title: GEM2005 trial update comparing VMP/VTP as induction in elderly multiple myeloma patients: do we still need alkylators?
abstract: Melphalan (M), in combination with prednisone (MP), has been the backbone of new combinations, including bortezomib plus MP (VMP). However, new alkylator-free schemes, such as lenalidomide plus low-dose dexamethasone, are challenging the role of alkylators in myeloma treatment of elderly patients. Here we have updated, after a long follow-up (median 6 years), the results of the GEM2005 study that addressed this question by comparing VMP with bortezomib plus thalidomide and prednisone (VTP) as induction. Between April 2005 and October 2008, 260 patients were randomized to receive 6 cycles of VMP or VTP as induction. The median progression-free survival was 32 months for the VMP and 23 months for the VTP arms (P 5 .09). VMP significantly prolonged the overall survival (OS) compared with VTP (median of 63 and 43 months, respectively; hazard ratio [HR]: 0.67, P 5 .01). Achieving immunophenotypic complete response was associated with a significantly longer OS, especially in the VMP arm (66%remain alive after 8 years). Melphalan, plus bortezomib, should be maintained as standard care for the treatment of elderly multiple myeloma patients. This trial was registered at www.clinicaltrials.gov as #NCT00443235.
authors.forename: María-Victoria
authors.initials: MV
authors.lastname: Mateos
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.forename: Joaquín
authors.initials: J
authors.lastname: Martínez-López
authors.forename: Ana-Isabel
authors.initials: AI
authors.lastname: Teruel
authors.forename: Ana
authors.initials: A
authors.lastname: López de la Guía
authors.forename: Javier
authors.initials: J
authors.lastname: López
authors.forename: Enrique
authors.initials: E
authors.lastname: Bengoechea
authors.forename: Montserrat
authors.initials: M
authors.lastname: Pérez
authors.forename: Rafael
authors.initials: R
authors.lastname: Martínez
authors.forename: Luis
authors.initials: L
authors.lastname: Palomera
authors.forename: Felipe
authors.initials: F
authors.lastname: de Arriba
authors.forename: Yolanda
authors.initials: Y
authors.lastname: González
authors.forename: José Mariano
authors.initials: JM
authors.lastname: Hernández
authors.forename: Miquel
authors.initials: M
authors.lastname: Granell
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Bello
authors.forename: Joan
authors.initials: J
authors.lastname: Bargay
authors.forename: Francisco-Javier
authors.initials: FJ
authors.lastname: Peñalver
authors.forename: María-Luisa
authors.initials: ML
authors.lastname: Martín-Mateos
authors.forename: Bruno
authors.initials: B
authors.lastname: Paiva
authors.forename: María-Angeles
authors.initials: MA
authors.lastname: Montalbán
authors.forename: Joan
authors.initials: J
authors.lastname: Bladé
authors.forename: Juan-Jose
authors.initials: JJ
authors.lastname: Lahuerta
authors.forename: Jesús F
authors.initials: JF
authors.lastname: San-Miguel
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D060046:Maintenance Chemotherapy; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage; D011719:Pyrazines / Q000008:administration & dosage; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D008558:Melphalan; D011241:Prednisone