Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study.
Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study.
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验证21基因测试是对ER+，HER2阴性乳腺癌的新辅助激素治疗的临床反应的预测指标：Transneos研究。
DOI：
10.1007/s10549-018-4964-y
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发表时间：
2019-01
影响因子：
3.8
通讯作者：
Ohashi Y
中科院分区：
文献类型：
--
作者：
Iwata H;Masuda N;Yamamoto Y;Fujisawa T;Toyama T;Kashiwaba M;Ohtani S;Taira N;Sakai T;Hasegawa Y;Nakamura R;Akabane H;Shibahara Y;Sasano H;Yamaguchi T;Sakamaki K;Bailey H;Cherbavaz DB;Jakubowski DM;Sugiyama N;Chao C;Ohashi Y
复发评分检验经验证可预测辅助化疗的获益。TransNEOS是一项新的原发性内分泌治疗起源研究（NEOS）的转化研究，评估了复发评分结果是否可以预测新辅助来曲唑的临床反应。NEOS是一项激素治疗±辅助化疗的3期临床试验，用于治疗绝经后ER+、HER 2阴性、临床淋巴结阴性乳腺癌患者，这些患者接受了6个月的新辅助来曲唑和乳腺手术。TransNEOS患者的肿瘤≥ 2 cm，在新辅助来曲唑治疗前采集了存档的核心活检样本，随后送去进行复发评分检测。主要终点是评价RS < 18与RS ≥ 31对来曲唑新辅助治疗的临床（完全或部分）应答。次要终点包括通过连续复发评分结果、ESR 1和PGR单基因评分以及ER基因组评分评估临床反应和保乳手术（BCS）率。在295例TransNEOS患者中（中位年龄63岁;中位肿瘤大小25 mm; 66%为1级），53.2%的RS < 18，28.5%的RS 18 -30，18.3%的RS ≥ 31。临床应答率分别为54%（RS < 18）、42%（RS 18 -30）和22%（RS ≥ 31）。RS < 18的患者有临床应答的比例较高（p < 0.001 vs. RS ≥ 31）。在多变量分析中，连续复发评分结果（p < 0.001）、ESR 1评分（p = 0.049）、PGR评分（p < 0.001）和ER基因组评分（p < 0.001）与临床反应相关。复发评分组与新辅助治疗后BCS发生率显著相关（RS < 18 vs. RS ≥ 31，p = 0.010）。复发评分检验经验证可预测ER+、HER 2阴性、临床淋巴结阴性的绝经后乳腺癌患者对来曲唑新辅助治疗的临床应答。本文的在线版本（10.1007/s10549-018-4964-y）包含补充材料，可供授权用户使用。
The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole. NEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result, ESR1 and PGR single-gene scores, and ER gene-group score. Of 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18–30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18–30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses (p < 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result (p < 0.001), ESR1 score (p = 0.049), PGR score (p < 0.001), and ER gene-group score (p < 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31, p = 0.010). The Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer. The online version of this article (10.1007/s10549-018-4964-y) contains supplementary material, which is available to authorized users.
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DOI：
10.1016/j.jamcollsurg.2009.01.035
发表时间：
2009-05
影响因子：
5.2
作者：
Olson, John A., Jr.;Budd, G. Thomas;Carey, Lisa A.;Harris, Lyndsay A.;Esserman, Laura J.;Fleming, Gini F.;Marcom, Paul K.;Leight, George S., Jr.;Giuntoli, Therese;Commean, Paul;Bae, Kyongtae;Luo, Jingqin;Ellis, Matthew J.
通讯作者：
Ellis, Matthew J.
影响因子：
3.9
作者：
Akashi-Tanaka, Sadako;Shimizu, Chikako;Yoshimura, Kenichi
通讯作者：
Yoshimura, Kenichi
影响因子：
3.9
作者：
Akashi-Tanaka, Sadako;Omatsu, Mutsuko;Fukutomi, Takashi
通讯作者：
Fukutomi, Takashi
影响因子：
5.8
作者：
Pivot, Xavier;Mansi, Laura;Villanueva, Christian
通讯作者：
Villanueva, Christian
影响因子：
3.8
作者：
Chang, Jenny C.;Makris, Andreas;Shak, Steven
通讯作者：
Shak, Steven