目的:WSG-PRIMe研究前瞻性评估了70基因签名MammaPrint®(MP)和80基因分子亚型分析BluePrint®对腔内早期乳腺癌临床治疗决策的影响。
方法:招募452名激素受体(HR)阳性和HER2阴性患者(N0,N1)。医师根据临床病理因素提供初步治疗建议。在通过MammaPrint/BluePrint进行前瞻性风险分类后,记录试验后治疗建议和实际治疗情况.通过问卷调查测量决策冲突和焦虑。
结果:29.1%的病例发生了测试后转换(在化疗(CT)推荐中)。总的来说,医师对MP风险评估的依从性低风险为92.3%,高危MP评分为94.3%.在“不和谐”组中,依从性非常高:74.7%的医生最初建议在低风险MP评分后将CT转换为CT遗漏;相反,88.9%的医生最初建议CT遗漏,在高风险MP评分后转向CT建议。大多数患者(99.2%)建议放弃CT检查后,21.3%有CT检查后建议的患者没有接受CT检查;在MP低风险患者中有CT检查前和检查后建议,40%的人实际上没有接受CT检查。在34%的患者中,通过BluePrint进行的管腔亚型评估与IHC评估不一致。患者状态焦虑评分总体上显著改善,尤其是MP低危患者。MP高危患者的特质焦虑评分略有增加,MP低危患者的特质焦虑评分略有下降。
结论:MammaPrint和BluePrint测试结果强烈影响医师在腔内EBC中的治疗决策,涉及多达三个淋巴结。对遗传确定的风险评估的高度坚持是实现个性化的具有成本效益的早期乳腺癌疾病管理方法的关键先决条件。
OBJECTIVE: The WSG-PRIMe
Study prospectively evaluated the impact of the 70-gene signature MammaPrint® (MP) and the 80-gene molecular subtyping assay
BluePrint® on clinical therapy decisions in luminal early breast cancer.
METHODS: 452 hormone receptor (HR)-positive and HER2-negative patients were recruited (N0, N1). Physicians provided initial therapy recommendations based on clinicopathological factors. After prospective risk classification by MammaPrint/
BluePrint was revealed, post-test treatment recommendations and actual treatment were recorded. Decisional Conflict and anxiety were measured by questionnaires.
RESULTS: Post-test switch (in chemotherapy (CT) recommendation) occurred in 29.1% of cases. Overall, physician adherence to MP risk assessment was 92.3% for low-risk and 94.3% for high-risk MP scores. Adherence was remarkably high in \"discordant\" groups: 74.7% of physicians initially recommending CT switched to CT omission following low-risk MP scores; conversely, 88.9% of physicians initially recommending CT omission switched to CT recommendations following high-risk MP scores. Most patients (99.2%) recommended to forgo CT post-test and 21.3% of patients with post-test CT recommendations did not undergo CT; among MP low-risk patients with pre-test and post-test CT recommendations, 40% did not actually undergo CT. Luminal subtype assessment by
BluePrint was discordant with IHC assessment in 34% of patients. Patients\' State Anxiety scores improved significantly overall, particularly in MP low-risk patients. Trait Anxiety scores increased slightly in MP high risk and decreased slightly in MP low-risk patients.
CONCLUSIONS: MammaPrint and
BluePrint test results strongly impacted physicians\' therapy decisions in luminal EBC with up to three involved lymph nodes. The high adherence to genetically determined risk assessment represents a key prerequisite for achieving a personalized cost-effective approach to disease management of early breast cancer.