Shi Zhiqiang, Qiu Pengfei, Wang Yongsheng, Liu Hong
Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Breast Cancer Prevention and Therapy, Tianjin Medical University, Ministry of Education, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.
Department of Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Gland Surg. 2025 Jul 31;14(7):1263-1271. doi: 10.21037/gs-2025-103. Epub 2025 Jul 28.
Neoadjuvant therapy (NAT) is widely used in the treatment of breast cancer, and the pathological complete response (pCR) rate is increasing. However, currently, the prediction of pCR still lacks accuracy. This study aimed to investigate the accuracy of minimally invasive biopsy techniques in predicting breast pCR (bpCR) after NAT in breast cancer.
From October 2022 to October 2024, a prospective single-arm study was conducted on 132 patients with primary breast cancer who achieved breast radiologic complete response (brCR) or breast radiologic partial response (brPR) after NAT at the Breast Center of Shandong Cancer Hospital. Before NAT, a marker clip was placed at the center of the tumor bed. After NAT, in patients with no residual lesions suggested by ultrasound, iodine-125 was placed under the guidance of mammography, followed by routine breast surgery (breast-conserving surgery or mastectomy). Postoperatively, multiple-site core needle biopsy (CNB) under ultrasound guidance was performed on the surgical specimen. The pathological results of CNB specimens were compared with those of surgical specimens to assess the accuracy of CNB in predicting bpCR (ypT0) after NAT.
A total of 52 patients (39.4%) achieved bpCR after NAT. Univariate analysis showed that tumor molecular subtypes, brCR after NAT, and axillary pathological complete response (apCR) were significantly associated with bpCR (P=0.02, 0.02, and P<0.001, respectively). Ultrasound-guided multiple-site CNB had an accuracy, negative predictive value (NPV), and false-negative rate (FNR) of 90.9%, 81.0%, and 14.8%, respectively, in predicting bpCR after NAT, which were superior to those of ultrasound, mammography, and magnetic resonance imaging. The combination of imaging examinations and ultrasound-guided multiple-site CNB significantly reduced the FNR compared with CNB alone (7.4% 14.8%; P<0.001). No false-negative results were found in 45 cases using large-bore CNB needles (12G).
The combination of imaging examinations and ultrasound-guided multiple-site CNB has the potential to accurately predict bpCR after NAT, making it possible to selectively avoid breast surgery in breast cancer patients after NAT.
新辅助治疗（NAT）广泛应用于乳腺癌治疗，病理完全缓解（pCR）率不断提高。然而，目前pCR的预测仍缺乏准确性。本研究旨在探讨微创活检技术在预测乳腺癌NAT后乳腺pCR（bpCR）方面的准确性。
2022年10月至2024年10月，对山东肿瘤医院乳腺中心132例NAT后达到乳腺影像学完全缓解（brCR）或乳腺影像学部分缓解（brPR）的原发性乳腺癌患者进行前瞻性单臂研究。NAT前，在肿瘤床中心放置标记夹。NAT后，对于超声未提示残留病变的患者，在乳腺钼靶引导下植入碘-125，随后进行常规乳腺手术（保乳手术或乳房切除术）。术后，对手术标本在超声引导下进行多部位粗针活检（CNB）。将CNB标本的病理结果与手术标本的结果进行比较，以评估CNB在预测NAT后bpCR（ypT0）方面的准确性。
共有52例患者（39.4%）在NAT后达到bpCR。单因素分析显示，肿瘤分子亚型、NAT后的brCR以及腋窝病理完全缓解（apCR）与bpCR显著相关（P分别为0.02、0.02和P<0.001）。超声引导下多部位CNB在预测NAT后bpCR方面的准确率、阴性预测值（NPV）和假阴性率（FNR）分别为90.9%、81.0%和14.8%，优于超声、乳腺钼靶和磁共振成像。与单独使用CNB相比，影像学检查与超声引导下多部位CNB联合使用显著降低了FNR（7.4%对14.8%；P<0.001）。使用大口径CNB针（12G）的45例病例中未发现假阴性结果。
影像学检查与超声引导下多部位CNB联合使用有可能准确预测NAT后的bpCR，从而有可能选择性地避免乳腺癌患者NAT后的乳腺手术。
