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Multicenter Study
. 2024 Feb;31(2):957-965.
doi: 10.1245/s10434-023-14551-8. Epub 2023 Nov 10.

Minimally Invasive Breast Biopsy After Neoadjuvant Systemic Treatment to Identify Breast Cancer Patients with Residual Disease for Extended Neoadjuvant Treatment: A New Concept

André Pfob #  1   2   3 , Lie Cai #  4 , Andreas Schneeweiss  5 , Geraldine Rauch  6 , Bettina Thomas  7 , Benedikt Schaefgen  4 , Sherko Kuemmel  8   9 , Toralf Reimer  10 , Markus Hahn  11 , Marc Thill  12 , Jens-Uwe Blohmer  9 , John Hackmann  13 , Wolfram Malter  14 , Inga Bekes  15 , Kay Friedrichs  16 , Sebastian Wojcinski  17 , Sylvie Joos  18 , Stefan Paepke  19 , Tom Degenhardt  20 , Joachim Rom  21 , Achim Rody  22 , Marion van Mackelenbergh  23 , Maggie Banys-Paluchowski  22 , Regina Große  24 , Mattea Reinisch  8 , Maria Margarete Karsten  9 , Chris Sidey-Gibbons  25   26 , Markus Wallwiener  4 , Michael Golatta  4   27 , Joerg Heil  4   27
Affiliations
Multicenter Study

Minimally Invasive Breast Biopsy After Neoadjuvant Systemic Treatment to Identify Breast Cancer Patients with Residual Disease for Extended Neoadjuvant Treatment: A New Concept

André Pfob et al. Ann Surg Oncol. 2024 Feb.

Abstract

Background: Breast cancer patients with residual disease after neoadjuvant systemic treatment (NAST) have a worse prognosis compared with those achieving a pathologic complete response (pCR). Earlier identification of these patients might allow timely, extended neoadjuvant treatment strategies. We explored the feasibility of a vacuum-assisted biopsy (VAB) after NAST to identify patients with residual disease (ypT+ or ypN+) prior to surgery.

Methods: We used data from a multicenter trial, collected at 21 study sites (NCT02948764). The trial included women with cT1-3, cN0/+ breast cancer undergoing routine post-neoadjuvant imaging (ultrasound, MRI, mammography) and VAB prior to surgery. We compared the findings of VAB and routine imaging with the histopathologic evaluation of the surgical specimen.

Results: Of 398 patients, 34 patients with missing ypN status and 127 patients with luminal tumors were excluded. Among the remaining 237 patients, tumor cells in the VAB indicated a surgical non-pCR in all patients (73/73, positive predictive value [PPV] 100%), whereas PPV of routine imaging after NAST was 56.0% (75/134). Sensitivity of the VAB was 72.3% (73/101), and 74.3% for sensitivity of imaging (75/101).

Conclusion: Residual cancer found in a VAB specimen after NAST always corresponds to non-pCR. Residual cancer assumed on routine imaging after NAST corresponds to actual residual cancer in about half of patients. Response assessment by VAB is not safe for the exclusion of residual cancer. Response assessment by biopsies after NAST may allow studying the new concept of extended neoadjuvant treatment for patients with residual disease in future trials.

Keywords: Extended neoadjuvant treatment; Neoadjuvant systemic treatment; Pathologic complete response; Residual disease; Vacuum-assisted biopsy.

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Conflict of interest statement

Sherko Kuemmel has received personal fees for consulting or advisory services from Roche/Genentech, Genomic Health, Novartis, AstraZeneca, Amgen, Celgene, SOMATEX, Daiichi Sankyo, PFM Medical, Pfizer, MSD Oncology, Lilly, Sonoscape, Gilead Sciences, Seagen, and Agendia; funding for travel and accommodation expenses from Roche, Daiichi Sankyo, and Sonoscape; and is Co-Director of the WSG Study group. Marc Thill has been a member of the Advisory Boards of Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Norgine, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, PFM Medical, Pierre-Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, and Sysmex; has received manuscript support from Amgen, ClearCut, Clovis, PFM Medical, Roche, and Servier; received funding for travel expenses from Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, Neodynamics, Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, and Seagen; received congress support from Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Hexal, Neodynamics, Novartis, Pfizer, Roche, and Sirius Medical; received lecture honoraria from Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther et al., Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, PFM Medical, Roche, Seagen, StreamedUp, Sysmex, Vifor, and Viatris; received trial funding from Endomag and Exact Sciences; and received trial honoraria from AstraZeneca, Biom’Up, Celgene, Clearcut, Neodynamics, Novartis, PFM Medical, Roche, and RTI Surgical. Marion van Mackelenbergh has received personal fees, honoraria, or travel grants from Amgen, AstraZeneca, Daiichi Sankyo, GenomicHealth, Gilead, GSK, Lilly, Molecular Health, MSD, Mylan, Novartis, Pfizer, PierreFabre, Roche, and Seagen. Maggie Banys-Paluchowski has received honoraria for lectures and advisory boards from Roche, Novartis, Pfizer, PFM Medical, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Pintuition, Pierre Fabre, and ExactSciences; and has received study support from EndoMag, Mammotome, MeritMedical, Gilead, Hologic, and ExactSciences. Mattea Reinisch has received honoraria and/or consultancy fees and/or travel support from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, and Somatex. André Pfob, Lie Cai, Andreas Schneeweiss, Geraldine Rauch, Bettina Thomas, Benedikt Schaefgen, Toralf Reimer, Markus Hahn, Jens-Uwe Blohmer, John Hackmann, Wolfram Malter, Inga Bekes, Kay Friedrichs, Sebastian Wojcinski, Sylvie Joos, Stefan Paepke, Tom Degenhardt, Joachim Rom, Achim Rody, Regina Große, Maria Margarete Karsten, Chris Sidey-Gibbons, Markus Wallwiener, Michael Golatta, and Joerg Heil have no conflicts of interest to declare in relation to this study.

Figures

Fig. 1
Fig. 1
Flowchart of eligible patients used for analysis
Fig. 2
Fig. 2
Concept of individualized post-neoadjuvant treatment strategy based on response assessment via vacuum-assisted biopsy. NAST neoadjuvant systemic treatment, VAB vacuum-assisted biopsy
See this image and copyright information in PMC

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