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74 results on '"Blohmer, Jens Uwe"'

1. Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023

Author: Park-Simon, Tjoung-Won; https://orcid.org/0000-0002-2863-3040, Müller, Volkmar, Jackisch, Christian; https://orcid.org/0000-0001-8537-3743, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe; https://orcid.org/0000-0002-7969-250X, Budach, Wilfried, Dall, Peter; https://orcid.org/0000-0002-0565-7840, Ditsch, Nina, Fallenberg, Eva Maria; https://orcid.org/0000-0001-8060-0468, Fasching, Peter A, Fehm, Tanja, Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia; https://orcid.org/0000-0002-9744-7372, Hartkopf, Andreas D, Heil, Joerg, Huober, Jens, Kolberg-Liedtke, Cornelia, Kreipe, Hans H, Krug, David; https://orcid.org/0000-0001-8811-5416, Kühn, Thorsten, Kümmel, Sherko, Loibl, Sibylle, Lüftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, et al, Park-Simon, Tjoung-Won; https://orcid.org/0000-0002-2863-3040, Müller, Volkmar, Jackisch, Christian; https://orcid.org/0000-0001-8537-3743, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe; https://orcid.org/0000-0002-7969-250X, Budach, Wilfried, Dall, Peter; https://orcid.org/0000-0002-0565-7840, Ditsch, Nina, Fallenberg, Eva Maria; https://orcid.org/0000-0001-8060-0468, Fasching, Peter A, Fehm, Tanja, Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia; https://orcid.org/0000-0002-9744-7372, Hartkopf, Andreas D, Heil, Joerg, Huober, Jens, Kolberg-Liedtke, Cornelia, Kreipe, Hans H, Krug, David; https://orcid.org/0000-0001-8811-5416, Kühn, Thorsten, Kümmel, Sherko, Loibl, Sibylle, Lüftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, and et al
Abstract: Background: Each year the interdisciplinary Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), German Gynecological Oncology Group Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer. Summary: The updated evidence-based treatment recommendation for early and metastatic breast cancer has been released in March 2023. Key Messages: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter.
Published: 2023

2. ASO Visual Abstract : Retrospective Multicenter Analysis Comparing Conventional with Oncoplastic Breast-Conserving Surgery: Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Published: 2022
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3. Retrospective, Multicenter Analysis Comparing Conventional with Oncoplastic Breast Conserving Surgery : Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Abstract: Introduction Recent data suggest that margins >= 2 mm after breast-conserving surgery may improve local control in invasive breast cancer (BC). By allowing large resection volumes, oncoplastic breast-conserving surgery (OBCII; Clough level II/Tubingen 5-6) may achieve better local control than conventional breast conserving surgery (BCS; Tubingen 1-2) or oncoplastic breast conservation with low resection volumes (OBCI; Clough level I/Tubingen 3-4). Methods Data from consecutive high-risk BC patients treated in 15 centers from the Oncoplastic Breast Consortium (OPBC) network, between January 2010 and December 2013, were retrospectively reviewed. Results A total of 3,177 women were included, 30% of whom were treated with OBC (OBCI n = 663; OBCII n = 297). The BCS/OBCI group had significantly smaller tumors and smaller resection margins compared with OBCII (pT1: 50% vs. 37%, p = 0.002; proportion with margin <1 mm: 17% vs. 6%, p < 0.001). There were significantly more re-excisions due to R1 ("ink on tumor") in the BCS/OBCI compared with the OBCII group (11% vs. 7%, p = 0.049). Univariate and multivariable regression analysis adjusted for tumor biology, tumor size, radiotherapy, and systemic treatment demonstrated no differences in local, regional, or distant recurrence-free or overall survival between the two groups. Conclusions Large resection volumes in oncoplastic surgery increases the distance from cancer cells to the margin of the specimen and reduces reexcision rates significantly. With OBCII larger tumors are resected with similar local, regional and distant recurrence-free as well as overall survival rates as BCS/OBCI.
Published: 2022
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4. ASO Visual Abstract : Retrospective Multicenter Analysis Comparing Conventional with Oncoplastic Breast-Conserving Surgery: Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Published: 2022
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5. Retrospective, Multicenter Analysis Comparing Conventional with Oncoplastic Breast Conserving Surgery : Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Abstract: Introduction Recent data suggest that margins >= 2 mm after breast-conserving surgery may improve local control in invasive breast cancer (BC). By allowing large resection volumes, oncoplastic breast-conserving surgery (OBCII; Clough level II/Tubingen 5-6) may achieve better local control than conventional breast conserving surgery (BCS; Tubingen 1-2) or oncoplastic breast conservation with low resection volumes (OBCI; Clough level I/Tubingen 3-4). Methods Data from consecutive high-risk BC patients treated in 15 centers from the Oncoplastic Breast Consortium (OPBC) network, between January 2010 and December 2013, were retrospectively reviewed. Results A total of 3,177 women were included, 30% of whom were treated with OBC (OBCI n = 663; OBCII n = 297). The BCS/OBCI group had significantly smaller tumors and smaller resection margins compared with OBCII (pT1: 50% vs. 37%, p = 0.002; proportion with margin <1 mm: 17% vs. 6%, p < 0.001). There were significantly more re-excisions due to R1 ("ink on tumor") in the BCS/OBCI compared with the OBCII group (11% vs. 7%, p = 0.049). Univariate and multivariable regression analysis adjusted for tumor biology, tumor size, radiotherapy, and systemic treatment demonstrated no differences in local, regional, or distant recurrence-free or overall survival between the two groups. Conclusions Large resection volumes in oncoplastic surgery increases the distance from cancer cells to the margin of the specimen and reduces reexcision rates significantly. With OBCII larger tumors are resected with similar local, regional and distant recurrence-free as well as overall survival rates as BCS/OBCI.
Published: 2022
Full Text: View/download PDF

