Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study

[EN]Standard first-line treatment for elderly multiple myeloma (MM) patients ineligible for stem cell transplantation is melphalan plus prednisone (MP). However, complete responses (CRs) are rare. Bortezomib is active in patients with relapsed MM, including elderly patients. This phase 1/2 trial in...

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Detalles Bibliográficos
Autores: Mateos Manteca, María Victoria, Hernández, José M., Hernández, Miguel T., Gutiérrez Gutiérrez, Norma Carmen, Palomera, Luis, Fuertes, M., Díaz-Mediavilla, Joaquín, Lahuerta, Juan José, De la Rubia, Javier, Terol, María-José, Sureda, Anna, Bargay, Joan, Ribas, Paz, De Arriba, Felipe, Alegre, Adrian, Oriol, Albert, Carrera, Dolores, García-Laraña, José, García Sanz, Ramón, Bladé, Joan, Prósper, Felipe, Mateo, Gemma, Esseltine, Dixie-Lee, van de Velde, Helgi, San Miguel Izquierdo, Jesús Fernando
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2006
País:España
Institución:Universidad de Salamanca (USAL)
Repositorio:GREDOS. Repositorio Institucional de la Universidad de Salamanca
OAI Identifier:oai:gredos.usal.es:10366/154234
Acceso en línea:http://hdl.handle.net/10366/154234
Access Level:acceso abierto
Palabra clave:Mieloma múltiple
Disease-Free Survival
Immunophenotyping
Aged
Boronic Acids
Humans
Pyrazines
Melphalan
Antineoplastic Combined Chemotherapy Protocols
Antineoplastic Agents
Multiple Myeloma
Maximum Tolerated Dose
Cohort Studies
Prednisone
protocolos de quimioterapia antineoplásica combinada
humanos
anciano
mieloma múltiple
supervivencia sin enfermedad
prednisona
inmunofenotipificación
ácidos borónicos
dosis máxima tolerada
estudios de cohortes
antineoplásicos
piracinas
melfalán
Descripción
Sumario:[EN]Standard first-line treatment for elderly multiple myeloma (MM) patients ineligible for stem cell transplantation is melphalan plus prednisone (MP). However, complete responses (CRs) are rare. Bortezomib is active in patients with relapsed MM, including elderly patients. This phase 1/2 trial in 60 untreated MM patients aged at least 65 years (half older than 75 years) was designed to determine dosing, safety, and efficacy of bortezomib plus MP (VMP). VMP response rate was 89%, including 32% immunofixation-negative CRs, of whom half of the IF- CR patients analyzed achieved immunophenotypic remission (no detectable plasma cells at 10(-4) to 10(-5) sensitivity). VMP appeared to overcome the poor prognosis conferred by retinoblastoma gene deletion and IgH translocations. Results compare favorably with our historical control data for MP--notably, response rate (89% versus 42%), event-free survival at 16 months (83% versus 51%), and survival at 16 months (90% versus 62%). Side effects were predictable and manageable; principal toxicities were hematologic, gastrointestinal, and peripheral neuropathy and were more evident during early cycles and in patients aged 75 years or more. In conclusion, in elderly patients ineligible for transplantation, the combination of bortezomib plus MP appears significantly superior to MP, producing very high CR rates, including immunophenotypic CRs, even in patients with poor prognostic features.

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