MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial
MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial
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DOI：
10.1186/s12885-020-6534-z
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发表时间：
2020-01-31
期刊：
影响因子：
3.8
通讯作者：
Audeh, William
中科院分区：
文献类型：
--
作者：
Soliman, Hatem;Shah, Varsha;Audeh, William
背景基因组风险评估分析的使用增加表明，越来越依赖于这些分析提供的数据来指导治疗决策。目前的研究旨在评估治疗决策的变化和医生的信心的基础上70基因的复发风险签名（70-GS，MammaPrint）和80基因的分子亚型签名（80-GS，BluePrint）在早期乳腺癌patients.MethodsIMPACt，前瞻性，仅病例研究，2015年11月和2017年8月之间招募了452例患者。主要目标人群包括358例I-II期、激素受体阳性、HER 2阴性乳腺癌患者。在收到70-GS和80-GS的结果之前和之后，收集推荐的治疗计划和医生信心。获得结果后开始治疗。评估了70-GS高风险（HR）和低风险（LR）患者的分布，结果70-GS分型率为62.5%，（n=224/358）例患者为LR，37.5% 24.0%（n=86/358）的患者在收到70-GS和80-GS结果后改变了治疗决定。在最初处方CT的LR患者中，71.0%（44/62）的患者从其治疗建议中删除了CT。在最初未处方CT的HR患者中，65.1%（41/63）添加了CT。在收到70-GS结果后，83.6%（n=112/134）的70-GS HR患者治疗计划包括CT，91.5%（n=205/224）的70-GS LR患者治疗计划不包括CT。对于不同意医生推荐治疗的患者，大多数（94.1%，n=16/17）选择在推荐时不接受CT。对于患者的医生推荐的治疗计划是不一致的70-GS的结果，不一致性显着相关的年龄和淋巴结status.ConclusionsThe IMPACt试验表明，治疗计划是88.5%（n=317/358）与70-GS的结果一致，表明医生在临床实践中作出治疗决定的基础上的70-GS的结果。在临床高风险、70-GS低风险患者中，包括CT在内的治疗建议减少了60.0%。此外，医生报告称，在72%（n=258/358）的病例中，在收到70-GS结果后，他们对患者的治疗决策更有信心。试验注册“测量MammaPrint对乳腺癌患者辅助和新辅助治疗的影响：前瞻性注册”（NCT 02670577）于2016年1月27日回顾性注册。
BackgroundIncreased usage of genomic risk assessment assays suggests increased reliance on data provided by these assays to guide therapy decisions. The current study aimed to assess the change in treatment decision and physician confidence based on the 70-gene risk of recurrence signature (70-GS, MammaPrint) and the 80-gene molecular subtype signature (80-GS, BluePrint) in early stage breast cancer patients.MethodsIMPACt, a prospective, case-only study, enrolled 452 patients between November 2015 and August 2017. The primary objective population included 358 patients with stage I-II, hormone receptor-positive, HER2-negative breast cancer. The recommended treatment plan and physician confidence were captured before and after receiving results for 70-GS and 80-GS. Treatment was started after obtaining results. The distribution of 70-GS High Risk (HR) and Low Risk (LR) patients was evaluated, in addition to the distribution of 80-GS compared to IHC status.ResultsThe 70-GS classified 62.5% (n=224/358) of patients as LR and 37.5% (n=134/358) as HR. Treatment decisions were changed for 24.0% (n=86/358) of patients after receiving 70-GS and 80-GS results. Of the LR patients initially prescribed CT, 71.0% (44/62) had CT removed from their treatment recommendation. Of the HR patients not initially prescribed CT, 65.1% (41/63) had CT added. After receiving 70-GS results, CT was included in 83.6% (n=112/134) of 70-GS HR patient treatment plans, and 91.5% (n=205/224) of 70-GS LR patient treatment plans did not include CT. For patients who disagreed with the treatment recommended by their physicians, most (94.1%, n=16/17) elected not to receive CT when it was recommended. For patients whose physician-recommended treatment plan was discordant with 70-GS results, discordance was significantly associated with age and lymph node status.ConclusionsThe IMPACt trial showed that treatment plans were 88.5% (n=317/358) in agreement with 70-GS results, indicating that physicians make treatment decisions in clinical practice based on the 70-GS result. In clinically high risk, 70-GS Low Risk patients, there was a 60.0% reduction in treatment recommendations that include CT. Additionally, physicians reported having greater confidence in treatment decisions for their patients in 72% (n=258/358) of cases after receiving 70-GS results.Trial registration"Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry" (NCT02670577) retrospectively registered on Jan 27, 2016.