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Tjan-Heijnen, Vivianne C G; van Hellemond, Irene E G; Peer, Petronella G M; Swinkels, Astrid C P; Smorenburg, Carolien H; van der Sangen, Maurice J C; Kroep, Judith R; De Graaf, Hiltje; Honkoop, Aafke H; Erdkamp, Frans L G; van den Berkmortel, Franchette W P J; de Boer, Maaike; de Roos, Wilfred K; Linn, Sabine C; Imholz, Alexander L T; Seynaeve, Caroline M; Kitzen, J.J.E.M.; Strobbe, L.J.A.; Kouwenhoven, E.A.; van Dalen, T.; van Overbeeke, A.J.; Nuytinck, J.K.S.; Arntz, I.E.; Blaisse, R.J.B.; Stockmann, H.B.A.C.; Nijhuis, P.H.A.; Veldhuis, G.J.; Mastboom, W.J.B.; van Riel, J.M.G.H.; van Dam, J.H.; den Boer, M.O.; Agterof, M.J.; de Roos, M.A.J.; Roumen, R.M.H.; van der Hoeven, J.J.M.; Beeker, A.; Koelemij, R.; van Bochove, A.; Madretsma, G.S.; Siemerink, E.J.M.; Guicherit, O.R.; Vos, A.H.; Nieuwenhuijzen, G.A.P.; Kehrer, D.F.S.; Valster, F.A.A.; Tanis, B.C.; van Voorthuizen, T.; van der Velden, A.M.T.; Hellingman, R.A.; Vree, R.; van Rossum-Schornagel, Q.; Meerum Terwogt, J.M.; van Leeuwen-Breuk, W.G.; Haasjes, J.G.; Davidis-van Schoonhoven, M.A.; Vriens, E.J.C.; Jagers, M.; Muller, E.W.; Schiphorst, P.P.J.B.M.; van Groeningen, C.J.; van Dijk, M.A.; Janssens- van Vliet, E.; Schepers, E.E.M.; Merkus, J.W.S.; van Diemen, N.G.J.; van Doorn, R.C.; Bosscha, K.; den Toom, R.; van der Velden, P.C.; van Rossum, C.T.A.M.; Oosterkamp, H.M.; van Hillegersberg, R.; Jas, B.; Weernink, E.E.M.; Ketel, J.M.A.; Jansen, J.J.; Maring, J.K.; Govaert, M.J.P.M.; Kamm, Y.J.L.; Vleugel, M.M.; Hovenga, S.; de Boer, J.; Potthoff, H.; Sommeijer, D.W.; van Dulken, E.J.
The lancet oncology, November 2017, 2017-Nov, 2017-11-00, 20171101, Letnik: 18, Številka: 11Journal Article
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. 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. 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%). 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. AstraZeneca.
