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J Clin Oncol. 2014 Mar 1;32(7):634-40. doi: 10.1200/JCO.2013.52.0023. Epub 2014 Jan 21.

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.

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1
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.

Abstract

PURPOSE:

Bortezomib-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 METHODS:

We 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).

RESULTS:

In 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.

CONCLUSION:

Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01063179.

PMID:
24449241
DOI:
10.1200/JCO.2013.52.0023
[Indexed for MEDLINE]

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