دورية أكاديمية
Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.
| العنوان: | Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial. |
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| المؤلفون: | García-Sanz R; Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain rgarcias@usal.es., Oriol A; ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain., Moreno MJ; Hospital Morales Meseguer, Spain., de la Rubia J; 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., Ribas P; 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., Ocio EM; Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain., Ribera JM; ICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain., San Miguel JF; Clínica Universidad de Navarra-CIMA, Spain., Mateos MV; Hospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain. |
| مؤلفون مشاركون: | Spanish Myeloma Group (GEM/PETHEMA) |
| المصدر: | Haematologica [Haematologica] 2015 Sep; Vol. 100 (9), pp. 1207-13. Date of Electronic Publication: 2015 Jun 11. |
| نوع المنشور: | Comparative Study; Journal Article; Multicenter Study; Observational Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Ferrata Storti Foundation Country of Publication: Italy NLM ID: 0417435 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1592-8721 (Electronic) Linking ISSN: 03906078 NLM ISO Abbreviation: Haematologica Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 1999- : Pavia, Italy : Ferrata Storti Foundation Original Publication: Pavia [etc.] |
| مواضيع طبية MeSH: | Bone Diseases/*drug therapy , Bone Diseases/*mortality , Diphosphonates/*administration & dosage , Imidazoles/*administration & dosage , Multiple Myeloma/*drug therapy , Multiple Myeloma/*mortality, Adult ; Aged ; Bone Diseases/pathology ; Disease-Free Survival ; Humans ; Middle Aged ; Multiple Myeloma/pathology ; Survival Rate ; Zoledronic Acid |
| مستخلص: | 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. (Copyright© Ferrata Storti Foundation.) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT01087008 |
| المشرفين على المادة: | 0 (Diphosphonates) 0 (Imidazoles) 6XC1PAD3KF (Zoledronic Acid) |
| تواريخ الأحداث: | Date Created: 20150613 Date Completed: 20160321 Latest Revision: 20181202 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC4800701 |
| DOI: | 10.3324/haematol.2015.128439 |
| PMID: | 26069291 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1592-8721 |
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| DOI: | 10.3324/haematol.2015.128439 |