Breast Cancer Translational Research Laboratory BCTL, J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Ann Oncol. 2013 Mar;24(3):647-54. doi: 10.1093/annonc/mds645. Epub 2013 Jan 20.
We critically evaluated the available evidence on genomic tests in breast cancer to define their prognostic ability and likelihood to determine treatment benefit.
Independent evaluation of six genomic tests [Oncotype Dx™, MammaPrint(®), Genomic Grade Index, PAM50 (ROR-S), Breast Cancer Index, and EndoPredict] was carried out by a panel of experts in three parameters: analytical validity, clinical validity, and clinical utility based on the principles of the EGAPP criteria. PANEL STATEMENTS: The majority of the working group members found the available evidence on the analytical and clinical validity of Oncotype Dx™ and MammaPrint(®) to be convincing. None of the genomic tests demonstrated robust evidence of clinical utility: it was not clear from the current evidence that modifying treatment decisions based on the results of a given genomic test could result in improving clinical outcome.
The IMPAKT 2012 Working Group proposed the following recommendations: (i) a need to develop models that integrate clinicopathologic factors along with genomic tests; (ii) demonstration of clinical utility should be made in the context of a prospective randomized trial; and (iii) the creation of registries for patients who are subjected to genomic testing in the daily practice.
我们批判性地评估了乳腺癌基因组检测的现有证据，以确定其预后能力和确定治疗获益的可能性。
由一组专家独立评估六项基因组检测[Oncotype Dx™、MammaPrint(®)、基因组分级指数、PAM50 (ROR-S)、乳腺癌指数和 EndoPredict]，根据 EGAPP 标准的原则，评估其在三个参数方面的分析有效性、临床有效性和临床实用性。
大多数工作组的成员发现，关于 Oncotype Dx™和 MammaPrint(®)的分析和临床有效性的现有证据令人信服。没有一项基因组检测显示出具有良好临床实用性的证据：目前的证据尚不清楚，基于特定基因组检测结果修改治疗决策是否能改善临床结局。
IMP AKT 2012 工作组提出了以下建议：（i）需要开发整合临床病理因素和基因组检测的模型；（ii）应该在前瞻性随机试验的背景下证明临床实用性；（iii）为在日常实践中接受基因组检测的患者创建登记处。
