A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
Hájek, R. (University Hospital Ostrava)
Masszi, T. (St László Hospital (Hongria))
Petrucci, M. T. (Sapienza Università di Roma)
Palumbo, A. (Università di Torino)
Rosiñol, L. (Hospital Clínic i Provincial de Barcelona)
Nagler, Arnon. (Chaim Sheba Medical Center (Israel))
Yong, K. L. (University College London Cancer Institute)
Oriol, Albert (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Minarik, J. (University Hospital Olomouc (Olomouc, República Txeca))
Pour, L. (University Hospital Ostrava)
Dimopoulos, Meletios (The National and Kapodistrian University of Athens)
Maisnar, V. (Charles University. Faculty of Medicine in Hradec Králové)
Rossi, Davide (Amedeo Avogadro University of Eastern Piedmont)
Kasparu, H. (Ordensklinikum Linz Elisabethinen)
Van Droogenbroeck, J. (AZ Sint-Jan, Brugge, Belgium)
Yehuda, D. B. (Hadassah Medical Center, Jerusalem, Israel)
Hardan, I. (Meir Medical Center, Kfar-Saba, Israel)
Jenner, M. (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Calbecka, M. (Nicolaus Copernicus Hospital, Toruń Poland)
Dávid, M. (University of Pécs, Hungary)
de la Rubia, Javier (Hospital Universitari i Politècnic La Fe (València))
Drach, J. (Medical University of Vienna)
Gasztonyi, Z. (Petz Aladár Megyei Oktató Kórház, Vasvári Pál, Hungary)
Górnik, S. (Zamojski Szpital Niepubliczny, Zamosc, Poland)
Leleu, Xavier (Hopital Huriez, CHRU, Lille, France)
Munder, M. (University Medicine Mainz, Germany)
Offidani, M. (Clinica di Ematologia Azienda Ospedaliero-Universitaria, Ospedali Riuniti di Ancona, Italy)
Zojer, N. (Center for Oncology, Hematology with Outpatient Department and Palliative Care, Wilhelminenspital, Vienna, Austria)
Rajangam, K. (Onyx Pharmaceuticals, Inc.)
Chang, Y. L. (Onyx Pharmaceuticals, Inc.)
San-Miguel, J. F. (Clínica Universidad de Navarra. Centro de Investigación Médica Aplicada)
Ludwig, H. (Wilhelminen Cancer Research Institute (Viena, Àustria))

Fecha:	2017
Resumen:	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/m2 on days 1 and 2 of cycle 1; 27 mg/m2 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 arfilzomib vs control. Median OS for single-agent carfilzomib was similar to that for an active doublet control regimen in heavily pretreated RRMM patients.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	Leukemia, Vol. 31 (2017) , p. 107-114, ISSN 1476-5551

DOI: 10.1038/leu.2016.176
PMID: 27416912

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