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

Autores de IIS La Fe

• María Dolores Hernandez Fernandez De Rojas

  Autor

• 

  Javier De La Rubia Comos

  Autor

• Abelardo Garcia De Lorenzo Mateos

  Autor

• Jesus Antonio Martinez Dominguez

  Autor

Participantes ajenos a IIS La Fe

• Rosiñol L
• Oriol A
• Teruel AI
• López-Jiménez J
• Granell M
• Besalduch J
• Palomera L
• González Y
• Etxebeste MA
• Díaz-Mediavilla J
• Hernández MT
• de Arriba F
• Gutiérrez NC
• Martín-Ramos ML
• Cibeira MT
• Alegre A
• Lahuerta JJ
• San Miguel J
• Bladé J
• Programa para el Estudio y la Terapéutica de las Hemopatías Malignas/Grupo Españ

Grupos

• Alergia y enfermedades respiratorias de la Infancia

• Hematología y Hemoterapia

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).