{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T23:18:17Z","timestamp":1788045497507,"version":"build-2784847793"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,3,21]],"date-time":"2019-03-21T00:00:00Z","timestamp":1553126400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Dutch Uro-Oncology Group","award":["16105"],"award-info":[{"award-number":["16105"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Docetaxel has been approved for the treatment of metastatic prostate cancer in combination with prednisone. Since prednisone is known to induce the cytochrome P450 iso\u2010enzyme CYP3A4, which is the main metabolizing enzyme of docetaxel in the liver, a potential drug\u2013drug interaction may occur. In this prospective randomized pharmacokinetic cross\u2010over study we investigated docetaxel exposure with concomitant prednisone, compared to docetaxel monotherapy in men with metastatic prostate cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients scheduled to receive at least 6\u00a0cycles of docetaxel (75\u00a0mg\/m<jats:sup>2<\/jats:sup>) and who gave written informed consent were randomized to receive either the 1<jats:sup>st<\/jats:sup> 3\u00a0cycles, or the last 3 consecutive cycles with prednisone (twice daily 5\u00a0mg). Pharmacokinetic blood sampling was performed during cycle 3 and cycle 6. Primary endpoint was difference in docetaxel exposure, calculated as area under the curve (AUC<jats:sub>0\u2010inf<\/jats:sub>) and analysed by means of a linear mixed model. Given the cross\u2010over design the study was powered on 18 patients to answer the primary, pharmacokinetic, endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eighteen evaluable patients were included in the trial. Docetaxel concentration with concomitant prednisone (AUC<jats:sub>0\u2010inf<\/jats:sub> 2784\u00a0ng*h\/mL, 95% confidence interval 2436\u20133183\u00a0ng*h\/mL) was similar to the concentration of docetaxel monotherapy (AUC<jats:sub>0\u2010inf<\/jats:sub> 2647\u00a0ng*h\/mL, 95% confidence interval 2377\u20132949\u00a0ng*h\/mL). Exploratory analysis showed no toxicity differences between docetaxel monotherapy and docetaxel cycles with prednisone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>No significant difference in docetaxel concentrations was observed. In addition, we found similar toxicity profiles in absence and presence of prednisone. Therefore, from a pharmacokinetic point of view, docetaxel may be administrated with or without prednisone.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13889","type":"journal-article","created":{"date-parts":[[2019,2,9]],"date-time":"2019-02-09T05:25:12Z","timestamp":1549689912000},"page":"986-992","source":"Crossref","is-referenced-by-count":10,"title":["Effects of prednisone on docetaxel pharmacokinetics in men with metastatic prostate cancer: A randomized drug\u2013drug interaction study"],"prefix":"10.1111","volume":"85","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8891-475X","authenticated-orcid":false,"given":"Bodine P.S.","family":"Belderbos","sequence":"first","affiliation":[{"name":"Department of Medical Oncology Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koen G.A.M.","family":"Hussaarts","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonie J.","family":"van Harten","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Oomen\u2010de Hoop","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"de Bruijn","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Hamberg","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Franciscus Gasthuis &amp; 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