乳腺癌新辅助化疗后病理完全缓解检测的活检可行性试验：影像学评估和相关终点。
Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints.
机构信息
Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
出版信息
Ann Surg Oncol. 2018 Jul;25(7):1953-1960. doi: 10.1245/s10434-018-6481-y. Epub 2018 Apr 17.
PURPOSE
This study was designed to present the secondary imaging endpoints of the trial for evaluating mammogram (MMG), ultrasound (US) and image guided biopsy (IGBx) assessment of pathologic complete response (pCR) in breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NAC).
METHODS
Patients with T1-3, N0-3, M0 triple-negative or HER2-positive BC who received NAC were enrolled in an Institutional Review Board-approved prospective, clinical trial. Patients underwent US and MMG at baseline and after NAC. Images were evaluated for residual abnormality and to determine modality for IGBx [US-guided (USG) or stereotactic guided (SG)]. Fine-needle aspiration and 9-G, vacuum-assisted core biopsy (VACBx) of tumor bed was performed after NAC and was compared with histopathology at surgery.
RESULTS
Forty patients were enrolled. Median age was 50.5 (range 26-76) years; median baseline tumor size was 2.4 cm (range 0.8-6.3) and 1 cm (range 0-5.5) after NAC. Nineteen patients had pCR: 6 (32%) had residual Ca presurgery, 5 (26%) residual mass, 1 (5%) mass with calcifications, and 7 (37%) no residual imaging abnormality. Sensitivity, specificity, and accuracy of US, MMG, and IGBx for pCR were 47/95/73%, 53/90/73%, and 100/95/98%, respectively. Twenty-five (63%) patients had SGBx and 15 (37%) had US-guided biopsy (USGBx). Median number of cores was higher with SGBx (12, range 6-14) than with USGBx (8, range 4-12), p < 0.002. Positive predictive value for pCR was significantly higher for SG VACBx than for USG VACBx (100 vs. 60%, p < 0.05).
CONCLUSIONS
SG VACBx is the preferred IGBx modality for identifying patients with pCR for trials testing the safety of eliminating surgery.
目的
本研究旨在介绍评估乳腺癌（BC）患者新辅助化疗（NAC）后病理完全缓解（pCR）的乳腺 X 线摄影（MMG）、超声（US）和图像引导活检（IGBx）的次要影像学终点。
方法
本研究纳入了接受 NAC 的 T1-3、N0-3、M0 三阴性或 HER2 阳性 BC 患者，这些患者均入组了一项机构审查委员会批准的前瞻性临床试验。患者在基线和 NAC 后接受 US 和 MMG 检查。评估图像中是否存在残留异常，并确定 IGBx 的方式[US 引导（USG）或立体定向引导（SG）]。NAC 后对肿瘤床进行细针抽吸和 9-G、真空辅助核心活检（VACBx），并与手术时的组织病理学进行比较。
结果
本研究共纳入了 40 例患者。中位年龄为 50.5 岁（范围 26-76 岁）；中位基线肿瘤大小为 2.4cm（范围 0.8-6.3cm）和 1cm（范围 0-5.5cm）。19 例患者获得了 pCR：6 例（32%）术前有残留钙，5 例（26%）有残留肿块，1 例（5%）有肿块伴钙化，7 例（37%）无残留影像学异常。US、MMG 和 IGBx 对 pCR 的敏感性、特异性和准确性分别为 47%/95%/73%、53%/90%/73%和 100%/95%/98%。25 例（63%）患者行 SGBx，15 例（37%）患者行 USG 引导活检（USGBx）。SGBx 的中位活检芯数高于 USGBx（12 个，范围 6-14 个），p<0.002。SG VACBx 的 pCR 阳性预测值明显高于 USG VACBx（100%比 60%，p<0.05）。
结论
SG VACBx 是识别 pCR 患者的首选 IGBx 方式，适用于试验检测消除手术安全性的试验。
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