Breast Unit, Department of Surgical Science, Policlinico Tor Vergata, Rome, Italy.
Breast Unit, Department of Surgical Science, Policlinico Tor Vergata, Rome, Italy;
Anticancer Res. 2024 May;44(5):2021-2030. doi: 10.21873/anticanres.17005.
BACKGROUND/AIM: In the context of surgical de-escalation in early breast cancer (EBC), this study aimed to evaluate the contrast enhancement ultrasound (CEUS) sentinel lymph node (SLN) procedure as a non-invasive axillary staging procedure in EBC in comparison with standard SLN biopsy (SLNB).
A subanalysis of the AX-CES study, a prospective single-arm, monocentric phase 3 study was performed (EudraCT: 2020-000393-20). The study included patients with EBC undergoing upfront surgery and SLN resection, with no prior history of locoregional treatment, and weighing between 40-85 kg. All patients underwent the CEUS SLN procedure as a non-invasive axillary staging procedure, with CEUS SLN accumulation marked using blue dye. After the CEUS SLN procedure, all patients underwent the standard mapping procedure. Data on success rate, systemic reactions, mean procedure time, mean surgical procedure, mean procedure without axillary staging, CEUS SLN appearance (normal/pathological), SLN number, and concordance with standard mapping procedure were collected.
After the CEUS SLN procedure, 29 LNs among 16 patients were identified and marked. In all cases, CEUS SLN revealed at least one LN enhancement. Six (37.50%) LNs were defined as pathological after the CEUS SLN procedure. Definitive staining of CEUS SLN pathology revealed metastatic involvement in four (66.67%) of the cases. Two SLNs were identified during the CEUS SLN procedure; however, owing to the low disease burden, no change in the surgical plan was reported.
The CEUS SLN procedure shows promise as a technique for non-invasive assessment of the axilla, potentially enabling safe axillary de-escalation in EBC by estimating the axillary disease burden.
背景/目的:在早期乳腺癌(EBC)的外科降阶治疗中,本研究旨在评估对比增强超声(CEUS)前哨淋巴结(SLN)检测作为 EBC 非侵入性腋窝分期的方法,并与标准 SLN 活检(SLNB)进行比较。
AX-CES 研究的一项亚分析,一项前瞻性、单臂、单中心 III 期研究(EudraCT:2020-000393-20)。该研究纳入了接受初始手术和 SLN 切除的 EBC 患者,无局部区域治疗史,体重在 40-85kg 之间。所有患者均接受 CEUS SLN 检测作为非侵入性腋窝分期的方法,使用蓝染剂标记 CEUS SLN 聚集。CEUS SLN 检测后,所有患者均进行标准的 SLN 绘图检测。收集的资料包括:成功率、全身反应、平均手术时间、平均手术时间(不包括腋窝分期)、CEUS SLN 外观(正常/异常)、SLN 数量和与标准 SLN 绘图检测的一致性。
CEUS SLN 检测后,16 例患者中有 29 个淋巴结被识别和标记。在所有病例中,CEUS SLN 均显示至少一个淋巴结增强。CEUS SLN 检测后,6 个(37.50%)淋巴结被定义为异常。CEUS SLN 检测异常的 4 例(66.67%)中,有 2 例证实存在转移性浸润。CEUS SLN 检测中发现了 2 个 SLN,但由于疾病负担低,未报告手术计划的改变。
CEUS SLN 检测作为一种评估腋窝的非侵入性技术具有应用前景,可通过估计腋窝疾病负担,实现 EBC 的安全降阶治疗。