Division of Surgical Oncology, Department of Surgery, Cedars Sinai Medical Center, West Hollywood, CA, USA.
Marion-Louise Saltzman Women's Center, Einstein Medical Center Philadelphia, Philadelphia, PA, USA.
Ann Surg Oncol. 2021 Oct;28(11):5907-5917. doi: 10.1245/s10434-021-09814-1. Epub 2021 Mar 21.
Biomarker changes in patients with residual disease (RD) after neoadjuvant systemic therapy (NAT) have unclear consequences. This study examined the prevalence of biomarker [hormone receptor (HR) and HER2] change and its effect on disease-free survival (DFS) and overall survival (OS).
A total of 303 patients treated with NAT from 2008 to 2016 were identified from a prospective database. Biomarker status at diagnosis was determined and retested after NAT in patients with RD. DFS and OS were compared among three groups: no biomarker change, clinically insignificant change in either ER or PR without alteration in HR status, and clinically significant change in at least one biomarker with resultant change in HR or HER2 status. Subgroups with no change and HR change were examined [HR+HER2- no change, triple negative (TN) no change, HR+HER2- to TN, TN to HR+HER2].
Overall, 61.4% of patients had RD. Of these, 32.8% had changes in at least one biomarker. At median follow up of 5.48 years, no biomarker change was associated with improved DFS compared with changes in HR or HER2 status (p = 0.043). In addition, no biomarker change (p = 0.005) and clinically insignificant changes in biomarker status (p = 0.019) were associated with improved OS compared with clinically significant changes in HR or HER2 status. Among subgroups, HR+HER2- to TN was associated with worse DFS (p = 0.029) and OS (p = 0.008) compared with HR+HER2- no change.
Among those with RD, biomarker status change was common and impacted survival in subgroups of HR+ or TN disease. Retesting biomarkers after NAT has prognostic implications.
新辅助系统治疗（NAT）后残留疾病（RD）患者的生物标志物变化后果尚不清楚。本研究检查了生物标志物（激素受体（HR）和 HER2）变化的发生率及其对无病生存（DFS）和总生存（OS）的影响。
从一个前瞻性数据库中确定了 2008 年至 2016 年间接受 NAT 治疗的 303 名患者。在 RD 患者中，在诊断时确定生物标志物状态，并在 NAT 后进行重复检测。在三组之间比较 DFS 和 OS：无生物标志物变化、HR 状态不变的 ER 或 PR 临床无显著变化，以及至少一种生物标志物的临床显著变化，导致 HR 或 HER2 状态改变。无变化和 HR 变化的亚组进行了检查[HR+HER2-无变化、三阴性（TN）无变化、HR+HER2-至 TN、TN 至 HR+HER2]。
总体而言，61.4%的患者有 RD。其中，32.8%的患者至少有一种生物标志物发生了变化。在中位随访 5.48 年后，与 HR 或 HER2 状态变化相比，无生物标志物变化与改善 DFS 相关（p=0.043）。此外，与 HR 或 HER2 状态的临床显著变化相比，无生物标志物变化（p=0.005）和生物标志物状态的临床无显著变化（p=0.019）与改善 OS 相关。在亚组中，与 HR+HER2-无变化相比，HR+HER2-至 TN 与更差的 DFS（p=0.029）和 OS（p=0.008）相关。
在 RD 患者中，生物标志物状态的变化很常见，并影响 HR+或 TN 疾病亚组的生存。NAT 后重新检测生物标志物具有预后意义。
