title: Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.
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. This trial was registered in the ClinicalTrials.gov database with code NCT01087008.
authors.affiliation: Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain rgarcias@usal.es.
authors.forename: Ramón
authors.initials: R
authors.lastname: García-Sanz
authors.affiliation: ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: Hospital Morales Meseguer, Spain.
authors.forename: María J
authors.initials: MJ
authors.lastname: Moreno
authors.affiliation: Hospital Universitario La Fe and Universidad Católica de Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: de la Rubia
authors.affiliation: Hospital Universitario Central de Asturias, Spain.
authors.forename: Angel R
authors.initials: AR
authors.lastname: Payer
authors.affiliation: Hospital Universitario de Canarias, Spain.
authors.forename: Miguel T
authors.initials: MT
authors.lastname: Hernández
authors.affiliation: Hospital Lozano Blesa de Zaragoza, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Palomera
authors.affiliation: Hospital Clínico Universitario de Valencia, Spain.
authors.forename: Ana I
authors.initials: AI
authors.lastname: Teruel
authors.affiliation: Hospital Universitario Ramón y Cajal de Madrid, Spain.
authors.forename: María J
authors.initials: MJ
authors.lastname: Blanchard
authors.affiliation: Hospital Universitario Vall de Hebrón de Barcelona, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Gironella
authors.affiliation: Hospital Universitario Dr. Peset de Valencia, Spain.
authors.forename: Paz
authors.initials: P
authors.lastname: Ribas
authors.affiliation: Hospital Son Llàtzer de Palma de Mallorca, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Bargay
authors.affiliation: Hospital del Mar de Barcelona, Spain.
authors.forename: Eugenia
authors.initials: E
authors.lastname: Abellá
authors.affiliation: Hospital de la Santa Creu i Sant Pau de Barcelona, Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Granell
authors.affiliation: Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain.
authors.forename: Enrique M
authors.initials: EM
authors.lastname: Ocio
authors.affiliation: ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Ribera
authors.affiliation: Clínica Universidad de Navarra-CIMA, Spain.
authors.forename: Jesús F
authors.initials: JF
authors.lastname: San Miguel
authors.affiliation: Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain.
authors.forename: María V
authors.initials: MV
authors.lastname: Mateos
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D008875:Middle Aged; D001847:Bone Diseases / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D004164:Diphosphonates / Q000008:administration & dosage; D018572:Disease-Free Survival; D007093:Imidazoles / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid