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21 基因复发评分检测对具有统一治疗政策的肿瘤临床实践中早期雌激素受体阳性乳腺癌辅助化疗决策的影响。

The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy.

机构信息

Department of Oncology, Ben-Gurion University of the Negev, Beer Sheva.

Department of Oncology, Ben-Gurion University of the Negev, Beer Sheva.

出版信息

Ann Oncol. 2011 Nov;22(11):2381-2386. doi: 10.1093/annonc/mdq769. Epub 2011 Mar 1.

DOI:10.1093/annonc/mdq769
PMID:21363879
Abstract

BACKGROUND

The 21-gene recurrence score (RS) assay has been validated in retrospective studies as prognostic of distant disease recurrence and predictive of the benefit of adjuvant chemotherapy in estrogen-receptor-positive breast cancer (BC). There is limited published data on the impact of the assay on clinical practice, particularly in the context of a single practice with a unified treatment policy.

PATIENTS AND METHODS

Between 2006 and 2009, RS was obtained on 135 patients in a single practice with a uniform treatment policy. Treatment recommendations before and after RS result were analyzed retrospectively. Pre-RS treatment recommendations were based on clinicopathological features and Adjuvant! Online (AO) calculated survival advantage. RS and AO survival advantage for adding chemotherapy were compared for each patient.

RESULTS

The distribution by risk group of RS was low- 49.6%, intermediate-37.8%, and high-12.6%. In 34 patients (25.2%, 95% confidence interval 17.9% to 32.5%), recommendation for chemotherapy was changed after obtaining assay result. Most changes (70.6%) were from chemotherapy to no chemotherapy. The RS correlated poorly with AO predictions.

CONCLUSION

The 21-gene assay, when applied in a consistent manner in early-stage BC, changes treatment recommendations in one-quarter of patients tested.

摘要

背景

21 基因复发评分 (RS) 检测已在回顾性研究中得到验证,可预测远处疾病复发的风险,并预测雌激素受体阳性乳腺癌 (BC) 患者接受辅助化疗的获益。关于该检测对临床实践的影响,特别是在单一实践中采用统一治疗政策的情况下,相关数据有限。

患者和方法

在单一实践中,于 2006 年至 2009 年间对 135 例患者进行了 RS 检测,对检测前后的治疗建议进行了回顾性分析。RS 检测前的治疗建议基于临床病理特征和 Adjuvant! Online (AO) 计算的生存优势。比较了每位患者 RS 和 AO 预测添加化疗的生存优势。

结果

RS 风险组的分布为低风险组 49.6%、中风险组 37.8%和高风险组 12.6%。在 34 例患者 (25.2%,95%置信区间 17.9%至 32.5%)中,获得检测结果后改变了化疗建议。大多数改变 (70.6%)是从化疗改为不化疗。RS 与 AO 预测相关性差。

结论

21 基因检测在早期 BC 中一致应用时,会改变四分之一接受检测患者的治疗建议。

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