Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative .
Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting .
Purpose To up date guideline recommendations on the role of bone-modifying agents in multiple myeloma .
Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
In a phase 3 trial of denosumab vs zoledronic acid in patients ( n=1776 ) with bone metastases and solid tumors or multiple myeloma , denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events . There was no difference in overall survival between the two groups ; however , an ad hoc overall survival analysis in the multiple myeloma subset of patients ( n=180 ) favored zoledronic acid ( hazard ratio ( HR ) 2.26 ; 95 % confidence interval ( CI ) 1.13–4.50 ; P=0.014 ) . In the present analysis , we found imbalances between the groups with respect to baseline risk characteristics . HRs with two-sided 95 % CIs were estimated using the Cox model . After adjustment in a covariate analysis , the CI crossed unity ( HR 1.86 ; 95 % CI 0.90–3.84 ; P=0.0954 ) . Furthermore , we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group ; after accounting for these , the HR was 1.31 ( 95 % CI 0.80–2.15 ; P=0.278 ) . In conclusion , the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial
Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative .
Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting .
Purpose To up date guideline recommendations on the role of bone-modifying agents in multiple myeloma .