Universität zu Köln

Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter ORCID: 0000-0003-2836-6699, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe ORCID: 0000-0002-7969-250X, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Grosse, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria and Golatta, Michael (2022). Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast Cancer Patients by Minimal Invasive Biopsy: Oral Presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, Program Number GS5-03. Ann. Surg., 275 (3). S. 576 - 582. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1528-1140

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Abstract

Objective:We evaluated the ability of minimally invasive, image-guided vacuum-assisted biopsy (VAB) to reliably diagnose a pathologic complete response in the breast (pCR-B).Summary Background Data:Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in up to 80% of women with breast cancer. In such cases, breast surgery, the gold standard for confirming pCR-B, may be considered overtreatment.Methods:This multicenter, prospective trial enrolled 452 women presenting with initial stage 1-3 breast cancer of all biological subtypes. Fifty-four women dropped out; 398 were included in the full analysis. All participants had an imaging-confirmed partial or complete response to NST and underwent study-specific image-guided VAB before guideline-adherent breast surgery. The primary endpoint was the false-negative rate (FNR) of VAB-confirmed pCR-B.Results:Image-guided VAB alone did not detect surgically confirmed residual tumor in 37 of 208 women [FNR, 17.8%; 95% confidence interval (CI), 12.8-23.7%]. Of these 37 women, 12 (32.4%) had residual DCIS only, 20 (54.1%) had minimal residual tumor (<5mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of <less than or equal to>10%. In 19 of the 37 cases (51.4%), the false-negative result was potentially avoidable. Exploratory analysis showed that performing VAB with the largest needle by volume (7-gauge) resulted in no false-negative results and that combining imaging and image-guided VAB into a single diagnostic test lowered the FNR to 6.2% (95% CI, 3.4%-10.5%).Conclusions:Image-guided VAB missed residual disease more often than expected. Refinements in procedure and patient selection seem possible and necessary before omitting breast surgery.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Heil, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfob, Andre UNSPECIFIED UNSPECIFIED UNSPECIFIED Sinn, Hans-Peter UNSPECIFIED orcid.org/0000-0003-2836-6699 UNSPECIFIED Rauch, Geraldine UNSPECIFIED UNSPECIFIED UNSPECIFIED Bach, Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED Thomas, Bettina UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaefgen, Benedikt UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmel, Sherko UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, Toralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Hahn, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Thill, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Blohmer, Jens-Uwe UNSPECIFIED orcid.org/0000-0002-7969-250X UNSPECIFIED Hackmann, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Malter, Wolfram UNSPECIFIED UNSPECIFIED UNSPECIFIED Bekes, Inga UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedrichs, Kay UNSPECIFIED UNSPECIFIED UNSPECIFIED Wojcinski, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Joos, Sylvie UNSPECIFIED UNSPECIFIED UNSPECIFIED Paepke, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Ditsch, Nina UNSPECIFIED UNSPECIFIED UNSPECIFIED Rody, Achim UNSPECIFIED UNSPECIFIED UNSPECIFIED Grosse, Regina UNSPECIFIED UNSPECIFIED UNSPECIFIED van Mackelenbergh, Marion UNSPECIFIED UNSPECIFIED UNSPECIFIED Reinisch, Mattea UNSPECIFIED UNSPECIFIED UNSPECIFIED Karsten, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Golatta, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-695983
DOI:	10.1097/SLA.0000000000004246
Journal or Publication Title:	Ann. Surg.
Volume:	275
Number:	3
Page Range:	S. 576 - 582
Date:	2022
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1528-1140
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CHEMOTHERAPY; THERAPY; SURGERY; NODE; MRI; ACCURACY; RADIOTHERAPY; METAANALYSIS; MULTICENTER; MAMMOGRAPHY Multiple languages Surgery Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69598