title: Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma.
abstract: We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
authors.affiliation: Clinica di Ematologia Ospedali Riuniti Ancona, Via Conca, 71, 60020 Ancona, Italy. m.offidani@ao-umbertoprimo.marche.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Laura
authors.initials: L
authors.lastname: Corvatta
authors.forename: Maria-Novella
authors.initials: MN
authors.lastname: Piersantelli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Visani
authors.forename: Francesco
authors.initials: F
authors.lastname: Alesiani
authors.forename: Marino
authors.initials: M
authors.lastname: Brunori
authors.forename: Piero
authors.initials: P
authors.lastname: Galieni
authors.forename: Massimo
authors.initials: M
authors.lastname: Catarini
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: Serena
authors.initials: S
authors.lastname: Rupoli
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Scortechini
authors.forename: Luciano
authors.initials: L
authors.lastname: Giuliodori
authors.forename: Marco
authors.initials: M
authors.lastname: Candela
authors.forename: Debora
authors.initials: D
authors.lastname: Capelli
authors.forename: Mauro
authors.initials: M
authors.lastname: Montanari
authors.forename: Attilio
authors.initials: A
authors.lastname: Olivieri
authors.forename: Antonella
authors.initials: A
authors.lastname: Poloni
authors.forename: Claudia
authors.initials: C
authors.lastname: Polloni
authors.forename: Monica
authors.initials: M
authors.lastname: Marconi
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000494:pharmacology*; D018931:Antineoplastic Agents, Hormonal / Q000494:pharmacology*; D003907:Dexamethasone / Q000494:pharmacology*; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000494:pharmacology*; D011446:Prospective Studies; D012074:Remission Induction; D013792:Thalidomide / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D018931:Antineoplastic Agents, Hormonal; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D013792:Thalidomide; D003907:Dexamethasone; D004317:Doxorubicin