A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
Hájek R (1), Masszi T (2), Petrucci MT (3), Palumbo A (4), Rosiñol L (5), Nagler A (6), Yong KL (7), Oriol A (8), Minarik J (9), Pour L (1), Dimopoulos MA (10), Maisnar V (11), Rossi D (12), Kasparu H (13), Van Droogenbroeck J (14), Yehuda DB (15), Hardan I (16), Jenner M (17), Calbecka M 18, Dávid M (19), de la Rubia J (20), Drach J (21), Gasztonyi Z (22), Górnik S (23), Leleu X 24, Munder M (25), Offidani M (26), Zojer N (27), Rajangam K (28), Chang YL (28), San-Miguel JF (29), Ludwig H (30).
(1) University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
(2) St István and St László Hospital of Budapest, Budapest, Hungary.
(3) Sapienza University of Rome, Rome, Italy.
(4) University of Torino, Torino, Italy.
(5) Hospital Clínic de Barcelona, Barcelona, Spain.
(6) Chaim Sheba Medical Center, Tel Hashomer, Israel.
(7) University College London Cancer Institute, London, UK.
(8) Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Barcelona, Spain.
(9) University Hospital Olomouc and Medical Faculty of Palacky, University Olomouc, Olomouc, Czech Republic.
(10) National and Kapodistrian University of Athens, Athens, Greece.
(11) Charles University Teaching Hospital, Hradec Králové, Czech Republic.
(12) Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.
(13) Hospital Elisabethinen Linz, Linz, Austria.
(14) AZ Sint-Jan, Brugge, Belgium.
(15) Hadassah Medical Center, Jerusalem, Israel.
(16) Meir Medical Center, Kfar-Saba, Israel.
(17) Southampton General Hospital, Hampshire, UK.
(18) Nicolaus Copernicus Hospital, Toruń, Poland.
(19) University of Pécs, Pécs, Hungary.
(20) University Hospital La Fe and Universidad Católica de València 'San Vicente Mártir', València, Spain.
(21) Medical University of Vienna, Vienna, Austria.
(22) Petz Aladár Megyei Oktató Kórház, Vasvári Pál, Hungary.
(23) Zamojski Szpital Niepubliczny, Zamosc, Poland.
(24) Hopital Huriez, CHRU, Lille, France.
(25) University Medicine Mainz, Mainz, Germany.
(26) Clinica di Ematologia Azienda Ospedaliero-Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy.
(27) Center for Oncology, Hematology with Outpatient Department and Palliative Care, Wilhelminenspital, Vienna, Austria.
(28) Onyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA, USA.
(29) Clínica Universidad de Navarra-CIMA-IDISNA, Navarra, Spain.
(30) Wilhelminen Cancer Research Institute, Vienna, Austria.
Date: Jul 15, 2016Haematology and Hameotherapy
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 carfilzomib vs control.
Median OS for single-agent carfilzomib was similar to that for an active doublet control regimen in heavily pretreated RRMM patients.
CITATION Leukemia. 2016 Jul 15. doi: 10.1038/leu.2016.176
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