Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma.
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.
Offidani
Massimo
M
Clinica di Ematologia Ospedali Riuniti Ancona, Via Conca, 71, 60020 Ancona, Italy. m.offidani@ao-umbertoprimo.marche.it
Corvatta
Laura
L
Piersantelli
Maria-Novella
MN
Visani
Giuseppe
G
Alesiani
Francesco
F
Brunori
Marino
M
Galieni
Piero
P
Catarini
Massimo
M
Burattini
Maurizio
M
Centurioni
Riccardo
R
Ferranti
Mario
M
Rupoli
Serena
S
Scortechini
Anna Rita
AR
Giuliodori
Luciano
L
Candela
Marco
M
Capelli
Debora
D
Montanari
Mauro
M
Olivieri
Attilio
A
Poloni
Antonella
A
Polloni
Claudia
C
Marconi
Monica
M
Leoni
Pietro
P
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
D020533:Angiogenesis Inhibitors; D018931:Antineoplastic Agents, Hormonal; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D013792:Thalidomide; D003907:Dexamethasone; D004317:Doxorubicin