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Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth
MA. Dimopoulos, S. Lonial, D. White, P. Moreau, A. Palumbo, J. San-Miguel, O. Shpilberg, K. Anderson, S. Grosicki, I. Spicka, A. Walter-Croneck, H. Magen, MV. Mateos, A. Belch, D. Reece, M. Beksac, E. Bleickardt, V. Poulart, J. Sheng, O. Sy, J....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
28677826
DOI
10.1111/bjh.14787
Knihovny.cz E-zdroje
- MeSH
- dexamethason aplikace a dávkování škodlivé účinky MeSH
- humanizované monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- imunoglobuliny krev MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom farmakoterapie patologie MeSH
- následné studie MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- recidiva MeSH
- senioři MeSH
- thalidomid aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity.
AbbVie Biotherapeutics Inc Redwood City CA USA
Clinica Universidad de Navarra Investigación Médica Aplicada IDISNA CIBERONC Pamplona Spain
Clinical Pharmacology and Pharmacometrics Bristol Myers Squibb Lawrenceville NJ USA
Davidoff Cancer Center Rabin Medical Center Petah Tikva Israel
Department of Cancer Prevention Medical University of Silesia Katowice Poland
Department of Haematology Ankara University Ankara Turkey
Department of Haematology University Hospital Nantes France
Department of Medical Oncology and Haematology Princess Margaret Cancer Centre Toronto ON Canada
Department of Medical Oncology Dana Farber Cancer Institute Boston MA USA
Department of Oncology Cross Cancer Institute and University of Alberta Edmonton AB Canada
Division of Hematologic Oncology Dana Farber Cancer Institute Boston MA USA
Global Biometric Sciences Bristol Myers Squibb Lawrenceville NJ USA
Global Biostatistics Bristol Myers Squibb Lawrenceville NJ USA
Global Clinical Research Bristol Myers Squibb Lawrenceville NJ USA
Institute of Haematology Assuta Medical Centers Tel Aviv Israel
Oncology Clinical Development Bristol Myers Squibb Lawrenceville NJ USA
Citace poskytuje Crossref.org
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