Department of Clinical Pathology, Faculty of Medicine, Ain shams University, Cairo, Egypt.
The Bolles School, High School Senior Sparks Scholar, Jacksonville, FL.
Cancer Treat Res Commun. 2021;26:100306. doi: 10.1016/j.ctarc.2021.100306. Epub 2021 Jan 7.
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®.
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.
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.
The agreement between ODX and Prosigna® is low, and this has management implications, especially when chemotherapy is needed.
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。
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。
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（50/7864%）的病例被分类为低 RS。少数 luminal B 病例（1/224.5%）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。
ODX 和 Prosigna®之间的一致性较低，这对管理有影响，特别是当需要化疗时。
