Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
Grantová podpora
Millennium Pharmaceuticals, Inc., Cambridge, MA, United States, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
PubMed
33769076
DOI
10.2217/fon-2020-1225
Knihovny.cz E-zdroje
- Klíčová slova
- effectiveness, ixazomib, multiple myeloma, proteasome inhibitor, relapsed/refractory, routine clinical practice,
- MeSH
- chemorezistence MeSH
- dexamethason aplikace a dávkování škodlivé účinky MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- glycin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- lenalidomid aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie mortalita MeSH
- mnohočetný myelom farmakoterapie mortalita patologie MeSH
- prospektivní studie MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sloučeniny boru aplikace a dávkování škodlivé účinky 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
- multicentrická studie MeSH
- pozorovací studie MeSH
- Názvy látek
- dexamethason MeSH
- glycin MeSH
- ixazomib MeSH Prohlížeč
- lenalidomid MeSH
- sloučeniny boru MeSH
Aim: To evaluate the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory multiple myeloma in routine clinical practice. Patients & methods: Patient-level data from the global, observational INSIGHT MM and the Czech Registry of Monoclonal Gammopathies were integrated and analyzed. Results: At data cut-off, 263 patients from 13 countries were included. Median time from diagnosis to start of IRd was 35.8 months; median duration of follow-up was 14.8 months. Overall response rate was 73%, median progression-free survival, 21.2 months and time-to-next therapy, 33.0 months. Ixazomib/lenalidomide dose reductions were required in 17%/36% of patients; 32%/30% of patients discontinued ixazomib/lenalidomide due to adverse events. Conclusion: The effectiveness and safety of IRd in routine clinical practice are comparable to those reported in TOURMALINE-MM1. Clinical trial registration: NCT02761187 (ClinicalTrials.gov).
Lay abstract Proteasome inhibitors are drugs used in multiple myeloma (MM), a blood cancer that develops from cells in the bone marrow. Ixazomib is the first oral proteasome inhibitor to be approved for use in MM, when given in combination with two other oral drugs, lenalidomide and dexamethasone, to adult patients who have received one prior therapy. Our study, which was conducted in routine clinical practice, found that the effectiveness and safety of ixazomib + lenalidomide + dexamethasone in previously treated MM patients were similar to those seen in the Phase III clinical trial on which approval was based. These findings are important because they suggest that MM patients in everyday practice can achieve the same benefits from this treatment as patients in clinical trials, despite often being in poorer health.
Advocate Aurora Research Institute Advocate Aurora Health Milwaukee WI 53227 USA
Alfred Health Monash University Melbourne 3004 Australia
Barbara Ann Karmanos Cancer Institute Wayne State University School of Medicine Detroit MI 48201 USA
Charles University Hospital and Faculty of Medicine Hradec Králové 121 08 Czech Republic
Clinica São Germano and Santa Casa Medical School São Paulo 04537 081 Brazil
Department of Hematology Hospital Universitario de Salamanca Salamanca 37007 Spain
Faculty Hospital Pilsen Pilsen 301 00 Czech Republic
General Teaching Hospital Prague 128 08 Czech Republic
Hospital Pablo Tobón Uribe Medellin 11001 Colombia
Icahn School of Medicine at Mount Sinai New York NY 10029 USA
Indiana University School of Medicine Indianapolis IN 46202 USA
Institute of Biostatistics and Analyses Ltd Brno 602 00 Czech Republic
Leeds Teaching Hospital Leeds LS1 3EX UK
Levine Cancer Institute Charlotte NC 115 27 USA
M D Anderson Cancer Center Houston TX 77030 USA
Moores Cancer Center University of California San Diego La Jolla CA 92037 USA
National and Kapodistrian University of Athens School of Medicine Athens 115 27 Greece
Palacky University and University Hospital Olomouc Olomouc 771 47 Czech Republic
Perlmutter Cancer Center NYU Langone New York NY 10016 USA
Pôle Régional de Cancérologie CHU de Poitiers Poitiers 86000 France
Rocky Mountain Cancer Centers US Oncology Research Denver CO 80218 USA
Sarah Cannon Research Institute Nashville TN 37203 USA
UMAE Especialidades Centro Medico La Raza IMSS Ciudad de México 02990 Mexico
University Hospital Brno 625 00 Czech Republic
University Medical Center Hamburg Eppendorf Hamburg 20251 Germany
University of Arkansas for Medical Sciences Little Rock AR 72205 USA
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT02761187
