Oncotype DX 和 Prosigna 在乳腺癌患者中的应用：一项比较研究。

Oncotype DX and Prosigna in breast cancer patients: A comparison study.

机构信息

Department of Clinical Pathology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

The Bolles School, High School Senior Sparks Scholar, Jacksonville, FL.

出版信息

Cancer Treat Res Commun. 2021;26:100306. doi: 10.1016/j.ctarc.2021.100306. Epub 2021 Jan 7.

DOI:10.1016/j.ctarc.2021.100306

PMID:33444922

Abstract

BACKGROUND

Oncotype Dx® (ODX) is the most used prognostic and predictive assay for ER + breast cancer (BCa) and is categorized into low (< 18), intermediate (18 to 30), or high (≥31) risk of recurrence. Prosigna® is a prognostic signature to estimate distant recurrence-free survival for stage I/II, ER+ cancer in postmenopausal women treated with adjuvant therapy. The goal of the study is to assess the agreement between ODX and Prosigna®.

MATERIALS AND METHODS

100 previously ODX classified peri and postmenopausal, early-stage (I or II) BCa patients were retrieved and Prosigna assay was performed on archived tumor blocks on a NanoString nCounter® DX Analysis System.

RESULTS

ODX assay was assigned as follows: 57% low, 39% intermediate, and 4% high. There were 8% two-step disagreements (high to low or vice versa) between ODX and Prosigna®; and 42% one-step disagreement (low to intermediate or vice versa). 78% were classified by Prosigna as luminal A and 22% as luminal B. The majority of luminal A cases (67/78; 85.9%) had low ROR score whereas ODX classified almost two-thirds (50/78~ 64%) as low RS. An insignificant percentage of luminal B cases (1/22 - 4.5%) were classified as high RS by ODX, and a modest percentage were classified as high ROR by Prosigna (15/22 ~68%). According to our follow up results, recurrence was detected in three cases. In all three cases; Prosigna was a better indicator of recurrence.

CONCLUSIONS

The agreement between ODX and Prosigna® is low, and this has management implications, especially when chemotherapy is needed.

摘要

背景

Oncotype Dx®（ODX）是用于 ER+乳腺癌（BCa）的最常用预后和预测检测方法，分为低风险（<18）、中风险（18 至 30）或高风险（≥31）复发。Prosigna®是一种预测签名，用于估计接受辅助治疗的绝经后妇女的 I/II 期、ER+癌症的远处无复发生存率。该研究的目的是评估 ODX 和 Prosigna®之间的一致性。

材料和方法

回顾性分析了 100 例先前 ODX 分类的围绝经期和绝经后、早期（I 期或 II 期）BCa 患者，在 NanoString nCounter®DX 分析系统上对存档肿瘤块进行了 Prosigna 检测。

结果

ODX 检测结果如下：57%为低风险，39%为中风险，4%为高风险。ODX 和 Prosigna®之间存在 8%的两步不一致（高风险到低风险或反之亦然）；和 42%的一步不一致（低风险到中风险或反之亦然）。78%的患者被 Prosigna 分类为 luminal A，22%的患者被分类为 luminal B。大多数 luminal A 病例（67/78；85.9%）的 ROR 评分较低，而 ODX 几乎三分之二（50/78~~64%）的病例被分类为低 RS。少数 luminal B 病例（1/22~~4.5%）被 ODX 分类为高 RS，相当一部分病例被 Prosigna 分类为高 ROR（15/22~68%）。根据我们的随访结果，有 3 例患者复发。在所有 3 例中；Prosigna 是复发的更好指标。