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Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial - 07/11/17

Doi : 10.1016/S1470-2045(17)30600-9 
Vivianne C G Tjan-Heijnen, ProfMD a, , Irene E G van Hellemond, MD a, Petronella G M Peer, PhD b, Astrid C P Swinkels, MSc c, Carolien H Smorenburg, MD d, Maurice J C van der Sangen, MD e, Judith R Kroep, MD f, Hiltje De Graaf, MD g, Aafke H Honkoop, MD h, Frans L G Erdkamp, MD i, Franchette W P J van den Berkmortel, MD j, Maaike de Boer, MD a, Wilfred K de Roos, MD k, Sabine C Linn, ProfMD l, m, Alexander L T Imholz, MD n, Caroline M Seynaeve, MD o
on behalf of the

Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators

  Members listed in the Supplementary Material
J.J.E.M. Kitzen, L.J.A. Strobbe, E.A. Kouwenhoven, T. van Dalen, A.J. van Overbeeke, J.K.S. Nuytinck, I.E. Arntz, R.J.B. Blaisse, H.B.A.C. Stockmann, P.H.A. Nijhuis, G.J. Veldhuis, W.J.B. Mastboom, J.M.G.H. van Riel, J.H. van Dam, M.O. den Boer, M.J. Agterof, M.A.J. de Roos, R.M.H. Roumen, J.J.M. van der Hoeven, A. Beeker, R. Koelemij, A. van Bochove, G.S. Madretsma, E.J.M. Siemerink, O.R. Guicherit, A.H. Vos, G.A.P. Nieuwenhuijzen, D.F.S. Kehrer, F.A.A. Valster, B.C. Tanis, T. van Voorthuizen, A.M.T. van der Velden, R.A. Hellingman, R. Vree, Q. van Rossum-Schornagel, J.M. Meerum Terwogt, W.G. van Leeuwen-Breuk, J.G. Haasjes, M.A. Davidis-van Schoonhoven, E.J.C. Vriens, M. Jagers, E.W. Muller, P.P.J.B.M. Schiphorst, C.J. van Groeningen, M.A. van Dijk, E. Janssens- van Vliet, E.E.M. Schepers, J.W.S. Merkus, N.G.J. van Diemen, R.C. van Doorn, K. Bosscha, R. den Toom, P.C. van der Velden, C.T.A.M. van Rossum, H.M. Oosterkamp, R. van Hillegersberg, B. Jas, E.E.M. Weernink, J.M.A. Ketel, J.J. Jansen, J.K. Maring, M.J.P.M. Govaert, Y.J.L. Kamm, M.M. Vleugel, S. Hovenga, J. de Boer, H. Potthoff, D.W. Sommeijer, E.J. van Dulken

a Division of Medical Oncology, GROW – School of Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands 
b Department for Health Evidence, Radboud Institute Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands 
c Clinical Research Department, Netherlands Comprehensive Cancer Organisation (IKNL), Nijmegen, Netherlands 
d Department of Medical Oncology, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, Netherlands 
e Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands 
f Department of Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands 
g Department of Medical Oncology, Medical Centre Leeuwarden, Leeuwarden, Netherlands 
h Department of Medical Oncology, Isala Clinics, Zwolle, Netherlands 
i Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Sittard-Geleen, Geleen, Netherlands 
j Department of Medical Oncology, Zuyderland Medical Center Heerlen-Sittard-Geleen, Heerlen, Netherlands 
k Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands 
l Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands 
m Department of Pathology, University Medical Centre Utrecht, Netherlands 
n Department of Medical Oncology, Deventer Hospital, Deventer, Netherlands 
o Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands 

* Correspondence to Prof Vivianne C G Tjan-Heijnen, Division of Medical Oncology, Department of Internal Medicine, Maastricht University Medical Center, PO Box 5800, 6202 AZ Maastricht, Netherlands Division of Medical Oncology Department of Internal Medicine Maastricht University Medical Center PO Box 5800 Maastricht AZ 6202 Netherlands

Summary

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.

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Vol 18 - N° 11

P. 1502-1511 - novembre 2017 Retour au numéro
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