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Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice
J. Minarik, T. Pika, J. Radocha, A. Jungova, J. Straub, T. Jelinek, L. Pour, P. Pavlicek, M. Mistrik, L. Brozova, P. Krhovska, K. Machalkova, P. Jindra, I. Spicka, H. Plonkova, M. Stork, J. Bacovsky, L. Capkova, M. Sykora, P. Kessler, L....
Jazyk angličtina Země Velká Británie
Typ dokumentu srovnávací studie, časopisecké články
NLK
BioMedCentral
od 2001-12-01
BioMedCentral Open Access
od 2001
Directory of Open Access Journals
od 2001
Free Medical Journals
od 2001
PubMed Central
od 2001
Europe PubMed Central
od 2001
ProQuest Central
od 2009-01-01
Open Access Digital Library
od 2001-01-01
Open Access Digital Library
od 2001-01-01
Open Access Digital Library
od 2001-01-01
Medline Complete (EBSCOhost)
od 2001-01-01
Health & Medicine (ProQuest)
od 2009-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2001
Springer Nature OA/Free Journals
od 2001-12-01
- MeSH
- aplikace orální MeSH
- chemorezistence MeSH
- dexamethason farmakologie terapeutické užití MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- glycin analogy a deriváty farmakologie terapeutické užití MeSH
- Kaplanův-Meierův odhad MeSH
- lenalidomid farmakologie terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie mortalita patologie MeSH
- mnohočetný myelom farmakoterapie mortalita patologie MeSH
- následné studie MeSH
- prospektivní studie MeSH
- protokoly protinádorové kombinované chemoterapie farmakologie terapeutické užití MeSH
- registrace statistika a číselné údaje MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sloučeniny boru farmakologie terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: We have performed a head to head comparison of all-oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRD) versus lenalidomide and dexamethasone (RD) in patients with relapsed and refractory multiple myeloma (RRMM) in the routine clinical practice. METHODS: A total of 344 patients treated with IRD (N = 127) or RD (N = 217) were selected for analysis from the Czech Registry of Monoclonal Gammopathies (RMG). Descriptive statistics were used to assess patient's characteristics associated with the respective therapy. The primary endpoint was progression free survival (PFS), secondary end points included response rates and overall survival (OS). Survival endpoints were plotted using Kaplan-Meier methodology at 95% Greenwood confidence interval. Univariable and multivariable Cox proportional hazards models were used to evaluate the effect of treatment regimens and the significance of uneven variables. Statistical tests were performed at significance level 0.05. RESULTS: In the whole cohort, median PFS for IRD was 17.5 and for RD was 11.5 months favoring the all-oral triplet, p = 0.005; in patients within relapse 1-3, the median PFS was 23.1 vs 11.6 months, p = 0.001. The hazard ratio for PFS was 0.67 (95% confidence interval [CI] 0.51-0.89, p = 0.006). The PFS advantage translated into improved OS for patients treated with IRD, median 36.6 months vs 26.0 months (p = 0.008). The overall response rate (ORR) was 73.0% in the IRD group vs 66.2% in the RD group with a complete response rate (CR) of 11.1% vs 8.8%, and very good partial response (VGPR) 22.2% vs 13.9%, IRD vs RD respectively. The IRD regimen was most beneficial in patients ≤75 years with ISS I, II, and in the first and second relapse. Patients with the presence of extramedullary disease did not benefit from IRD treatment (median PFS 6.5 months). Both regimens were well tolerated, and the incidence of total as well as grade 3/4 toxicities was comparable. CONCLUSIONS: Our analysis confirms the results of the TOURMALINE-MM1 study and shows benefit of all-oral triplet IRD treatment versus RD doublet. It demonstrates that the addition of ixazomib to RD improves key survival endpoints in patients with RRMM in a routine clinical setting.
Department of Clinical Hematology Hospital Ceske Budejovice Ceske Budejovice Czech Republic
Department of Hematology and Transfusion Medicine Hospital Pelhrimov Pelhrimov Czech Republic
Department of Hematology Hospital Liberec Liberec Czech Republic
Department of Hematology Silesian Hospital in Opava Opava Czech Republic
Hematology and Oncology Department Charles University Hospital Pilsen Pilsen Czech Republic
Institute of Biostatistics and Analyses Ltd Brno Czech Republic
Citace poskytuje Crossref.org
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