In the Era of Genomics, Should Tumor Size Be Reconsidered as a Criterion for Neoadjuvant Chemotherapy?
In the Era of Genomics, Should Tumor Size Be Reconsidered as a Criterion for Neoadjuvant Chemotherapy?
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DOI：
10.1634/theoncologist.2014-0198
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发表时间：
2015-04-01
期刊：
影响因子：
5.8
通讯作者：
Villanueva, Christian
中科院分区：
文献类型：
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作者：
Pivot, Xavier;Mansi, Laura;Villanueva, Christian
背景Oncotype DX复发评分（RS）检测已被验证用于预测雌激素受体（ER）阳性、HER 2阴性早期乳腺癌患者的10年远处复发风险和化疗获益可能性。具有高RS肿瘤的患者具有实质性益处，而具有低RS肿瘤的患者从化疗中获益极小（如果有的话）。肿瘤大小是选择新辅助化疗患者的关键参数。本研究的目的是评估RS在根据肿瘤大小选择进行新辅助化疗的患者中的分布。本研究纳入了来自3项试验的ER阳性和HER 2阴性肿瘤患者，这些患者为淋巴结阴性或阳性淋巴结不超过1个。Oncotype DX在Genomic Health，Inc.，对临床数据不知情。对所有病例的RS分布进行描述性统计。在277例患者中，96例符合合格标准，81例有足够的材料进行分析。中位肿瘤大小为40 mm（四分位距[IQR]，30-50 mm）。Ⅰ级13例，Ⅱ级49例，Ⅲ级17例，RS分布广泛，中位数21.4（IQR，16.05-26.75）。结果：高RS 23例（28.3%），中RS 28例（34.6%），低RS 30例（37%）。RS可为临床实践和研究中选定患者的新辅助治疗决策提供相关信息。在新辅助治疗试验中纳入低RS疾病患者可能只会削弱观察治疗效果的能力。
Background. The Oncotype DX recurrence score (RS) assay has been validated for prediction of 10-year risk of distant recurrence and likelihood of benefit from chemotherapy in patients with estrogen receptor (ER)-positive, HER2-negative early breast cancer. Patients with high RS tumors have substantial benefit, and patients with low RS tumors have minimal if any benefit from chemotherapy. Tumor size is used as a key parameter when selecting patients for neoadjuvant chemotherapy. The aim of this study was to assess the distribution of RS in patients selected for neoadjuvant chemotherapy primarily according to tumor size.Patients and Methods. Patients with ER-positive and HER2-negative tumors that were node-negative or had no more than 1 positive node from three trials were included in this study. Oncotype DX was performed at Genomic Health, Inc., blinded to the clinical data. Descriptive statistics were calculated for distribution of RS for all cases.Results. Of 277 patients, 96 met eligibility criteria, and 81 had sufficient material for analysis. Median tumor size was 40 mm (interquartile range [IQR], 30-50 mm). Grade I, II, and III were observed in 13, 49, and 17 cases, respectively.There was a wide distribution of RS with a median of 21.4 (IQR, 16.05-26.75). In total, 23 (28.3%) had high, 28 (34.6%) intermediate, and 30 (37%) low RS results.Conclusion. The RS may provide relevant information for neoadjuvant treatment decisions in select patients both in clinical practice and in studies. Inclusion of low RS disease patients in neoadjuvant trials will likely only dilute the ability to look at treatment effects.