Anne Kuijer, Marieke Straver, Bianca den Dekker, Annelotte C.M. van Bommel, and Thijs van Dalen, Diakonessenhuis; Anne Kuijer, Sjoerd G. Elias, Sabine C. Linn, and Thijs van Dalen, University Medical Centre Utrecht; Sabine Siesling, Netherlands Comprehensive Cancer Organization, Utrecht; Carolien H. Smorenburg and Jelle Wesseling, Antoni van Leeuwenhoek Hospital; Carolien H. Smorenburg, Jelle Wesseling, Sabine C. Linn, and Emiel J.Th. Rutgers, Netherlands Cancer Institute, Amsterdam; and Sabine Siesling, University of Twente, Enschede, the Netherlands.
J Clin Oncol. 2017 Aug 20;35(24):2814-2819. doi: 10.1200/JCO.2016.70.3959. Epub 2017 Mar 13.
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.
目的 基因表达谱越来越多地被用于辅助化疗 (CT) 决策，以补充传统的预后因素。荷兰指南建议在雌激素受体 (ER) 阳性、无明显淋巴结转移的早期乳腺癌患者中使用经验证的基因表达谱。我们旨在评估 70 基因特征 (70-GS) 检测对 ER 阳性、早期乳腺癌患者 CT 决策的影响。
患者和方法 在一项针对年龄小于 70 岁的接受 ER 阳性、早期乳腺癌手术的患者的前瞻性、观察性、多中心研究中，在部署 70-GS 检测之前和获得检测结果后，医生被问及他们是否打算进行辅助 CT。
结果 2013 年 10 月 1 日至 2015 年 12 月 31 日，共纳入 660 例患者，在 33 家医院接受治疗。51%的患者为 pT1cN0、BRII、HER2-Neu 阴性乳腺癌。基于传统的临床病理特征，医生建议对 660 例患者中的 270 例（41%）进行 CT，建议对 660 例患者中的 107 例（16%）不进行 CT。对于其余 43%的患者，医生在进行 70-GS 检测之前无法确定并提供建议。在最初建议进行 CT 或不建议进行 CT 的患者中，分别有 56%和 59%的患者被 70-GS 检测分配到低风险组（κ，0.02；95%CI，-0.08 至 0.11）。在披露 70-GS 检测结果后，在接受检测前接受建议的 51%的患者中，初步建议发生改变；医生的明确 CT 建议与 96%的患者的 70-GS 结果一致。
结论 在这项针对 ER 阳性、早期乳腺癌患者的选择患者的前瞻性、多中心研究中，70-GS 的使用改变了一半患者的医生意向性 CT 治疗建议。
