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Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study

MA. Dimopoulos, AK. Stewart, T. Masszi, I. Špička, A. Oriol, R. Hájek, L. Rosiñol, D. Siegel, GG. Mihaylov, V. Goranova-Marinova, P. Rajnics, A. Suvorov, R. Niesvizky, A. Jakubowiak, J. San-Miguel, H. Ludwig, A. Palumbo, M. Obreja, S. Aggarwal, P. Moreau,

. 2017 ; 177 (3) : 404-413. [pub] 20170217

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc17031033

A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old. Median PFS for patients <70 years old was 28·6 months for the carfilzomib group versus 17·6 months for the control group [hazard ratio (HR), 0·701]. Median PFS for patients ≥70 years old was 23·8 months for the carfilzomib group versus 16·0 months for the control group (HR, 0·753). For patients <70 years the overall response rate (ORR) was 86·0% (carfilzomib group) and 66·9% (control group); for patients ≥70 years old the ORR was 90·3% (carfilzomib group) and 66·1% (control group). Within the carfilzomib group, grade ≥3 cardiovascular adverse events occurred more frequently among patients ≥70 years old compared with patients <70 years old. Carfilzomib-lenalidomide-dexamethasone has a favourable benefit-risk profile for patients with RMM, including elderly patients ≥70 years old. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01080391.

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$a A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old. Median PFS for patients <70 years old was 28·6 months for the carfilzomib group versus 17·6 months for the control group [hazard ratio (HR), 0·701]. Median PFS for patients ≥70 years old was 23·8 months for the carfilzomib group versus 16·0 months for the control group (HR, 0·753). For patients <70 years the overall response rate (ORR) was 86·0% (carfilzomib group) and 66·9% (control group); for patients ≥70 years old the ORR was 90·3% (carfilzomib group) and 66·1% (control group). Within the carfilzomib group, grade ≥3 cardiovascular adverse events occurred more frequently among patients ≥70 years old compared with patients <70 years old. Carfilzomib-lenalidomide-dexamethasone has a favourable benefit-risk profile for patients with RMM, including elderly patients ≥70 years old. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01080391.
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$a Stewart, A Keith $u Mayo Clinic, Scottsdale, AZ, USA.
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$a Masszi, Tamás $u St István and St Laszlo Hospital, 3rd Dept. of Internal Medicine, Semmelweis University, Budapest, Hungary.
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$a Špička, Ivan $u First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
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$a Oriol, Albert $u Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Barcelona, Spain.
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$a Hájek, Roman $u University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
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$a Rosiñol, Laura $u Hospital Clínic de Barcelona, Barcelona, Spain.
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$a Siegel, David $u John Theurer Cancer Center at Hackensack University, Hackensack, NJ, USA.
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$a Mihaylov, Georgi G $u Queen Joanna University Hospital, Sofia, Bulgaria.
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$a Goranova-Marinova, Vesselina $u Haematology Clinic University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria.
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$a Rajnics, Péter $u Department of Haematology, Mór Kaposi Teaching Hospital, Kaposvár, Hungary.
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$a Suvorov, Aleksandr $u Haematological Department, First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.
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$a Niesvizky, Ruben $u Weill Cornell Medical College, New York, NY, USA.
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$a Jakubowiak, Andrzej $u University of Chicago Medical Center, Chicago, IL, USA.
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$a San-Miguel, Jesus $u Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.
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$a Ludwig, Heinz $u Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.
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$a Palumbo, Antonio $u University of Torino, Torino, Italy.
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$a Obreja, Mihaela $u Onyx Pharmaceuticals, Inc. an Amgen subsidiary, South San Francisco, CA, USA.
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$a Aggarwal, Sanjay $u Onyx Pharmaceuticals, Inc. an Amgen subsidiary, South San Francisco, CA, USA. $7 gn_A_00002142
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