Schaefgen B, Mati M, Sinn H P, Golatta M, Stieber A, Rauch G, Hennigs A, Richter H, Domschke C, Schuetz F, Sohn C, Schneeweiss A, Heil Joerg
Department of Gynecology, University Breast Unit, Heidelberg, Germany.
Institute of Pathology, University of Heidelberg, Heidelberg, Germany.
Ann Surg Oncol. 2016 Mar;23(3):789-95. doi: 10.1245/s10434-015-4918-0. Epub 2015 Oct 14.
This study evaluated breast imaging procedures for predicting pathologic complete response (pCR = ypT0) after neoadjuvant chemotherapy (NACT) for breast cancer to challenge surgery as a diagnostic procedure after NACT.
This retrospective, exploratory, monocenter study included 150 invasive breast cancers treated by NACT. The patients received magnetic resonance imaging (MRI), mammography (MGR), and ultrasound (US). The results were classified in three response subgroups according to response evaluation criteria in solid tumors. To incorporate specific features of MRI and MGR, an additional category [clinical near complete response (near-cCR)] was defined. Residual cancer in imaging and pathology was defined as a positive result. Negative predictive values (NPVs), false-negative rates (FNRs), and false-positive rates (FPRs) of all imaging procedures were analyzed for the whole cohort and for triple-negative (TN), HER2-positive (HER2+), and HER2-negative/hormone-receptor-positive (HER2-/HR+) cancers, respectively.
In 46 cases (31%), pCR (ypT0) was achieved. Clinical complete response (cCR) and near-cCR showed nearly the same NPVs and FNRs. The NPV was highest with 61% for near-cCR in MRI and lowest with 44% for near-cCR in MGR for the whole cohort. The FNRs ranged from 4 to 25% according to different imaging methods. The MRI performance seemed to be superior, especially in TN cancers (NPV 94%; FNR 5%). The lowest FPR was 10 % in MRI, and the highest FPR was 44% in US.
Neither MRI nor MGR or US can diagnose a pCR (ypT0) with sufficient accuracy to replace pathologic diagnosis of the surgical excision specimen.
本研究评估了在乳腺癌新辅助化疗（NACT）后预测病理完全缓解（pCR = ypT0）的乳腺成像程序，以挑战将手术作为NACT后的诊断程序。
这项回顾性、探索性、单中心研究纳入了150例接受NACT治疗的浸润性乳腺癌患者。患者接受了磁共振成像（MRI）、乳腺X线摄影（MGR）和超声（US）检查。根据实体瘤疗效评价标准，将结果分为三个反应亚组。为纳入MRI和MGR的特定特征，定义了一个额外类别[临床接近完全缓解（near-cCR）]。成像和病理中的残留癌定义为阳性结果。分别分析了整个队列以及三阴性（TN）、HER2阳性（HER2+）和HER2阴性/激素受体阳性（HER2-/HR+）癌症的所有成像程序的阴性预测值（NPV）、假阴性率（FNR）和假阳性率（FPR）。
46例（31%）患者实现了pCR（ypT0）。临床完全缓解（cCR）和near-cCR显示出几乎相同的NPV和FNR。对于整个队列，MRI中near-cCR的NPV最高，为61%，MGR中near-cCR的NPV最低，为44%。根据不同的成像方法，FNR范围为4%至25%。MRI的表现似乎更优，尤其是在TN癌症中（NPV 94%；FNR 5%）。MRI的最低FPR为10%，US的最高FPR为44%。
MRI、MGR或US均不能以足够的准确性诊断pCR（ypT0）以取代手术切除标本的病理诊断。
