• Je něco špatně v tomto záznamu ?

Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk

K. Weisel, A. Spencer, S. Lentzsch, H. Avet-Loiseau, TM. Mark, I. Spicka, T. Masszi, B. Lauri, MD. Levin, A. Bosi, V. Hungria, M. Cavo, JJ. Lee, A. Nooka, H. Quach, M. Munder, C. Lee, W. Barreto, P. Corradini, CK. Min, AA. Chanan-Khan, N....

. 2020 ; 13 (1) : 115. [pub] 20200820

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21020249

BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. RESULTS: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.

Ankara University Ankara Turkey

Clinical Department of Haematology 1st Medical Department Charles University Prague Prague Czech Republic

Department of Hematology Careggi Hospital and University of Florence Firenze Italy

Department of Hematology Oncology Chonnam National University Hwasun Hospital Hwasun Jeollanamdo South Korea

Department of Hematology Sunderbyn Hospital Luleå Sweden

Department of Internal Medicine Albert Schweitzer Hospital Dordrecht The Netherlands

Department of Internal Medicine Pusan National University Hospital Busan South Korea

Department of Medicine University of Colorado Aurora CO USA

Department of Oncology Hematology and Bone Marrow Transplantation with Section of Pneumology University Medical Center Hamburg Eppendorf Hamburg Germany

Division of Hematology Oncology Columbia University New York NY USA

Erasmus MC Rotterdam The Netherlands

Fondazione IRCCS Istituto Nazionale dei Tumori University of Milan Milan Italy

Hospital Angeles Lomas Naucalpan de Juárez y alrededores Mexico

Instituto do Cancer Hospital Mae de Deus Porto Alegre Brazil

Irmandade Da Santa Casa De Misericordia De São Paulo São Paulo Brazil

Janssen Global Scientific Affairs Horsham PA USA

Janssen Research and Development LLC Beerse Belgium

Janssen Research and Development LLC Raritan NJ USA

Janssen Research and Development LLC Spring House PA USA

László Hospital 3rd Department of Internal Medicine Semmelweis University Budapest Hungary

Malignant Haematology and Stem Cell Transplantation Service Alfred Health Monash University Melbourne Australia

Mayo Clinic Florida Jacksonville FL USA

Royal Adelaide Hospital North Terrace Adelaide Australia

Seoul St Mary's Hospital Seoul South Korea

Seràgnoli Institute of Hematology Department of Experimental Diagnostic and Specialty Medicine University of Bologna Bologna Italy

Ulsan University Hospital Ulsan South Korea

Unite de Genomique du Myelome CHU Rangueil Toulouse France

University Hospital of Salamanca IBSAL Cancer Research Center IBMCC Salamanca Spain

University Medical Center of the Johannes Gutenberg University 3rd Department of Medicine Mainz Germany

