Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo.
Department of Oncology, University of North Norway, Tromsø; Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø.
ESMO Open. 2024 Jun;9(6):103475. doi: 10.1016/j.esmoop.2024.103475. Epub 2024 Jun 4.
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.
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.
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).
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.
EMIT-1 是一项全国性的、观察性的、单臂试验，旨在评估 Prosigna、使用 50 基因分类器的微阵列预测分析（PAM50）/复发风险（ROR）的预测分析作为常规诊断工具的价值，检查其对辅助治疗决策、临床结果、副作用和成本效益的影响。这里我们介绍对治疗决策的影响。
纳入激素受体阳性、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）患者。进行了 Prosigna 检测和标准组织病理学评估。记录了临床医生在 Prosigna 检测结果公布之前（预 Prosigna）和之后（后 Prosigna）的治疗决策。
2217 例患者中，2178 例有明确的 Prosigna 检测结果。预 Prosigna 的治疗决策为：27%的患者不进行全身治疗（NT），38%的患者单独进行内分泌治疗（ET），35%的患者进行化疗（CT）后再进行 ET（CT+ET）。后 Prosigna 的治疗决策分别为 25%的 NT、51%的 ET 和 24%的 CT+ET。28%的患者接受了辅助治疗的改变，其中 21%的 CT 使用率发生了改变。在前 Prosigna 被分配到 CT+ET 的患者中，45%的患者在后 Prosigna 时被降级为 ET。在被分配到 ET 的患者中，12%的患者被升级为 CT+ET，8%的患者被降级为 NT；在被分配到 NT 的患者中，18%的患者被升级为 ET/CT+ET。CT 更常被推荐用于年龄≤50 岁的患者。在 pT1c-pT2 G2 和中间 Ki67（0.5-1.5×局部实验室 Ki67 评分中位数）的亚组中，预 Prosigna 的 CT 治疗决策在各医院之间差异很大（3%-51%）。在后 Prosigna，CT 的使用变化明显减少（8%-24%）。在这个亚组中，Ki67 和 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 评分范围很宽（G1 0-79、G2 0-90、G3 16-94）。
Prosigna 检测结果改变了所有 EBC 临床风险组的辅助治疗决策，显著降低了在前 Prosigna 被归类为高临床风险的患者中 CT 的使用率，并减少了医院之间治疗决策的差异。
