Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen
Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen
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DOI：
10.1634/theoncologist.12-6-631
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发表时间：
2007-01-01
期刊：
影响因子：
5.8
通讯作者：
Paik, Soonmyung
中科院分区：
文献类型：
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作者：
Paik, Soonmyung
虽然诊断为腋窝淋巴结阴性雌激素受体阳性乳腺癌的患者预后良好，但其中约15%的患者在他莫昔芬治疗5年后失败。临床试验提供的证据表明，化疗对这些患者有显着的益处，但如果所有患者都接受化疗，则会显着过度治疗。因此，可以识别除了他莫昔芬之外还需要化疗的患者或基本上通过他莫昔芬单独治愈的患者，并且可以使用常规处理的肿瘤活检组织进行的上下文特异性预后测定在临床上是有用的。使用逐步的方法，通过独立的建模和验证集，21个基因的复发评分（RS），基于监测的mRNA表达水平的16个癌症相关基因的关系，5个参考基因，已经开发。RS确定了大约50%的患者在单独使用他莫昔芬后预后良好。随后的研究表明，高危患者确定与RS优先受益于化疗。理想情况下，RS应用作连续变量。一项前瞻性研究-
Although patients diagnosed with axillary node-negative estrogen receptor-positive breast cancer have an excellent prognosis, about 15% of them fail after 5 years of tamoxifen treatment. Clinical trials have provided evidence that there is a significant benefit from chemotherapy for these patients, but it would be significant overtreatment if all of them were treated with chemotherapy. Therefore, context-specific prognostic assays that can identify those who need chemotherapy in addition to tamoxifen, or those who are essentially cured by tamoxifen alone, and can be performed using routinely processed tumor biopsy tissue would be clinically useful. Using a stepwise approach of going through independent model-building and validation sets, a 21-gene recurrence score (RS), based on monitoring of mRNA expression levels of 16 cancer-related genes in relation to five reference genes, has been developed. The RS identified approximately 50% of the patients who had excellent prognosis after tamoxifen alone. Subsequent study suggested that high-risk patients identified with the RS preferentially benefit from chemotherapy. Ideally the RS should be used as a continuous variable. A prospective study - the Trial Assigning Individualized Options for Treatment (Rx) (TAILORx) - to examine whether chemotherapy is required for the intermediate-risk group defined by the RS is accruing in North America.