title: A randomized trial with melphalan and prednisone versus melphalan and prednisone plus thalidomide in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant.
abstract: Several trials comparing the efficacy of standard melphalan and prednisone (MP) therapy with MP plus thalidomide (MPT) in elderly patients with multiple myeloma (MM) have been reported, with inconsistent results. The primary goal of our study was to evaluate the efficacy and toxicity of MP versus MPT in newly diagnosed patients with MM who were transplant-ineligible or over age 65. A total of 135 patients were enrolled. Either minimal response or better or partial response or better were more frequent with MPT treatment (p = 0.001). After a median follow-up of 30 months, median progression-free survival (PFS) and overall survival (OS) were 33 and 52 months for MPT versus 22 and 32 months for MP, respectively. The comparison showed a significant advantage for MPT versus MP in PFS (p = 0.02) and only a trend for OS (p = 0.07). Severe adverse events were observed more frequently with MPT. In conclusion, our results show an improved activity of MPT at a cost of increased toxicity. We believe that MPT can be considered one of the new standard of care for elderly or transplant-ineligible patients with MM.
authors.affiliation: Department of Oncology and Hematology, University of Modena and Reggio Emilia, Modena, Italy. stefano.sacchi@unimore.it
authors.forename: Stefano
authors.initials: S
authors.lastname: Sacchi
authors.forename: Raffaella
authors.initials: R
authors.lastname: Marcheselli
authors.forename: Antonio
authors.initials: A
authors.lastname: Lazzaro
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
authors.forename: Alberto
authors.initials: A
authors.lastname: Fragasso
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Enrico
authors.initials: E
authors.lastname: Balleari
authors.forename: Santo
authors.initials: S
authors.lastname: Neri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Quarta
authors.forename: Raimondo
authors.initials: R
authors.lastname: Ferrara
authors.forename: Maria Luigia
authors.initials: ML
authors.lastname: Vigliotti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Polimeno
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Ugo
authors.initials: U
authors.lastname: Consoli
authors.forename: Alessandra
authors.initials: A
authors.lastname: Zoboli
authors.forename: Gabriele
authors.initials: G
authors.lastname: Buda
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pastorini
authors.forename: Luciano
authors.initials: L
authors.lastname: Masini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008558:Melphalan / Q000627:therapeutic use; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000627:therapeutic use; D016019:Survival Analysis; D013792:Thalidomide / Q000627:therapeutic use / Q000633:toxicity; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone