Adjuvant denosumab in postmenopausal patients with hormone receptor-positive breast cancer (ABCSG-18): Disease-free survival results from a randomised, double-blind, placebo-controlled, phase 3 trial
The Lancet Oncology Feb 25, 2019
Gnant M, et al. - Researchers report disease-free survival outcomes from ABCSG-18 trial, a prospective, double-blind, placebo-controlled, phase 3 trial, wherein a significant attenuation in clinical fractures has been reported in association with the use of denosumab as an adjuvant to aromatase inhibitor therapy in postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast enrolled at 58 trial centres in Austria and Sweden. Subcutaneous denosumab (60 mg) or matching placebo was received (1:1) by participants every 6 months during aromatase inhibitor therapy. Total enrollees were 3425, of those, 1711 were treated with denosumab (the denosumab group) and 1709 received placebo (the placebo group)(with five others withdrawing consent). The denosumab group vs the placebo group had significantly improved disease-free survival. In the denosumab group vs in the placebo group, the most common serious adverse events experienced were: osteoarthritis (3·6% vs 3·4%), meniscus injury (1·3% vs 1·4%), and cataract (0·9% vs 1·7%). Overall, denosumab was proved effective and safe when used as adjuvant therapy in patients who were receiving aromatase inhibitor therapy for postmenopausal hormone receptor-positive early breast cancer.
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