TY - JOUR
T1 - Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy
T2 - Imaging Assessment and Correlation Endpoints
AU - Rauch, Gaiane M.
AU - Kuerer, Henry M.
AU - Adrada, Beatriz
AU - Santiago, Lumarie
AU - Moseley, Tanya
AU - Candelaria, Rosalind P.
AU - Arribas, Elsa
AU - Sun, Jia
AU - Leung, Jessica W.T.
AU - Krishnamurthy, Savitri
AU - Yang, Wei T.
N1 - Publisher Copyright:
© 2018, Society of Surgical Oncology.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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 2+ 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.
AB - 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 2+ 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.
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U2 - 10.1245/s10434-018-6481-y
DO - 10.1245/s10434-018-6481-y
M3 - Article
C2 - 29667115
AN - SCOPUS:85045436986
SN - 1068-9265
VL - 25
SP - 1953
EP - 1960
JO - Annals of surgical oncology
JF - Annals of surgical oncology
IS - 7
ER -