Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petach-Tikva, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Cancer Med. 2020 Jul;9(13):4603-4612. doi: 10.1002/cam4.3088. Epub 2020 May 6.
Decision-making regarding adjuvant chemotherapy for early-stage breast cancer can be guided by genomic assays such as OncotypeDX. The concordance of expected clinical decisions guided by OncotypeDX and prognostication online tools such as PREDICT is unknown.
We performed a retrospective single-center cohort study comprising all women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative, node negative disease, whose tumors were sent for OncotypeDX analysis. Expected decision on adjuvant chemotherapy was evaluated using OncotypeDX and using PREDICT. The concordance between these two tools was calculated. The impact on concordance of prespecified features was assessed, including age, tumor size, intensity of ER and progesterone receptor (PR), grade, Ki67 and perineural and lymphovascular invasion.
A total of 445 women were included. Overall concordance was 75% (K = 0.284). The concordance was significantly higher for grade 1 disease compared to grade 2-3 (93% vs 72%, P < .001), tumor ≤ 1 cm compared to >1 cm (85% vs 72%, P = .009), PR positive compared to PR negative (78% vs 58%, P < .001) and ki67 < 10% compared to ≥10% (92% vs 63%, P < .001). The intensity of ER and the presence of perineural or lymphovascular invasion had no significant impact on concordance.
Compared to PREDICT, using OncotypeDx in node negative, ER positive disease is expected to change the clinical decision in a quarter of patients. The concordance between OncotypeDx and PREDICT is influenced by pathological features. In patients with very low risk, treatment decisions may be made based solely on clinical risk assessment.
早期乳腺癌的辅助化疗决策可以通过基因组检测，如 OncotypeDX 来指导。目前尚不清楚 OncotypeDX 指导的预期临床决策与 PREDICT 等预后在线工具的一致性。
我们进行了一项回顾性单中心队列研究，纳入所有雌激素受体（ER）阳性、人表皮生长因子受体 2（HER2）阴性、淋巴结阴性疾病的女性，其肿瘤均进行了 OncotypeDX 分析。使用 OncotypeDX 和 PREDICT 评估辅助化疗的预期决策。计算这两种工具之间的一致性。评估了包括年龄、肿瘤大小、ER 和孕激素受体（PR）强度、分级、Ki67、神经周围和血管淋巴管浸润在内的特定特征对一致性的影响。
共纳入 445 例女性。总体一致性为 75%（K=0.284）。1 级疾病的一致性明显高于 2-3 级（93% vs 72%，P<.001），肿瘤≤1cm 与>1cm 相比（85% vs 72%，P=.009），PR 阳性与 PR 阴性相比（78% vs 58%，P<.001），Ki67<10%与≥10%相比（92% vs 63%，P<.001）。ER 强度和神经周围或血管淋巴管浸润的存在对一致性没有显著影响。
与 PREDICT 相比，在淋巴结阴性、ER 阳性疾病中使用 OncotypeDx 预计将改变四分之一患者的临床决策。OncotypeDx 与 PREDICT 之间的一致性受病理特征的影响。在低危患者中，治疗决策可能仅基于临床风险评估做出。
