Long-Term Outcomes of Adjuvant Denosumab in Breast Cancer.
NEJM Evid
; 1(12): EVIDoa2200162, 2022 Dec.
Article
en En
| MEDLINE
| ID: mdl-38319865
ABSTRACT
BACKGROUND:
Adjuvant aromatase inhibitors increase osteoporosis and fractures in patients with hormone receptorpositive breast cancer. We have previously reported outcomes of the ABCSG-18 (study 18 from the Austrian Breast & Colorectal Cancer Study Group) trial showing that adjuvant antireceptor activator of nuclear factor-κB ligand denosumab treatment counteracts these adverse effects and may improve outcomes. We report here the final long-term outcomes.METHODS:
ABCSG-18 is a prospective, double-blind, placebo-controlled, phase 3 trial in which 3425 postmenopausal patients with early hormone receptorpositive breast cancer receiving aromatase inhibitor therapy were randomly assigned in 58 trial centers to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months. The primary end point was the time to first clinical fracture after randomization. Secondary disease outcomerelated end points were disease-free survival (DFS), bone metastasisfree survival (BMFS), and overall survival (OS).RESULTS:
For this final protocol-defined analysis, median follow-up is 8 years (interquartile range, 6 to 9.6 years). There were 309 versus 368 DFS events (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.97) in the denosumab versus the placebo group, respectively, resulting in an absolute 9-year DFS benefit of 3.5 percentage points (79.4 vs. 75.9%). Adjuvant denosumab improved BMFS by 2.5 percentage points (88.9 vs. 86.4%; hazard ratio, 0.81; 95% CI, 0.65 to 1.00) and OS by 1.0 percentage point (90.9 vs. 89.9%; hazard ratio, 0.80; 95% CI, 0.64 to 1.01). No new toxicities for this dose of adjuvant denosumab were observed.CONCLUSIONS:
DFS, BMFS, and OS continued to show benefit in this final long-term analysis of ABCSG-18. There were no new toxicities. (Funded by Amgen; ClinicalTrials.gov number, NCT00556374.)
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Neoplasias de la Mama
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Female
/
Humans
Idioma:
En
Revista:
NEJM Evid
/
NEJM evid
/
NEJM evidence
Año:
2022
Tipo del documento:
Article