Pfob, Andre, Sidey-Gibbons, Chris, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko ORCID: 0000-0001-9355-494X, Reimer, Toralf ORCID: 0000-0003-3014-370X, 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, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Grosse, Regina, Reinisch, Mattea, Karsten, Maria, Golatta, Michael and Heil, Joerg (2022). Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J. Clin. Oncol., 40 (17). S. 1903 - 1917. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1527-7755

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Abstract

PURPOSE Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in 40%-70% of women with breast cancer. These patients may not need surgery as all local tumor has already been eradicated by NST. However, nonsurgical approaches, including imaging or vacuum-assisted biopsy (VAB), were not able to accurately identify patients without residual cancer in the breast or axilla. We evaluated the feasibility of a machine learning algorithm (intelligent VAB) to identify exceptional responders to NST. METHODS We trained, tested, and validated a machine learning algorithm using patient, imaging, tumor, and VAB variables to detect residual cancer after NST (ypT+ or in situ or ypN+) before surgery. We used data from 318 women with cT1-3, cN0 or +, human epidermal growth factor receptor 2-positive, triple-negative, or high-proliferative Luminal B-like breast cancer who underwent VAB before surgery (ClinicalTrials.gov identifier: , RESPONDER trial). We used 10-fold cross-validation to train and test the algorithm, which was then externally validated using data of an independent trial (ClinicalTrials.gov identifier: ). We compared findings with the histopathologic evaluation of the surgical specimen. We considered false-negative rate (FNR) and specificity to be the main outcomes. RESULTS In the development set (n = 318) and external validation set (n = 45), the intelligent VAB showed an FNR of 0.0%-5.2%, a specificity of 37.5%-40.0%, and an area under the receiver operating characteristic curve of 0.91-0.92 to detect residual cancer (ypT+ or in situ or ypN+) after NST. Spiegelhalter's Z confirmed a well-calibrated model (z score -0.746, P = .228). FNR of the intelligent VAB was lower compared with imaging after NST, VAB alone, or combinations of both. CONCLUSION An intelligent VAB algorithm can reliably exclude residual cancer after NST. The omission of breast and axillary surgery for these exceptional responders may be evaluated in future trials.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pfob, AndreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sidey-Gibbons, ChrisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rauch, GeraldineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomas, BettinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefgen, BenediktUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuemmel, SherkoUNSPECIFIEDorcid.org/0000-0001-9355-494XUNSPECIFIED
Reimer, ToralfUNSPECIFIEDorcid.org/0000-0003-3014-370XUNSPECIFIED
Hahn, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thill, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blohmer, Jens-UweUNSPECIFIEDorcid.org/0000-0002-7969-250XUNSPECIFIED
Hackmann, JohnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malter, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bekes, IngaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Friedrichs, KayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wojcinski, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joos, SylvieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paepke, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Degenhardt, TomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rom, JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rody, AchimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Mackelenbergh, MarionUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Banys-Paluchowski, MaggieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grosse, ReginaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinisch, MatteaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karsten, MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Golatta, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heil, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-696459
DOI: 10.1200/JCO.21.02439
Journal or Publication Title: J. Clin. Oncol.
Volume: 40
Number: 17
Page Range: S. 1903 - 1917
Date: 2022
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PREDICTION; CHEMOTHERAPYMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69645

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