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Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study

Authors :
Rosiñol, Laura
Oriol, Albert
Teruel, Ana Isabel
Hernández, Dolores
López-Jiménez, Javier
de la Rubia, Javier
Granell, Miquel
Besalduch, Joan
Palomera, Luis
González, Yolanda
Etxebeste, Mª Asunción
Díaz-Mediavilla, Joaquín
Hernández, Miguel T.
de Arriba, Felipe
Gutiérrez, Norma C.
Martín-Ramos, Mª Luisa
Cibeira, Mª Teresa
Mateos, Mª Victoria
Martínez, Joaquín
Alegre, Adrián
Lahuerta, Juan José
San Miguel, Jesús
Bladé, Joan
Source :
Blood; August 2012, Vol. 120 Issue: 8 p1589-1596, 8p
Publication Year :
2012

Abstract

The Spanish Myeloma Group conducted a trial to compare bortezomib/thalidomide/dexamethasone (VTD) versus thalidomide/dexamethasone (TD) versus vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, doxorubicin, dexamethasone/bortezomib (VBMCP/VBAD/B) in patients aged 65 years or younger with multiple myeloma. The primary endpoint was complete response (CR) rate postinduction and post–autologous stem cell transplantation (ASCT). Three hundred eighty-six patients were allocated to VTD (130), TD (127), or VBMCP/VBAD/B (129). The CR rate was significantly higher with VTD than with TD (35% vs 14%, P = .001) or with VBMCP/VBAD/B (35% vs 21%, P = .01). The median progression-free survival (PFS) was significantly longer with VTD (56.2 vs 28.2 vs 35.5 months, P = .01). In an intention-to-treat analysis, the post-ASCT CR rate was higher with VTD than with TD (46% vs 24%, P = .004) or with VBMCP/VBAD/B (46% vs 38%, P = .1). Patients with high-risk cytogenetics had a shorter PFS and overall survival in the overall series and in all treatment groups. In conclusion, VTD resulted in a higher pre- and posttransplantation CR rate and in a significantly longer PFS although it was not able to overcome the poor prognosis of high-risk cytogenetics. Our results support the use of VTD as a highly effective induction regimen prior to ASCT. The study was registered with http://www.clinicaltrials.gov (NCT00461747) and Eudra CT (no. 2005-001110-41).

Details

Language :
English
ISSN :
00064971 and 15280020
Volume :
120
Issue :
8
Database :
Supplemental Index
Journal :
Blood
Publication Type :
Periodical
Accession number :
ejs28138177
Full Text :
https://doi.org/10.1182/blood-2012-02-408922