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Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
- Source :
-
Blood [Blood] 2012 Jul 05; Vol. 120 (1), pp. 9-19. Date of Electronic Publication: 2012 Apr 12. - Publication Year :
- 2012
-
Abstract
- In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.
- Subjects :
- Antineoplastic Agents administration & dosage
Antineoplastic Agents, Hormonal administration & dosage
Boronic Acids administration & dosage
Bortezomib
Combined Modality Therapy
Dexamethasone administration & dosage
Disease-Free Survival
Female
Humans
Immunosuppressive Agents administration & dosage
Kaplan-Meier Estimate
Male
Middle Aged
Multiple Myeloma diagnosis
Prognosis
Pyrazines administration & dosage
Thalidomide administration & dosage
Transplantation, Autologous
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Hematopoietic Stem Cell Transplantation methods
Multiple Myeloma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0020
- Volume :
- 120
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 22498745
- Full Text :
- https://doi.org/10.1182/blood-2012-02-408898