Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints
Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints
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DOI：
10.1245/s10434-018-6481-y
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发表时间：
2018-07-01
影响因子：
3.7
通讯作者：
Yang, Wei T.
中科院分区：
文献类型：
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作者：
Rauch, Gaiane M.;Kuerer, Henry M.;Yang, Wei T.
本研究旨在提供试验的次要成像终点，用于评价接受新辅助化疗（NAC）的乳腺癌（BC）患者的乳房X线检查（MMG）、超声（US）和图像引导活检（IGBx）病理完全缓解（pCR）评估。接受NAC的M0三阴性或HER 2阳性BC入组机构审查委员会批准的前瞻性临床试验。患者在基线和NAC后接受了US和MMG。评价图像的残留异常，并确定IGBx的模式[US引导（USG）或立体定向引导（SG）]。在NAC后进行细针抽吸和9-G，真空辅助的瘤床活检（VACBx），并与手术时的组织病理学进行比较。中位年龄为50.5（范围26-76）岁;中位基线肿瘤大小为2.4 cm（范围0.8-6.3），NAC后为1 cm（范围0-5.5）。19例患者有pCR：6例（32%）术前有Ca ~（2+）残留，5例（26%）有肿块残留，1例（5%）肿块伴钙化，7例（37%）无影像学异常残留。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%）患者接受了SGBx，15例（37%）患者接受了超声引导活检（USGBx）。SGBx组的中位核心数（12，范围6-14）高于USGBx组（8，范围4-12），p < 0.002。SG VACBx的pCR阳性预测值显着高于USG VACBx（100%与60%，p < 0.05）。SG VACBx是在测试取消手术安全性的试验中识别pCR患者的首选IGBx方式。
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).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.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 Ca2+ 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).SG VACBx is the preferred IGBx modality for identifying patients with pCR for trials testing the safety of eliminating surgery.