@article {7050,
	title = {A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)},
	journal = {Leukemia},
	volume = {31},
	year = {2017},
	note = {Export Date: 18 February 2017References: Kumar, S.K., Rajkumar, S.V., Dispenzieri, A., Lacy, M.Q., Hayman, S.R., Buadi, F.K., Improved survival in multiple myeloma and the impact of novel therapies (2008) Blood, 111, pp. 2516-2520;Kumar, S.K., Therneau, T.M., Gertz, M.A., Lacy, M.Q., Dispenzieri, A., Rajkumar, S.V., Clinical course of patients with relapsed multiple myeloma (2004) Mayo Clin Proc, 79, pp. 867-874; 
Kumar, S.K., Lee, J.H., Lahuerta, J.J., Morgan, G., Richardson, P.G., Crowley, J., Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: A multicenter international myeloma working group study (2012) Leukemia, 26, pp. 149-157; 
Durie, B.G., Moreau, P., Sonneveld, P., Morgan, G.J., Lahuerta, J.J., Beksac, M., Regional differences in the treatment approaches for relapsed multiple myeloma: An IMF study (2012) J Clin Oncol, 30, p. 15s. , abstract 8095; 
Richardson, P.G., Sonneveld, P., Schuster, M., Irwin, D., Stadtmauer, E., Facon, T., Extended follow-up of a phase 3 trial in relapsed multiple myeloma: Final time-toevent results of the APEX trial (2007) Blood, 110, pp. 3557-3560; 
Anderson, K.C., Kyle, R.A., Rajkumar, S.V., Stewart, A.K., Weber, D., Richardson, P., Clinically relevant end points and new drug approvals for myeloma (2008) Leukemia, 22, pp. 231-239; 
Van De Donk, N.W., Lokhorst, H.M., Dimopoulous, M., Cavo, M., Morgan, G., Einsele, H., Treatment of relapsed and refractory multiple myeloma in the era of novel agents (2011) Cancer Treat Rev, 37, pp. 266-283; 
Dimopoulos, M.A., Richardson, P.G., Moreau, P., Anderson, K.C., Current treatment landscape for relapsed and/or refractory multiple myeloma (2015) Nat Rev Clin Oncol, 12, pp. 42-54; 
Offidani, M., Corvatta, L., Caraffa, P., Leoni, P., Pautasso, C., Larocca, A., Pomalidomide for the treatment of relapsed-refractory multiple myeloma: A review of biological and clinical data (2014) Expert Rev Anticancer Ther, 14, pp. 499-510; 
Siegel, D.S., Martin, T., Wang, M., Vij, R., Jakubowiak, A.J., Lonial, S., A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma (2012) Blood, 120, pp. 2817-2825; 
Jagannath, S., Vij, R., Stewart, A.K., Trudel, S., Jakubowiak, A.J., Reiman, T., An openlabel, single-arm pilot phase II study (PX-171-003-A0) of low-dose, single-agent carfilzomib in patients with relapsed and refractory multiple myeloma (2012) Clin Lymphoma Myeloma Leuk, 12, pp. 310-318; 
Vij, R., Siegel, D.S., Jagannath, S., Stewart, A.K., McDonagh, K., Bahlis, N., An openlabel, single-arm, phase 2 study of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib (2012) Br J Haematol, 158, pp. 739-748; 
Vij, R., Wang, M., Kaufman, J.L., Lonial, S., Jakubowiak, A.J., Stewart, A.K., An openlabel, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma (2012) Blood, 119, pp. 5661-5670; 
Badros, A.Z., Vij, R., Martin, T., Zonder, J.A., Kunkel, L., Wang, Z., Carfilzomib in multiple myeloma patients with renal impairment: Pharmacokinetics and safety (2013) Leukemia, 27, pp. 1707-1714; 
Siegel, D., Martin, T., Nooka, A., Harvey, R.D., Vij, R., Niesvizky, R., Integrated safety profile of single-agent carfilzomib: Experience from 526 patients enrolled in 4 phase II trials (2013) Haematologica, 98, pp. 1753-1761; 
Brandes, L.J., Israels, L.G., Weekly low-dose cyclophosphamide and alternate-day prednisone: An effective low toxicity regimen for advanced myeloma (1987) Eur J Haematol, 39, pp. 362-368; 
De Weerdt, O., Van De Donk, N.W., Veth, G., Bloem, A.C., Hagenbeek, A., Lokhorst, H.M., Continuous low-dose cyclophosphamide-prednisone is effective and well tolerated in patients with advanced multiple myeloma (2001) Neth J Med, 59, pp. 50-56; 
Zhou, F., Guo, L., Shi, H., Lin, C., Hou, J., Continuous administration of low-dose cyclophosphamide and prednisone as a salvage treatment for multiple myeloma (2010) Clin Lymphoma Myeloma Leuk, 10, pp. 51-55; 
Durie, B.G., Harousseau, J.L., Miguel, J.S., Blad{\'e}, J., Barlogie, B., Anderson, K., International uniform response criteria for multiple myeloma (2006) Leukemia, 20, pp. 1467-1473; 
Blad{\'e}, J., Samson, D., Reese, D., Apperley, J., Bj{\"o}rkstrand, B., Gahrton, G., Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (1998) Br J Haematol, 102, pp. 1115-1123; 
Richardson, P.G., Sonneveld, P., Schuster, M.W., Irwin, D., Stadtmauer, E.A., Facon, T., Bortezomib or high-dose dexamethasone for relapsed multiple myeloma (2005) N Engl J Med, 352, pp. 2487-2498; 
(2015) NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma Version 4, , http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf, accessed 23 April 2015; 
Stewart, A.K., Rajkumar, S.V., Dimopoulos, M.A., Masszi, T., {\v S}pika, I., Oriol, A., Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma (2015) N Engl J Med, 372, pp. 142-152; 
Dimopoulos, M.A., Moreau, P., Palumbo, A., Joshua, D., Pour, L., Hajek, R., Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): A randomised, phase 3, open-label, multicentre study (2016) Lancet Oncol, 17, pp. 27-38
},
	month = {2017},
	pages = {107 - 114},
	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. {\textcopyright} 2017 Macmillan Publishers Limited, part of Springer Nature.},
	url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-84978544451\&doi=10.1038\%2fleu.2016.176\&partnerID=40\&md5=80be47775f5c1f74c9e97da2d1ceb080},
	author = {H{\'a}jek, R. and Masszi, T. and Petrucci, M.T. and Palumbo, A. and Rosi{\~n}ol, L. and Nagler, A. and Yong, K.L. and Oriol, A. and Minarik, J. and Pour, L. and Dimopoulos, M.A. and Maisnar, V. and Rossi, D. and Kasparu, H. and Van Droogenbroeck, J. and Yehuda, D.B. and Hardan, I. and Jenner, M. and Calbecka, M. and D{\'a}vid, M. and De La Rubia, J. and Drach, J. and Gasztonyi, Z. and G{\'o}rnik, S. and Leleu, X. and Munder, M. and Offidani, M. and Zojer, N. and Rajangam, K. and Chang, Y.-L. and San-Miguel, J.F. and Ludwig, H.}
}
