背景:EMIT-1是一个国家,观察,旨在评估Prosigna价值的单臂试验,使用50基因分类器(PAM50)/复发风险(ROR)进行微阵列预测分析,测试作为常规诊断工具,检查其对辅助治疗决定的影响,临床结果,副作用和成本效益。在这里,我们介绍了对治疗决策的影响。
方法:激素受体阳性的患者,纳入人表皮生长因子受体2阴性pT1-pT2淋巴结阴性早期乳腺癌(EBC).进行Prosigna试验和标准组织病理学评估。在披露Prosigna测试结果之前(Prosigna之前)和之后(Prosigna之后)记录临床医生的治疗决定。
结果:纳入2217例患者,2178有结论性的Prosigna结果。Prosigna治疗前的决定是:27%的患者没有全身治疗(NT),仅内分泌治疗(ET)占38%,化疗(CT)其次是ET(CTET)占35%。Prosigna治疗后的决定是25%NT,51%ET和24%CT+ET,分别。28%的患者发生了辅助治疗改变,包括21%的CT使用变化。在接受CT+ET前检查的患者中,45%的人在Prosigna后降级为ET。在分配给ET的患者中,12%被升级为CT+ET,8%被降级为NT;在那些被分配到NT的人中,18%升级为ET/CT+ET。年龄≤50岁的患者更常推荐CT。在pT1c-pT2G2和中间Ki67的亚组(0.5-1.5×当地实验室中位Ki67评分),ProsignaCT治疗前的决定在各医院差异很大(3%-51%).Post-Prosigna,CT使用的变异性显著降低(8%-24%).Ki67与ROR评分之间的相关性较差(r=0.25-0.39)。随着组织学分级的增加,中位ROR评分增加,但ROR评分范围较宽(G10-79,G20-90,G316-94).
结论:Prosigna测试结果改变了所有EBC临床风险组的辅助治疗决策,显著减少了被归类为临床风险较高的患者在Prosigma前的CT使用,并减少了医院之间的治疗决策差异.
BACKGROUND: EMIT-1 is a national, observational, single-arm trial designed to assess the value of the Prosigna, Prediction Analysis of Microarray using the 50 gene classifier (PAM50)/Risk of Recurrence (ROR), test as a routine diagnostic tool, examining its impact on adjuvant treatment decisions, clinical outcomes, side-effects and cost-effectiveness. Here we present the impact on treatment decisions.
METHODS: Patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative pT1-pT2 lymph node-negative early breast cancer (EBC) were included. The
Prosigna test and standard histopathology assessments were carried out. Clinicians\' treatment decisions were recorded before (pre-
Prosigna) and after (post-
Prosigna) the
Prosigna test results were disclosed.
RESULTS: Of 2217 patients included, 2178 had conclusive
Prosigna results. The pre-Prosigna treatment decisions were: no systemic treatment (NT) in 27% of patients, endocrine treatment alone (ET) in 38% and chemotherapy (CT) followed by ET (CT + ET) in 35%. Post-Prosigna treatment decisions were 25% NT, 51% ET and 24% CT + ET, respectively. Adjuvant treatment changed in 28% of patients, including 21% change in CT use. Among patients assigned to CT + ET pre-
Prosigna, 45% were de-escalated to ET post-
Prosigna. Of patients assigned to ET, 12% were escalated to CT + ET and 8% were de-escalated to NT; of those assigned to NT, 18% were escalated to ET/CT + ET. CT was more frequently recommended for patients aged ≤50 years. In the subgroup with pT1c-pT2 G2 and intermediate Ki67 (0.5-1.5× local laboratory median Ki67 score), the pre-Prosigna CT treatment decision varied widely across hospitals (3%-51%). Post-
Prosigna, the variability of CT use was markedly reduced (8%-24%). The correlation between Ki67 and ROR score within this subgroup was poor (r = 0.25-0.39). The median ROR score increased by increasing histological grade, but the ROR score ranges were wide (for G1 0-79, G2 0-90, G3 16-94).
CONCLUSIONS: The Prosigna test result changed adjuvant treatment decisions in all EBC clinical risk groups, markedly decreased the CT use for patients categorized as higher clinical risk pre-Prosigna and reduced treatment decision discrepancies between hospitals.