Peter A Fasching1, Andreas D Hartkopf2, Paul Gass3, Lothar Häberle3,4, Leyla Akpolat-Basci5, Alexander Hein3, Bernhard Volz3, Florin-Andrei Taran2, Naiba Nabieva3, Birgit Pott5, Friedrich Overkamp6, Hanna Einarson2, Peyman Hadji7, Hans Tesch8, Johannes Ettl9, Diana Lüftner10, Markus Wallwiener11, Volkmar Müller12, Wolfgang Janni13, Tanja N Fehm14, Andreas Schneeweiss15, Michael Untch16, Dirk Pott17, Michael P Lux3, Thomas Geyer3, Cornelia Liedtke18, Harald Seeger2, Sarah Wetzig5, Arndt Hartmann19, Rüdiger Schulz-Wendtland20, Erik Belleville21, Diethelm Wallwiener2, Matthias W Beckmann3, Sara Y Brucker2, Hans-Christian Kolberg5. 1. Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany. peter.fasching@uk-erlangen.de. 2. Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany. 3. Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Universitätsstrasse 21-23, 91054, Erlangen, Germany. 4. Biostatistics Unit, Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen, Germany. 5. Marienhospital Bottrop, Bottrop, Germany. 6. Oncologianova GmbH, Recklinghausen, Germany. 7. Frankfurter Hormon und Osteoporosezentrum Goethestrasse, Goethestr.23, Frankfurt, Germany. 8. Oncology Practice, Bethanien Hospital, Frankfurt am Main, Germany. 9. Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. 10. Department of Hematology, Oncology and Tumor Immunology, Charité University Hospital, Campus Benjamin Franklin, Berlin, Germany. 11. Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany. 12. Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany. 13. Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany. 14. Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Düsseldorf, Germany. 15. National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany. 16. Department of Gynecology and Obstetrics, Helios Clinics Berlin-Buch, Berlin, Germany. 17. Onkologische Schwerpunktpraxis Bottrop, Bottrop, Germany. 18. Department of Gynecology and Breast Center, Charité University Hospital, Campus Mitte, Berlin, Germany. 19. Institute of Pathology, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany. 20. Institute of Diagnostic Radiology, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany. 21. ClinSol GmbH & Co KG, Würzburg, Germany.
Abstract
PURPOSE: Neoadjuvant combination treatment with chemotherapy (CTX), trastuzumab (TZM), and pertuzumab (PTZ) has been shown to result in higher pathological complete response rates (pCR) in comparison with treatment with chemotherapy and trastuzumab (CTX/TZM). This analysis was aimed at real-world validation of these results from prospective randomized trials. METHODS: In a retrospective analysis conducted in the PRAEGNANT network, patients were eligible for inclusion if they had either received neoadjuvant therapy with CTX/TZM or chemotherapy, trastuzumab, and pertuzumab (CTX/TZM/PTZ) and subsequently underwent surgery for their primary breast cancer. The effect of the two neoadjuvant regimens on pCR in addition to commonly applicable predictors of pCR was analyzed in 300 patients from three study sites, using logistic regression analyses with treatment arm, age, clinical tumor stage, grading, and hormone receptor status as predictors. RESULTS: pCR with complete disappearance of all tumor cells was seen in 30.2% (n = 58) of patients treated with CTX/TZM and in 52.8% (n = 57) of those treated with CTX/TZM/PTZ. CTX/TZM/PTZ was positively associated with pCR (adjusted odds ratio 2.44; 95% CI 1.49-4.02). Mastectomy rates were not influenced by the therapy. CONCLUSIONS: The results of clinical trials were confirmed in this dataset of patients who were treated outside of clinical trials in everyday routine work. pCR rates can be improved by 20% with pertuzumab in routine clinical use.
PURPOSE: Neoadjuvant combination treatment with chemotherapy (CTX), trastuzumab (TZM), and pertuzumab (PTZ) has been shown to result in higher pathological complete response rates (pCR) in comparison with treatment with chemotherapy and trastuzumab (CTX/TZM). This analysis was aimed at real-world validation of these results from prospective randomized trials. METHODS: In a retrospective analysis conducted in the PRAEGNANT network, patients were eligible for inclusion if they had either received neoadjuvant therapy with CTX/TZM or chemotherapy, trastuzumab, and pertuzumab (CTX/TZM/PTZ) and subsequently underwent surgery for their primary breast cancer. The effect of the two neoadjuvant regimens on pCR in addition to commonly applicable predictors of pCR was analyzed in 300 patients from three study sites, using logistic regression analyses with treatment arm, age, clinical tumor stage, grading, and hormone receptor status as predictors. RESULTS: pCR with complete disappearance of all tumor cells was seen in 30.2% (n = 58) of patients treated with CTX/TZM and in 52.8% (n = 57) of those treated with CTX/TZM/PTZ. CTX/TZM/PTZ was positively associated with pCR (adjusted odds ratio 2.44; 95% CI 1.49-4.02). Mastectomy rates were not influenced by the therapy. CONCLUSIONS: The results of clinical trials were confirmed in this dataset of patients who were treated outside of clinical trials in everyday routine work. pCR rates can be improved by 20% with pertuzumab in routine clinical use.
Entities:
Keywords:
Breast cancer; Neoadjuvant; Pertuzumab; Real-world data; Registry; Trastuzumab; pCR
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