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: María-Victoria Mateos, Albert Oriol, Joaquín Martínez-López, Ana-Isabel Teruel, Ana López de la Guía, Javier López, Enrique Bengoechea, Montserrat Pérez, Rafael Martínez, Luis Palomera, Felipe de Arriba, Yolanda González, José Mariano Hernández, Miquel Granell, José-Luis Bello, Joan Bargay, Francisco-Javier Peñalver, María-Luisa Martín-Mateos, Bruno Paiva, María-Angeles Montalbán, Joan Bladé, Juan-Jose Lahuerta, Jesús F San-Miguel
• Journal: Blood (Blood) Vol. 124 Issue 12 Pg. 1887-93 (Sep 18 2014) ISSN: 1528-0020 [Electronic] United States
• PMID: 25102853 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Boronic Acids
• Pyrazines
• Thalidomide
• Bortezomib
• Melphalan
• Prednisone

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Boronic Acids (administration & dosage)
• Bortezomib
• Disease-Free Survival
• Female
• Follow-Up Studies
• Humans
• Induction Chemotherapy
• Kaplan-Meier Estimate
• Maintenance Chemotherapy
• Male
• Melphalan (administration & dosage)
• Multiple Myeloma (drug therapy)
• Prednisone (administration & dosage)
• Pyrazines (administration & dosage)
• Thalidomide (administration & dosage)