6. Retrospective, Multicenter Analysis Comparing Conventional with Oncoplastic Breast Conserving Surgery : Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Abstract: Introduction Recent data suggest that margins >= 2 mm after breast-conserving surgery may improve local control in invasive breast cancer (BC). By allowing large resection volumes, oncoplastic breast-conserving surgery (OBCII; Clough level II/Tubingen 5-6) may achieve better local control than conventional breast conserving surgery (BCS; Tubingen 1-2) or oncoplastic breast conservation with low resection volumes (OBCI; Clough level I/Tubingen 3-4). Methods Data from consecutive high-risk BC patients treated in 15 centers from the Oncoplastic Breast Consortium (OPBC) network, between January 2010 and December 2013, were retrospectively reviewed. Results A total of 3,177 women were included, 30% of whom were treated with OBC (OBCI n = 663; OBCII n = 297). The BCS/OBCI group had significantly smaller tumors and smaller resection margins compared with OBCII (pT1: 50% vs. 37%, p = 0.002; proportion with margin <1 mm: 17% vs. 6%, p < 0.001). There were significantly more re-excisions due to R1 ("ink on tumor") in the BCS/OBCI compared with the OBCII group (11% vs. 7%, p = 0.049). Univariate and multivariable regression analysis adjusted for tumor biology, tumor size, radiotherapy, and systemic treatment demonstrated no differences in local, regional, or distant recurrence-free or overall survival between the two groups. Conclusions Large resection volumes in oncoplastic surgery increases the distance from cancer cells to the margin of the specimen and reduces reexcision rates significantly. With OBCII larger tumors are resected with similar local, regional and distant recurrence-free as well as overall survival rates as BCS/OBCI.
Published: 2022
Full Text: View/download PDF

7. ASO Visual Abstract : Retrospective Multicenter Analysis Comparing Conventional with Oncoplastic Breast-Conserving Surgery: Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Published: 2022
Full Text: View/download PDF

8. ASO Visual Abstract : Retrospective Multicenter Analysis Comparing Conventional with Oncoplastic Breast-Conserving Surgery: Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Published: 2022
Full Text: View/download PDF

