Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial.
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.
Hospital universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto de Biología Molecular y Celular del Cáncer (Universidad de Salamanca-Consejo Superior de Investigaciones Científicas), Salamanca, Spain. mvmateos@usal.es
María-Victoria
MV
Mateos
Albert
A
Oriol
Joaquín
J
Martínez-López
Norma
N
Gutiérrez
Ana-Isabel
AI
Teruel
Ana
A
López de la Guía
Javier
J
López
Enrique
E
Bengoechea
Montserrat
M
Pérez
Marta
M
Polo
Luis
L
Palomera
Felipe
F
de Arriba
Yolanda
Y
González
Jose-Mariano
JM
Hernández
Miquel
M
Granell
José-Luis
JL
Bello
Joan
J
Bargay
Francisco-Javier
FJ
Peñalver
José-María
JM
Ribera
María-Luisa
ML
Martín-Mateos
Ramón
R
García-Sanz
Juan-José
JJ
Lahuerta
Joan
J
Bladé
Jesús F
JF
San-Miguel
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D002869:Chromosome Aberrations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D060046:Maintenance Chemotherapy; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D011719:Pyrazines / Q000008:administration & dosage; D012074:Remission Induction; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage
D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D011241:Prednisone