• Tjan-Heijnen Vivianne C G VCG Division of Medical Oncology, GROW - School of Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherl, Irene E G van Hellemond, Petronella G M Peer, Astrid C P Swinkels, Carolien H Smorenburg, van der Sangen Maurice J C MJC Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands., Judith R Kroep, Hiltje De Graaf, Aafke H Honkoop, Erdkamp Frans L G FLG Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Sittard-Geleen, Geleen, Netherlands., van den Berkmortel Franchette W P J FWPJ Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Heerlen, Netherlands., Maaike de Boer, Wilfred K de Roos, Sabine C Linn, Alexander L T Imholz, Caroline M Seynaeve, and Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators.
• Division of Medical Oncology, GROW - School of Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands. Electronic address: vcg.tjan.heijnen@mumc.nl.
• Lancet Oncol. 2017 Nov 1; 18 (11): 1502-1511.

BackgroundThe 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.MethodsDATA 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.FindingsBetween 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%]).InterpretationWe 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.FundingAstraZeneca.Copyright © 2017 Elsevier Ltd. All rights reserved.

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