CanAssist Breast 在乳腺癌复发风险评估中的作用优于 Ki67。

The usefulness of CanAssist Breast over Ki67 in breast cancer recurrence risk assessment.

机构信息

OncoStem Diagnostics Private Limited, Bangalore, India.

HCG Cancer Centre, Bangalore, India.

出版信息

Cancer Med. 2023 Jun;12(12):13342-13351. doi: 10.1002/cam4.6032. Epub 2023 May 28.

DOI:10.1002/cam4.6032

PMID:37245224

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10315758/

Abstract

BACKGROUND

Assessment of Ki67 by immunohistochemistry (IHC) has limited utility in clinical practice owing to analytical validity issues. According to International Ki67 Working Group (IKWG) guidelines, treatment should be guided by a prognostic test in patients expressing intermediate Ki67 range, >5%-<30%. The objective of the study is to compare the prognostic performance of CanAssist Breast (CAB) with that of Ki67 across various Ki67 prognostic groups.

METHODS

The cohort had 1701 patients. Various risk groups were compared for the distant relapse-free interval (DRFi) derived from Kaplan-Meier survival analysis. As per IKWG, patients are categorized into three risk groups: low-risk (<5%), intermediate risk (>5%-<30%), and high-risk (>30%). CAB generates two risk groups, low and high risk based on a predefined cutoff.

RESULTS

In the total cohort, 76% of the patients were low risk (LR) by CAB as against 46% by Ki67 with a similar DRFi of 94%. In the node-negative sub-cohort, 87% were LR by CAB with a DRFi of 97% against 49% by Ki67 with a DRFi of 96%. In subgroups of patients with T1 or N1 or G2 tumors, Ki67-based risk stratification was not significant while it was significant by CAB. In the intermediate Ki67 (>5%-<30%) category up to 89% (N0 sub-cohort) were LR by CAB and the percentage of LR patients was 25% (p < 0.0001) higher compared to NPI or mAOL. In the low Ki67 (≤5%) group, up to 19% were segregated as high-risk by CAB with 86% DRFi suggesting the requirement of chemotherapy in these low Ki67 patients.

CONCLUSION

CAB provided superior prognostic information in various Ki67 subgroups, especially in the intermediate Ki67 group.

摘要

背景

由于分析有效性问题，免疫组织化学（IHC）评估 Ki67 在临床实践中的应用有限。根据国际 Ki67 工作组（IKWG）指南，对于表达中等 Ki67 范围（>5%-<30%）的患者，应通过预后检测来指导治疗。本研究的目的是比较 CanAssist Breast（CAB）与 Ki67 在各种 Ki67 预后组中的预后性能。

方法

该队列包含 1701 名患者。通过 Kaplan-Meier 生存分析比较各种风险组的远处无复发生存期（DRFi）。根据 IKWG，患者分为低危（<5%）、中危（>5%-<30%）和高危（>30%）三个风险组。CAB 根据预设的截止值生成低危和高危两个风险组。

结果

在总队列中，76%的患者为 CAB 低危（LR），而 Ki67 为 46%，DRFi 相似，为 94%。在淋巴结阴性亚组中，87%的患者为 CAB LR，DRFi 为 97%，而 Ki67 为 49%，DRFi 为 96%。在 T1 或 N1 或 G2 肿瘤的亚组中，Ki67 风险分层不显著，而 CAB 则显著。在中等 Ki67（>5%-<30%）范围内，高达 89%（N0 亚组）的患者为 CAB LR，LR 患者的百分比比 NPI 或 mAOL 高 25%（p<0.0001）。在低 Ki67（≤5%）组中，高达 19%的患者被 CAB 划分为高危，DRFi 为 86%，表明这些低 Ki67 患者需要化疗。