Division of Hematology/Oncology, University of Pittsburgh Cancer Center, Pittsburgh, PA.
Am J Clin Oncol. 2014 Aug;37(4):404-10. doi: 10.1097/COC.0000000000000086.
The addition of adjuvant chemotherapy to hormonal therapy is recommended for patients with estrogen receptor-positive (ER+), node-positive (N+) early breast cancer (EBC). Some of these patients, however, are not likely to benefit from treatment and may, therefore, be overtreated while also incurring unnecessary treatment-related adverse events and health care costs. The 21-gene Recurrence Score assay has been clinically validated and recommended for use in patients with ER+, node-negative (N0) EBC to assess the 10-year risk of distant disease recurrence and predict the likelihood of response to adjuvant chemotherapy. A growing body of evidence from several large phase III clinical trials reports similar findings in patients with ER+, N+ EBC. A systematic review of published literature from key clinical trials that have used the 21-gene breast cancer assay in patients with ER+, N+ EBC was performed. The Recurrence Score has been shown to be an independent predictor of disease-free survival, overall survival, and distant recurrence-free interval in patients with ER+, N+ EBC. Outcomes from decision impact and health economics studies further indicate that the Recurrence Score affects physician treatment recommendations equally in patients with N+ or N0 disease. It also indicates that a reduction in Recurrence Score-directed chemotherapy is cost-effective. There is a large body of evidence to support the use of the 21-gene assay Recurrence Score in patients with N+ EBC. Use of this assay could help guide treatment decisions for patients who are most likely to receive benefit from chemotherapy.
对于雌激素受体阳性（ER+）、淋巴结阳性（N+）的早期乳腺癌（EBC）患者，建议在激素治疗的基础上添加辅助化疗。然而，这些患者中的一些不太可能从中受益，因此可能会过度治疗，同时还会产生不必要的治疗相关不良事件和医疗保健费用。21 基因复发评分检测已在临床上得到验证，并建议用于 ER+、淋巴结阴性（N0）EBC 患者，以评估 10 年远处疾病复发风险，并预测对辅助化疗的反应可能性。几项大型 III 期临床试验的大量证据报告了 ER+、N+EBC 患者中类似的发现。对使用 21 基因乳腺癌检测的 ER+、N+EBC 患者的关键临床试验发表文献进行了系统评价。复发评分已被证明是 ER+、N+EBC 患者无病生存、总生存和远处无复发生存期的独立预测因子。决策影响和健康经济学研究的结果进一步表明，复发评分在 N+或 N0 疾病患者中同样影响医生的治疗建议。它还表明，降低复发评分指导的化疗具有成本效益。有大量证据支持在 N+EBC 患者中使用 21 基因检测复发评分。该检测的使用可以帮助指导最有可能从化疗中获益的患者的治疗决策。
