire de Pharmacologie-Toxicologie, 21000, Dijon, France.
Jérôme GuittonHôpital Lyon-Sud, Hospices Civils de Lyon, Biochemistry and Pharmacology-Toxicology Laboratory, 69495, Pierre Benite, France.
Charles DarianeDepartment of Urology, Université Paris Cité, Inserm UMR-S1151, CNRS UMR-S8253, Institut Necker Enfants-Malades (INEM), AP-HP, Hôpital européen Georges-Pompidou, 75015, Paris, France.
Florence JolyDepartment of Medical Oncology, Centre François Baclesse, University Unicaen, 14000, Caen, France.
Evanguelos XylinasDepartment of Urology, Université de Paris Cité, AP-HP, Hôpital Bichat-Claude Bernard, 75018, Paris, France.
Jean Louis GolmardRetired Academic Statistician, Paris, France.
Hendy AbdoulUniversité Paris Cité, AP-HP, URC Paris Centre, 75014, Paris, France.
Alicja PuszkielUniversité Paris Cité, Inserm UMR-S1144, Paris, France.
Xavier DeclevesUniversité Paris Cité, Inserm UMR-S1144, Paris, France.
Edith CartonInstitut de Cancérologie et de Radiothérapie Brétilien, Oncologie, 35760, Saint-Grégoire, France.
Audrey ThomasUniversité de Paris Cité; CNRS, INSERM, CiTCoM, U1268, 75006, Paris, France.
Michel VidalBiologie du Médicament-Toxicologie, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin, 75014, Paris, France.
Olivier HuillardMedical Oncology Department, Université Paris Cité, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin-Port Royal, 75014, Paris, France.
Benoit BlanchetBiologie du Médicament-Toxicologie, Institut du Cancer Paris CARPEM, AP-HP, Hôpital Cochin, 75014, Paris, France. benoit.blanchet@aphp.fr.ORCID 0000-0003-3096-4305

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveTrough abiraterone concentration (ABI C

methodsThis multicentre, non-randomised study consisted of two sequential steps. In step 1, all patients started treatment with 1000 mg of AA once daily. Abiraterone C

resultsIn the intention-to-treat analysis (ITT), 81 patients were included in step 1. In all, 21 (26%) patients were underexposed in step 1, and 8 of them (38%) experienced tumour progression within the first 6 months. A total of 71 patients (88%) completed the Girerd self-reported questionnaire. Of the patients, 62% had a score of 0, and 38% had a score of 1 or 2 (minimal compliance failure), without a significant difference in mean ABI C

conclusionThe ITT and per-protocol analyses showed no statistical association between ABI underexposure and an increased risk of early tumour progression in patients with mCRPC, while the Bayesian estimator showed an association. However, other strategies than dose escalation at the time of progression need to be evaluated. Treatment adherence appeared to be uniformly good in the present study. Finally, the use of a Bayesian approach to recover samples collected outside the predefined blood collection time window could benefit the conduct of clinical trials based on drug monitoring. OPTIMABI trial is registered as National Clinical Trial number NCT03458247, with the EudraCT number 2017-000560-15).

Indexed as

Prostatic Neoplasms, Castration-ResistantAbiraterone AcetateAgedAged, 80 and overAndrostenesAntineoplastic AgentsDisease ProgressionDose-Response Relationship, DrugHumansMaleMiddle AgedNeoplasm MetastasisabirateroneAbiraterone AcetateAndrostenesAntineoplastic Agents

Identifiers

PMID38963459

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.