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Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma
H. Avet-Loiseau, R. Fonseca, D. Siegel, MA. Dimopoulos, I. Špička, T. Masszi, R. Hájek, L. Rosiñol, V. Goranova-Marinova, G. Mihaylov, V. Maisnar, MV. Mateos, M. Wang, R. Niesvizky, A. Oriol, A. Jakubowiak, J. Minarik, A. Palumbo, W. Bensinger,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
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- MeSH
- dexamethason aplikace a dávkování MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- mladiství MeSH
- mnohočetný myelom farmakoterapie mortalita MeSH
- oligopeptidy aplikace a dávkování MeSH
- přežití po terapii bez příznaků nemoci MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování MeSH
- recidiva MeSH
- rizikové faktory MeSH
- senioři MeSH
- thalidomid aplikace a dávkování analogy a deriváty MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization. Of 417 patients with known cytogenetic risk status, 100 patients (24%) were categorized with high-risk cytogenetics (KRd, n = 48; Rd, n = 52) and 317 (76%) were categorized with standard-risk cytogenetics (KRd, n = 147; Rd, n = 170). For patients with high-risk cytogenetics, treatment with KRd resulted in a median PFS of 23.1 months, a 9-month improvement relative to treatment with Rd. For patients with standard-risk cytogenetics, treatment with KRd led to a 10-month improvement in median PFS vs Rd. The overall response rates for KRd vs Rd were 79.2% vs 59.6% (high-risk cytogenetics) and 91.2% vs 73.5% (standard-risk cytogenetics); approximately fivefold as many patients with high- or standard-risk cytogenetics achieved a complete response or better with KRd vs Rd (29.2% vs 5.8% and 38.1% vs 6.5%, respectively). KRd improved but did not abrogate the poor prognosis associated with high-risk cytogenetics. This regimen had a favorable benefit-risk profile in patients with relapsed MM, irrespective of cytogenetic risk status, and should be considered a standard of care in these patients. This trial was registered at www.clinicaltrials.gov as #NCT01080391.
Centre de Recherche en Cancérologie de Toulouse INSERM U1037 Toulouse France
Charles University Faculty Hospital and Faculty of Medicine Hradec Králové Czech Republic
Department of Hemato oncology University Hospital Olomouc Olomouc Czech Republic
Department of Internal Medicine University Hospital Praha Czech Republic
Fred Hutchinson Cancer Research Center Seattle WA
Hadassah Hebrew University Medical Center Jerusalem Israel
Hospital Clínic de Barcelona Barcelona Spain
Institut Català d'Oncologia Institut Josep Carreras Hospital Germans Trias i Pujol Barcelona Spain
John Theurer Cancer Center at Hackensack University Hackensack NJ
National and Kapodistrian University of Athens Athens Greece
Onyx Pharmaceuticals Inc South San Francisco CA
Princess Margaret Cancer Centre Toronto ON Canada
Queen Joanna University Hospital Sofia Bulgaria
St István and St Laszlo Hospital Budapest Hungary
The University of Texas MD Anderson Cancer Center Houston TX
University Hospital of Salamanca Instituto de Investigación Biomédica de Salamanca Salamanca Spain
University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic
University of Chicago Medical Center Chicago IL
University of Nantes Nantes France
University of Torino Torino Italy
Weill Cornell Medical College New York Presbyterian Hospital New York NY
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- $a The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization. Of 417 patients with known cytogenetic risk status, 100 patients (24%) were categorized with high-risk cytogenetics (KRd, n = 48; Rd, n = 52) and 317 (76%) were categorized with standard-risk cytogenetics (KRd, n = 147; Rd, n = 170). For patients with high-risk cytogenetics, treatment with KRd resulted in a median PFS of 23.1 months, a 9-month improvement relative to treatment with Rd. For patients with standard-risk cytogenetics, treatment with KRd led to a 10-month improvement in median PFS vs Rd. The overall response rates for KRd vs Rd were 79.2% vs 59.6% (high-risk cytogenetics) and 91.2% vs 73.5% (standard-risk cytogenetics); approximately fivefold as many patients with high- or standard-risk cytogenetics achieved a complete response or better with KRd vs Rd (29.2% vs 5.8% and 38.1% vs 6.5%, respectively). KRd improved but did not abrogate the poor prognosis associated with high-risk cytogenetics. This regimen had a favorable benefit-risk profile in patients with relapsed MM, irrespective of cytogenetic risk status, and should be considered a standard of care in these patients. This trial was registered at www.clinicaltrials.gov as #NCT01080391.
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