Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma
Jazyk angličtina Země Spojené státy americké Médium electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
30796199
PubMed Central
PMC6386751
DOI
10.1038/s41408-019-0181-0
PII: 10.1038/s41408-019-0181-0
Knihovny.cz E-zdroje
- MeSH
- adherence pacienta MeSH
- bortezomib MeSH
- chemorezistence MeSH
- dexamethason MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru MeSH
- mnohočetný myelom diagnóza farmakoterapie epidemiologie MeSH
- oligopeptidy MeSH
- protokoly antitumorózní kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- průzkumy a dotazníky MeSH
- průzkumy zdravotní péče MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- bortezomib MeSH
- carfilzomib MeSH Prohlížeč
- dexamethason MeSH
- oligopeptidy MeSH
We examined effects of carfilzomib-dexamethasone (Kd56) versus bortezomib-dexamethasone (Vd) on health-related quality of life (HR-QoL) in relapsed/refractory multiple myeloma (MM) patients from the ENDEAVOR study. HR-QoL was assessed by the European Organisation for Research and Treatment of Cancer QoL Questionnaire (QLQ-C30), MM-specific module (QLQ-MY20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx) "Additional Concerns" neurotoxicity subscale. The QLQ-C30 Global Health Status (GHS)/QoL scale and seven prespecified subscales were compared between groups using mixed model for repeated measures. Of 929 randomized patients, 911 with ≥1 post-baseline assessment were included. Kd56 was associated with statistically significant improvements in GHS/QoL, fatigue, pain, side effects, and FACT/GOG-Ntx scores versus Vd, although mean differences did not meet thresholds for clinical significance. The Kd56 group had longer time to deterioration (TTD) in GHS/QoL (median 3.7 versus 2.8 months, p = 0.0046), physical function (5.6 versus 3.7 months, p = 0.0390), nausea/vomiting (17.6 versus 8.2 months, p = 0.0358), side effects (6.4 versus 3.7 months p < 0.0001), and FACT/GOG-Ntx (11.1 versus 5.5 months, p = 0.0004). Overall, Kd56 resulted in statistically but not clinically significant improvements in mean GHS/QoL scores versus Vd. Treatment with Kd56 versus Vd also significantly prolonged TTD in GHS/QoL, physical function, nausea/vomiting, side effects, and FACT/GOG-Ntx.
Amgen Inc Thousand Oaks CA USA
National and Kapodistrian University of Athens School of Medicine Athens Greece
The Institute of Cancer Research London UK
Universitatsklinikum Tubingen Tubingen Germany
University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic
University Hospital Salamanca Salamanca Spain
University of Nantes Nantes France
Wilhelminen Cancer Research Institute Wilhelminenhospital Vienna Austria
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