Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Department of Surgery, New York Presbyterian Queens Weill Cornell Medicine, Flushing, NY, USA.
Ann Surg Oncol. 2024 Nov;31(12):8068-8075. doi: 10.1245/s10434-024-15879-5. Epub 2024 Aug 1.
Breast conservation therapy is a widely accepted approach in treating breast cancer, yet the average re-excision rates are approximately 25% despite surgical advancements. The Food and Drug Administration (FDA)-approved MarginProbe device uses radiofrequency spectroscopy for intraoperative margin assessment, potentially reducing re-excision rates. This study evaluated the effectiveness of MarginProbe in reducing re-excisions compared with standard of care (SOC).
A prospective cohort with MarginProbe usage during partial mastectomies from June 2019 to July 2023 (153 patients) was compared with a retrospective control group without the device from January 2015 to May 2019 (300 patients). Both groups underwent partial mastectomies performed by two breast surgeons. Positive margins were defined as tumor on ink for invasive cancers and within 2 mm for ductal carcinoma in situ.
When control was used for patient demographics and tumor characteristics, the findings showed that MarginProbe significantly decreased the probability of re-excision by 58% (p < 0.001), although it led to a higher shave volume, with an average of 9.8 cc additional tissue removed compared with SOC (p < 0.001). Human epidermal growth factor 2 (HER2) positivity was significantly associated with increased odds of re-excision (p = 0.036). MarginProbe demonstrated a sensitivity of 70.1% and a specificity of 47.5%.
MarginProbe is an effective adjunct for intraoperative margin assessment to decrease re-excision rates. However, patient selection is paramount. Given its significant increase in shave volume, women with small breasts may be at higher risk for poor cosmesis. Surgeons should exercise clinical judgement when determining the suitability of MarginProbe use for patients undergoing breast conservation. Further research is necessary to refine MarginProbe's specificity and to optimize its clinical application.
保乳治疗是治疗乳腺癌的一种广泛接受的方法，但尽管手术技术有所进步，平均再次切除率仍约为 25%。美国食品和药物管理局（FDA）批准的 MarginProbe 设备使用射频光谱学进行术中切缘评估，有可能降低再次切除率。本研究评估了 MarginProbe 与标准护理（SOC）相比在降低再次切除率方面的有效性。
一项前瞻性队列研究，纳入 2019 年 6 月至 2023 年 7 月期间接受部分乳房切除术的 MarginProbe 使用者（153 例患者），并与同期无该设备的回顾性对照组（300 例患者）进行比较。两组均由两名乳腺外科医生行部分乳房切除术。阳性切缘定义为浸润性癌的墨水切缘阳性和原位导管癌的 2 毫米内。
当以患者人口统计学和肿瘤特征为对照时，研究结果表明，尽管 MarginProbe 导致了更高的刮除体积，平均比 SOC 多切除 9.8 立方厘米的组织，但它显著降低了 58%的再次切除概率（p<0.001）。人表皮生长因子 2（HER2）阳性与再次切除的几率增加显著相关（p=0.036）。MarginProbe 的敏感性为 70.1%，特异性为 47.5%。
MarginProbe 是一种有效的术中切缘评估辅助手段，可降低再次切除率。然而，患者选择至关重要。鉴于其显著增加的刮除体积，乳房较小的女性可能面临更高的美容风险。外科医生在决定是否适合患者进行保乳治疗时，应运用临床判断。需要进一步研究来提高 MarginProbe 的特异性，并优化其临床应用。
