Heil Joerg, Kümmel Sherko, Schaefgen Benedikt, Paepke Stefan, Thomssen Christoph, Rauch Geraldine, Ataseven Beyhan, Große Regina, Dreesmann Volker, Kühn Thorsten, Loibl Sibylle, Blohmer Jens-Uwe, von Minckwitz Gunter
Department of Gynecology, University Breast Unit, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Kliniken Essen Mitte, Klinik für Senologie, Henricistraße 92, 45136 Essen, Germany.
Br J Cancer. 2015 Dec 1;113(11):1565-70. doi: 10.1038/bjc.2015.381. Epub 2015 Nov 10.
Neoadjuvant chemotherapy (NACT) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete response (pCR) can be achieved. Up to date, there is no reliable way of predicting a pCR. For the first time, we explore the ability of minimal invasive biopsy (MIB) techniques to diagnose pCR in patients with clinical complete response (cCR) to NACT in this study. This question is of high clinical relevance because a reliable pCR prediction could have direct implications for clinical practice.
In all, 164 patients were included in this review-board approved, multicenter pooled analysis of prospectively assembled data. Core-cut (CC)-MIB or vacuum-assisted (VAB)-MIB were performed after NACT and before surgery. Negative predictive values (NPV) and false-negative rates (FNR) to predict a pCR in surgical specimen (diagnose pCR through MIB) were the main outcome measures.
Pathological complete response in surgical specimen was diagnosed in 93 (56.7%) cases of the whole cohort. The NPV of the MIB diagnosis of pCR was 71.3% (95% CI: (63.3%; 79.3%)). The FNR was 49.3% (95% CI: (40.4%; 58.2%)). Existence of a clip marker tended to improve the NPV (odds ratio 1.98; 95% CI: (0.81; 4.85)). None of the mammographically guided VABs (n=16) was false-negative (FNR 0%, NPV 100%).
Overall accuracy of MIB diagnosis of pCR was insufficient to suggest changing clinical practice. However, subgroup analyses (mammographically guided VABs) suggest a potential capacity of MIB techniques to precisely diagnose pCR after NACT. Representativity of MIB could be a crucial factor to be focused on in further analyses.
新辅助化疗（NACT）作为一种有效的乳腺癌治疗方法被广泛应用。理想情况下，可实现病理完全缓解（pCR）。迄今为止，尚无可靠的方法预测pCR。在本研究中，我们首次探讨了微创活检（MIB）技术诊断对NACT达到临床完全缓解（cCR）患者的pCR的能力。这个问题具有高度临床相关性，因为可靠的pCR预测可能对临床实践有直接影响。
本前瞻性汇总数据分析经审查委员会批准，为多中心研究，共纳入164例患者。在NACT后手术前进行芯针活检（CC）-MIB或真空辅助活检（VAB）-MIB。预测手术标本中pCR（通过MIB诊断pCR）的阴性预测值（NPV）和假阴性率（FNR）是主要观察指标。
整个队列中93例（56.7%）手术标本诊断为病理完全缓解。MIB诊断pCR的NPV为71.3%（95%CI：（63.3%；79.3%））。FNR为49.3%（95%CI：（40.4%；58.2%））。存在夹子标记倾向于提高NPV（优势比1.98；95%CI：（0.81；4.85））。所有乳腺X线引导下的VAB（n = 16）均无假阴性（FNR 0%，NPV 100%）。
MIB诊断pCR的总体准确性不足以建议改变临床实践。然而，亚组分析（乳腺X线引导下的VAB）表明MIB技术在NACT后精确诊断pCR具有潜在能力。MIB的代表性可能是进一步分析中需要关注的关键因素。
