title: Thalidomide-dexamethasone versus interferon-alpha-dexamethasone as maintenance treatment after ThaDD induction for multiple myeloma: a prospective, multicentre, randomised study.
abstract: 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.
authors.affiliation: Clinica di Ematologia Azienda Ospedaliero-Universitaria, Ospedali Riuniti Ancona, Ancona, Italy. m.offidani@ospedaliriuniti.marche.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Laura
authors.initials: L
authors.lastname: Corvatta
authors.forename: Claudia
authors.initials: C
authors.lastname: Polloni
authors.forename: Maria-Novella
authors.initials: MN
authors.lastname: Piersantelli
authors.forename: Silvia
authors.initials: S
authors.lastname: Gentili
authors.forename: Piero
authors.initials: P
authors.lastname: Galieni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Visani
authors.forename: Francesco
authors.initials: F
authors.lastname: Alesiani
authors.forename: Massimo
authors.initials: M
authors.lastname: Catarini
authors.forename: Marino
authors.initials: M
authors.lastname: Brunori
authors.forename: Arduino
authors.initials: A
authors.lastname: Samori
authors.forename: Maurizio
authors.initials: M
authors.lastname: Burattini
authors.forename: Riccardo
authors.initials: R
authors.lastname: Centurioni
authors.forename: Mario
authors.initials: M
authors.lastname: Ferranti
authors.forename: Luciano
authors.initials: L
authors.lastname: Giuliodori
authors.forename: Marco
authors.initials: M
authors.lastname: Candela
authors.forename: Anna
authors.initials: A
authors.lastname: Mele
authors.forename: Monica
authors.initials: M
authors.lastname: Marconi
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
mesh_terms: 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
chemical_list: D007166:Immunosuppressive Agents; D016898:Interferon-alpha; D013792:Thalidomide; D003907:Dexamethasone