University of Melbourne St Vincent's Hospital Melbourne Australia

University of São Paulo Ribeirão Preto Brazil

Winship Cancer Institute Emory University Atlanta GA USA

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21020249
003      
CZ-PrNML
005      
20210830101852.0
007      
ta
008      
210728s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1186/s13045-020-00948-5 $2 doi
035    __
$a (PubMed)32819447
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Weisel, Katja $u Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.weisel@uke.de
245    10
$a Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk / $c K. Weisel, A. Spencer, S. Lentzsch, H. Avet-Loiseau, TM. Mark, I. Spicka, T. Masszi, B. Lauri, MD. Levin, A. Bosi, V. Hungria, M. Cavo, JJ. Lee, A. Nooka, H. Quach, M. Munder, C. Lee, W. Barreto, P. Corradini, CK. Min, AA. Chanan-Khan, N. Horvath, M. Capra, M. Beksac, R. Ovilla, JC. Jo, HJ. Shin, P. Sonneveld, T. Casneuf, N. DeAngelis, H. Amin, J. Ukropec, R. Kobos, MV. Mateos
520    9_
$a BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. RESULTS: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.
650    _2
$a abnormální karyotyp $7 D059786
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a monoklonální protilátky $x aplikace a dávkování $7 D000911
650    _2
$a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $7 D000971
650    _2
$a bortezomib $x aplikace a dávkování $7 D000069286
650    _2
$a dexamethason $x aplikace a dávkování $7 D003907
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    _2
$a lidé $7 D006801
650    _2
$a hybridizace in situ fluorescenční $7 D017404
650    _2
$a Kaplanův-Meierův odhad $7 D053208
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a mnohočetný myelom $x farmakoterapie $x genetika $x patologie $7 D009101
650    _2
$a reziduální nádor $7 D018365
650    _2
$a doba přežití bez progrese choroby $7 D000077982
650    _2
$a recidiva $7 D012008
650    _2
$a riziko $7 D012306
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Spencer, Andrew $u Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia
700    1_
$a Lentzsch, Suzanne $u Division of Hematology/Oncology, Columbia University, New York, NY, USA
700    1_
$a Avet-Loiseau, Hervé $u Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France
700    1_
$a Mark, Tomer M $u Department of Medicine, University of Colorado, Aurora, CO, USA
700    1_
$a Spicka, Ivan $u Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic
700    1_
$a Masszi, Tamas $u László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary
700    1_
$a Lauri, Birgitta $u Department of Hematology, Sunderbyn Hospital, Luleå, Sweden
700    1_
$a Levin, Mark-David $u Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands
700    1_
$a Bosi, Alberto $u Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy
700    1_
$a Hungria, Vania $u Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil
700    1_
$a Cavo, Michele $u "Seràgnoli" Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy
700    1_
$a Lee, Je-Jung $u Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea
700    1_
$a Nooka, Ajay $u Winship Cancer Institute, Emory University, Atlanta, GA, USA
700    1_
$a Quach, Hang $u University of Melbourne, St Vincent's Hospital, Melbourne, Australia
700    1_
$a Munder, Markus $u University Medical Center of the Johannes Gutenberg University, Third Department of Medicine, Mainz, Germany
700    1_
$a Lee, Cindy $u Royal Adelaide Hospital, North Terrace, Adelaide, Australia
700    1_
$a Barreto, Wolney $u University of São Paulo, Ribeirão Preto, Brazil
700    1_
$a Corradini, Paolo $u Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy
700    1_
$a Min, Chang-Ki $u Seoul St. Mary's Hospital, Seoul, South Korea
700    1_
$a Chanan-Khan, Asher A $u Mayo Clinic Florida, Jacksonville, FL, USA
700    1_
$a Horvath, Noemi $u Royal Adelaide Hospital, North Terrace, Adelaide, Australia
700    1_
$a Capra, Marcelo $u Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil
700    1_
$a Beksac, Meral $u Ankara University, Ankara, Turkey
700    1_
$a Ovilla, Roberto $u Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, Mexico
700    1_
$a Jo, Jae-Cheol $u Ulsan University Hospital, Ulsan, South Korea
700    1_
$a Shin, Ho-Jin $u Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea
700    1_
$a Sonneveld, Pieter $u Erasmus MC, Rotterdam, The Netherlands
700    1_
$a Casneuf, Tineke $u Janssen Research & Development, LLC, Beerse, Belgium
700    1_
$a DeAngelis, Nikki $u Janssen Research & Development, LLC, Spring House, PA, USA
700    1_
$a Amin, Himal $u Janssen Research & Development, LLC, Raritan, NJ, USA
700    1_
$a Ukropec, Jon $u Janssen Global Scientific Affairs, Horsham, PA, USA
700    1_
$a Kobos, Rachel $u Janssen Research & Development, LLC, Raritan, NJ, USA
700    1_
$a Mateos, Maria-Victoria $u University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain
773    0_
$w MED00165458 $t Journal of hematology & oncology $x 1756-8722 $g Roč. 13, č. 1 (2020), s. 115
856    41
$u https://pubmed.ncbi.nlm.nih.gov/32819447 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210728 $b ABA008
991    __
$a 20210830101852 $b ABA008
999    __
$a ok $b bmc $g 1690935 $s 1140695
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 13 $c 1 $d 115 $e 20200820 $i 1756-8722 $m Journal of hematology & oncology $n J Hematol Oncol $x MED00165458
LZP    __
$a Pubmed-20210728

Najít záznam

Citační ukazatele

    Možnosti archivace