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Abstract：
BACKGROUND: Neoadjuvant chemotherapy (NACT) is widely used in the treatment of triple-negative and HER2-positive breast cancer (BC), but its use in estrogen receptor (ER) and/or progesterone receptor (PR) positive/HER2-negative BC is questioned because of the low pathologic complete response (pCR) rates. This retrospective study assessed the mRNA-based MammaTyper® assay\'s capability of predicting pCR with NACT, and ER, PR, Ki67, and HER2 status at immunohistochemical (IHC) through transcriptomics.
METHODS: Diagnostic biopsies from 76 BC patients treated at the Cremona Hospital between 2012-2018 were analyzed. Relative mRNA expression levels of ERBB2, ESR1, PGR, and MKI67 were measured using the MammaTyper® kit and integrated into a pCR score. Predicting capability of pCR and standard IHC biomarkers could be assessed with ROC curves in 75 and 76 patients, respectively.
RESULTS: Overall, 68.0% patients obtained a MammaTyper® high-score and 32.0% a MammaTyper® low-score. Among high-score patients, 62.7% achieved pCR, compared to 16.7% in the low-score group (p = 0.0003). The binary MammaTyper® score showed good prediction of pCR in the overall cohort (area under curve [AUC] = 0.756) and in HR+/HER2-negative cases (AUC = 0.774). In cases with residual disease, the continuous MammaTyper® score correlated moderately with residual tumor size and decrease in tumor size. MammaTyper® showed substantial agreement with IHC for ESR1/ER and ERBB2/HER2, and moderate agreement for PGR/PR and MKI67/Ki67.
CONCLUSIONS: Overall, MammaTyper® pCR score may serve as a standardized tool for predicting NACT response in HR+/HER2-negative BC, potentially guiding treatment strategies. Additionally, it could provide a more standardized and reproducible assessment of ER, PR, HER2, and Ki67 status.
METHODS: Diagnostic biopsies from 76 BC patients treated at the Cremona Hospital between 2012-2018 were analyzed. Relative mRNA expression levels of ERBB2, ESR1, PGR, and MKI67 were measured using the MammaTyper® kit and integrated into a pCR score. Predicting capability of pCR and standard IHC biomarkers could be assessed with ROC curves in 75 and 76 patients, respectively.
RESULTS: Overall, 68.0% patients obtained a MammaTyper® high-score and 32.0% a MammaTyper® low-score. Among high-score patients, 62.7% achieved pCR, compared to 16.7% in the low-score group (p = 0.0003). The binary MammaTyper® score showed good prediction of pCR in the overall cohort (area under curve [AUC] = 0.756) and in HR+/HER2-negative cases (AUC = 0.774). In cases with residual disease, the continuous MammaTyper® score correlated moderately with residual tumor size and decrease in tumor size. MammaTyper® showed substantial agreement with IHC for ESR1/ER and ERBB2/HER2, and moderate agreement for PGR/PR and MKI67/Ki67.
CONCLUSIONS: Overall, MammaTyper® pCR score may serve as a standardized tool for predicting NACT response in HR+/HER2-negative BC, potentially guiding treatment strategies. Additionally, it could provide a more standardized and reproducible assessment of ER, PR, HER2, and Ki67 status.
摘要：
背景：新辅助化疗（NACT）广泛用于治疗三阴性和HER2阳性乳腺癌（BC），但其在雌激素受体(ER)和/或孕激素受体(PR)阳性/HER2阴性BC中的应用因病理完全缓解(pCR)率低而受到质疑.这项回顾性研究评估了基于mRNA的MammaTyper®测定用NACT预测pCR的能力，ER,PR,Ki67和HER2状态在免疫组织化学（IHC）通过转录组学。
方法：分析2012-2018年间在克雷莫纳医院接受治疗的76例BC患者的诊断性活检。ERBB2、ESR1、PGR的相对mRNA表达水平,和MKI67使用MammaTyper®试剂盒测量并整合到pCR评分中。pCR和标准IHC生物标志物的预测能力可以用75和76例患者的ROC曲线进行评估。分别。
结果：总体而言，68.0％的患者获得MammaTyper®高分，32.0％的患者获得MammaTyper®低分。在高分患者中，实现了62.7%的pCR，相比之下，低评分组的16.7%（p=0.0003）。二元MammaTyper®评分在整个队列(曲线下面积[AUC]=0.756)和HR+/HER2阴性病例(AUC=0.774)中显示pCR的良好预测。在有残留疾病的情况下，连续MammaTyper®评分与残余肿瘤大小和肿瘤大小减小中度相关。MammaTyper®对ESR1/ER和ERBB2/HER2显示与IHC的基本一致，对PGR/PR和MKI67/Ki67显示中等一致。
结论：总体而言，MammaTyper®pCR评分可作为预测HR+/HER2阴性BC患者NACT反应的标准化工具，潜在的指导治疗策略。此外,它可以提供更标准化和可重复的ER评估，PR,HER2和Ki67状态。
方法：分析2012-2018年间在克雷莫纳医院接受治疗的76例BC患者的诊断性活检。ERBB2、ESR1、PGR的相对mRNA表达水平,和MKI67使用MammaTyper®试剂盒测量并整合到pCR评分中。pCR和标准IHC生物标志物的预测能力可以用75和76例患者的ROC曲线进行评估。分别。
结果：总体而言，68.0％的患者获得MammaTyper®高分，32.0％的患者获得MammaTyper®低分。在高分患者中，实现了62.7%的pCR，相比之下，低评分组的16.7%（p=0.0003）。二元MammaTyper®评分在整个队列(曲线下面积[AUC]=0.756)和HR+/HER2阴性病例(AUC=0.774)中显示pCR的良好预测。在有残留疾病的情况下，连续MammaTyper®评分与残余肿瘤大小和肿瘤大小减小中度相关。MammaTyper®对ESR1/ER和ERBB2/HER2显示与IHC的基本一致，对PGR/PR和MKI67/Ki67显示中等一致。
结论：总体而言，MammaTyper®pCR评分可作为预测HR+/HER2阴性BC患者NACT反应的标准化工具，潜在的指导治疗策略。此外,它可以提供更标准化和可重复的ER评估，PR,HER2和Ki67状态。
