PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer
PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer
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DOI：
10.1200/jco.2017.74.6586
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发表时间：
2018-03-10
影响因子：
45.3
通讯作者：
Ejlertsen, Bent
中科院分区：
文献类型：
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作者：
Laenkholm, Anne-Vibeke;Jensen, Maj-Britt;Ejlertsen, Bent
目的基于PAM 50的Prosigna复发风险（ROR）评分已在随机临床试验中得到验证，可预测10年远处复发（DR）。Prosigna用于预测DR的价值在一个全面的全国性丹麦队列中进行了检查，该队列由绝经后激素受体阳性的早期乳腺癌妇女组成，这些妇女接受了5年的内分泌治疗。患者和方法使用基于人群的丹麦乳腺癌合作组数据库，收集了2000年至2003年诊断的所有患者的随访数据，根据全国性指南，内分泌治疗5年。使用Prosigna检测了2，740例患者的原发性肿瘤块，在确定人表皮生长因子受体2（HER 2）状态后，分析了2，558例激素受体阳性/HER 2阴性样本的数据，其中包括1，395例淋巴结阳性患者。精细和灰色模型，以确定DR的ROR的预后价值。结果平均随访复发为9.2年。26%的淋巴结阳性患者被归类为低ROR（n = 359），DR风险为3.5%（95%置信区间[CI]，1.9%至6.1%），而10年时被归类为高ROR的患者（n = 648）的DR风险为22.1%（95% CI，18.6%至25.8%）。分类为低和高ROR的淋巴结阴性患者的DR风险分别为5.0%（95% CI，2.9%-8.0%）和17.8%（95% CI，14.0%-22.0%）。管腔型B类肿瘤（n = 947; DR风险，18.4% [95%CI：15.7%~ 21.3%]）的预后显著差于管腔型A类肿瘤（n = 1,474，;DR风险，7.6% [95%CI：6.1%~ 9.2%]; P <0.001）。在现实世界中，Prosigna可以可靠地识别淋巴结阴性患者和相当大比例的具有1至3个阳性淋巴结的患者，这些患者可以免于辅助化疗。(C)2018年美国临床肿瘤学会
PurposeThe PAM50-based Prosigna risk of recurrence (ROR) score has been validated in randomized clinical trials to predict 10-year distant recurrence (DR). The value of Prosigna for predicting DR was examined in a comprehensive nationwide Danish cohort consisting of postmenopausal women with hormone receptor-positive early breast cancer treated with 5 years of endocrine therapy alone.Patients and MethodsUsing the population-based Danish Breast Cancer Cooperative Group database, follow-up data were collected on all patients diagnosed from 2000 through 2003 who, by nationwide guidelines, were treated with endocrine therapy for 5 years. Primary tumor blocks from 2,740 patients were tested with Prosigna and, after determination of human epidermal growth factor receptor 2 (HER2) status, data from 2,558 hormone receptor-positive/HER2-negative samples were analyzed, including 1,395 node-positive patients. Fine and Gray models were applied to determine the prognostic value of ROR for DR.ResultsMedian follow-up for recurrence was 9.2 years. Twenty-six percent of the node-positive patients were classified as low ROR (n = 359) with a DR risk of 3.5% (95% confidence interval [CI], 1.9% to 6.1%) versus a DR risk of 22.1% (95% CI, 18.6% to 25.8%) at 10 years for patients classified as high ROR (n = 648). Node-negative patients classified as low and high ROR had a risk of DR of 5.0% (95% CI, 2.9% to 8.0%) and 17.8% (95% CI, 14.0% to 22.0%), respectively. Luminal B tumors (n = 947; DR risk, 18.4% [95% CI: 15.7% to 21.3%]) had a significantly worse outcome than luminal A tumors (n = 1,474,;DR risk, 7.6% [95% CI: 6.1% to 9.2%]; P < .001).ConclusionProsigna ROR score improved the prediction of outcome in this nationwide Danish population. In a real-world setting, Prosigna can reliably identify node-negative patients and a significant proportion of patients with one to three positive nodes who can be spared treatment with adjuvant chemotherapy. (C) 2018 by American Society of Clinical Oncology