Objective: To explore the association between the 21-gene recurrence score (RS) and clinicopathologic characteristics as well as prognosis in patients with axillary lymph node negative, hormone receptor (HR) positive breast cancer. Methods: The clinicopathologic data of 439 early breast cancer patients who underwent 21 gene RS testing was retrospectively analyzed. According to the 21 gene RS, the patients were divided into low risk (295 cases), intermediate risk (111 cases) and high-risk (33 cases) group. The relationship between the 21 gene RS and clinicopathological characteristics, treatment, recurrence and metastasis was analyzed. Univariate and multivariate statistical analyses were used to analyze the risk factors for relapse free survival (RFS). Results: Tumor grade, estrogen receptor (ER), progesterone receptor (PR) and Ki-67 index were significantly different among the 3 risk cohorts (P<0.001 for all). After a median follow-up of 32 months, the recurrence rate in low risk group (3.7%) was significantly lower than that in the intermediate-high risk group (9.0%), the locoregional recurrence (LRR) rate of low, intermediate and high risk group was 2.4%, 6.3% and 9.1%; and the distant metastasis (DM) rate in low risk group was 1.4% and 2.1% in the intermediate-high risk group. Univariate analysis showed RS, ER status and endocrine therapy were prognostic factors for RFS (P<0.05 for all). Multivariate analysis showed that RS was an independent significant predictor for RFS (P=0.04). Conclusions: The 21-gene RS is related to tumor grade, ER, PR and Ki-67 index. RS is an independent risk factor for RFS in patients with hormone receptor positive early-stage breast cancer.
目的： 探讨激素受体阳性腋窝淋巴结阴性早期乳腺癌21基因检测复发风险评分(RS)与临床病理特征的关系，及其在治疗选择和预后评估中的价值。 方法： 收集439例行21基因检测的早期乳腺癌患者的临床病理资料，并进行随访。根据21基因RS评分将患者分为低危组(295例)、中危组(111例)和高危组(33例)，分析21基因RS评分与临床病理特征、治疗以及复发转移的关系，采用单因素和多因素统计分析方法分析患者无复发生存期(RFS)的影响因素。 结果： 低危组、中危组和高危组之间，肿瘤分级、雌激素受体(ER)、孕激素受体(PR)、Ki-67指数差异均有统计学意义(均P<0.001)。中位随访32个月，低危组的复发转移率(3.7%)明显低于中高危组(9.0%)，其中低危组局部区域复发率为2.4%，中危组为6.3%，高危组为9.1%；低危组远处转移率为1.4%，中高危组为2.1%。单因素分析显示，RS评分、ER表达和分泌治疗与RFS有关(均P<0.05)。多因素Cox回归分析显示，RS评分是影响患者无复发生存的独立因素(P＝0.04)。 结论： 21基因RS评分与肿瘤组织学分级、ER、PR及Ki-67指数有关。RS评分是影响肿瘤无复发生存的独立影响因素。.
Keywords: 21-gene assay; Breast neoplasms; Prognosis; Recurrence score.