Informace o publikaci

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

Autoři	JEWELL Roxanne C. KIPPS Thomas J. DÜRIG Jan GRISKEVICIUS Laimonas STILGENBAUER Stephan SMOLEJ Lukáš MAYER Jiří HESS Georg HERNANDEZ-ILIZALITURRI Francisco J. PADMANABHAN-IYER Swaminathan FANG Lei GOLDSTEIN Nancy GORCZYCA Michele GUPTA Ira LISBY Steen WIERDA William G.
Rok publikování	2017
Druh	Článek v odborném periodiku
Časopis / Zdroj	Leukemia & Lymphoma
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	http://dx.doi.org/10.1080/10428194.2016.1195497
Doi	http://dx.doi.org/10.1080/10428194.2016.1195497
Obor	Onkologie a hematologie
Klíčová slova	Chemoimmunotherapy; chronic lymphocytic leukemia; ofatumumab; pharmacokinetics
Přiložené soubory	EL_1349648.pdf
Popis	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.