The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use.

The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use.
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DOI:
10.1093/annonc/mds512
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发表时间:
2013-03
期刊:
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子:
--
通讯作者:
Blohmer J
Blohmer J
中科院分区:
其他
文献类型:
--
作者:
Eiermann W;Rezai M;Kümmel S;Kühn T;Warm M;Friedrichs K;Schneeweiss A;Markmann S;Eggemann H;Hilfrich J;Jackisch C;Witzel I;Eidtmann H;Bachinger A;Hell S;Blohmer J

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我们进行了一项前瞻性临床研究,以评估复发评分(RS)对早期乳腺癌(EBC)治疗决策的影响。共招募了379名符合条件的雌激素受体阳性(ER+)、HER 2阴性EBC和0-3个阳性淋巴结的女性。记录治疗建议、患者的决策冲突、医生对RS的信心以及实际治疗数据。在366例可评估患者中,244例为淋巴结阴性(N 0),122例为淋巴结阳性(N+)。33%的患者(N 0 30%,N+ 39%)改变了治疗建议。在所有最初建议进行化学内分泌治疗的患者中,38%(N 0 39%,N+ 37%)的RS后建议改为内分泌治疗,25%(N 0 22%,N+ 39%)的最初建议仅进行内分泌治疗改为联合化学内分泌治疗。患者的决策冲突评分改善了6%(P = 0.028),45%(P < 0.001)的医生信心增加。总体而言,与试验前推荐化疗的患者相比,实际接受化疗的患者减少了33%(N 0 29%,N+ 38%)。与目前的临床实践相比,使用该测试可以节省成本。RS指导的化疗决策导致淋巴结阴性和淋巴结阳性ER+ EBC的辅助化疗使用的实质性修改。
We carried out a prospective clinical study to evaluate the impact of the Recurrence Score (RS) on treatment decisions in early breast cancer (EBC). A total of 379 eligible women with estrogen receptor positive (ER+), HER2-negative EBC and 0–3 positive lymph nodes were enrolled. Treatment recommendations, patients' decisional conflict, physicians' confidence before and after knowledge of the RS and actual treatment data were recorded. Of the 366 assessable patients 244 were node negative (N0) and 122 node positive (N+). Treatment recommendations changed in 33% of all patients (N0 30%, N+ 39%). In 38% of all patients (N0 39%, N+ 37%) with an initial recommendation for chemoendocrine therapy, the post-RS recommendation changed to endocrine therapy, in 25% (N0 22%, N+ 39%) with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy, respectively. A patients' decisional conflict score improved by 6% (P = 0.028) and physicians' confidence increased in 45% (P < 0.001) of all cases. Overall, 33% (N0 29%, N+ 38%) of fewer patients actually received chemotherapy as compared with patients recommended chemotherapy pre-test. Using the test was cost-saving versus current clinical practice. RS-guided chemotherapy decision-making resulted in a substantial modification of adjuvant chemotherapy usage in node-negative and node-positive ER+ EBC.
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