Joerg Heil1, André Pfob1, Hans-Peter Sinn2, Geraldine Rauch3,4, Paul Bach3,4, Bettina Thomas5, Benedikt Schaefgen1, Sherko Kuemmel6, Toralf Reimer7, Markus Hahn8, Marc Thill9, Jens-Uwe Blohmer10, John Hackmann11, Wolfram Malter12, Inga Bekes13, Kay Friedrichs14, Sebastian Wojcinski15, Sylvie Joos16, Stefan Paepke17, Nina Ditsch18,19, Achim Rody20, Regina Große21, Marion van Mackelenbergh20, Mattea Reinisch6, Maria Karsten10, Michael Golatta1. 1. Department of Gynecology/Breast Unit, University Hospital Heidelberg, Heidelberg, Germany. 2. Department of Pathology, University Hospital Heidelberg, Heidelberg, Germany. 3. 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. 4. Berlin Institute of Health, Berlin, Germany. 5. Coordination Centre for Clinical Trials (KKS), University Heidelberg, Heidelberg, Germany. 6. Breast Unit, Kliniken Essen-Mitte, Essen, Germany. 7. Department of Gynecology/Breast Unit, University Hospital Rostock, Rostock, Germany. 8. Department of Gynecology/Breast Unit, University Hospital Tuebingen, Tuebingen, Germany. 9. Department of Gynecology and Gynecological Oncology/Breast Unit, Agaplesion Markus Hospital Frankfurt, Frankfurt, Germany. 10. Department of Gynecology/Breast Unit, University Hospital Berlin, Berlin, Germany. 11. Department of Gynecology/Breast Unit, Marienhospital, Witten, Germany. 12. Department of Gynecology/Breast Unit, University Hospital of Cologne, Köln, Germany. 13. Department of Gynecology/Breast Unit, University Hospital Ulm, Ulm, Germany. 14. Department of Gynecology/Breast Unit, Jerusalem Hospital Hamburg, Hamburg, Germany. 15. Department of Gynecology/Breast Unit, Franziskus Hospital Bielefeld, Bielefeld, Germany. 16. Department of Radiology, Visiorad, Pinneberg, Germany. 17. Department of Gynecology/Breast Unit, Hospital rechts der Isar, Munich, Germany. 18. Department of Gynecology/Breast Unit, University Hospital Munich, Munich, Germany. 19. Department of Gynecology/Breast Unit, University Hospital Augsburg, Augsburg, Germany. 20. Department of Gynecology/Breast Unit, University Hospital Schleswig-Holstein, Luebeck, Germany. 21. Department of Gynecology/Breast Unit, University Hospital Halle, Halle, Germany.
Abstract
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.
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.
Authors: Maggie Banys-Paluchowski; Marc Thill; Thorsten Kühn; Nina Ditsch; Jörg Heil; Achim Wöckel; Eva Fallenberg; Michael Friedrich; Sherko Kümmel; Volkmar Müller; Wolfgang Janni; Ute-Susann Albert; Ingo Bauerfeind; Jens-Uwe Blohmer; Wilfried Budach; Peter Dall; Peter Fasching; Tanja Fehm; Oleg Gluz; Nadia Harbeck; Jens Huober; Christian Jackisch; Cornelia Kolberg-Liedtke; Hans H Kreipe; David Krug; Sibylle Loibl; Diana Lüftner; Michael Patrick Lux; Nicolai Maass; Christoph Mundhenke; Ulrike Nitz; Tjoung Won Park-Simon; Toralf Reimer; Kerstin Rhiem; Achim Rody; Marcus Schmidt; Andreas Schneeweiss; Florian Schütz; H Peter Sinn; Christine Solbach; Erich-Franz Solomayer; Elmar Stickeler; Christoph Thomssen; Michael Untch; Isabell Witzel; Bernd Gerber Journal: Geburtshilfe Frauenheilkd Date: 2022-09-30 Impact factor: 2.754
Authors: Fernando A Angarita; Robert Brumer; Matthew Castelo; Nestor F Esnaola; Stephen B Edge; Kazuaki Takabe Journal: Cancers (Basel) Date: 2022-09-20 Impact factor: 6.575