Short-term thalidomide incorporated into double autologous stem-cell transplantation improves outcomes in comparison with double autotransplantation for multiple myeloma.
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.
Cavo
Michele
M
Dipartimento di Ematologia e Scienze Oncologiche Seràgnoli, Istituto di Ematologia Seràgnoli, Università di Bologna, Bologna, Italy. michele.cavo@unibo.it
Di Raimondo
Francesco
F
Zamagni
Elena
E
Patriarca
Francesca
F
Tacchetti
Paola
P
Casulli
Antonio Francesco
AF
Volpe
Silvestro
S
Perrone
Giulia
G
Ledda
Antonio
A
Ceccolini
Michela
M
Califano
Catello
C
Bigazzi
Catia
C
Offidani
Massimo
M
Stefani
Piero
P
Ballerini
Filippo
F
Fiacchini
Mauro
M
de Vivo
Antonio
A
Brioli
Annamaria
A
Tosi
Patrizia
P
Baccarani
Michele
M
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
D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D013792:Thalidomide; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D007372:Interferons; D002066:Busulfan; D008558:Melphalan