Thalidomide-dexamethasone versus interferon-alpha-dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma: a prospective, multicentre, randomised study.
Maintenance therapy was explored in multiple myeloma (MM) patients after conventional thalidomide, dexamethasone and pegylated liposomal doxorubicin (ThaDD). Patients with newly or relapsed MM obtaining at least minor response after 6 ThaDD courses, were randomised to receive alpha-interferon (IFN) 3 MU 3 times a week or thalidomide 100 mg daily until relapse. Both groups also received pulsed dexamethasone 20 mg 4 d a month. Fifty-one patients were randomized in the IFN-dexamethasone (ID) arm and 52 in the thalidomide-dexamethasone (TD) arm. The characteristics of two groups were similar. A significantly better 2-years progression-free survival (PFS; 63% vs. 32%; P = 0.024) and overall survival (84% vs. 68%; P = 0.030) was observed in the thalidomide arm. In high-risk patients and in those achieving less than very good partial response after induction, TD fared better in term of PFS. Main side effects were peripheral neuropathy and constipation in TD group, fatigue, anorexia and haematological toxicity in ID arm. There was a 21% probability of discontinuation at 3 years in the thalidomide arm and 44% in the IFN arm (P = 0.014). Low-dose thalidomide plus pulsed low-dose dexamethasone after conventional thalidomide combination-based therapy was also feasible in the long term, enabling significantly better residual disease control if compared with a standard maintenance therapy.
Offidani
Massimo
M
Clinica di Ematologia Azienda Ospedaliero-Universitaria, Ospedali Riuniti Ancona, Ancona, Italy. m.offidani@ospedaliriuniti.marche.it
Corvatta
Laura
L
Polloni
Claudia
C
Piersantelli
Maria-Novella
MN
Gentili
Silvia
S
Galieni
Piero
P
Visani
Giuseppe
G
Alesiani
Francesco
F
Catarini
Massimo
M
Brunori
Marino
M
Samori
Arduino
A
Burattini
Maurizio
M
Centurioni
Riccardo
R
Ferranti
Mario
M
Giuliodori
Luciano
L
Candela
Marco
M
Mele
Anna
A
Marconi
Monica
M
Leoni
Pietro
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003907:Dexamethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D018709:Statistics, Nonparametric; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000627:therapeutic use
D007166:Immunosuppressive Agents; D016898:Interferon-alpha; D013792:Thalidomide; D003907:Dexamethasone