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临床和基因组风险指导乳腺癌辅助治疗使用
背景:乳腺癌患者辅助化疗的使用可能受临床病理因素和基于21基因测定的评分来确定复发风险的指导。乳腺癌复发的临床风险水平是否为复发评分增加预后信息尚不清楚。 方法:我们进行了一项前瞻性试验,涉及9427名荷尔蒙受体阳性,人表皮生长因子受体2阴性,腋窝淋巴结阴性的女性,该研究已对21个基因进行了分析,根据肿瘤的大小和组织学分级,我们将乳腺癌复发的临床风险分为低或高。通过使用Cox比例风险模型计算远距离复发的风险比来评估临床风险的效果。最初的内分泌治疗仅在50岁或更年轻的绝经前妇女中单独使用他莫昔芬。 结果:临床风险水平是21基因中级复发评分为11到25(范围为0到100)的女性远处复发的预后,评分越高表明预后越差或随机分配接受内分泌治疗(比较高和低临床风险的危险比,危险比2.73; 95%置信区间[CI],1.93至3.87)或化疗加内分泌(化学内分泌)治疗(风险比为2.41; 95%CI为1.66至3.48)和复发评分较高的女性(得分为26至100),均被分配为化学内分泌疗法(风险比为3.17; CI为95%, 1.94至5.19)。在仅接受内分泌治疗的50岁以下的女性中,9岁时远处复发的估计(±SE)率低于5%(≤1.8±0.9%),且复发评分较低( (0到10),与临床风险无关,为4.7±1.0%,复发评分中等,临床风险较低。在这一年龄组中,仅接受内分泌治疗的临床风险高且复发评分中等的女性(92.3±2.4%)和接受化学内分泌治疗的复发分数高的女性在9岁时的远距离复发估计超过10% (15.2±3.3%)。 结论:临床风险分层提供了预后信息,将其添加到21基因复发评分中后,可用于确定可以从更有效的治疗中受益的绝经前妇女。 (由美国国家癌症研究所等资助; ClinicalTrials.gov编号,NCT00310180。)。**
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer
BACKGROUND: The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known. METHODS: We performed a prospective trial involving 9427 women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, axillary node-negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade. The effect of clinical risk was evaluated by calculating hazard ratios for distant recurrence with the use of Cox proportional-hazards models. The initial endocrine therapy was tamoxifen alone in the majority of the premenopausal women who were 50 years of age or younger. RESULTS: The level of clinical risk was prognostic of distant recurrence in women with an intermediate 21-gene recurrence score of 11 to 25 (on a scale of 0 to 100, with higher scores indicating a worse prognosis or a greater potential benefit from chemotherapy) who were randomly assigned to endocrine therapy (hazard ratio for the comparison of high vs. low clinical risk, 2.73; 95% confidence interval [CI], 1.93 to 3.87) or to chemotherapy plus endocrine (chemoendocrine) therapy (hazard ratio, 2.41; 95% CI, 1.66 to 3.48) and in women with a high recurrence score (a score of 26 to 100), all of whom were assigned to chemoendocrine therapy (hazard ratio, 3.17; 95% CI, 1.94 to 5.19). Among women who were 50 years of age or younger who had received endocrine therapy alone, the estimated (±SE) rate of distant recurrence at 9 years was less than 5% (≤1.8±0.9%) with a low recurrence score (a score of 0 to 10), irrespective of clinical risk, and 4.7±1.0% with an intermediate recurrence score and low clinical risk. In this age group, the estimated distant recurrence at 9 years exceeded 10% among women with a high clinical risk and an intermediate recurrence score who received endocrine therapy alone (12.3±2.4%) and among those with a high recurrence score who received chemoendocrine therapy (15.2±3.3%). CONCLUSIONS: Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.).
pmid: 31157962 N Engl J Med 影响因子: 70.67 发表日期: 20190603 官网 免费下载
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