Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F15%3A33155454" target="_blank" >RIV/61989592:15110/15:33155454 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1093/annonc/mdv103" target="_blank" >http://dx.doi.org/10.1093/annonc/mdv103</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/annonc/mdv103" target="_blank" >10.1093/annonc/mdv103</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma

Popis výsledku v původním jazyce

Background: In a randomized, double- blind phase II trial in patients with metastatic renal cell carcinoma ( mRCC), axitinib versus placebo titration yielded a significantly higher objective response rate. We evaluated pharmacokinetic and blood pressure( BP) data from this study to elucidate relationships among axitinib exposure, BP change, and efficacy. Patients and methods: Patients received axitinib 5 mg twice daily during a lead- in period. Patients who met dose- titration criteria were randomized1: 1 to stepwise dose increases with axitinib or placebo. Patients ineligible for randomization continued without dose increases. Serial 6- h and sparse pharmacokinetic sampling were carried out; BP was measured at clinic visits and at home in all patients, and by 24- h ambulatory BP monitoring ( ABPM) in a subset of patients. Results: Area under the plasma concentration- time curve from 0 to 24 h throughout the course of treatment ( AUCstudy) was higher in patients with complete or part

Název v anglickém jazyce

Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma

Popis výsledku anglicky

Background: In a randomized, double- blind phase II trial in patients with metastatic renal cell carcinoma ( mRCC), axitinib versus placebo titration yielded a significantly higher objective response rate. We evaluated pharmacokinetic and blood pressure( BP) data from this study to elucidate relationships among axitinib exposure, BP change, and efficacy. Patients and methods: Patients received axitinib 5 mg twice daily during a lead- in period. Patients who met dose- titration criteria were randomized1: 1 to stepwise dose increases with axitinib or placebo. Patients ineligible for randomization continued without dose increases. Serial 6- h and sparse pharmacokinetic sampling were carried out; BP was measured at clinic visits and at home in all patients, and by 24- h ambulatory BP monitoring ( ABPM) in a subset of patients. Results: Area under the plasma concentration- time curve from 0 to 24 h throughout the course of treatment ( AUCstudy) was higher in patients with complete or part

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Annals of Oncology

ISSN

0923-7534

e-ISSN

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Svazek periodika

26

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

1372-1377

Kód UT WoS článku

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EID výsledku v databázi Scopus

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