UCD School of Biomolecular and Biomedical Science, UCD Conway Institute, University College Dublin, Belfield, Dublin, 4, Ireland.
OncoMark Limited, Belfield, Dublin, 4, Ireland.
Eur J Cancer. 2021 Jul;152:78-89. doi: 10.1016/j.ejca.2021.04.016. Epub 2021 Jun 2.
The aim of the study was to assess the prognostic performance of a 6-gene molecular score (OncoMasTR Molecular Score [OMm]) and a composite risk score (OncoMasTR Risk Score [OM]) and to conduct a within-patient comparison against four routinely used molecular and clinicopathological risk assessment tools: Oncotype DX Recurrence Score, Ki67, Nottingham Prognostic Index and Clinical Risk Category, based on the modified Adjuvant! Online definition and three risk factors: patient age, tumour size and grade.
Biospecimens and clinicopathological information for 404 Irish women also previously enrolled in the Trial Assigning Individualized Options for Treatment [Rx] were provided by 11 participating hospitals, as the primary objective of an independent translational study. Gene expression measured via RT-qPCR was used to calculate OMm and OM. The prognostic value for distant recurrence-free survival (DRFS) and invasive disease-free survival (IDFS) was assessed using Cox proportional hazards models and Kaplan-Meier analysis. All statistical tests were two-sided ones.
OMm and OM (both with likelihood ratio statistic [LRS] P < 0.001; C indexes = 0.84 and 0.85, respectively) were more prognostic for DRFS and provided significant additional prognostic information to all other assessment tools/factors assessed (all LRS P ≤ 0.002). In addition, the OM correctly classified more patients with distant recurrences (DRs) into the high-risk category than other risk classification tools. Similar results were observed for IDFS.
Both OncoMasTR scores were significantly prognostic for DRFS and IDFS and provided additional prognostic information to the molecular and clinicopathological risk factors/tools assessed. OM was also the most accurate risk classification tool for identifying DR. A concise 6-gene signature with superior risk stratification was shown to increase prognosis reliability, which may help clinicians optimise treatment decisions.
本研究旨在评估 6 基因分子评分（OncoMasTR 分子评分 [OMm]）和复合风险评分（OncoMasTR 风险评分 [OM]）的预后性能，并与四种常规使用的分子和临床病理风险评估工具进行患者内比较：Oncotype DX 复发评分、Ki67、诺丁汉预后指数和临床风险类别，基于改良的 Adjuvant! Online 定义和三个风险因素：患者年龄、肿瘤大小和分级。
11 家参与医院提供了 404 名爱尔兰女性的生物样本和临床病理信息，这些女性之前也参加了 Trial Assigning Individualized Options for Treatment [Rx]，这是一项独立转化研究的主要目的。通过 RT-qPCR 测量的基因表达用于计算 OMM 和 OM。使用 Cox 比例风险模型和 Kaplan-Meier 分析评估远处无复发生存率 (DRFS) 和浸润性无病生存率 (IDFS) 的预后价值。所有统计检验均为双侧检验。
OMm 和 OM（均具有似然比统计 [LRS] P < 0.001；C 指数分别为 0.84 和 0.85）对 DRFS 的预后更具预测性，并为所有其他评估工具/评估因素提供了显著的额外预后信息（所有 LRS P ≤ 0.002）。此外，OM 比其他风险分类工具更准确地将更多的患者分为远处复发（DR）的高危类别。IDFS 也观察到类似的结果。
OncoMasTR 评分均对 DRFS 和 IDFS 具有显著的预后意义，并为评估的分子和临床病理风险因素/工具提供了额外的预后信息。OM 也是识别 DR 的最准确的风险分类工具。具有优越风险分层的简洁 6 基因特征显示可提高预后可靠性，这可能有助于临床医生优化治疗决策。