9. Retrospective, Multicenter Analysis Comparing Conventional with Oncoplastic Breast Conserving Surgery : Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Abstract: Introduction Recent data suggest that margins >= 2 mm after breast-conserving surgery may improve local control in invasive breast cancer (BC). By allowing large resection volumes, oncoplastic breast-conserving surgery (OBCII; Clough level II/Tubingen 5-6) may achieve better local control than conventional breast conserving surgery (BCS; Tubingen 1-2) or oncoplastic breast conservation with low resection volumes (OBCI; Clough level I/Tubingen 3-4). Methods Data from consecutive high-risk BC patients treated in 15 centers from the Oncoplastic Breast Consortium (OPBC) network, between January 2010 and December 2013, were retrospectively reviewed. Results A total of 3,177 women were included, 30% of whom were treated with OBC (OBCI n = 663; OBCII n = 297). The BCS/OBCI group had significantly smaller tumors and smaller resection margins compared with OBCII (pT1: 50% vs. 37%, p = 0.002; proportion with margin <1 mm: 17% vs. 6%, p < 0.001). There were significantly more re-excisions due to R1 ("ink on tumor") in the BCS/OBCI compared with the OBCII group (11% vs. 7%, p = 0.049). Univariate and multivariable regression analysis adjusted for tumor biology, tumor size, radiotherapy, and systemic treatment demonstrated no differences in local, regional, or distant recurrence-free or overall survival between the two groups. Conclusions Large resection volumes in oncoplastic surgery increases the distance from cancer cells to the margin of the specimen and reduces reexcision rates significantly. With OBCII larger tumors are resected with similar local, regional and distant recurrence-free as well as overall survival rates as BCS/OBCI.
Published: 2022
Full Text: View/download PDF

10. AGO Recommendations for the Surgical Therapy of Breast Cancer: Update 2022

Author: Banys-Paluchowski, Maggie, Thill, Marc, Kuhn, Thorsten, Ditsch, Nina, Heil, Jorg, Woeckel, Achim, Fallenberg, Eva, Friedrich, Michael, Kuemmel, Sherko, Mueller, Volkmar, Janni, Wolfgang, Albert, Ute-Susann, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fasching, Peter, Fehm, Tanja, Gluz, Oleg, Harbeck, Nadia, Huober, Jens, Jackisch, Christian, Kolberg-Liedtke, Cornelia, Kreipe, Hans H., Krug, David, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, H. Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Gerber, Bernd, Banys-Paluchowski, Maggie, Thill, Marc, Kuhn, Thorsten, Ditsch, Nina, Heil, Jorg, Woeckel, Achim, Fallenberg, Eva, Friedrich, Michael, Kuemmel, Sherko, Mueller, Volkmar, Janni, Wolfgang, Albert, Ute-Susann, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fasching, Peter, Fehm, Tanja, Gluz, Oleg, Harbeck, Nadia, Huober, Jens, Jackisch, Christian, Kolberg-Liedtke, Cornelia, Kreipe, Hans H., Krug, David, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, H. Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, and Gerber, Bernd
Abstract: The recommendations of the AGO Breast Committee on the surgical therapy of breast cancer were last updated in March 2022 (www.ago-online.de). Since surgical therapy is one of several partial steps in the treatment of breast cancer, extensive diagnostic and oncological expertise of a breast surgeon and good interdisciplinary cooperation with diagnostic radiologists is of great importance. The most important changes concern localization techniques, resection margins, axillary management in the neoadjuvant setting and the evaluation of the meshes in reconstructive surgery. Based on meta-analyses of randomized studies, the level of recommendation of an intraoperative breast ultrasound for the localization of non-palpable lesions was elevated to ++. Thus, the technique is considered to be equivalent to wire localization, provided that it is a lesion which can be well represented by sonography, the surgeon has extensive experience in breast ultrasound and has access to a suitable ultrasound device during the operation. In invasive breast cancer, the aim is to reach negative resection margins (no tumor on ink), regardless of whether an extensive intraductal component is present or not. Oncoplastic operations can also replace a mastectomy in selected cases due to the large number of existing techniques, and are equivalent to segmental resection in terms of oncological safety at comparable rates of complications. Sentinel node excision is recommended for patients with cN0 status receiving neoadjuvant chemotherapy after completion of chemotherapy. Minimally invasive biopsy is recommended for initially suspect lymph nodes. After neoadjuvant chemotherapy, patients with initially 1-3 suspicious lymph nodes and a good response (ycN0) can receive the targeted axillary dissection and the axillary dissection as equivalent options.
Published: 2022

11. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2022

Author: Thill, Marc, Lueftner, Diana, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lux, Michael, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, Ditsch, Nina, Thill, Marc, Lueftner, Diana, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lux, Michael, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, and Ditsch, Nina
Abstract: The Breast Committee of the Arbeitsgemeinschaft Gynakologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2022 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer. (C) 2022 S. Karger AG, Basel
Published: 2022

12. AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2022

Author: Ditsch, Nina, Woecke, Achim, Untch, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja N., Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans H., Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Kolberg-Liedtke, Cornelia, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Mueller, Volkmar, Janni, Wolfgang, Thill, Marc, Ditsch, Nina, Woecke, Achim, Untch, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja N., Friedrich, Michael, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans H., Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Kolberg-Liedtke, Cornelia, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Mueller, Volkmar, Janni, Wolfgang, and Thill, Marc
Abstract: Introduction: The AGO (Arbeitsgemeinschaft Gynakologische Onkologie, German Gynecological Oncology Group) Task Force on Diagnosis and Treatment of Breast Cancer as an interdisciplinary team consists of specialists from gynecological oncology, pathology, diagnostic radiology, medical oncology, and radiation oncology with a special focus on breast cancer. Methods: The updated evidence-based treatment recommendation 2022 for early breast cancer (EBC) and metastatic breast cancer of the AGO Task Force has been released. Results and Conclusion: This paper captures the update of EBC. (C) 2022 S. Karger AG, Basel
Published: 2022

13. Pathological Response in the Breast and Axillary Lymph Nodes after Neoadjuvant Systemic Treatment in Patients with Initially Node-Positive Breast Cancer Correlates with Disease Free Survival: An Exploratory Analysis of the GeparOcto Trial

Author: Gerber, Bernd, Schneeweiss, Andreas, Moebus, Volker, Golatta, Michael, Tesch, Hans, Krug, David, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Heil, Joerg, Huober, Jens, Ataseven, Beyhan, Klare, Peter, Hahn, Markus, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Seither, Fenja, Blohmer, Jens-Uwe, Rhiem, Kerstin, Fasching, Peter A., Nekljudova, Valentina, Loibl, Sibylle, Kuehn, Thorsten, Gerber, Bernd, Schneeweiss, Andreas, Moebus, Volker, Golatta, Michael, Tesch, Hans, Krug, David, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Heil, Joerg, Huober, Jens, Ataseven, Beyhan, Klare, Peter, Hahn, Markus, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Seither, Fenja, Blohmer, Jens-Uwe, Rhiem, Kerstin, Fasching, Peter A., Nekljudova, Valentina, Loibl, Sibylle, and Kuehn, Thorsten
Abstract: Simple Summary The extent of axillary surgery has been reduced in recent years to minimize side effects. However, a negative impact of reduced surgery on outcome must be avoided. We investigated for whom the extent of surgery can be safely reduced by examining early-stage breast cancer patients converting from lymph node (LN)-positive to LN-negative disease after neoadjuvant systemic treatment (NAST). Of 242 initially LN-positive patients treated within the GeparOcto trial, 54.5% were classified as LN-negative after NAST, 31.8% as LN-positive, and for 13.6% data were missing. Overall, 92.1% of patients underwent complete axillary LN dissection, with 6.6% undergoing sentinel LN dissection only. At surgery, 55.4% of patients had no signs of cancer in the LN, 45.0% had no signs of cancer in the breast (of those 8.3% had involved LN), and 41.3% had no signs of cancer at all. Patients with involved LN still had a bad prognosis. Conversion from LN-positive to LN-negative after NAST is of highest prognostic value. Surgical axillary staging after NAST is essential in these patients to offer tailored treatment. Background: The conversion of initially histologically confirmed axillary lymph node-positive (pN+) to ypN0 after neoadjuvant systemic treatment (NAST) is an important prognostic factor in breast cancer (BC) patients and may influence surgical de-escalation strategies. We aimed to determine pCR rates in lymph nodes (pCR-LN), the breast (pCR-B), and both (tpCR) in women who present with pN+ BC, to assess predictors for response and the impact of pCR-LN, pCR-B, and tpCR on invasive disease-free survival (iDFS). Methods: Retrospective, exploratory analysis of 242 patients with pN+ at diagnosis from the multicentric, randomized GeparOcto trial. Results: Of 242 patients with initially pN+ disease, 134 (55.4%) had a pCR-LN, and 109 (45.0%) a pCR-B. Of the 109 pCR-B patients, 9 (8.3%) patients had involved LN, and 100 (41.3%) patients had tpCR. Those with involved LN still h
Published: 2022

