Department of Oncology, KU Leuven, Leuven, Belgium.
Deptartment of Human Genetics, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Mod Pathol. 2021 Jul;34(7):1297-1309. doi: 10.1038/s41379-021-00743-8. Epub 2021 Feb 8.
Multigene signatures (MGS) are used to guide adjuvant chemotherapy (aCT) decisions in patients diagnosed with estrogen receptor (ER)-positive HER2-negative early breast cancer. We used results from three MGS (Oncotype DX® (ODX), MammaPrint® (MP) or Prosigna®) and assessed the concordance between high or low risk of recurrence and the predicted risk of recurrence based on statistical models. In addition, we looked at the impact of MGS results on final aCT administration during the multidisciplinary meeting (MDM). We retrospectively included 129 patients with ER-positive HER2-negative early breast cancer for which MGS testing was performed after MDM at University Hospitals Leuven between May 2013 and April 2019 in case there was doubt about aCT recommendation. Tumor tissue was analyzed either by ODX (N = 44), MP (N = 28), or Prosigna® (N = 57). Eight statistical models were computed: Magee equations (ME), Memorial Sloan Kettering simplified risk score (MSK-SRS), Breast Cancer Recurrence Score Estimator (BCRSE), OncotypeDXCalculator (ODXC), new Adjuvant! Online (nAOL), Mymammaprint.com (MyMP), PREDICT, and SiNK. Concordance, negative percent agreement, and positive percent agreement were calculated. Of 129 cases, 53% were MGS low and 47% MGS high risk. Concordances of 100.0% were observed between risk results obtained by ODX and ME. For MP, BCRSE demonstrated the best concordance, and for Prosigna® the average of ME. Concordances of <50.0% were observed between risk results obtained by ODX and nAOL, ODX and MyMP, ODX and SiNK, MP and MSK-SRS, MP and nAOL, MP and MyMP, MP and SiNK, and Prosigna® and ODXC. Integration of MGS results during MDM resulted in change of aCT recommendation in 47% of patients and a 15% relative and 9% absolute reduction. In conclusion, statistical models, especially ME and BCRSE, can be useful in selecting ER-positive HER2-negative early breast cancer patients who may need MGS testing resulting in enhanced cost-effectiveness and reduced delay in therapeutic decision-making.
多基因标志物 (MGS) 用于指导诊断为雌激素受体 (ER) 阳性 HER2 阴性早期乳腺癌患者的辅助化疗 (aCT) 决策。我们使用了三种 MGS（Oncotype DX® (ODX)、MammaPrint® (MP) 或 Prosigna®）的结果，并评估了高或低复发风险与基于统计模型预测的复发风险之间的一致性。此外，我们还观察了 MGS 结果对多学科会议 (MDM) 期间最终 aCT 给药的影响。我们回顾性纳入了 2013 年 5 月至 2019 年 4 月在鲁汶大学医院进行 MDM 后进行 MGS 检测的 129 例 ER 阳性 HER2 阴性早期乳腺癌患者，如果对 aCT 推荐有疑问。肿瘤组织通过 ODX（N=44）、MP（N=28）或 Prosigna®（N=57）进行分析。计算了 8 个统计模型：Magee 方程 (ME)、纪念斯隆凯特琳简化风险评分 (MSK-SRS)、乳腺癌复发评分估测器 (BCRSE)、OncotypeDXCalculator (ODXC)、新 Adjuvant! Online (nAOL)、Mymammaprint.com (MyMP)、PREDICT 和 SiNK。计算了一致性、负百分比一致性和正百分比一致性。在 129 例患者中，53%为 MGS 低风险，47%为 MGS 高风险。ODX 和 ME 获得的风险结果一致性为 100.0%。对于 MP，BCRSE 显示出最佳的一致性，而对于 Prosigna®，ME 的平均值。ODX 和 nAOL、ODX 和 MyMP、ODX 和 SiNK、MP 和 MSK-SRS、MP 和 nAOL、MP 和 MyMP、MP 和 SiNK 以及 Prosigna®和 ODXC 之间的风险结果一致性<50.0%。在 MDM 期间整合 MGS 结果导致 47%的患者改变了 aCT 推荐，并相对减少了 15%，绝对减少了 9%。总之，统计模型，尤其是 ME 和 BCRSE，可以用于选择可能需要 MGS 检测的 ER 阳性 HER2 阴性早期乳腺癌患者，从而提高成本效益，减少治疗决策的延迟。
