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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

2012; Elsevier BV; Volume: 120; Issue: 8 Linguagem: Inglês

10.1182/blood-2012-02-408922

1528-0020

Laura Rosiñol, Albert Oriol, Ana Isabel Teruel, Dolores Hernández‐Maraver, Javier López‐Jiménez, Javier de la Rubia, Miquel Granell, Joan Besalduch, Luis Palomera, Yolanda Campos, Ma Asunción Etxebeste, Joaquín Diaz‐Mediavilla, Miguel‐Teodoro Hernández, Felipe de Arriba, Norma C. Gutiérrez, Ma Luisa Martín-Ramos, Ma Teresa Cibeira, Ma Victoria Mateos, Joaquín Martínez‐López, Adrián Alegre, Juan José Lahuerta, Jesús F. San Miguel, Joan Bladé,

Cancer therapeutics and mechanisms

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).