Vivianne C G Tjan-Heijnen1, Irene E G van Hellemond2, Petronella G M Peer3, Astrid C P Swinkels4, Carolien H Smorenburg5, Maurice J C van der Sangen6, Judith R Kroep7, Hiltje De Graaf8, Aafke H Honkoop9, Frans L G Erdkamp10, Franchette W P J van den Berkmortel11, Maaike de Boer2, Wilfred K de Roos12, Sabine C Linn13, Alexander L T Imholz14, Caroline M Seynaeve15. 1. Division of Medical Oncology, GROW - School of Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands. Electronic address: vcg.tjan.heijnen@mumc.nl. 2. Division of Medical Oncology, GROW - School of Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands. 3. Department for Health Evidence, Radboud Institute Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands. 4. Clinical Research Department, Netherlands Comprehensive Cancer Organisation (IKNL), Nijmegen, Netherlands. 5. Department of Medical Oncology, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands. 6. Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands. 7. Department of Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands. 8. Department of Medical Oncology, Medical Centre Leeuwarden, Leeuwarden, Netherlands. 9. Department of Medical Oncology, Isala Clinics, Zwolle, Netherlands. 10. Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Sittard-Geleen, Geleen, Netherlands. 11. Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Heerlen, Netherlands. 12. Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands. 13. Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands; Department of Pathology, University Medical Centre Utrecht, Netherlands. 14. Department of Medical Oncology, Deventer Hospital, Deventer, Netherlands. 15. Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
Abstract
BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequentialendocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands. We randomly assigned postmenopausal women with hormone receptor-positive early breast cancer with no signs of disease recurrence after 2-3 years of adjuvant tamoxifen to either 3 or 6 years ofanastrozole treatment (1 mg orally once a day) in a 1:1 ratio. We used TENALEA (Trans European Network for Clinical Trials Services) for the randomisation procedure. Stratification factors were nodal status, hormone receptor status, HER2 status, and tamoxifen treatment duration. The primary study endpoint of this analysis was disease-free survival starting beyond 3 years after randomisation (adapted disease-free survival). Here we report the final analysis from the DATA trial, which is registered with ClinicalTrials.gov, number NCT00301457. FINDINGS:Between June 28, 2006, and Aug 10, 2009, we screened 1912 patients of whom 955 were assigned to the 3-year group and 957 to the 6-year anastrozole treatment group. 1860 patients were eligible (931 in the 6-year group and 929 in the 3-year group) and 1660 were disease free 3 years after randomisation. The 5-year adapted disease-free survival was 83·1% (95% CI 80·0-86·3) in the 6-year group and 79·4% (76·1-82·8) in the 3-year group (hazard ratio [HR] 0·79 [95% CI 0·62-1·02]; p=0·066). Patients in the 6-year treatment group had more adverse events than those in the 3-year treatment group, including all-grade arthralgia or myalgia (478 [58%] of 827 in the 6-year treatment group vs 438 [53%] of 833 in the 3-year treatment group) and osteopenia or osteoporosis (173 [21%] vs 137 [16%]). INTERPRETATION: We cannot recommend the use of extended adjuvant aromatase inhibition after 5 years of sequential endocrine therapy in all postmenopausal women with hormone receptor-positive breast cancer. FUNDING: AstraZeneca.
RCT Entities:
BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequential endocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands. We randomly assigned postmenopausal women with hormone receptor-positive early breast cancer with no signs of disease recurrence after 2-3 years of adjuvant tamoxifen to either 3 or 6 years of anastrozole treatment (1 mg orally once a day) in a 1:1 ratio. We used TENALEA (Trans European Network for Clinical Trials Services) for the randomisation procedure. Stratification factors were nodal status, hormone receptor status, HER2 status, and tamoxifen treatment duration. The primary study endpoint of this analysis was disease-free survival starting beyond 3 years after randomisation (adapted disease-free survival). Here we report the final analysis from the DATA trial, which is registered with ClinicalTrials.gov, number NCT00301457. FINDINGS: Between June 28, 2006, and Aug 10, 2009, we screened 1912 patients of whom 955 were assigned to the 3-year group and 957 to the 6-year anastrozole treatment group. 1860 patients were eligible (931 in the 6-year group and 929 in the 3-year group) and 1660 were disease free 3 years after randomisation. The 5-year adapted disease-free survival was 83·1% (95% CI 80·0-86·3) in the 6-year group and 79·4% (76·1-82·8) in the 3-year group (hazard ratio [HR] 0·79 [95% CI 0·62-1·02]; p=0·066). Patients in the 6-year treatment group had more adverse events than those in the 3-year treatment group, including all-grade arthralgia or myalgia (478 [58%] of 827 in the 6-year treatment group vs 438 [53%] of 833 in the 3-year treatment group) and osteopenia or osteoporosis (173 [21%] vs 137 [16%]). INTERPRETATION: We cannot recommend the use of extended adjuvant aromatase inhibition after 5 years of sequential endocrine therapy in all postmenopausal women with hormone receptor-positive breast cancer. FUNDING: AstraZeneca.
Authors: Eleftherios P Mamounas; Hanna Bandos; Barry C Lembersky; Jong-Hyeon Jeong; Charles E Geyer; Priya Rastogi; Louis Fehrenbacher; Mark L Graham; Stephen K Chia; Adam M Brufsky; Janice M Walshe; Gamini S Soori; Shaker R Dakhil; Thomas E Seay; James L Wade; Edward C McCarron; Soonmyung Paik; Sandra M Swain; D Lawrence Wickerham; Norman Wolmark Journal: Lancet Oncol Date: 2018-11-30 Impact factor: 41.316
Authors: Hongchao Pan; Richard Gray; Jeremy Braybrooke; Christina Davies; Carolyn Taylor; Paul McGale; Richard Peto; Kathleen I Pritchard; Jonas Bergh; Mitch Dowsett; Daniel F Hayes Journal: N Engl J Med Date: 2017-11-09 Impact factor: 91.245