PDF(Pubmed)
Abstract：
OBJECTIVE: Oncotype DX (ODX) predicts the risk of recurrence and benefits of adding chemotherapy for patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer. We aimed to develop a simplified scoring system using readily available clinicopathological parameters to predict a high-risk ODX recurrence score (RS) while minimizing reproducibility issues regarding Ki-67 index evaluation methods.
METHODS: We enrolled 300 patients with ER+/HER2- early breast cancer, for whom ODX RS data were available in the test set. Using the QuPath image analysis platform, we systematically evaluated the average, hotspot, and hottest spot Ki-67 scores in the test set. Logistic regression analyses were conducted to establish a predictive scoring system for high-risk ODX RS. An independent validation set comprising 117 patients over different periods was established.
RESULTS: Factors such as age ≤ 50 years, invasive ductal carcinoma tumor type, histologic grade 2 or 3, tumor necrosis, progesterone receptor negativity, and a high Roche-analyzed Ki-67 score (> 20) were associated with high-risk ODX RS. These variables were incorporated into our scoring system. The area under the curve of the scoring system was 0.8057. When applied to both the test and validation sets with a cutoff value of 3, the sensitivity of our scoring system was 92%.
CONCLUSIONS: We successfully developed a scoring system based on the systematic evaluation of Ki-67 scoring methods. We believe that our user-friendly predictive scoring system for high risk ODX RS could help clinicians in identifying patients who may or may require additional ODX testing.
METHODS: We enrolled 300 patients with ER+/HER2- early breast cancer, for whom ODX RS data were available in the test set. Using the QuPath image analysis platform, we systematically evaluated the average, hotspot, and hottest spot Ki-67 scores in the test set. Logistic regression analyses were conducted to establish a predictive scoring system for high-risk ODX RS. An independent validation set comprising 117 patients over different periods was established.
RESULTS: Factors such as age ≤ 50 years, invasive ductal carcinoma tumor type, histologic grade 2 or 3, tumor necrosis, progesterone receptor negativity, and a high Roche-analyzed Ki-67 score (> 20) were associated with high-risk ODX RS. These variables were incorporated into our scoring system. The area under the curve of the scoring system was 0.8057. When applied to both the test and validation sets with a cutoff value of 3, the sensitivity of our scoring system was 92%.
CONCLUSIONS: We successfully developed a scoring system based on the systematic evaluation of Ki-67 scoring methods. We believe that our user-friendly predictive scoring system for high risk ODX RS could help clinicians in identifying patients who may or may require additional ODX testing.
摘要：
目的：对于雌激素受体阳性(ER+)/人表皮生长因子受体2阴性(HER2-)的早期乳腺癌患者，ODX(ODX)可预测其复发风险和增加化疗的益处。我们旨在使用现成的临床病理参数开发简化的评分系统，以预测高风险ODX复发评分（RS），同时最大程度地减少有关Ki-67指数评估方法的可重复性问题。
方法：我们招募了300例ER+/HER2-早期乳腺癌患者，测试集中有ODXRS数据的人。使用QuPath图像分析平台,我们系统地评估了平均值，,热点和测试集中最热门的Ki-67分数。采用Logistic回归分析建立高危ODXRS的预测评分系统。建立了一个独立的验证集，包括不同时期的117名患者。
结果：年龄≤50岁等因素，浸润性导管癌肿瘤类型，组织学2级或3级，肿瘤坏死，孕激素受体阴性，Roche分析的Ki-67评分高(>20)与高风险ODXRS相关。这些变量被纳入我们的评分系统。评分系统的曲线下面积为0.8057。当应用于截止值为3的测试集和验证集时，我们的评分系统的灵敏度为92％。
结论：我们成功开发了一种基于Ki-67评分方法系统评价的评分系统。我们相信，我们的用户友好的高风险ODXRS预测评分系统可以帮助临床医生识别可能或可能需要额外ODX测试的患者。
方法：我们招募了300例ER+/HER2-早期乳腺癌患者，测试集中有ODXRS数据的人。使用QuPath图像分析平台,我们系统地评估了平均值，,热点和测试集中最热门的Ki-67分数。采用Logistic回归分析建立高危ODXRS的预测评分系统。建立了一个独立的验证集，包括不同时期的117名患者。
结果：年龄≤50岁等因素，浸润性导管癌肿瘤类型，组织学2级或3级，肿瘤坏死，孕激素受体阴性，Roche分析的Ki-67评分高(>20)与高风险ODXRS相关。这些变量被纳入我们的评分系统。评分系统的曲线下面积为0.8057。当应用于截止值为3的测试集和验证集时，我们的评分系统的灵敏度为92％。
结论：我们成功开发了一种基于Ki-67评分方法系统评价的评分系统。我们相信，我们的用户友好的高风险ODXRS预测评分系统可以帮助临床医生识别可能或可能需要额外ODX测试的患者。
