TY - JOUR
T1 - Extended adjuvant aromatase inhibition after sequential endocrine therapy in postmenopausal women with breast cancer
T2 - follow-up analysis of the randomised phase 3 DATA trial
AU - Tjan-Heijnen, Vivianne C.G.
AU - Lammers, Senna W.M.
AU - Geurts, Sandra M.E.
AU - Vriens, Ingeborg J.H.
AU - Swinkels, Astrid C.P.
AU - Smorenburg, Carolien H.
AU - van der Sangen, Maurice J.C.
AU - Kroep, Judith R.
AU - de Graaf, Hiltje
AU - Honkoop, Aafke H.
AU - Erdkamp, Frans L.G.
AU - de Roos, Wilfred K.
AU - Linn, Sabine C.
AU - Imholz, Alexander L.T.
AU - Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators
N1 - Funding Information:
This study was funded by AstraZeneca . We would like to thank all treating physicians, trial site principal investigators, and local data managers who contributed to the recruitment, treatment, and follow-up of study participants. In addition, we would like to thank Irene van Hellemond, who was extensively involved in the primary analysis of the DATA study. Furthermore, we acknowledge the contributions from Petronella Peer and Wim Lemmens (Radboud University Medical Centre, Netherlands) who conducted all statistical analyses for the primary analysis of the DATA study.
Funding Information:
AstraZeneca.This study was funded by AstraZeneca. We would like to thank all treating physicians, trial site principal investigators, and local data managers who contributed to the recruitment, treatment, and follow-up of study participants. In addition, we would like to thank Irene van Hellemond, who was extensively involved in the primary analysis of the DATA study. Furthermore, we acknowledge the contributions from Petronella Peer and Wim Lemmens (Radboud University Medical Centre, Netherlands) who conducted all statistical analyses for the primary analysis of the DATA study.
Publisher Copyright:
© 2023 The Authors
PY - 2023/4/1
Y1 - 2023/4/1
N2 - Background: The DATA study evaluated the use of two different durations of anastrozole in patients with hormone receptor-positive breast cancer who were disease-free after 2–3 years of tamoxifen. We hereby present the follow-up analysis, which was performed after all patients reached a minimum follow-up of 10 years beyond treatment divergence. Methods: The open-label, randomised, phase 3 DATA study was performed in 79 hospitals in the Netherlands (ClinicalTrials.gov, number NCT00301457). Postmenopausal women with hormone receptor-positive breast cancer who were disease-free after 2–3 years of adjuvant tamoxifen treatment were assigned to either 3 or 6 years of anastrozole (1 mg orally once a day). Randomisation (1:1) was stratified by hormone receptor status, nodal status, HER2 status, and prior tamoxifen duration. The primary outcome was adapted disease-free survival, defined as disease-free survival from 3 years after randomisation onwards. Adapted overall survival was assessed as a secondary outcome. Analyses were performed according to the intention-to-treat design. Findings: Between June 28, 2006, and August 10, 2009, 1912 patients were randomly assigned to 3 years (n = 955) or 6 years (n = 957) of anastrozole. Of these, 1660 patients were eligible and disease-free at 3 years after randomisation. The 10-year adapted disease-free survival was 69.2% (95% CI 55.8–72.3) in the 6-year group (n = 827) and 66.0% (95% CI 62.5–69.2) in the 3-year group (n = 833) (hazard ratio (HR) 0.86; 95% CI 0.72–1.01; p = 0.073). The 10-year adapted overall survival was 80.9% (95% CI 77.9–83.5) in the 6-year group and 79.2% (95% CI 76.2–81.9) in the 3-year group (HR 0.93; 95% CI 0.75–1.16; p = 0.53). Interpretation: Extended aromatase inhibition beyond 5 years of sequential endocrine therapy did not improve the adapted disease-free survival and adapted overall survival of postmenopausal women with hormone receptor-positive breast cancer. Funding: AstraZeneca.
AB - Background: The DATA study evaluated the use of two different durations of anastrozole in patients with hormone receptor-positive breast cancer who were disease-free after 2–3 years of tamoxifen. We hereby present the follow-up analysis, which was performed after all patients reached a minimum follow-up of 10 years beyond treatment divergence. Methods: The open-label, randomised, phase 3 DATA study was performed in 79 hospitals in the Netherlands (ClinicalTrials.gov, number NCT00301457). Postmenopausal women with hormone receptor-positive breast cancer who were disease-free after 2–3 years of adjuvant tamoxifen treatment were assigned to either 3 or 6 years of anastrozole (1 mg orally once a day). Randomisation (1:1) was stratified by hormone receptor status, nodal status, HER2 status, and prior tamoxifen duration. The primary outcome was adapted disease-free survival, defined as disease-free survival from 3 years after randomisation onwards. Adapted overall survival was assessed as a secondary outcome. Analyses were performed according to the intention-to-treat design. Findings: Between June 28, 2006, and August 10, 2009, 1912 patients were randomly assigned to 3 years (n = 955) or 6 years (n = 957) of anastrozole. Of these, 1660 patients were eligible and disease-free at 3 years after randomisation. The 10-year adapted disease-free survival was 69.2% (95% CI 55.8–72.3) in the 6-year group (n = 827) and 66.0% (95% CI 62.5–69.2) in the 3-year group (n = 833) (hazard ratio (HR) 0.86; 95% CI 0.72–1.01; p = 0.073). The 10-year adapted overall survival was 80.9% (95% CI 77.9–83.5) in the 6-year group and 79.2% (95% CI 76.2–81.9) in the 3-year group (HR 0.93; 95% CI 0.75–1.16; p = 0.53). Interpretation: Extended aromatase inhibition beyond 5 years of sequential endocrine therapy did not improve the adapted disease-free survival and adapted overall survival of postmenopausal women with hormone receptor-positive breast cancer. Funding: AstraZeneca.
KW - Adjuvant
KW - Aromatase inhibitor
KW - Breast cancer
KW - Endocrine therapy
KW - Extended treatment
U2 - 10.1016/j.eclinm.2023.101901
DO - 10.1016/j.eclinm.2023.101901
M3 - Article
C2 - 36992863
SN - 2589-5370
VL - 58
JO - EClinicalMedicine
JF - EClinicalMedicine
IS - 1
M1 - 101901
ER -