Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2– Early Breast Cancer

医学 乳腺癌 肿瘤科 内科学 置信区间 临床终点 人口 内分泌系统 癌症 临床试验 激素 环境卫生
作者
Ulrike Nitz,Oleg Gluz,Sherko Kümmel,Matthias Christgen,Michael Braun,Bahriye Aktas,Kerstin Lüdtke-Heckenkamp,Helmut Forstbauer,Eva‐Maria Grischke,Claudia Schumacher,Maren Darsow,Katja Krauss,Benno Nuding,Marc Thill,Jochem Potenberg,Christoph Uleer,Mathias Warm,Hans Holger Fischer,Wolfram Malter,Michael Hauptmann
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:40 (23): 2557-2567 被引量:89
标识
DOI:10.1200/jco.21.02759
摘要

To our knowledge, WSG-ADAPT-HR+/HER2- (ClinicalTrials.gov identifier: NCT01779206; n = 5,625 registered) is the first trial combining the 21-gene expression assay (recurrence score [RS]) and response to 3-week preoperative endocrine therapy (ET) to guide systemic therapy in early breast cancer.Baseline and postendocrine Ki67 (Ki67post) were evaluated centrally. In the endocrine trial, all patients received exclusively ET: patients with pathologic regional lymph node status (pN) 0-1 (ie, 0-3 involved lymph nodes) entered control arm if RS ≤ 11 and experimental arm if RS12-25 with ET response (Ki67post ≤ 10%). All other patients (including N0-1 RS12-25 without ET response) received dose-dense chemotherapy (CT) followed by ET in the CT trial. Primary end point of the endocrine trial was noninferiority of 5-year invasive disease-free survival (5y-iDFS) in experimental (v control) arm; secondary end points included distant DFS, overall survival, and translational research.Intention-to-treat population comprised 2,290 patients (n = 1,422 experimental v n = 868 control): 26.3% versus 34.6% premenopausal and 27.4% versus 24.0% pN1. One-sided 95% lower confidence limit of the 5y-iDFS difference was -3.3%, establishing prespecified noninferiority (P = .05). 5y-iDFS was 92.6% (95% CI, 90.8 to 94.0) in experimental versus 93.9% (95% CI, 91.8 to 95.4) in control arm; 5-year distant DFS was 95.6% versus 96.3%, and 5-year overall survival 97.3% versus 98.0%, respectively. Differences were similar in age and nodal subgroups. In N0-1 RS12-25, outcome of ET responders (ET alone) was comparable with that of ET nonresponders (CT) for age > 50 years and superior for age ≤ 50 years. ET response was more likely with aromatase inhibitors (mostly postmenopausal) than with tamoxifen (mostly premenopausal): 78.1% versus 41.1% (P < .001). ET response was 78.8% in RS0-11, 62.2% in RS12-25, and 32.7% in RS > 25 (n = 4,203, P < .001).WSG-ADAPT-HR+/HER2- demonstrates that guiding systemic treatment by both RS and ET response is feasible in clinical routine and spares CT in pre- and postmenopausal patients with ≤ 3 involved lymph nodes.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
g7001完成签到,获得积分10
1秒前
blue发布了新的文献求助10
1秒前
刘铭晨完成签到,获得积分10
1秒前
XYZ完成签到 ,获得积分10
2秒前
wmszhd完成签到,获得积分10
2秒前
付艳完成签到,获得积分10
2秒前
CAOHOU应助论文顺利采纳,获得10
3秒前
nancy93228完成签到 ,获得积分10
4秒前
搜集达人应助JW采纳,获得10
6秒前
???完成签到,获得积分10
8秒前
优秀的白曼完成签到,获得积分10
10秒前
王小西发布了新的文献求助10
11秒前
碧蓝莫言完成签到 ,获得积分10
13秒前
清璃完成签到 ,获得积分10
14秒前
虚心的寒梦完成签到,获得积分10
14秒前
秋秋发布了新的文献求助10
14秒前
kkk完成签到,获得积分10
16秒前
bnhh完成签到,获得积分10
16秒前
Betty应助lindahuang采纳,获得10
17秒前
ilk666完成签到,获得积分10
18秒前
小王同学发布了新的文献求助10
18秒前
奶油布丁完成签到,获得积分10
21秒前
酶没美镁完成签到,获得积分10
21秒前
天天快乐应助李治海采纳,获得10
22秒前
星辰大海应助lll采纳,获得10
22秒前
龙1完成签到,获得积分10
22秒前
yzhilson完成签到 ,获得积分10
23秒前
量子星尘发布了新的文献求助10
24秒前
RRR完成签到,获得积分10
25秒前
金色天际线完成签到,获得积分10
26秒前
明ming到此一游完成签到 ,获得积分10
29秒前
pophoo完成签到,获得积分10
29秒前
11发布了新的文献求助10
30秒前
酷炫的黄豆完成签到 ,获得积分10
31秒前
hzz完成签到,获得积分10
34秒前
35秒前
深情安青应助科研通管家采纳,获得10
35秒前
fang应助科研通管家采纳,获得10
35秒前
Passskd发布了新的文献求助10
35秒前
fang应助科研通管家采纳,获得10
35秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038303
求助须知:如何正确求助?哪些是违规求助? 3576013
关于积分的说明 11374210
捐赠科研通 3305780
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029