Abstract：
BACKGROUND: EndoPredict® (EP) is a multigene assay to predict distant recurrence risk in luminal breast cancer. EP measures the expression of 12 genes in primary tumor by qRT-PCR from formalin-fixed paraffin-embedded (FFPE) tissues and calculates EP risk score that indicates the risk of distant recurrence. We evaluated the performance of EP in predicting distant recurrence risk using microarray data from fresh frozen (FF) tissues. We also examined the applicability of EP to microarray data from FFPE tissues.
METHODS: We analyzed the publicly available data of 431 node-negative and 270 node-positive patients with luminal breast cancer who received endocrine therapy alone. We evaluated the prognostic value of EP using microarray data from FF tissues. Next, we created an algorithm to calculate EP risk score using microarray data from FFPE tissues. We examined the correlation coefficient of EP risk score and concordance rate of EP risk high/low using microarray data from FFPE/FF tissue pairs in a validation set of 39 patients.
RESULTS: In 431 node-negative patients, the distant recurrence-free survival (DRFS) rate was significantly worse in those with high EP risk scores (P = 3.68 × 10-6, log-rank). The 5-year DRFS was 95.2% in those with low EP risk score. In the validation set, the correlation coefficient of EP risk score was 0.93 and the concordance rate of EP risk high/low was 91.7%.
CONCLUSIONS: EP using microarray data from FF tissues was useful in predicting distant recurrence risk in luminal breast cancer, and EP might be utilized in microarray data from FFPE tissues.
METHODS: We analyzed the publicly available data of 431 node-negative and 270 node-positive patients with luminal breast cancer who received endocrine therapy alone. We evaluated the prognostic value of EP using microarray data from FF tissues. Next, we created an algorithm to calculate EP risk score using microarray data from FFPE tissues. We examined the correlation coefficient of EP risk score and concordance rate of EP risk high/low using microarray data from FFPE/FF tissue pairs in a validation set of 39 patients.
RESULTS: In 431 node-negative patients, the distant recurrence-free survival (DRFS) rate was significantly worse in those with high EP risk scores (P = 3.68 × 10-6, log-rank). The 5-year DRFS was 95.2% in those with low EP risk score. In the validation set, the correlation coefficient of EP risk score was 0.93 and the concordance rate of EP risk high/low was 91.7%.
CONCLUSIONS: EP using microarray data from FF tissues was useful in predicting distant recurrence risk in luminal breast cancer, and EP might be utilized in microarray data from FFPE tissues.
摘要：
背景：EndoPredict®（EP）是一种多基因检测方法，用于预测管腔内乳腺癌的远处复发风险。EP通过qRT-PCR从福尔马林固定的石蜡包埋（FFPE）组织中测量原发性肿瘤中12个基因的表达，并计算指示远处复发风险的EP风险评分。我们使用来自新鲜冷冻（FF）组织的微阵列数据评估了EP在预测远处复发风险方面的性能。我们还检查了EP对来自FFPE组织的微阵列数据的适用性。
方法：我们分析了431例淋巴结阴性和270例淋巴结阳性的腔内乳腺癌患者的公开数据，这些患者仅接受内分泌治疗。我们使用来自FF组织的微阵列数据评估EP的预后价值。接下来,我们使用来自FFPE组织的微阵列数据创建了一种计算EP风险评分的算法.我们使用来自39名患者的FFPE/FF组织对的微阵列数据检查了EP风险评分的相关系数和EP风险高/低的一致率。
结果：在431个淋巴结阴性患者中，EP风险评分较高的患者的无远处复发生存率(DRFS)明显较差(P=3.68×10-6,log-rank).在低EP风险评分的患者中，5年DRFS为95.2％。在验证集中，EP风险评分的相关系数为0.93，EP风险高/低的一致率为91.7％。
结论：EP使用来自FF组织的微阵列数据可用于预测管腔乳腺癌的远处复发风险，和EP可用于来自FFPE组织的微阵列数据。
方法：我们分析了431例淋巴结阴性和270例淋巴结阳性的腔内乳腺癌患者的公开数据，这些患者仅接受内分泌治疗。我们使用来自FF组织的微阵列数据评估EP的预后价值。接下来,我们使用来自FFPE组织的微阵列数据创建了一种计算EP风险评分的算法.我们使用来自39名患者的FFPE/FF组织对的微阵列数据检查了EP风险评分的相关系数和EP风险高/低的一致率。
结果：在431个淋巴结阴性患者中，EP风险评分较高的患者的无远处复发生存率(DRFS)明显较差(P=3.68×10-6,log-rank).在低EP风险评分的患者中，5年DRFS为95.2％。在验证集中，EP风险评分的相关系数为0.93，EP风险高/低的一致率为91.7％。
结论：EP使用来自FF组织的微阵列数据可用于预测管腔乳腺癌的远处复发风险，和EP可用于来自FFPE组织的微阵列数据。
