2017
A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
HÁJEK, R., T. MASSZI, M. T. PETRUCCI, A. PALUMBO, L. ROSIÑOL et. al.Základní údaje
Originální název
A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
Autoři
HÁJEK, R., T. MASSZI, M. T. PETRUCCI, A. PALUMBO, L. ROSIÑOL, A. NAGLER, K. L. YONG, A. ORIOL, J. MINARIK, Luděk POUR, M. A. DIMOPOULOS, V. MAISNAR, D. ROSSI, H. KASPARU, J. Van DROOGENBROECK, D. B. YEHUDA, I. HARDAN, M. JENNER, M. CALBECKA, M. DÁVID, J. de la RUBIA, J. DRACH, Z. GASZTONYI, S. GÓRNIK, X. LELEU, M. MUNDER, M. OFFIDANI, N. ZOJER, K. RAJANGAM, Y.-L. CHANG, J. F. SAN-MIGUEL a H. LUDWIG
Vydání
Leukemia, London, Nature Publishing Group, 2017, 0887-6924
Další údaje
Jazyk
angličtina
Typ výsledku
Článek v odborném periodiku
Obor
30205 Hematology
Stát vydavatele
Velká Británie a Severní Irsko
Utajení
není předmětem státního či obchodního tajemství
Odkazy
Impakt faktor
Impact factor: 10.023
Organizační jednotka
Lékařská fakulta
UT WoS
000394058700014
Klíčová slova anglicky
SINGLE-AGENT CARFILZOMIB; OPEN-LABEL; BORTEZOMIB; PREDNISONE; ARM; DEXAMETHASONE; SURVIVAL; SAFETY
Štítky
Příznaky
Mezinárodní význam, Recenzováno
Změněno: 15. 3. 2018 17:10, Soňa Böhmová
Anotace
V originále
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.