Ontology type: schema:ScholarlyArticle Open Access: True
2014-04
AUTHORSChristina L. Addison, Nathaniel Bouganim, John Hilton, Lisa Vandermeer, Susan Dent, Eitan Amir, Sean Hopkins, Iryna Kuchuk, Roanne Segal, Xinni Song, Stan Gertler, Sasha Mazzarello, George Dranitsaris, Daylily Ooi, Gregory Pond, Mark Clemons
ABSTRACTThe optimal frequency of intravenous (IV) bisphosphonate administration is unclear. We thus performed a study evaluating the effects of switching from 3-4 to 12 weekly therapy in patients with biochemically defined low-risk bone metastases. Patients with serum C-telopeptide (CTx) levels ≤600 ng/L after ≥3 months of 3-4 weekly IV pamidronate were switched to 12 weekly therapy for 48 weeks. Primary endpoint was the proportion of patients maintaining CTx levels in the lower-risk range. All endpoints (serum CTx and bone-specific alkaline phosphatase (BSAP), skeletal-related events (SREs) and self-reported pain) were measured at baseline, 6, 12, 24, 36 and 48 weeks. Treatment failure was defined as biochemical failure (CTx > 600 ng/L) or a SRE. Exploratory biomarkers including; serum TGF-β, activin-A, bone sialoprotein (BSP), procollagen type 1 N-terminal propeptide and urinary N-telopeptide (NTx) were assessed at baseline as predictors for failure to complete treatment. Seventy-one patients accrued and 43 (61 %) completed 48 weeks of de-escalated therapy. Reasons for failure to complete treatment included; biochemical failure (CTx > 600 ng/L) (n = 10, 14.1 %), on-study SRE (n = 9, 12.7 %), disease progression (n = 7, 9.9 % including death from disease [n = 1, 1.4 %]) or patient choice (n = 2, 2.8 %). Elevated baseline levels of CTx, BSAP, NTx and BSP were associated with treatment failure. The majority of patients in this biochemically defined low-risk population could switch from 3-4 weekly to 12 weekly bisphosphonate therapy with no effect on CTx levels or SREs during the 48 week study. Larger trials are required to assess the roles of biomarkers as predictors of adequacy of de-escalated therapy. More... »
PAGES615-624
http://scigraph.springernature.com/pub.10.1007/s10549-014-2906-x
DOIhttp://dx.doi.org/10.1007/s10549-014-2906-x
DIMENSIONShttps://app.dimensions.ai/details/publication/pub.1041087414
PUBMEDhttps://www.ncbi.nlm.nih.gov/pubmed/24638849
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