title: Short-term thalidomide incorporated into double autologous stem-cell transplantation improves outcomes in comparison with double autotransplantation for multiple myeloma.
abstract: OBJECTIVE
  To assess potential benefits with thalidomide incorporated into double autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM).
  
  
  METHODS
  One hundred thirty-five patients who received thalidomide from induction until the second ASCT were retrospectively analyzed in comparison with an equal number of pair mates treated with double ASCT not including thalidomide.
  
  
  RESULTS
  On an intention-to-treat basis, the addition of thalidomide to double ASCT effected a significant improvement in the rate (68% v 49%; P = .001) and duration (62% v 33% at 4 years; P < .001) of at least very good partial response (VGPR), time to progression (TTP; 61% v 41% at 4 years; P < .001) and progression-free survival (PFS; 51% v 31% at 4 years; P = .001). A trend was also noted for extended overall survival (OS) among thalidomide-treated patients (69% at 5 years v 53% for the control group), although the difference between the two groups was not statistically significant (P = .07). Benefits with thalidomide in increasing the rate of VGPR or better response, TTP, and PFS were confirmed in a multivariate analysis. Median OS after relapse was 24 months for patients receiving thalidomide added to double ASCT and 25 months for the control group. Overall, 17% of patients discontinued thalidomide, including 8% because of drug-related adverse events.
  
  
  CONCLUSIONS
  In comparison with double ASCT, the addition of first-line thalidomide to double ASCT improved clinical outcomes. Short-term thalidomide was generally well tolerated and had no adverse impact on postrelapse survival.
authors.affiliation: Dipartimento di Ematologia e Scienze Oncologiche Seràgnoli, Istituto di Ematologia Seràgnoli, Università di Bologna, Bologna, Italy. michele.cavo@unibo.it
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Elena
authors.initials: E
authors.lastname: Zamagni
authors.forename: Francesca
authors.initials: F
authors.lastname: Patriarca
authors.forename: Paola
authors.initials: P
authors.lastname: Tacchetti
authors.forename: Antonio Francesco
authors.initials: AF
authors.lastname: Casulli
authors.forename: Silvestro
authors.initials: S
authors.lastname: Volpe
authors.forename: Giulia
authors.initials: G
authors.lastname: Perrone
authors.forename: Antonio
authors.initials: A
authors.lastname: Ledda
authors.forename: Michela
authors.initials: M
authors.lastname: Ceccolini
authors.forename: Catello
authors.initials: C
authors.lastname: Califano
authors.forename: Catia
authors.initials: C
authors.lastname: Bigazzi
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Piero
authors.initials: P
authors.lastname: Stefani
authors.forename: Filippo
authors.initials: F
authors.lastname: Ballerini
authors.forename: Mauro
authors.initials: M
authors.lastname: Fiacchini
authors.forename: Antonio
authors.initials: A
authors.lastname: de Vivo
authors.forename: Annamaria
authors.initials: A
authors.lastname: Brioli
authors.forename: Patrizia
authors.initials: P
authors.lastname: Tosi
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D002066:Busulfan / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007372:Interferons / Q000008:administration & dosage; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D033581:Stem Cell Transplantation / Q000379:methods*; D013792:Thalidomide / Q000008:administration & dosage*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D013792:Thalidomide; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D007372:Interferons; D002066:Busulfan; D008558:Melphalan