title: Thalidomide-dexamethasone plus pegylated liposomal doxorubicin vs. thalidomide-dexamethasone: a case-matched study in advanced multiple myeloma.
abstract: OBJECTIVE
  Nearly all patients with multiple myeloma (MM) relapse or become refractory to front-line therapy. Several salvage therapies have been explored, but the optimal combination regimen has not been defined. We performed a case-matched study comparing patients with relapsed/refractory MM receiving thalidomide-dexamethasone alone or the combination thalidomide-dexamethasone-liposomal pegylated doxorubicin.
  
  
  METHODS
  Forty-seven patients received thalidomide (100 mg/d), dexamethasone (40 mg p.o. on days 1-4 and 9-12), and pegylated liposomal doxorubicin (40 mg/m(2) on day 1 every 28 d) (ThaDD). Their clinical outcome was compared with that of 47 pair mates selected from patients treated at relapse with thalidomide (100 mg/d) and dexamethasone (40 mg p.o. on days 1-4) (Thal-Dex) and matched for age, beta2-microglobulin and previous therapy.
  
  
  CONCLUSIONS
  Overall response rate was significantly higher in ThaDD group (92% vs. 63.5%; P < 0.0001) as partial response rate (> or =PR) (75.5% vs. 59.5%; P = 0.077), very good partial response rate (> or =VGPR) (36% vs. 15%; P = 0.018) and near complete remission rate (> or =nCR) (30% vs. 10.5%; P = 0.002). Non-hematologic toxicity was similar in the two groups of patients whereas hematologic toxicity and infections were significantly higher in ThaDD patients. Median progression-free survival, event-free survival, and overall survival were significantly longer in patients receiving ThaDD than in those treated with Thal-Dex. ThaDD regimen significantly improved response rate and overall survival in comparison with Thal-Dex. Although the frequency of hematologic toxicity and infections resulted higher in ThaDD group compared with control group, they were not particularly frequent after adequate prophylaxis was added and were easily managed when occurred.
authors.affiliation: Clinica di Ematologia Polo Ospedaliero-Universitario, Ospedali Riuniti Ancona Università Politecnica delle Marche, Ancona, Italy. m.offidani@ao-umbertoprimo.marche.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.forename: Laura
authors.initials: L
authors.lastname: Corvatta
authors.forename: Patrizia
authors.initials: P
authors.lastname: Falco
authors.forename: Monica
authors.initials: M
authors.lastname: Marconi
authors.forename: Ilaria
authors.initials: I
authors.lastname: Avonto
authors.forename: Maria-Novella
authors.initials: MN
authors.lastname: Piersantelli
authors.forename: Claudia
authors.initials: C
authors.lastname: Polloni
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.forename: Pietro
authors.initials: P
authors.lastname: Leoni
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016022:Case-Control Studies; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012189:Retrospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D008081:Liposomes; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D013792:Thalidomide; D003907:Dexamethasone; D004317:Doxorubicin