Jung Lisa, Huwer Sarah Isabelle, Jungmann Peter, Medl Markus, Taran Florin-Andrei, Neubauer Jakob, Wilpert Carolin, Juhasz-Böss Ingolf, Müller Carolin
Department of Obstetrics and Gynecology at the Medical Center, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.
Department of Radiology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
Arch Gynecol Obstet. 2025 Feb;311(2):443-449. doi: 10.1007/s00404-024-07753-2. Epub 2024 Oct 30.
For many years, staging tests have not been routinely employed for low-risk early breast cancer (EBC). However, the role of Ki-67 in determining the need for staging tests in low-risk EBC remains unclear. Our study aimed to assess the number and types of staging diagnostics, additional imaging, false-positive results, and rate of distant metastases in low-risk EBC with low and high Ki-67 (< / ≥ 25%).
This is a retrospective, single institution cohort study. All patients with newly diagnosed low-risk breast cancer at the University Medical Center in Freiburg in 2017 and 2021 were included. Low-risk was defined as clinical tumor stage T1/2, node negative (N0), hormone receptor positive, HER2 negative, asymptomatic EBC. Information on demographics, clinical and pathological characteristics, as well as number and type of performed staging diagnostics was obtained. Rate and type of additional imaging or follow-up diagnostics due to suspicious findings was analyzed. The patients were divided into two groups (Ki-67 < and ≥ 25%) and rates of distant metastases, performed staging diagnostics and false positive rates were compared.
A total of 189 patients with low-risk EBC were identified, with 54% (n = 102) having Ki-67 < 25% and 46% (n = 87) having Ki-67 ≥ 25%. Risk for distant metastases was 0% in Ki-67 < 25% and 1.1% in patients with Ki-67 ≥ 25% (p = 0.46). Due to suspicious findings in the initial staging diagnostic, additional imaging was required for 11.8% (n = 12) of patients with Ki-67 < 25% compared to 19.5% (n = 17) of patients with Ki-67 ≥ 25% (p = 0.16). False positive rates did not differ significantly between the two groups (7.6% in Ki-67 < 25% vs. 9.8% in Ki-67 ≥ 25%; p = 0.55).
Distant metastases are rare in low-risk EBC. All in all, staging diagnostics should not be routinely employed in this patient population. Only patients with high Ki-67 developed distant metastases. In these cases, staging diagnostics may be discussed with the patient.
多年来，分期检查未被常规用于低风险早期乳腺癌（EBC）。然而，Ki-67在确定低风险EBC分期检查必要性方面的作用仍不明确。我们的研究旨在评估低风险EBC中Ki-67低和高（< / ≥ 25%）的分期诊断数量和类型、额外影像学检查、假阳性结果以及远处转移率。
这是一项回顾性单机构队列研究。纳入了2017年和2021年在弗莱堡大学医学中心新诊断为低风险乳腺癌的所有患者。低风险定义为临床肿瘤分期T1/2、淋巴结阴性（N0）、激素受体阳性、HER2阴性、无症状EBC。获取了人口统计学、临床和病理特征以及所进行的分期诊断数量和类型的信息。分析了因可疑发现而进行的额外影像学检查或随访诊断的发生率和类型。将患者分为两组（Ki-67 < 25%和≥ 25%），比较远处转移率、所进行的分期诊断以及假阳性率。
共确定了189例低风险EBC患者，其中54%（n = 102）的Ki-67 < 25%，46%（n = 87）的Ki-67 ≥ 25%。Ki-67 < 25%的患者远处转移风险为0%，Ki-67 ≥ 25%的患者为1.1%（p = 0.46）。由于初始分期诊断中的可疑发现，Ki-67 < 25%的患者中有11.8%（n = 12）需要额外影像学检查，而Ki-67 ≥ 25%的患者中有19.5%（n = 17）需要（p = 0.16）。两组之间的假阳性率无显著差异（Ki-67 < 25%为7.6%，Ki-67 ≥ 25%为9.8%；p = 0.55）。
低风险EBC中远处转移罕见。总体而言，该患者群体不应常规进行分期检查。只有Ki-67高表达的患者发生了远处转移。在这些情况下，可与患者讨论分期诊断。
