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Concomitant intake of abiraterone acetate and food to increase pharmacokinetic exposure: real life data from a therapeutic drug monitoring programme.
Groenland, Stefanie L; van Nuland, Merel; Bergman, Andries M; de Feijter, Jeantine M; Dezentje, Vincent O; Rosing, Hilde; Beijnen, Jos H; Huitema, Alwin D R; Steeghs, Neeltje.
Afiliação
  • Groenland SL; Department of Clinical Pharmacology, Division of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands. Electronic address: s.groenland@nki.nl.
  • van Nuland M; Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands.
  • Bergman AM; Division of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands.
  • de Feijter JM; Division of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands.
  • Dezentje VO; Division of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands.
  • Rosing H; Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands.
  • Beijnen JH; Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands; Department of Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
  • Huitema ADR; Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, the Netherlands; Department of Clinical Pharmacy, University Medical Center, Utrecht University, Utrecht, the Netherlalnds.
  • Steeghs N; Department of Clinical Pharmacology, Division of Medical Oncology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.
Eur J Cancer ; 130: 32-38, 2020 05.
Article em En | MEDLINE | ID: mdl-32172196
AIM: Abiraterone acetate is approved for the treatment of metastatic prostate cancer. At the currently used fixed dose of 1000 mg once daily in modified fasting state, 40% of patients do not reach the efficacy threshold of a minimum plasma concentration (Cmin) ≥ 8.4 ng/mL and are thereby at risk of decreased treatment efficacy. This study aims to evaluate whether pharmacokinetically (PK) guided abiraterone acetate dosing with a food intervention is feasible and results in an increased percentage of patients with concentrations above the target. METHODS: Patients starting regular treatment with abiraterone acetate in modified fasting state were included. Pharmacokinetic analysis was performed 4, 8 and 12 weeks after start of treatment and every 12 weeks thereafter. In case of Cmin < 8.4 ng/mL and acceptable toxicity, a PK-guided intervention was recommended. The first step was concomitant intake of abiraterone acetate with a light meal or a snack. RESULTS: In total, 32 evaluable patients were included, of which 20 patients (63%) had a Cmin < 8.4 ng/mL at a certain time point during treatment. These patients were recommended to take abiraterone acetate concomitantly with food, after which Cmin increased from 6.9 ng/mL to 27 ng/mL (p < 0.001) without additional toxicities. This intervention led to adequate exposure in 28 patients (87.5%). CONCLUSION: Therapeutic drug monitoring of abiraterone was applied in clinical practice and proved to be feasible. Concomitant intake with food resulted in a significant increase in Cmin and offers a cost-neutral opportunity to optimise exposure in patients with low Cmin.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ingestão de Alimentos / Neoplasias de Próstata Resistentes à Castração / Acetato de Abiraterona / Antineoplásicos Tipo de estudo: Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ingestão de Alimentos / Neoplasias de Próstata Resistentes à Castração / Acetato de Abiraterona / Antineoplásicos Tipo de estudo: Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Ano de publicação: 2020 Tipo de documento: Article