Department of Gynecology, Breast Unit, Heidelberg University, Heidelberg, Germany.
Department of Pathology, Heidelberg University, Heidelberg, Germany.
Eur J Radiol. 2020 Jul;128:109025. doi: 10.1016/j.ejrad.2020.109025. Epub 2020 May 1.
To compare the validity of Shear Wave Elastography (SWE) for the preoperative assessment of pathological complete response (pCR) to standard clinical assessment in breast cancer patients undergoing neoadjuvant chemotherapy (NACT).
This prospective, consecutive clinical trial was conducted under routine clinical practice. Analysis included 134 patients. SWE served as index test, final pathology from surgical specimen as reference standard. PCR (ypT0) was defined as primary endpoint. Elasticity changes were compared for the pCR- vs. non-pCR group. To determine the validity of shear wave velocity (V), ROC analyses and diagnostic accuracy parameters were calculated and compared to the final standard clinical assessment by physical examination, mammography and B-mode ultrasound (ycT + vs. ycT0).
V was significantly reduced in pCR and non-pCR groups during NACT (pCR: ΔV(abs) = 3.90 m/s, p < 0.001; non-pCR: ΔV(abs) = 3.10 m/s, p < 0.001). The pCR-group showed significant lower V for all control visits (t: p < 0.001). ROC analysis of V yielded moderate AUCs for the total population (t: 0.613, t: 0.745, t: 0.685, t: 0.718). Compared to standard clinical assessment, V(t) (cut-off: ≤3.35 m/s) was superior in sensitivity (79.6 % vs. 54.5 %), NPV (86.4 % vs. 77.5 %), FNR (20.4 % vs. 45.5 %), inferior in specificity (58.6 % vs. 77.5 %), PPV (46.3 % vs. 54.5 %), FPR (41.4 % vs. 22.5 %).
SWE measures significant differences in tumour elasticity changes in pCR vs. non-pCR cases. SWE shows improved sensitivity compared to standard clinical assessment, high NPV and low FNR, but failed in specificity in order to predict pCR under routine conditions.
比较剪切波弹性成像（SWE）在预测接受新辅助化疗（NACT）的乳腺癌患者病理完全缓解（pCR）方面的术前评估的有效性，与标准临床评估相比。
这是一项在常规临床实践下进行的前瞻性、连续临床试验。共纳入 134 名患者。SWE 作为指数测试，手术标本的最终病理为参考标准。PCR（ypT0）为主要终点。比较 pCR 组与非 pCR 组的弹性变化。为了确定剪切波速度（V）的有效性，对 ROC 分析和诊断准确性参数进行了计算，并与物理检查、乳房 X 线照相术和 B 型超声（ycT+与 ycT0）的最终标准临床评估进行了比较。
在 NACT 期间，pCR 和非 pCR 组的 V 明显降低（pCR：ΔV(abs)=3.90 m/s，p<0.001；非 pCR：ΔV(abs)=3.10 m/s，p<0.001）。pCR 组在所有对照就诊时的 V 明显较低（t：p<0.001）。V 的 ROC 分析在总人群中获得了中等 AUC（t：0.613，t：0.745，t：0.685，t：0.718）。与标准临床评估相比，V(t)（截止值：≤3.35 m/s）在敏感性（79.6%比 54.5%）、阴性预测值（86.4%比 77.5%）、FNR（20.4%比 45.5%）方面更优，特异性（58.6%比 77.5%）、阳性预测值（46.3%比 54.5%）、FPR（41.4%比 22.5%）较差。
SWE 测量了 pCR 与非 pCR 病例中肿瘤弹性变化的显著差异。SWE 在敏感性方面优于标准临床评估，具有较高的阴性预测值和较低的 FNR，但特异性较差，无法在常规条件下预测 pCR。
