| Autor: |
Gnant M; Medical University of Vienna, Comprehensive Cancer Center, Vienna.; ABCSG (Austrian Breast & Colorectal Cancer Study Group), Vienna., Frantal S; ABCSG (Austrian Breast & Colorectal Cancer Study Group), Vienna., Pfeiler G; Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Medical University of Vienna, Vienna., Steger GG; Department of Internal Medicine I, Medical University of Vienna, Vienna., Egle D; Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria., Greil R; Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute, Center for Clinical Cancer and Immunology Trials; Cancer Cluster Salzburg, Salzburg, Austria., Fitzal F; Department of General Surgery and Breast Health Center of the Comprehensive Cancer Center, Medical University of Vienna, Vienna., Wette V; Breast Center Carinthia, St. Veit, Austria., Balic M; Division of Oncology, Department of Internal Medicine, and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria., Haslbauer F; Department of Internal Medicine, Salzkammergut Klinikum Hospital Vöcklabruck, Vöcklabruck, Austria., Melbinger-Zeinitzer E; Department of Surgery, Hospital Wolfsberg, Wolfsberg, Austria., Bjelic-Radisic V; Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.; Breast Unit, Helios University Hospital Wuppertal, Wuppertal Germany, University Witten/Herdecke, Germany., Artner-Matuschek S; Department of Gynecology, Hanusch Hospital Vienna, Vienna., Kainberger F; Division of Neuro- and Musculoskeletal Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna., Ritter M; Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria., Rinnerthaler G; Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute, Center for Clinical Cancer and Immunology Trials; Cancer Cluster Salzburg, Salzburg, Austria., Sevelda P; Department of Gynecology, Karl Landsteiner Institute for Gynecologic Oncology and Senology, Hospital Hietzing, Vienna., Bergh J; Department of Oncology-Pathology, Cancer Research Karolinska Institutet, Stockholm., Kacerovsky-Strobl S; Department of General Surgery and Breast Health Center of the Comprehensive Cancer Center, Medical University of Vienna, Vienna.; Breast Health Center, St. Francis Hospital Vienna, Vienna., Suppan C; Division of Oncology, Department of Internal Medicine, and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria., Brunner C; Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria., Deutschmann C; Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Medical University of Vienna, Vienna., Gampenrieder SP; Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute, Center for Clinical Cancer and Immunology Trials; Cancer Cluster Salzburg, Salzburg, Austria., Fohler H; ABCSG (Austrian Breast & Colorectal Cancer Study Group), Vienna., Jakesz R; Department of General Surgery and Breast Health Center of the Comprehensive Cancer Center, Medical University of Vienna, Vienna., Fesl C; ABCSG (Austrian Breast & Colorectal Cancer Study Group), Vienna., Singer C; Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Medical University of Vienna, Vienna. |
| Abstrakt: |
BACKGROUND: Adjuvant aromatase inhibitors increase osteoporosis and fractures in patients with hormone receptor–positive 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 anti–receptor 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 receptor–positive 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 outcome–related end points were disease-free survival (DFS), bone metastasis–free 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.) |
