Marrone Michael, Stewart Alison, Dotson W David
1] McKing Consulting Corporation, Atlanta, Georgia, USA [2] Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Genet Med. 2015 Jul;17(7):519-32. doi: 10.1038/gim.2014.140. Epub 2014 Dec 4.
This overview systematically evaluates the clinical utility of using Oncotype DX and MammaPrint gene-expression profiling tests to direct treatment decisions in women with breast cancer. The findings are intended to inform an updated recommendation from the Evaluation of Genomic Applications in Practice and Prevention Working Group.
Evidence reported in systematic reviews evaluating the clinical utility of Oncotype DX and MammaPrint, as well as the ability to predict treatment outcomes, change in treatment decisions, and cost-effectiveness, was qualitatively synthesized.
Five systematic reviews found no direct evidence of clinical utility for either test. Indirect evidence showed Oncotype DX was able to predict treatment effects of adjuvant chemotherapy, whereas no evidence of predictive value was found for MammaPrint. Both tests influenced a change in treatment recommendations in 21 to 74% of participants. The cost-effectiveness of Oncotype DX varied with the alternative compared. For MammaPrint, lack of evidence of the predictive value led to uncertainty in the cost-effectiveness.
No studies were identified that provided direct evidence that using gene-expression profiling tests to direct treatment decisions improved outcomes in women with breast cancer. Three ongoing studies may provide direct evidence for determining the clinical utility of gene-expression profiling testing.
本综述系统评估了使用Oncotype DX和MammaPrint基因表达谱检测来指导乳腺癌女性治疗决策的临床效用。研究结果旨在为实践和预防中基因组应用评估工作组的最新建议提供参考。
对系统评价中报告的证据进行定性综合分析，这些证据评估了Oncotype DX和MammaPrint的临床效用，以及预测治疗结果、改变治疗决策和成本效益的能力。
五项系统评价均未发现这两种检测具有临床效用的直接证据。间接证据表明Oncotype DX能够预测辅助化疗的治疗效果，而未发现MammaPrint具有预测价值的证据。两种检测在21%至74%的参与者中影响了治疗建议的改变。Oncotype DX的成本效益因比较的替代方案而异。对于MammaPrint，缺乏预测价值的证据导致成本效益存在不确定性。
未发现有研究提供直接证据表明使用基因表达谱检测来指导治疗决策能改善乳腺癌女性的预后。三项正在进行的研究可能会为确定基因表达谱检测的临床效用提供直接证据。
