Senologie - Zeitschrift für Mammadiagnostik und -therapie 2021; 18(02): e16
DOI: 10.1055/s-0041-1730173
Abstracts
Senologie

RESPONDER AI - Reliable exclusion of residual cancer after neoadjuvant systemic treatment for women with breast cancer by an intelligent vacuum-assisted biopsy

A Pfob
1   Heidelberg University Hospital, University Breast Unit, Department of Obstetrics & Gynecology, Heidelberg, Deutschland
2   The University of Texas MD Anderson Cancer Center, MD Anderson Center for INSPiRED Cancer Care (Integrated Systems for Patient Reported Data), Houston, Vereinigte Staaten von Amerika
,
C Sidey-Gibbons
2   The University of Texas MD Anderson Cancer Center, MD Anderson Center for INSPiRED Cancer Care (Integrated Systems for Patient Reported Data), Houston, Vereinigte Staaten von Amerika
3   The University of Texas MD Anderson Cancer Center, Department of Symptom Research, Houston, Vereinigte Staaten von Amerika
,
G Rauch
4   Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Deutschland
5   Berlin Institute of Health, Berlin, Deutschland
,
M Golatta
1   Heidelberg University Hospital, University Breast Unit, Department of Obstetrics & Gynecology, Heidelberg, Deutschland
,
J Heil
1   Heidelberg University Hospital, University Breast Unit, Department of Obstetrics & Gynecology, Heidelberg, Deutschland
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    Objective Increasing use of neoadjuvant systemic treatment (NST) and improved efficacy of treatment regimens have led to increasing numbers of patients without any detectable residual cancer upon surgery (pathologic complete response). Recently, an intelligent vacuum-assisted biopsy (combining patient, tumor, VAB variables and Artificial Intelligence techniques) showed promising results to identify these exceptional responders to NST (0 % false-negative rate in an external validation set. Pfob et al. Eur J Cancer. 2021). In this trial, we aim to prove that an intelligent VAB is as accurate as surgery to reliably exclude residual cancer after NST.

    Methods The primary outcome of this multicenter, prospective, confirmatory clinical trial is the amount of false-negative intelligent VAB results, i.e. no residual disease (ypT0, ypN0) in intelligent VAB (=index test) but residual disease (ypT+ and/or ypN+) in surgery (=reference test). Secondary objectives include a comparison of diagnostic performance between ultrasound, mammography, MRI, (intelligent) VAB, and liquid biopsies for the response assessment to NST with respect to pCR, RCB, and yAJCC. The null hypothesis to be assessed within the confirmatory analysis states that the rate of patients with non-detected residual tumor is larger or equal to 10 % whereas the alternative hypothesis for which this trial is powered states that this rate is at most 3 %.

    Results We expect the results of the primary endpoint evaluation in 2024.

    Conclusion If this evidence could be obtained, a subsequent randomized controlled trial may evaluate the long-term oncologic safety of omitting breast and axillary surgery for exceptional responders to NST.


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    Publication History

    Article published online:
    01 June 2021

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