Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial.
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.
Palumbo
Antonio
A
Divisione di Ematologia dell'Università di Torino, Ospedale Molinette, Via Genova 3, 10126 Torino, Italy.
Bringhen
Sara
S
Petrucci
Maria Teresa
MT
Musto
Pellegrino
P
Rossini
Fausto
F
Nunzi
Martina
M
Lauta
Vito Michele
VM
Bergonzi
Cesare
C
Barbui
Anna
A
Caravita
Tommaso
T
Capaldi
Antonio
A
Pregno
Patrizia
P
Guglielmelli
Tommasina
T
Grasso
Mariella
M
Callea
Vincenzo
V
Bertola
Alessandra
A
Cavallo
Federica
F
Falco
Patrizia
P
Rus
Cecilia
C
Massaia
Massimo
M
Mandelli
Franco
F
Carella
Angelo Michele
AM
Pogliani
Enrico
E
Liberati
Anna Marina
AM
Dammacco
Franco
F
Ciccone
Giovannino
G
Boccadoro
Mario
M
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
D018906:Antineoplastic Agents, Alkylating; D008558:Melphalan