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| Leukemia. 2016 Jul 15. pii: leu2016176. doi: 10.1038/leu.2016.176 |
| A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). |
| Hájek R1, Masszi T2, Petrucci MT3, Palumbo A4, Rosiñol L5, Nagler A6, Yong KL7, Oriol A8, Minarik J9, Pour L10, Dimopoulos MA11, Maisnar V12, Rossi D13, Kasparu H14, Van Droogenbroeck J15, Yehuda DB16, Hardan I17, Jenner M18, Calbecka M19, Dávid M20, de la Rubia J21, Drach J22, Gasztonyi Z23, Górnik S24, Leleu X25, Munder M26, Offidani M27, Zojer N28, Rajangam K29, Chang YL30, San-Miguel JF31, Ludwig H32 |
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Abstract 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.Leukemia advance online publication, 15 July 2016; doi:10.1038/leu.2016.176. |
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Publikations ID: 27416912 Quelle: öffnen |
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