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Br J Cancer. 2015 Dec 1;113(11):1565-70. doi: 10.1038/bjc.2015.381. Epub 2015 Nov 10.

Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques.

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Department of Gynecology, University Breast Unit, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Kliniken Essen Mitte, Klinik für Senologie, Henricistraße 92, 45136 Essen, Germany.
Department of Gynecology and Obstetrics, Technische Universität München, Ismaninger Straße 22, 81675 München, Germany.
Department of Gynecology, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Straße 40, 06120 Halle an der Saale, Germany.
Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120 Heidelberg, Germany.
Department of Gynaecology and Obstetrics, Interdisciplinary Breast Centre, Klinikum Esslingen, Hirschlandstraße 97, 73730 Esslingen, Germany.
German Breast Group c/o GBG Forschungs GmbH, Schleussnerstrasse 42, 63263 Neu-Isenburg, Germany.
Department of Gynecology, Charité, Chariteplatz 1, 10117 Berlin, Germany.



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.

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