Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial

• Published in: Blood 2012-09, Vol.120 (13), p.2581-2588
• Main Authors: Mateos, María-Victoria, Oriol, Albert, Martínez-López, Joaquín, Gutiérrez, Norma, Teruel, Ana-Isabel, López de la Guía, Ana, López, Javier, Bengoechea, Enrique, Pérez, Montserrat, Polo, Marta, Palomera, Luis, de Arriba, Felipe, González, Yolanda, Hernández, Jose-Mariano, Granell, Miquel, Bello, José-Luis, Bargay, Joan, Peñalver, Francisco-Javier, Ribera, José-María, Martín-Mateos, María-Luisa, García-Sanz, Ramón, Lahuerta, Juan-José, Bladé, Joan, San-Miguel, Jesús F.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Boronic Acids - administration & dosage; Bortezomib; Chromosome Aberrations; Female; Follow-Up Studies; Hematologic and hematopoietic diseases; Humans; Immunodeficiencies. Immunoglobulinopathies; Immunoglobulinopathies; Immunopathology; In Situ Hybridization, Fluorescence; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Maintenance Chemotherapy; Male; Medical sciences; Multiple Myeloma - drug therapy; Multiple Myeloma - genetics; Multiple Myeloma - mortality; Prednisone - administration & dosage; Prognosis; Pyrazines - administration & dosage; Remission Induction; Survival Rate; Thalidomide - administration & dosage
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2012-05-427815

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.