Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: Results of the randomized AZABACHE Spanish trial

García-Sanz, R. ; Oriol, A. ; Moreno, M.J. ; Rubia, De La ; Payer, A.R. ; Hernández, M.T. ; Palomera, L. (Universidad de Zaragoza) ; Teruel, A.I. ; Blanchard, M.J. ; Gironella, M. ; Ribas, P. ; Bargay, J. ; Abellá, E. ; Granell, M. ; Ocio, E.M. ; Ribera, J.M. ; San Miguel, J.F. ; Mateos, M.V.

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 ver- sus 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 dif- ferent for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunc- tion (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 compli- cations. This trial was registered in the ClinicalTrials.gov database with code NCT01087008

Idioma: Inglés

DOI: 10.3324/haematol.2015.128439

Año: 2015

Publicado en: Haematologica 100, 9 (2015), 1207-1213
ISSN: 0390-6078

Factor impacto JCR: 6.671 (2015)

Categ. JCR: HEMATOLOGY rank: 4 / 70 = 0.057 (2015) - Q1 - T1

Factor impacto SCIMAGO: 2.959 - Hematology (Q1)

Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PI12-02311
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/PS09-01450
Financiación: info:eu-repo/grantAgreement/ES/MINECO-FEDER/INNOCAMPUS-CEI-2010-1-0010

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)