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.

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: NCT02948764, 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: NCT02575612). 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.

• Authors: André Pfob, Chris Sidey-Gibbons, Geraldine Rauch, Bettina Thomas, Benedikt Schaefgen, Sherko Kuemmel, Toralf Reimer, Markus Hahn, Marc Thill, Jens-Uwe Blohmer, John Hackmann, Wolfram Malter, Inga Bekes, Kay Friedrichs, Sebastian Wojcinski, Sylvie Joos, Stefan Paepke, Tom Degenhardt, Joachim Rom, Achim Rody, Marion van Mackelenbergh, Maggie Banys-Paluchowski, Regina Große, Mattea Reinisch, Maria Karsten, Michael Golatta, Joerg Heil
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 40 Issue 17 Pg. 1903-1915 (06 10 2022) ISSN: 1527-7755 [Electronic] United States
• PMID: 35108029 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Topics

• Axilla (pathology)
• Breast Neoplasms (drug therapy, metabolism, surgery)
• Female
• Humans
• Image-Guided Biopsy (methods)
• Neoadjuvant Therapy (methods)
• Neoplasm, Residual