14. Effect of Denosumab Added to 2 Different nab-Paclitaxel Regimens as Neoadjuvant Therapy in Patients With Primary Breast Cancer The GeparX 2 x 2 Randomized Clinical Trial

Author: Blohmer, Jens-Uwe, Link, Theresa, Reinisch, Mattea, Just, Marianne, Untch, Michael, Stotzer, Oliver, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Seiler, Sabine, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Solbach, Christine, Hanusch, Claus, Seither, Fenja, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, Loibl, Sibylle, Blohmer, Jens-Uwe, Link, Theresa, Reinisch, Mattea, Just, Marianne, Untch, Michael, Stotzer, Oliver, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Seiler, Sabine, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Solbach, Christine, Hanusch, Claus, Seither, Fenja, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, and Loibl, Sibylle
Abstract: IMPORTANCE Adjuvant denosumab might improve disease-free survival in hormone receptor (HR)-positive primary breast cancer (BC). The optimal neoadjuvant nab-paclitaxel schedule in terms of efficacy and safety is unclear. OBJECTIVE To determine whether adding denosumab to anthracycline/taxane-containing neoadjuvant chemotherapy (NACT) increases the pathological complete response (pCR) rate and which nab-paclitaxel schedule is more effective in the NACT setting. DESIGN, SETTING, AND PARTICIPANTS The GeparX was a multicenter, prospective, open-label, phase 2b, 2 x 2 randomized clinical trial conducted by GBG and AGO-B at 38 German sites between February 2017 and March 2019. The analysis data set was locked September 4, 2020; analysis was completed November 13, 2020, Patients had unilateral or bilateral primary BC, stage cT2-cT4a-d or cT1c, with either clinically node-positive or pathologically node-positive or HR-negative disease, or Ki-67 proliferation index greater than 20%, or ERBB2 (formerly HER2)-positive BC. INTERVENTIONS Patients were randomized to receive or not receive denosumab, 120 mg subcutaneously every 4 weeks for 6 cycles, and either nab-paclitaxel, 125 mg/m(2) weekly for 12 weeks or days 1 and 8 every 3 weeks for 4 cycles (8 doses), followed by 4 cycles of epirubicin/cyclophosphamide, 90/600 mg/m(2) (every 2 weeks or every 3 weeks). Carboplatin was given in triple-negative BC (TNBC), and trastuzumab biosimilar ABP980 plus pertuzumab was given in ERBB2-positive BC (ERBB2-positive substudy). MAIN OUTCOMES AND MEASURES The primary outcome was pCR rates between arms for each randomization. RESULTS A total of 780 female (n = 779) and male (n = 1) patients (median [range] age, 49.0 [22-80] years) were randomized to the 4 treatment groups. The pCR (ypT0 ypN0) rate was 41.0% (90% CI, 37%-45%) with denosumab vs 42.8% (90% CI, 39%-47%) (P = .58) without denosumab, irrespective of BC subtype. Nab-paclitaxel weekly resulted in a significantly (significance level of
Published: 2022

15. 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

Author: Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Grosse, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, Heil, Joerg, Pfob, Andre, Sinn, Hans-Peter, Rauch, Geraldine, Bach, Paul, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Ditsch, Nina, Rody, Achim, Grosse, Regina, van Mackelenbergh, Marion, Reinisch, Mattea, Karsten, Maria, and Golatta, Michael
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 (<5mm), 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.
Published: 2022

16. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery

Author: Pfob, Andre, Sidey-Gibbons, Chris, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Grosse, Regina, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, Heil, Joerg, Pfob, Andre, Sidey-Gibbons, Chris, Rauch, Geraldine, Thomas, Bettina, Schaefgen, Benedikt, Kuemmel, Sherko, Reimer, Toralf, Hahn, Markus, Thill, Marc, Blohmer, Jens-Uwe, Hackmann, John, Malter, Wolfram, Bekes, Inga, Friedrichs, Kay, Wojcinski, Sebastian, Joos, Sylvie, Paepke, Stefan, Degenhardt, Tom, Rom, Joachim, Rody, Achim, van Mackelenbergh, Marion, Banys-Paluchowski, Maggie, Grosse, Regina, Reinisch, Mattea, Karsten, Maria, Golatta, Michael, and Heil, Joerg
Abstract: PURPOSE Neoadjuvant systemic treatment (NST) elicits a pathologic complete response in 40%-70% of women with breast cancer. These patients may not need surgery as all local tumor has already been eradicated by NST. However, nonsurgical approaches, including imaging or vacuum-assisted biopsy (VAB), were not able to accurately identify patients without residual cancer in the breast or axilla. We evaluated the feasibility of a machine learning algorithm (intelligent VAB) to identify exceptional responders to NST. METHODS We trained, tested, and validated a machine learning algorithm using patient, imaging, tumor, and VAB variables to detect residual cancer after NST (ypT+ or in situ or ypN+) before surgery. We used data from 318 women with cT1-3, cN0 or +, human epidermal growth factor receptor 2-positive, triple-negative, or high-proliferative Luminal B-like breast cancer who underwent VAB before surgery (ClinicalTrials.gov identifier: , RESPONDER trial). We used 10-fold cross-validation to train and test the algorithm, which was then externally validated using data of an independent trial (ClinicalTrials.gov identifier: ). We compared findings with the histopathologic evaluation of the surgical specimen. We considered false-negative rate (FNR) and specificity to be the main outcomes. RESULTS In the development set (n = 318) and external validation set (n = 45), the intelligent VAB showed an FNR of 0.0%-5.2%, a specificity of 37.5%-40.0%, and an area under the receiver operating characteristic curve of 0.91-0.92 to detect residual cancer (ypT+ or in situ or ypN+) after NST. Spiegelhalter's Z confirmed a well-calibrated model (z score -0.746, P = .228). FNR of the intelligent VAB was lower compared with imaging after NST, VAB alone, or combinations of both. CONCLUSION An intelligent VAB algorithm can reliably exclude residual cancer after NST. The omission of breast and axillary surgery for these exceptional responders may be evaluated in future trials.
Published: 2022

17. Survival analysis of the randomised phase III GeparOcto trial comparing neoadjuvant chemotherapy of intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for patients with high-risk early breast cancer

Author: Schneeweiss, Andreas, Michel, Laura L., Moebus, Volker, Tesch, Hans, Klare, Peter, Hahnen, Eric, Denkert, Carsten, Kast, Karin, Pohl-Rescigno, Esther, Hanusch, Claus, Link, Theresa, Untch, Michael, Jackisch, Christian, Blohmer, Jens-Uwe, Fasching, Peter A., Solbach, Christine, Schmutzler, Rita K., Huober, Jens, Rhiem, Kerstin, Nekljudova, Valentina, Luebbe, Kristina, Loibl, Sibylle, Schneeweiss, Andreas, Michel, Laura L., Moebus, Volker, Tesch, Hans, Klare, Peter, Hahnen, Eric, Denkert, Carsten, Kast, Karin, Pohl-Rescigno, Esther, Hanusch, Claus, Link, Theresa, Untch, Michael, Jackisch, Christian, Blohmer, Jens-Uwe, Fasching, Peter A., Solbach, Christine, Schmutzler, Rita K., Huober, Jens, Rhiem, Kerstin, Nekljudova, Valentina, Luebbe, Kristina, and Loibl, Sibylle
Abstract: Background: GeparOcto demonstrated that pathological complete response (pCR) of intense dose-dense epirubicin, paclitaxel and cyclophosphamide (iddEPC) was comparable to weekly paclitaxel/non-pegylated liposomal doxorubicin (plus carboplatin (PM(Cb) in triple negative breast cancer [TNBC]) in high-risk early breast cancer (BC). Here, we report time-to event secondary end-points. Patients and methods: Patients were randomised to receive 18 weeks of E (150 mg/m(2)) followed by P (225 mg/m(2)) followed by C (2000 mg/m2), each q2w or weekly P (80 mg/m(2)) plus M (20 mg/m2) plus, in TNBC, Cb (AUC 1.5). Patients with human epidermal growth factor receptor 2-positive (HER2+)BC received trastuzumab (6[loading dose 8]mg/kg q3w) and pertuzumab (420[840]mg q3w) with P and C cycles. Results: 945 patients started treatment (iddEPC n = 470; PM(Cb) n = 475). After a median follow-up of 47.0 (range 1.6-61.5) months, 162 (75 in iddEPC; 87 in PM(Cb)) invasive disease-free survival (iDFS) events and 79 (41 in iddEPC; 38 in PM(Cb)) deaths were reported. No significant difference was observed in 4-year iDFS (81.9% iddEPC versus 79.7% PM(Cb), HR = 1.16 [95%CI 0.85-1.59], log-rank p = 0.334) or 4-year overall survival (OS) (90.3% iddEPC versus 90.6% PM(Cb), HR = 0.90 [95%CI 0.58-1.40], log-rank p = 0.637) overall and in HER2+ and TNBC subgroups. HR+/HER2BC patients, however, had significantly better 4-year iDFS (77.9% iddEPC versus 62.5% PM, HR = 2.11 [95%CI 1.08-4.10], log-rank p = 0.025) and 4-year OS with iddEPC (94.7% iddEPC versus 80.1% PM, HR = 3.26 [95%CI 1.06-10.00], log-rank p = 0.029). Conclusion: While there was no difference in survival for the entire cohort, the HR+/HER2subgroup significantly benefits from iddEPC. This supports the concept of an additional effect of NACT beyond pCR in patients with HR+/HER2 - BC. (C) 2021 Elsevier Ltd. All rights reserved.
Published: 2022

