Informace o publikaci

A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)

Autoři	HÁJEK R. MASSZI T. PETRUCCI M. T. PALUMBO A. ROSINOL L. NAGLER A. YONG K. L. ORIOL A. MINARIK J. POUR Luděk DIMOPOULOS M. A. MAISNAR V. ROSSI D. KASPARU H. DROOGENBROECK J. Van YEHUDA D. B. HARDAN I. JENNER M. CALBECKA M. DÁVID M. RUBIA J. de la DRACH J. GASZTONYI Z. GÓRNIK S. LELEU X. MUNDER M. OFFIDANI M. ZOJER N. RAJANGAM K. CHANG Y.-L. SAN-MIGUEL J. F. LUDWIG H.
Rok publikování	2017
Druh	Článek v odborném periodiku
Časopis / Zdroj	Leukemia
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	http://dx.doi.org/10.1038/leu.2016.176
Doi	http://dx.doi.org/10.1038/leu.2016.176
Obor	Onkologie a hematologie
Klíčová slova	SINGLE-AGENT CARFILZOMIB; OPEN-LABEL; BORTEZOMIB; PREDNISONE; ARM; DEXAMETHASONE; SURVIVAL; SAFETY
Popis	This randomized, phase III, open-label, multicenter study compared carfilzomib monotherapy against low-dose corticosteroids and optional cyclophosphamide in relapsed and refractory multiple myeloma (RRMM). Relapsed and refractory multiple myeloma patients were randomized (1:1) to receive carfilzomib (10-min intravenous infusion; 20 mg/m 2 on days 1 and 2 of cycle 1; 27 mg/m 2 thereafter) or a control regimen of low-dose corticosteroids (84 mg of dexamethasone or equivalent corticosteroid) with optional cyclophosphamide (1400 mg) for 28-day cycles. The primary endpoint was overall survival (OS). Three-hundred and fifteen patients were randomized to carfilzomib (n=157) or control (n=158). Both groups had a median of five prior regimens. In the control group, 95% of patients received cyclophosphamide. Median OS was 10.2 (95% confidence interval (CI) 8.4-14.4) vs 10.0 months (95% CI 7.7-12.0) with carfilzomib vs control (hazard ratio=0.975; 95% CI 0.760-1.249; P=0.4172). Progression-free survival was similar between groups; overall response rate was higher with carfilzomib (19.1 vs 11.4%). The most common grade >=3 adverse events were anemia (25.5 vs 30.7%), thrombocytopenia (24.2 vs 22.2%) and neutropenia (7.6 vs 12.4%) with carfilzomib vs control. Median OS for single-agent carfilzomib was similar to that for an active doublet control regimen in heavily pretreated RRMM patients.