Reliable determination of Ki67 labeling index (Ki67-LI) on core needle biopsy (CNB) is essential for determining breast cancer molecular subtype for therapy planning. However, studies on agreement between molecular subtype and Ki67-LI between CNB and surgical resection (SR) specimens are conflicting. The present study analyzed the influence of clinicopathological and sampling-associated factors on agreement. Molecular subtype was determined visually by Ki67-LI in 484 pairs of CNB and SR specimens of invasive estrogen receptor (ER)-positive, human epidermal growth factor (HER2)-negative breast cancer. Luminal B disease was defined by Ki67-LI > 20% in SR. Correlation of molecular subtype agreement with age, menopausal status, CNB method, Breast Imaging Reporting and Data System imaging category, time between biopsies, type of surgery, and pathological tumor parameters was analyzed. Recurrence-free survival (RFS) and overall survival (OS) were analyzed using the Kaplan-Meier method. CNB had a sensitivity of 77.95% and a specificity of 80.97% for identifying luminal B tumors in CNB, compared with the final molecular subtype determination after surgery. The correlation of Ki67-LI between CNB and SR was moderate (ROC-AUC 0.8333). Specificity and sensitivity for CNB to correctly define molecular subtype of tumors according to SR were significantly associated with tumor grade, immunohistochemical progesterone receptor (PR) and p53 expression (p < 0.05). Agreement of molecular subtype did not significantly impact RFS and OS (p = 0.22 for both). The identified factors likely mirror intratumoral heterogeneity that might compromise obtaining a representative CNB. Our results challenge the robustness of a single CNB-driven measurement of Ki67-LI to identify luminal B breast cancer of low (G1) or intermediate (G2) grade.

中文翻译：

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Ki67标记指数在核心针穿刺活检和手术切除标本之间影响乳腺癌腔分子亚型一致性的因素。

可靠地确定芯针活检（CNB）的Ki67标记指数（Ki67-LI）对于确定治疗计划的乳腺癌分子亚型至关重要。然而，关于CNB和手术切除（SR）标本之间的分子亚型和Ki67-LI之间一致性的研究存在矛盾。本研究分析了临床病理和抽样相关因素对一致性的影响。通过Ki67-LI在484对侵袭性雌激素受体（ER）阳性，人表皮生长因子（HER2）阴性的乳腺癌的CNB和SR标本中目测确定分子亚型。SR中，Ki67-LI> 20％定义为B型发光疾病。分子亚型一致性与年龄，绝经状态，CNB方法，乳房成像报告和数据系统成像类别，活检之间的时间，手术类型，并分析肿瘤的病理参数。使用Kaplan-Meier方法分析了无复发生存期（RFS）和总生存期（OS）。与手术后的最终分子亚型测定相比，CNB在CNB中识别腔B肿瘤的敏感性为77.95％，特异性为80.97％。CNB和SR之间的Ki67-LI相关性为中等（ROC-AUC 0.8333）。CNB根据SR正确定义肿瘤分子亚型的特异性和敏感性与肿瘤等级，免疫组化孕激素受体（PR）和p53表达显着相关（p <0.05）。分子亚型的一致性并没有显着影响RFS和OS（两者p均= 0.22）。所确定的因素可能反映了瘤内异质性，可能会危及获得代表性CNB。