Portal de investigación
Zoledronic acid as compared with observation in multiple myeioma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Garcia-Sanz, R
- Oriol, A
- Moreno, MJ
- Payer, AR
- Hernandez, MT
- Palomera, L
- Teruel, AI
- Blanchard, MJ
- Gironella, M
- Ribas, P
- Bargay, J
- Abella, E
- Granell, M
- Ocio, EM
- Ribera, JM
- San Miguel, JF
- Mateos, MV
- Spanish Myeloma Grp GEM PETHEMA
Grupos
Abstract
This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P<0.001). In summary, zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma, but does reduce the risk of progression with symptomatic bone disease and skeletal complications.
Datos de la publicación
- ISSN/ISSNe:
- 0390-6078, 1592-8721
- Tipo:
- Article
- Páginas:
- 1207-1213
- PubMed:
- 26069291
- Factor de Impacto:
- 2,959 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
HAEMATOLOGICA FERRATA STORTI FOUNDATION
Citas Recibidas en Web of Science: 31
Documentos
- No hay documentos
Filiaciones
Campos de Estudio
Cita
Garcia R,Oriol A,Moreno MJ,DE LA RUBIA J,Payer AR,Hernandez MT,Palomera L,Teruel AI,Blanchard MJ,Gironella M,Ribas P,Bargay J,Abella E,Granell M,Ocio EM,Ribera JM,San Miguel JF,Mateos MV,Spanish Myeloma GEM PETHEMA GRP. Zoledronic acid as compared with observation in multiple myeioma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial. Haematologica. 2015. 100. (9):p. 1207-1213. IF:6,671. (1).