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.


Journal

Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354

Informations de publication

Date de publication:
01 03 2022
Historique:
pubmed: 14 7 2020
medline: 19 2 2022
entrez: 14 7 2020
Statut: ppublish

Résumé

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). 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. 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. 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 (<5 mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of ≤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%). Image-guided VAB missed residual disease more often than expected. Refinements in procedure and patient selection seem possible and necessary before omitting breast surgery.

Sections du résumé

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 (<5 mm), and 19 of 25 (76.0%) exhibited invasive cancer cellularity of ≤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.

Identifiants

pubmed: 32657944
pii: 00000658-202203000-00026
doi: 10.1097/SLA.0000000000004246
doi:

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

576-581

Informations de copyright

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Déclaration de conflit d'intérêts

The authors report no conflict of interests.

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Auteurs

Joerg Heil (J)

Department of Gynecology/Breast Unit, University Hospital Heidelberg, Heidelberg, Germany.

André Pfob (A)

Department of Gynecology/Breast Unit, University Hospital Heidelberg, Heidelberg, Germany.

Hans-Peter Sinn (HP)

Department of Pathology, University Hospital Heidelberg, Heidelberg, Germany.

Geraldine Rauch (G)

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Berlin Institute of Health, Berlin, Germany.

Paul Bach (P)

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Berlin Institute of Health, Berlin, Germany.

Bettina Thomas (B)

Coordination Centre for Clinical Trials (KKS), University Heidelberg, Heidelberg, Germany.

Benedikt Schaefgen (B)

Department of Gynecology/Breast Unit, University Hospital Heidelberg, Heidelberg, Germany.

Sherko Kuemmel (S)

Breast Unit, Kliniken Essen-Mitte, Essen, Germany.

Toralf Reimer (T)

Department of Gynecology/Breast Unit, University Hospital Rostock, Rostock, Germany.

Markus Hahn (M)

Department of Gynecology/Breast Unit, University Hospital Tuebingen, Tuebingen, Germany.

Marc Thill (M)

Department of Gynecology and Gynecological Oncology/Breast Unit, Agaplesion Markus Hospital Frankfurt, Frankfurt, Germany.

Jens-Uwe Blohmer (JU)

Department of Gynecology/Breast Unit, University Hospital Berlin, Berlin, Germany.

John Hackmann (J)

Department of Gynecology/Breast Unit, Marienhospital, Witten, Germany.

Wolfram Malter (W)

Department of Gynecology/Breast Unit, University Hospital of Cologne, Köln, Germany.

Inga Bekes (I)

Department of Gynecology/Breast Unit, University Hospital Ulm, Ulm, Germany.

Kay Friedrichs (K)

Department of Gynecology/Breast Unit, Jerusalem Hospital Hamburg, Hamburg, Germany.

Sebastian Wojcinski (S)

Department of Gynecology/Breast Unit, Franziskus Hospital Bielefeld, Bielefeld, Germany.

Sylvie Joos (S)

Department of Radiology, Visiorad, Pinneberg, Germany.

Stefan Paepke (S)

Department of Gynecology/Breast Unit, Hospital rechts der Isar, Munich, Germany.

Nina Ditsch (N)

Department of Gynecology/Breast Unit, University Hospital Munich, Munich, Germany.
Department of Gynecology/Breast Unit, University Hospital Augsburg, Augsburg, Germany.

Achim Rody (A)

Department of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany.

Regina Große (R)

Department of Gynecology/Breast Unit, University Hospital Halle, Halle, Germany.

Marion van Mackelenbergh (M)

Department of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany.

Mattea Reinisch (M)

Breast Unit, Kliniken Essen-Mitte, Essen, Germany.

Maria Karsten (M)

Department of Gynecology/Breast Unit, University Hospital Berlin, Berlin, Germany.

Michael Golatta (M)

Department of Gynecology/Breast Unit, University Hospital Heidelberg, Heidelberg, Germany.

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