Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.
Por:
García-Sanz R, Oriol A, Moreno MJ, de la Rubia J, Payer AR, Hernández MT, Palomera L, Teruel AI, Blanchard MJ, Gironella M, Ribas P, Bargay J, Abellá E, Granell M, Ocio EM, Ribera JM, San Miguel JF and Mateos MV
Publicada:
1 sep 2015
Ahead of Print:
11 jun 2015
Categoría:
Hematology
Resumen:
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. This trial was registered in the ClinicalTrials.gov database with code NCT01087008.
Filiaciones:
García-Sanz R:
Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain
Oriol A:
ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain
Moreno MJ:
Hospital Morales Meseguer, Spain
:
Hospital Universitario La Fe and Universidad Católica de Valencia, Spain
Payer AR:
Hospital Universitario Central de Asturias, Spain
Hernández MT:
Hospital Universitario de Canarias, Spain
Palomera L:
Hospital Lozano Blesa de Zaragoza, Spain
Teruel AI:
Hospital Clínico Universitario de Valencia, Spain
Blanchard MJ:
Hospital Universitario Ramón y Cajal de Madrid, Spain
Gironella M:
Hospital Universitario Vall de Hebrón de Barcelona, Spain
:
Hospital Universitario Dr. Peset de Valencia, Spain
Bargay J:
Hospital Son Llàtzer de Palma de Mallorca, Spain
Abellá E:
Hospital del Mar de Barcelona, Spain
Granell M:
Hospital de la Santa Creu i Sant Pau de Barcelona, Spain
Ribera JM:
ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain
San Miguel JF:
Clínica Universidad de Navarra-CIMA, Spain
Open Access
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