Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial
María-Victoria Mateos, Albert Oriol, Joaquín Martínez-López, Norma Gutiérrez, Ana-Isabel Teruel, Ana López de la Guía, Javier López, Enrique Bengoechea, Montserrat Pérez, Marta Polo, Luis Palomera, Felipe de Arriba, Yolanda González, Jose-Mariano Hernández, Miquel Granell, José-Luis Bello, Joan Bargay, Francisco-Javier Peñalver, José-María Ribera, María-Luisa Martín-Mateos, Ramón García-Sanz, Juan-José Lahuerta, Joan Bladé, Jesús F San-Miguel, María-Victoria Mateos, Albert Oriol, Joaquín Martínez-López, Norma Gutiérrez, Ana-Isabel Teruel, Ana López de la Guía, Javier López, Enrique Bengoechea, Montserrat Pérez, Marta Polo, Luis Palomera, Felipe de Arriba, Yolanda González, Jose-Mariano Hernández, Miquel Granell, José-Luis Bello, Joan Bargay, Francisco-Javier Peñalver, José-María Ribera, María-Luisa Martín-Mateos, Ramón García-Sanz, Juan-José Lahuerta, Joan Bladé, Jesús F San-Miguel
Abstract
Maintenance therapy has become a hot field in myeloma, and it may be particularly relevant in elderly patients because the major benefit results from the initial therapy. We report the results of a randomized comparison of maintenance with bortezomib plus thalidomide (VT) or prednisone (VP) in 178 elderly untreated myeloma patients who had received 6 induction cycles with bortezomib plus either melphalan and prednisone or thalidomide and prednisone. The complete response (CR) rate increased from 24% after induction up to 42%, higher for VT versus VP (46% vs 39%). Median progression-free survival (PFS) was superior for VT (39 months) compared with VP (32 months) and overall survival (OS) was also longer in VT patients compared with VP (5-year OS of 69% and 50%, respectively) but the differences did not reach statistical significance. CR achievement was associated with a significantly longer PFS (P < .001) and 5-year OS (P < .001). The incidence of G3-4 peripheral neuropathy was 9% for VT and 3% for VP. Unfortunately, this approach was not able to overcome the adverse prognosis of cytogenetic abnormalities. In summary, these maintenance regimens result in a significant increase in CR rate, remarkably long PFS, and acceptable toxicity profile. The trial is registered at www.clinicaltrials.gov as NCT00443235.
Source: PubMed