• J. Clin. Oncol. · Mar 2014

    Randomized Controlled Trial

    Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival.

    • Antonio Palumbo, Sara Bringhen, Alessandra Larocca, Davide Rossi, Francesco Di Raimondo, Valeria Magarotto, Francesca Patriarca, Anna Levi, Giulia Benevolo, Iolanda Donatella Vincelli, Mariella Grasso, Luca Franceschini, Daniela Gottardi, Renato Zambello, Vittorio Montefusco, Antonietta Pia Falcone, Paola Omedé, Roberto Marasca, Fortunato Morabito, Roberto Mina, Tommasina Guglielmelli, Chiara Nozzoli, Roberto Passera, Gianluca Gaidano, Massimo Offidani, Roberto Ria, Maria Teresa Petrucci, Pellegrino Musto, Mario Boccadoro, and Michele Cavo.
    • Antonio Palumbo, Sara Bringhen, Alessandra Larocca, Valeria Magarotto, Paola Omedé, Roberto Mina, Mario Boccadoro, and Giulia Benevolo, Azienda Ospedaliera (A.O.) Città della Salute e della Scienza di Torino; Daniela Gottardi, A.O. Ordine Mauriziano; Roberto Passera, San Giovanni Battista Hospital, University of Torino, Torino; Davide Rossi and Gianluca Gaidano, Amedeo Avogadro University of Eastern Piedmont, Novara; Francesco Di Raimondo, Ferrarotto Hospital, University of Catania, Catania; Francesca Patriarca, A.O. Universitaria, Udine; Anna Levi and Maria Teresa Petrucci, Sapienza University of Rome; Luca Franceschini, Tor Vergata University Hospital, Rome; Iolanda Donatella Vincelli, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria; Mariella Grasso, S. Croce e Carle Hospital, Cuneo; Renato Zambello, Università degli Studi di Padova, Padova; Vittorio Montefusco, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori Milano, University of Milano, Milan; Antonietta Pia Falcone, IRCCS Casa Sollievo della Sofferenza and Unità di Ematologia, San Giovanni Rotondo; Roberto Marasca, University of Modena, Modena; Fortunato Morabito, A.O. di Cosenza, Cosenza; Tommasina Guglielmelli, "S. Luigi Gonzaga" Hospital, Orbassano; Chiara Nozzoli, A.O. Universitaria Careggi, Firenze; Massimo Offidani, Ospedali Riuniti, Ancona; Roberto Ria, University of Bari "Aldo Moro" Medical School, Bari; Pellegrino Musto, IRCCS-Centro Regionale Oncologico Basilicata, Rionero in Vulture; and Michele Cavo, Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
    • J. Clin. Oncol. 2014 Mar 1; 32 (7): 634-40.

    PurposeBortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma.Patients And MethodsWe randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance).ResultsIn the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients.ConclusionBortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

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