Extended adjuvant aromatase inhibition after sequential endocrine therapy in postmenopausal women with breast cancer : follow-up analysis of the randomised phase 3 DATA trial
© 2023 The Authors..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:58 |
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| Enthalten in: |
EClinicalMedicine - 58(2023) vom: 31. Apr., Seite 101901 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tjan-Heijnen, Vivianne C G [VerfasserIn] |
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| Links: |
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| Themen: |
Adjuvant |
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| Anmerkungen: |
Date Revised 31.03.2023 published: Electronic-eCollection ClinicalTrials.gov: NCT00301457 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.eclinm.2023.101901 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Tjan-Heijnen, Vivianne C G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Extended adjuvant aromatase inhibition after sequential endocrine therapy in postmenopausal women with breast cancer |b follow-up analysis of the randomised phase 3 DATA trial |
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| 500 | |a Date Revised 31.03.2023 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT00301457 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023 The Authors. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a Funding: AstraZeneca | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adjuvant | |
| 650 | 4 | |a Aromatase inhibitor | |
| 650 | 4 | |a Breast cancer | |
| 650 | 4 | |a Endocrine therapy | |
| 650 | 4 | |a Extended treatment | |
| 700 | 1 | |a Lammers, Senna W M |e verfasserin |4 aut | |
| 700 | 1 | |a Geurts, Sandra M E |e verfasserin |4 aut | |
| 700 | 1 | |a Vriens, Ingeborg J H |e verfasserin |4 aut | |
| 700 | 1 | |a Swinkels, Astrid C P |e verfasserin |4 aut | |
| 700 | 1 | |a Smorenburg, Carolien H |e verfasserin |4 aut | |
| 700 | 1 | |a van der Sangen, Maurice J C |e verfasserin |4 aut | |
| 700 | 1 | |a Kroep, Judith R |e verfasserin |4 aut | |
| 700 | 1 | |a de Graaf, Hiltje |e verfasserin |4 aut | |
| 700 | 1 | |a Honkoop, Aafke H |e verfasserin |4 aut | |
| 700 | 1 | |a Erdkamp, Frans L G |e verfasserin |4 aut | |
| 700 | 1 | |a de Roos, Wilfred K |e verfasserin |4 aut | |
| 700 | 1 | |a Linn, Sabine C |e verfasserin |4 aut | |
| 700 | 1 | |a Imholz, Alexander L T |e verfasserin |4 aut | |
| 700 | 0 | |a Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators |e verfasserin |4 aut | |
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