Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study
Por:
Rosinol, L, Oriol, A, Teruel, AI, Hernandez, D, Lopez-Jimenez, J, de la Rubia, J, Granell, M, Besalduch, J, Palomera, L, Gonzalez, Y, Etxebeste, MA, Diaz-Mediavilla, J, Hernandez, MT, de Arriba, F, Gutierrez, NC, Martin-Ramos, ML, Cibeira, MT, Mateos, MV, Martinez, J, Alegre, A, Lahuerta, JJ, San Miguel, J, Blade, J
Publicada:
23 ago 2012
Resumen:
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). (Blood. 2012;120(8):1589-1596)
Filiaciones:
Oriol, A:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Teruel, AI:
Hosp Clin Univ Valencia, Valencia, Spain
Hernandez, D:
Hosp Univ La Paz, Madrid, Spain
Lopez-Jimenez, J:
Hosp Ramon & Cajal, E-28034 Madrid, Spain
de la Rubia, J:
Hosp La Fe, E-46009 Valencia, Spain
Granell, M:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Besalduch, J:
Hosp Son Espases, Palma De Mallorca, Spain
Palomera, L:
Hosp Clin Univ Lozano Blesa, Zaragoza, Spain
Gonzalez, Y:
Hosp Univ Dr Josep Trueta, Giorna, Spain
Etxebeste, MA:
Hosp Donostia, Donostia San Sebastian, Spain
Diaz-Mediavilla, J:
Hosp Clin San Carlos, Madrid, Spain
Hernandez, MT:
Hosp Univ Canarias, San Cristobal La Laguna, Spain
de Arriba, F:
Hosp Morales Messeguer, Murcia, Spain
Gutierrez, NC:
Hosp Clin Univ Salamanca, Salamanca, Spain
Martin-Ramos, ML:
Hosp Univ Doce Octubre, Madrid, Spain
Mateos, MV:
Hosp Clin Univ Salamanca, Salamanca, Spain
Martinez, J:
Hosp Univ Doce Octubre, Madrid, Spain
Alegre, A:
Hosp Univ La Princesa, Madrid, Spain
Lahuerta, JJ:
Hosp Univ Doce Octubre, Madrid, Spain
San Miguel, J:
Hosp Clin Univ Salamanca, Salamanca, Spain
Blade, J:
Hosp Clin Barcelona, Dept Hematol, E-08036 Barcelona, Spain
Bronze
|