TY - JOUR
T1 - Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma
AU - Cavo, Michele
AU - Pantani, Lucia
AU - Petrucci, Maria Teresa
AU - Patriarca, Francesca
AU - Zamagni, Elena
AU - Donnarumma, Daniela
AU - Crippa, Claudia
AU - Boccadoro, Mario
AU - Perrone, Giulia
AU - Falcone, Antonietta
AU - Nozzoli, Chiara
AU - Zambello, Renato
AU - Masini, Luciano
AU - Furlan, Anna
AU - Brioli, Annamaria
AU - Derudas, Daniele
AU - Ballanti, Stelvio
AU - Dessanti, Maria Laura
AU - De Stefano, Valerio
AU - Carella, Angelo Michele
AU - Marcatti, Magda
AU - Nozza, Andrea
AU - Ferrara, Felicetto
AU - Callea, Vincenzo
AU - Califano, Catello
AU - Pezzi, Annalisa
AU - Baraldi, Anna
AU - Grasso, Mariella
AU - Musto, Pellegrino
AU - Palumbo, Antonio
PY - 2012
Y1 - 2012
N2 - In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484. (Blood. 2012;120(1):9-19)
AB - In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484. (Blood. 2012;120(1):9-19)
KW - MULTIPLE MYELOMA
KW - MULTIPLE MYELOMA
UR - http://hdl.handle.net/10807/39612
U2 - 10.1182/blood-2012-02-408898
DO - 10.1182/blood-2012-02-408898
M3 - Article
SN - 1528-0020
VL - 120
SP - 9
EP - 19
JO - Blood
JF - Blood
ER -