title: Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial.
abstract: High-dose therapy is an effective standard treatment for multiple myeloma patients. Evidence that intermediate-dose therapy improves survival is limited. At diagnosis, about 70% of patients are older than 65. Intermediate-dose regimen is very well tolerated in older patients. In a multicenter study, 194 patients were randomized to receive at diagnosis either conventional chemotherapy (6 courses of oral melphalan and prednisone [MP]) or intermediate-dose therapy (2 courses of melphalan at 100 mg/m(2) [MEL100]) with stem cell support. Response rate was higher after MEL100. Near-complete remission (nCR) was 6% after MP and 25% after MEL100 (P = .0002). At 3 years, MEL100 increased event-free survival (EFS) from 16% to 37% and overall survival (OS) from 62% to 77% (P < .001). Similar results were observed in patients aged 65 to 70: nCR was 8% after MP and 25% after MEL100 (P = .05); at 3 years, MEL100 improved EFS from 18% to 31% (P = .01) and OS from 58% to 73% (P = .01). Patients aged 65 to 70 had a median OS of 37.2 months (MP) versus 58 months (MEL100). Intermediate-dose melphalan improves response rate, EFS, and OS in myeloma patients, specifically in those aged 65 to 70. It constitutes a more effective first-line regimen than standard treatment for elderly patients.
authors.affiliation: Divisione di Ematologia dell'Università di Torino, Ospedale Molinette, Via Genova 3, 10126 Torino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Fausto
authors.initials: F
authors.lastname: Rossini
authors.forename: Martina
authors.initials: M
authors.lastname: Nunzi
authors.forename: Vito Michele
authors.initials: VM
authors.lastname: Lauta
authors.forename: Cesare
authors.initials: C
authors.lastname: Bergonzi
authors.forename: Anna
authors.initials: A
authors.lastname: Barbui
authors.forename: Tommaso
authors.initials: T
authors.lastname: Caravita
authors.forename: Antonio
authors.initials: A
authors.lastname: Capaldi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Pregno
authors.forename: Tommasina
authors.initials: T
authors.lastname: Guglielmelli
authors.forename: Mariella
authors.initials: M
authors.lastname: Grasso
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Callea
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bertola
authors.forename: Federica
authors.initials: F
authors.lastname: Cavallo
authors.forename: Patrizia
authors.initials: P
authors.lastname: Falco
authors.forename: Cecilia
authors.initials: C
authors.lastname: Rus
authors.forename: Massimo
authors.initials: M
authors.lastname: Massaia
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.forename: Enrico
authors.initials: E
authors.lastname: Pogliani
authors.forename: Anna Marina
authors.initials: AM
authors.lastname: Liberati
authors.forename: Franco
authors.initials: F
authors.lastname: Dammacco
authors.forename: Giovannino
authors.initials: G
authors.lastname: Ciccone
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
mesh_terms: D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality*; D016879:Salvage Therapy; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D008558:Melphalan