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Impact of 70-Gene Signature Use on Adjuvant Chemotherapy Decisions in Patients With Estrogen Receptor–Positive Early Breast Cancer: Results of a Prospective Cohort Study
Journal of Clinical Oncology ( IF 42.1 ) Pub Date : 2017-08-20 , DOI: 10.1200/jco.2016.70.3959
Anne Kuijer 1 , Marieke Straver 1 , Bianca den Dekker 1 , Annelotte C.M. van Bommel 1 , Sjoerd G. Elias 1 , Carolien H. Smorenburg 1 , Jelle Wesseling 1 , Sabine C. Linn 1 , Emiel J.Th. Rutgers 1 , Sabine Siesling 1 , Thijs van Dalen 1
Affiliation  

Purpose Gene-expression profiles increasingly are used in addition to conventional prognostic factors to guide adjuvant chemotherapy (CT) decisions. The Dutch guideline suggests use of validated gene-expression profiles in patients with estrogen receptor (ER) -positive, early-stage breast cancer without overt lymph node metastases. We aimed to assess the impact of a 70-gene signature (70-GS) test on CT decisions in patients with ER-positive, early-stage breast cancer. Patients and Methods In a prospective, observational, multicenter study in patients younger than 70 years old who had undergone surgery for ER-positive, early-stage breast cancer, physicians were asked whether they intended to administer adjuvant CT before deployment of the 70-GS test and after the test result was available. Results Between October 1, 2013, and December 31, 2015, 660 patients, treated in 33 hospitals, were enrolled. Fifty-one percent of patients had pT1cN0, BRII, HER2-Neu-negative breast cancer. On the basis of conventional clinicopathological characteristics, physicians recommended CT in 270 (41%) of the 660 patients and recommended withholding CT in 107 (16%) of the 660 patients. For the remaining 43% of patients, the physicians were unsure and unable to give advice before 70-GS testing. In patients for whom CT was initially recommended or not recommended, 56% and 59%, respectively, were assigned to a low-risk profile by the 70-GS (κ, 0.02; 95% CI, -0.08 to 0.11). After disclosure of the 70-GS test result, the preliminary advice was changed in 51% of patients who received a recommendation before testing; the definitive CT recommendation of the physician was in line with the 70-GS result in 96% of patients. Conclusion In this prospective, multicenter study in a selection of patients with ER-positive, early-stage breast cancer, 70-GS use changed the physician-intended recommendation to administer CT in half of the patients.

中文翻译:

使用 70 基因特征对雌激素受体阳性早期乳腺癌患者辅助化疗决策的影响:一项前瞻性队列研究的结果

目的 除了常规预后因素外,越来越多地使用基因表达谱来指导辅助化疗 (CT) 决策。荷兰指南建议在没有明显淋巴结转移的雌激素受体 (ER) 阳性早期乳腺癌患者中使用经过验证的基因表达谱。我们旨在评估 70 基因特征 (70-GS) 测试对 ER 阳性早期乳腺癌患者 CT 决策的影响。患者和方法 在一项针对 70 岁以下因 ER 阳性早期乳腺癌接受手术的患者的前瞻性、观察性、多中心研究中,医生被问及他们是否打算在部署 70-GS 前进行辅助 CT测试并在测试结果可用后。结果 2013 年 10 月 1 日至 2015 年 12 月 31 日期间,招募了 660 名在 33 家医院接受治疗的患者。51% 的患者患有 pT1cN0、BRII、HER2-Neu 阴性乳腺癌。根据常规临床病理特征,660 名患者中有 270 名(41%)医生推荐 CT,660 名患者中有 107 名(16%)推荐不进行 CT。对于其余 43% 的患者,医生在 70-GS 测试之前不确定并且无法提供建议。在最初推荐或不推荐 CT 的患者中,分别有 56% 和 59% 的患者被 70-GS 分配为低风险特征(κ,0.02;95% CI,-0.08 至 0.11)。在 70-GS 检测结果公布后,51% 的患者在检测前收到了建议,其中的初步建议发生了变化;医生的最终 CT 推荐与 96% 的患者的 70-GS 结果一致。结论 在这项针对 ER 阳性、早期乳腺癌患者的前瞻性、多中心研究中,70-GS 的使用改变了医生对一半患者进行 CT 的建议。
更新日期:2017-08-20
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