18. Oncoplastic breast consortium recommendations for mastectomy and whole breast reconstruction in the setting of post-mastectomy radiation therapy

Author: Weber, Walter Paul, Shaw, Jane, Pusic, Andrea, Wyld, Lynda, Morrow, Monica, King, Tari, Mátrai, Zoltán, Heil, Jörg, Fitzal, Florian, Potter, Shelley, Rubio, Isabel T., Cardoso, Maria Joao, Gentilini, Oreste Davide, Galimberti, Viviana, Sacchini, Virgilio, Rutgers, Emiel J.T., Benson, John, Allweis, Tanir M., Haug, Martin, Paulinelli, Regis R., Kovacs, Tibor, Harder, Yves, Gulluoglu, Bahadir M., Gonzalez, Eduardo, Faridi, Andree, Elder, Elisabeth, Dubsky, Peter, Blohmer, Jens Uwe, Bjelic-Radisic, Vesna, Barry, Mitchel, Hay, Susanne Dieroff, Bowles, Kimberly, French, James, Reitsamer, Roland, Koller, Rupert, Schrenk, Peter, Kauer-Dorner, Daniela, Biazus, Jorge, Brenelli, Fabricio, Letzkus, Jaime, Saccilotto, Ramon, Joukainen, Sarianna, Kauhanen, Susanna, Karhunen-Enckell, Ulla, Hoffmann, Juergen, Kneser, Ulrich, Kühn, Thorsten, Kontos, Michalis, Tampaki, Ekaterini Christina, Carmon, Moshe, Hadar, Tal, Catanuto, Giuseppe, Garcia-Etienne, Carlos A., Koppert, Linetta, Gouveia, Pedro F., Lagergren, Jakob, Svensjö, Tor, Maggi, Nadia, Kappos, Elisabeth A., Schwab, Fabienne D., Castrezana, Liliana, Steffens, Daniel, Krol, Janna, Tausch, Christoph, Günthert, Andreas, Knauer, Michael, Katapodi, Maria C., Bucher, Susanne, Hauser, Nik, Kurzeder, Christian, Mucklow, Rosine, Tsoutsou, Pelagia G., Sezer, Atakan, Çakmak, Güldeniz Karadeniz, Karanlik, Hasan, Fairbrother, Patricia, Romics, Laszlo, Montagna, Giacomo, Urban, Cicero, Walker, Melanie, Formenti, Silvia C., Gruber, Guenther, Zimmermann, Frank, Zwahlen, Daniel Rudolf, Kuemmel, Sherko, El-Tamer, Mahmoud, Vrancken Peeters, Marie Jeanne, Kaidar-Person, Orit, Gnant, Michael, Poortmans, Philip, de Boniface, Jana, Weber, Walter Paul, Shaw, Jane, Pusic, Andrea, Wyld, Lynda, Morrow, Monica, King, Tari, Mátrai, Zoltán, Heil, Jörg, