Efficacy of low-dose thalidomide and dexamethasone as first salvage regimen in multiple myeloma.
OBJECTIVE
The efficacy of low-dose thalidomide (THAL) plus dexamethasone (DEX) has been evaluated in myeloma. The clinical outcome of patients treated with THAL-DEX was compared with that of a control group treated with conventional chemotherapy (CC).


METHODS
A total of 120 relapsed/refractory patients to one (52%), or two or more(48%) lines of chemotherapy were treated with THAL 100mg/day (continuous) and DEX 40 mg (days 1-4 of each month). Their clinical outcome was compared to a control group of 120 patients frequency matched for serum beta2-microglobulin levels and Durie and Salmon clinical stage. Clinical characteristics were homogeneous in the two groups.


RESULTS
In patients treated after one line of chemotherapy, THAL-DEX significantly improved outcome. Median progression-free survival (PFS) was superior in THAL-DEX group versus CC group (17 months versus 11 months, P = 0.0024). The median survival for THAL-DEX patients has not to been reached, but the probabilities of survival at 3 years were 60% after THAL-DEX and 26% after CC (P = 0.0016). The clinical outcome of patients receiving THAL-DEX or CC after two or more lines of chemotherapy, was similar. In the THAL-DEX group, the medianPFS was 11 months compared to 9 months in the CC group (P = NS). No differences in overall survival (OS) were observed (median OS 19 months for both THAL-DEX and CC).


CONCLUSIONS
As first salvage regimen, THAL-DEX was superior to CC, as second or third salvage regimen, it was equivalent to CC. THAL-DEX is not myelotoxic. It postpones the delivery of effective salvage chemotherapy. This might explain the survival benefit.
Palumbo
Antonio
A
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S Giovanni Battista di Torino, Torino, Italy.
Bertola
Alessandra
A
Falco
Patrizia
P
Rosato
Rosalba
R
Cavallo
Federica
F
Giaccone
Luisa
L
Bringhen
Sara
S
Musto
Pellegrino
P
Pregno
Patrizia
P
Caravita
Tommaso
T
Ciccone
Giovannino
G
Boccadoro
Mario
M
D003907:Dexamethasone / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D016879:Salvage Therapy / Q000379:methods; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
D013792:Thalidomide; D003907:Dexamethasone