当前位置: X-MOL 学术Lancet Oncol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial
The Lancet Oncology ( IF 51.1 ) Pub Date : 2017-10-11 , DOI: 10.1016/s1470-2045(17)30600-9
Vivianne C G Tjan-Heijnen , Irene E G van Hellemond , Petronella G M Peer , Astrid C P Swinkels , Carolien H Smorenburg , Maurice J C van der Sangen , Judith R Kroep , Hiltje De Graaf , Aafke H Honkoop , Frans L G Erdkamp , Franchette W P J van den Berkmortel , Maaike de Boer , Wilfred K de Roos , Sabine C Linn , Alexander L T Imholz , Caroline M Seynaeve , 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

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.



中文翻译:

序贯内分泌治疗(DATA)后辅助芳香化酶的广泛抑制:一项随机的3期临床试验

背景

在他莫昔芬序贯内分泌治疗后继之以芳香酶抑制剂治疗5年后,激素受体阳性乳腺癌中辅助佐剂芳香化酶抑制作用的延长仍需弄清。为了解决这个问题,我们开始了DATA研究,以评估他莫昔芬术后阿那曲唑治疗的不同持续时间。

方法

DATA是一项在荷兰的79家医院进行的前瞻性,随机,开放标签,多中心,3期研究。我们以1:1的比例将绝经后的激素受体阳性早期乳腺癌且无2到3年的他莫昔芬辅助治疗后没有疾病复发迹象的绝经后妇女分配给3或6年的阿那曲唑治疗(每天一次口服1 mg) 。我们使用TENALEA(跨欧洲临床试验服务网络)进行随机化程序。分层因素为淋巴结状态,激素受体状态,HER2状态和他莫昔芬的治疗持续时间。该分析的主要研究终点是随机分组后3年以上的无病生存期(适应的无病生存期)。在这里,我们报告了DATA试验的最终分析结果,该试验已在ClinicalTrials.gov中注册,编号NCT00301457

发现

在2006年6月28日至2009年8月10日之间,我们筛选了1912例患者,其中955例为3年组,957例为6年期阿那曲唑治疗组。随机分组后3年,有1860例患者符合条件(6年组931例,3年组929例),有1660例无疾病。6年组的5年适应性无病生存率为83·1%(95%CI 80·0–86·3),而3年组则为79·4%(76·1–82·8)。年组(危险比[HR] 0·79 [95%CI 0·62-1·02]; p = 0·066)。6年治疗组的患者发生的不良事件比3年治疗组的患者多,其中包括所有程度的关节痛或肌痛(6年治疗组的827人中有478人[58%],438人[53%]) 3年治疗组的833名患者)和骨质减少或骨质疏松症(173 [21%]137 [16%])。

解释

我们不建议对所有激素受体阳性乳腺癌的绝经后妇女进行连续内分泌治疗5年后使用延长的佐剂芳香化酶抑制作用。

资金

阿斯利康。

更新日期:2017-11-10
down
wechat
bug