Breast Cancer Unit, Hospital Universitario La Paz, 28046 Madrid, Spain.
Department of Gynecology, Hospital Universitario La Paz, 28046 Madrid, Spain.
Curr Oncol. 2022 Mar 23;29(4):2199-2210. doi: 10.3390/curroncol29040179.
Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast- conserving surgery (BCS) rates, provides an opportunity for us to assess in vivo NET effectiveness, and allows us to study any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the safety and effectiveness of NET, and to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From 2016 to 2020, a single-institution cohort of patients, treated with NET and further surgery, was evaluated. In patients with Ki67 ≥ 10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes was gathered. Results: A total of 115 estrogen receptor-positive (ER+)/HER2-negative patients were included. The median treatment duration was 5.0 months (IQR: 2.0−6.0). The median maximum size in the surgical sample was 40% smaller than the pretreatment size measured by ultrasound (p < 0.0001). The median pretreatment Ki67 expression was 20.0% (IQR: 12.0−30.0), and was reduced to 5.0% (IQR: 1.8−10.0) after four weeks, and to 2.0% (IQR: 1.0−8.0) in the surgical sample (p < 0.0001). BCS was performed on 98 patients (85.2%). No pathological complete responses were recorded. A larger Ki67 fold change after four weeks was significantly related to a PEPI score of zero (p < 0.002). No differences were observed between luminal A- and B-like tumors, with regard to fold change and PEPI score. Conclusions: In our cohort, NET was proven to be effective for tumor size and Ki67 downstaging. This resulted in a higher rate of conservative surgery, aided in therapeutic decision making, provided prognostic information, and constituted a safe and well-tolerated approach.
新辅助内分泌治疗（NET）已成为绝经后患者治疗腔型乳腺癌降期的有效手段。它使我们能够提高保乳手术（BCS）的比例，有机会评估体内 NET 的有效性，并使我们能够研究任何可能作为有效生物标志物的生物学变化。本研究旨在评估 NET 的安全性和有效性，并评估 Ki67 增殖率变化作为内分泌反应性指标的作用。
从 2016 年至 2020 年，对接受 NET 治疗并进一步手术的单机构队列患者进行了评估。在 Ki67≥10%的患者中，在四周后进行第二次核心活检。收集了有关组织病理学和临床变化的信息。
共纳入 115 例雌激素受体阳性（ER+）/HER2 阴性患者。中位治疗持续时间为 5.0 个月（IQR：2.0-6.0）。手术样本中最大尺寸的中位数比超声测量的预处理尺寸小 40%（p<0.0001）。预处理 Ki67 表达的中位数为 20.0%（IQR：12.0-30.0），四周后降至 5.0%（IQR：1.8-10.0），手术样本中降至 2.0%（IQR：1.0-8.0）（p<0.0001）。98 例患者（85.2%）行 BCS。未记录到病理完全缓解。四周后 Ki67 变化倍数较大与 PEPI 评分为零显著相关（p<0.002）。在 Ki67 变化倍数和 PEPI 评分方面，在腔型 A 和 B 样肿瘤之间未观察到差异。
在我们的队列中，NET 被证明对肿瘤大小和 Ki67 降期有效。这导致了更高比例的保守手术，有助于治疗决策，提供预后信息，并构成了一种安全且耐受良好的方法。
