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Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized 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, Mario Boccadoro

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/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 = .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.

  • Submitted February 2, 2004.
  • Accepted June 8, 2004.
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