Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
34520219
DOI
10.1200/jco.21.01045
Knihovny.cz E-zdroje
- MeSH
- bortezomib aplikace a dávkování škodlivé účinky MeSH
- časové faktory MeSH
- dexamethason aplikace a dávkování škodlivé účinky MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- konsolidační chemoterapie MeSH
- lenalidomid aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mnohočetný myelom farmakoterapie mortalita patologie MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- reziduální nádor MeSH
- senioři MeSH
- staging nádorů MeSH
- udržovací chemoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- bortezomib MeSH
- dexamethason MeSH
- lenalidomid MeSH
PURPOSE: To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial. PATIENTS AND METHODS: The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS). RESULTS: Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response ≥ complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively (P < .001). Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without (P < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease-negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable. CONCLUSION: Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone.
Albert Schweitzer Ziekenhuis Dordrecht the Netherlands
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy
Department of Haematology Aalborg University Hospital Aalborg Denmark
Department of Haematology Alfred Hospital Monash University Melbourne Australia
Department of Hematology Ankara University School of Medicine Ankara Turkey
Department of Hematology Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Hematology Haga Ziekenhuis The Hague the Netherlands
Department of Hematology HOVON Data Center Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Hematology Oslo University Hospital Oslo Norway
Department of Hematology Radboud University Medical Centre Nijmegen the Netherlands
Department of Hematology St Olav Hospital Trondheim Norway
Department of Hematology University Medical Centre Utrecht the Netherlands
Department of Hematology ZNA Stuivenberg Antwerp Belgium
Department of Immunology Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Oncology Hematology Kantonsspital St Gallen Switzerland
HOVON Data Center Erasmus MC Cancer Institute Rotterdam the Netherlands
IRCCS Azienda Ospedaliero Universitaria di Bologna Istituto di Ematologia Seràgnoli Bologna Italy
Maastricht University Medical Center Maastricht the Netherlands
Medical Oncology Luzerner Kantonshospital Luzern Switzerland
Ospedale San Camillo Forlanini Rome Italy
Sahlgrenska University Hospital Gothenburg Sweden
University Hospital Brno Brno Czech Republic
University Hospital Ostrava Ostrava Czech Republic
Wilhelminen Cancer Research Institute c o Wilhelminenspital Vienna Austria
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01208766
