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

被引：403

作者：

Rosinol, Laura

Oriol, Albert ^{[2
]}

Isabel Teruel, Ana ^{[3
]}

Hernandez, Dolores ^{[4
]}

Lopez-Jimenez, Javier ^{[5
]}

de la Rubia, Javier ^{[6
]}

Granell, Miquel ^{[7
]}

Besalduch, Joan ^{[8
]}

Palomera, Luis ^{[9
]}

Gonzalez, Yolanda ^{[10
]}

Asuncion Etxebeste, Ma ^{[11
]}

Diaz-Mediavilla, Joaquin ^{[12
]}

Hernandez, Miguel T. ^{[13
]}

de Arriba, Felipe ^{[14
]}

Gutierrez, Norma C. ^{[15
]}

Luisa Martin-Ramos, Ma ^{[16
]}

Teresa Cibeira, Ma

Victoria Mateos, Ma ^{[15
]}

Martinez, Joaquin ^{[16
]}

Alegre, Adrian ^{[17
]}

Jose Lahuerta, Juan ^{[16
]}

San Miguel, Jesus ^{[15
]}

Blade, Joan ^{[1
]}

机构：

[1] Hosp Clin Barcelona, Dept Hematol, E-08036 Barcelona, Spain

[2] Hosp Badalona Germans Trias & Pujol, Badalona, Spain

[3] Hosp Clin Univ Valencia, Valencia, Spain

[4] Hosp Univ La Paz, Madrid, Spain

[5] Hosp Ramon & Cajal, E-28034 Madrid, Spain

[6] Hosp La Fe, E-46009 Valencia, Spain

[7] Hosp Santa Creu & Sant Pau, Barcelona, Spain

[8] Hosp Son Espases, Palma De Mallorca, Spain

[9] Hosp Clin Univ Lozano Blesa, Zaragoza, Spain

[10] Hosp Univ Dr Josep Trueta, Giorna, Spain

[11] Hosp Donostia, Donostia San Sebastian, Spain

[12] Hosp Clin San Carlos, Madrid, Spain

[13] Hosp Univ Canarias, San Cristobal la Laguna, Spain

[14] Hosp Morales Messeguer, Murcia, Spain

[15] Hosp Clin Univ Salamanca, Salamanca, Spain

[16] Hosp Univ Doce Octubre, Madrid, Spain

[17] Hosp Univ La Princesa, Madrid, Spain

来源：

BLOOD | 2012年 / 120卷 / 08期

关键词：

STEM-CELL TRANSPLANTATION; HIGH-DOSE THERAPY; CONTINUED STANDARD CHEMOTHERAPY; PLUS DEXAMETHASONE; PERIPHERAL NEUROPATHY; COMPLETE RESPONSE; DOXORUBICIN; DELETION; TRIAL; ABNORMALITIES;

D O I：

10.1182/blood-2012-02-408922

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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)

引用

页码：1589 / 1596

页数：8

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