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Gnant, M; Fitzal, F; Rinnerthaler, G; Steger, GG; Greil-Ressler, S; Balic, M; Heck, D; Jakesz, R; Thaler, J; Egle, D; Manfreda, D; Bjelic-Radisic, V; Wieder, U; Singer, CF; Melbinger-Zeinitzer, E; Haslbauer, F; Sevelda, P; Trapl, H; Wette, V; Wimmer, K; Gampenrieder, SP; Bartsch, R; Kacerovsky-Strobl, S; Suppan, C; Brunner, C; Deutschmann, C; Soelkner, L; Fesl, C; Greil, R, , Austrian, Breast, and, Colorectal, Cancer, Study, Group;Austrian, Breast, and, Colorectal, Cancer, Study, Group.
Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer.
N Engl J Med. 2021; 385(5):395-405 Doi: 10.1056/NEJMoa2104162
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Co-Autor*innen der Med Uni Graz
Balic Marija
Bjelic-Radisic Vesna
Suppan Christoph
Study Group Mitglieder der Med Uni Graz:
Bader Arnim
Bauernhofer Thomas
Boandl Angelika
Dorfer Martha
Frudinger Andrea
Gold ehem Ulrich Daniela
Greimel Elfriede Renate
Humpel Victoria Sophie
Jaritz Lisa
Lerch Jasmin
Luschin-Ebengreuth Gero
Pristauz-Telsnigg Gunda
Schaberl-Moser Renate
Schreiner Nicole
Stöger Herbert
Trapp Elisabeth Katharina

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BACKGROUND: For postmenopausal women with hormone-receptor-positive breast cancer, the most effective duration for adjuvant therapy with an aromatase inhibitor remains unclear. METHODS: In this prospective, phase 3 trial, we randomly assigned postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy to receive the aromatase inhibitor anastrozole for an additional 2 years (2-year group, receiving a total of 7 years) or an additional 5 years (5-year group, receiving a total of 10 years). The primary end point was disease-free survival. The primary analysis included all the patients who were still participating in the trial and who had no recurrence 2 years after randomization (i.e., when treatment in the 2-year group had ended). Secondary end points were overall survival, contralateral breast cancer, second primary cancer, and clinical bone fracture. RESULTS: Among the 3484 women who were enrolled in the trial, 3208 remained in the trial without disease progression after the first 2 years of extended anastrozole treatment following randomization. Among these women, disease progression or death occurred in 335 women in each treatment group in the primary-analysis set at 8 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.90). No between-group differences occurred in most secondary end points, and subgroup analyses did not indicate differences in any particular subgroup. The risk of clinical bone fracture was higher in the 5-year group than in the 2-year group (hazard ratio, 1.35; 95% CI, 1.00 to 1.84). CONCLUSIONS: In postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy, extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture. (Funded by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group; ABCSG-16/SALSA number, NCT00295620.).
Find related publications in this database (using NLM MeSH Indexing)
Administration, Oral - administration & dosage
Aged - administration & dosage
Anastrozole - administration & dosage, adverse effects
Antineoplastic Agents, Hormonal - administration & dosage, therapeutic use
Aromatase Inhibitors - administration & dosage, adverse effects
Breast Neoplasms - drug therapy, mortality, surgery
Chemotherapy, Adjuvant - administration & dosage
Disease-Free Survival - administration & dosage
Fractures, Bone - epidemiology, etiology
Humans - administration & dosage
Kaplan-Meier Estimate - administration & dosage
Middle Aged - administration & dosage
Neoplasm Recurrence, Local - prevention & control
Postmenopause - administration & dosage
Prospective Studies - administration & dosage
Receptors, Estrogen - administration & dosage
Receptors, Progesterone - administration & dosage
Tamoxifen - therapeutic use

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