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Blood, 15 November 2004, Vol. 104, No. 10, pp. 3052-3057.
Prepublished online as a Blood First Edition Paper on July 20, 2004; DOI 10.1182/blood-2004-02-0408.
 Previous Article | Next Article 
Submitted February 2, 2004
Accepted June 8, 2004
Intermediate-Dose Melphalan Improves Survival of Myeloma Patients Aged 50-70: Results of A Randomised Controlled Trial
Antonio Palumbo, Sara Bringhen, Maria Teresa Petrucci, Pellegrino Musto, Fausto Rossini, Martina Nunzi, Vito Michele Lauta, Cesare Bergonzi, Anna Barbui, Tommaso Caravita, Antonio Capaldi, Patrizia Pregno, Tommasina Guglielmelli, Mariella Grasso, Vincenzo Callea, Alessandra Bertola, Federica Cavallo, Patrizia Falco, Cecilia Rus, Massimo Massaia, Franco Mandelli, Angelo Michele Carella, Enrico Pogliani, Anna Marina Liberati, Franco Dammacco, Giovannino Ciccone, and Mario Boccadoro*
Divisione Universitaria di Ematologia, Azienda ospedaliera San Giovanni Battista, Turin, Turin, Italy
Dipartimento di biotecnologie ed Ematologia, Universita' La Sapienza, Roma, Roma, Italy
U.O. di ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Ematologia, H S Gerardo, Monza, Milano, Italy
Clinica Medica I, Policlinico Monteluce, Perugia, Perugia, Italy
Sezione di Medicina Interna e Oncologia Clinica, Polclinico DIMO, Bari, Bari, Italy
Sezione di Ematologia, Azienda Istituti Ospedalieri, Cremona, Cremona, Italy
Divisione di Ematologia, Ospedali Riuniti, Bergamo, Bergamo, Italy
Cattedra e Divisione di Ematologia, Ospedale S Eugenio e Universita Tor Vergata, Roma, Roma, Italy
Divisione di Oncologia ed Ematologia, IRCC Candiolo, Candiolo, Torino, Italy
S C Ematologia Ospedaliera, Azienda Ospedaliera San Giovanni Battista, Torino, Torino, Italy
Medicina Interna II, Azienda Ospedaliera San Luigi, Orbassano, Torino, Italy
Divisione di Ematologia, Azienda Ospedaliera S Croce Carle, Cuneo, Cuneo, Italy
Divisione di Ematologia, Ospedale Riuniti, Reggio Calabria, Reggio Calabria, Italy
Divisione di Ematologia e malattie trombotiche, Ospedale Evangelico Valdese, Torino, Torino, Italy
Epidemiologia dei Tumori, Azienda Ospedaliera San Giovanni Battista, Torino, Torino, Italy
* Corresponding author; email: mario.boccadoro{at}unito.it.
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 (two courses of melphalan at 100 mg/m2, MEL100) with stem cell support. Response rate was higher after MEL100. Near complete remission (nCR) was 6% after MP and 25% after MEL100 (p=0.0002). At 3 years, MEL100 increased event-free survival (EFS) from 16% to 37% and overall survival (OS) from 62% to 77% (p<0.001). Similar results were observed in patients aged 65-70: nCR was 8% after MP and 25% after MEL100 (p=0.05), at 3 years, MEL100 improved both EFS from 18% to 31% (p=0.041) and OS from 58% to 73%(p=0.01). Patients aged 65-70 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, also and specifically in those aged 65-70. It constitutes a more effective first-line regimen than standard treatment for elderly patients.
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