Zoledronic acid as compared with observation in multiple myeioma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial
Por:
Garcia-Sanz, 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
Publicada:
1 sep 2015
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.
Filiaciones:
Garcia-Sanz, R:
IBMCC USAL CSIC, Hosp Univ Salamanca IBSAL, Salamanca, Spain
Oriol, A:
ICO Hosp Germans Trias i Pujol, Fdn Josep Carreras, Madrid, Spain
Moreno, MJ:
Hosp Morales Meseguer, Murcia, Spain
de la Rubia, J:
Hosp Univ La Fe, Valencia, Spain
Univ Catolica Valencia, Valencia, Spain
Payer, AR:
Hosp Univ Cent Asturias, Asturias, Spain
Hernandez, MT:
Hosp Univ Canarias, Las Palmas Gran Canaria, Spain
Palomera, L:
Hosp Lozano Blesa Zaragoza, Zaragoza, Spain
Teruel, AI:
Hosp Clin Univ Valencia, Valencia, Spain
Blanchard, MJ:
Hosp Univ Ramon y Cajal Madrid, Madrid, Spain
Gironella, M:
Hosp Univ Vall Hebron Barcelona, Barcelona, Spain
Ribas, P:
Hosp Univ Dr Peset Valencia, Valencia, Spain
Bargay, J:
Hosp Mar Barcelona, Barcelona, Spain
Abella, E:
Hosp Mar Barcelona, Barcelona, Spain
Granell, M:
Hosp Santa Creu & St Pau Barcelona, Barcelona, Spain
Ocio, EM:
IBMCC USAL CSIC, Hosp Univ Salamanca IBSAL, Salamanca, Spain
Ribera, JM:
ICO Hosp Germans Trias i Pujol, Fdn Josep Carreras, Madrid, Spain
San Miguel, JF:
Clin Univ Navarra CIMA, Navarra, Spain
Mateos, MV:
IBMCC USAL CSIC, Hosp Univ Salamanca IBSAL, Salamanca, Spain
Gold, Green Published
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