title: Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
abstract: 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.
authors.affiliation: Istituto di Ematologia Seràgnoli, Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. michele.cavo@unibo.it
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
authors.forename: Lucia
authors.initials: L
authors.lastname: Pantani
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Francesca
authors.initials: F
authors.lastname: Patriarca
authors.forename: Elena
authors.initials: E
authors.lastname: Zamagni
authors.forename: Daniela
authors.initials: D
authors.lastname: Donnarumma
authors.forename: Claudia
authors.initials: C
authors.lastname: Crippa
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.forename: Giulia
authors.initials: G
authors.lastname: Perrone
authors.forename: Antonietta
authors.initials: A
authors.lastname: Falcone
authors.forename: Chiara
authors.initials: C
authors.lastname: Nozzoli
authors.forename: Renato
authors.initials: R
authors.lastname: Zambello
authors.forename: Luciano
authors.initials: L
authors.lastname: Masini
authors.forename: Anna
authors.initials: A
authors.lastname: Furlan
authors.forename: Annamaria
authors.initials: A
authors.lastname: Brioli
authors.forename: Daniele
authors.initials: D
authors.lastname: Derudas
authors.forename: Stelvio
authors.initials: S
authors.lastname: Ballanti
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Dessanti
authors.forename: Valerio
authors.initials: V
authors.lastname: De Stefano
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.forename: Magda
authors.initials: M
authors.lastname: Marcatti
authors.forename: Andrea
authors.initials: A
authors.lastname: Nozza
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Callea
authors.forename: Catello
authors.initials: C
authors.lastname: Califano
authors.forename: Annalisa
authors.initials: A
authors.lastname: Pezzi
authors.forename: Anna
authors.initials: A
authors.lastname: Baraldi
authors.forename: Mariella
authors.initials: M
authors.lastname: Grasso
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy*; D011379:Prognosis; D011719:Pyrazines / Q000008:administration & dosage; D013792:Thalidomide / Q000008:administration & dosage; D014182:Transplantation, Autologous
chemical_list: D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D001897:Boronic Acids; D007166:Immunosuppressive Agents; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone