Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F17%3A00066117" target="_blank" >RIV/65269705:_____/17:00066117 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11150/17:10363636 RIV/00179906:_____/17:10363636

Výsledek na webu

<a href="http://www.tandfonline.com/doi/full/10.1080/10428194.2016.1195497" target="_blank" >http://www.tandfonline.com/doi/full/10.1080/10428194.2016.1195497</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/10428194.2016.1195497" target="_blank" >10.1080/10428194.2016.1195497</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy

Popis výsledku v původním jazyce

Relationships between patient characteristics, ofatumumab pharmacokinetics, and treatment outcomes were investigated in this phase 2 trial of ofatumumab plus fludarabine and cyclophospha-mide (FC) in untreated chronic lymphocytic leukemia. Patients were randomized 1:1 to receive 500 or 1000mg ofatumumab (Cycle 1; 300mg) plus FC every 4 weeks for six cycles. Median C-max and C-trough values were similar at Cycle 1 regardless of the ultimate clinical outcome. At later doses, these values were higher for patients with complete response (CR) than for other patients. Higher C-max and C-trough values at Cycles 3 and 6 were significantly associated with an increased likelihood of CR, whereas ofatumumab pharmacokinetics were not associated with an objective response (OR) on the basis of univariate analyses. Multivariate analyses indicated that baseline patient/disease factors were predominantly associated with CR (17p status) or OR (bulky lymph-adenopathy, gender, and serum thymidine kinase), rather than ofatumumab pharmacokinetics.

Název v anglickém jazyce

Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy

Popis výsledku anglicky

Relationships between patient characteristics, ofatumumab pharmacokinetics, and treatment outcomes were investigated in this phase 2 trial of ofatumumab plus fludarabine and cyclophospha-mide (FC) in untreated chronic lymphocytic leukemia. Patients were randomized 1:1 to receive 500 or 1000mg ofatumumab (Cycle 1; 300mg) plus FC every 4 weeks for six cycles. Median C-max and C-trough values were similar at Cycle 1 regardless of the ultimate clinical outcome. At later doses, these values were higher for patients with complete response (CR) than for other patients. Higher C-max and C-trough values at Cycles 3 and 6 were significantly associated with an increased likelihood of CR, whereas ofatumumab pharmacokinetics were not associated with an objective response (OR) on the basis of univariate analyses. Multivariate analyses indicated that baseline patient/disease factors were predominantly associated with CR (17p status) or OR (bulky lymph-adenopathy, gender, and serum thymidine kinase), rather than ofatumumab pharmacokinetics.

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

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

Leukemia &amp; Lymphoma

ISSN

1042-8194

e-ISSN

—

Svazek periodika

58

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

348-356

Kód UT WoS článku

000388601000013

EID výsledku v databázi Scopus

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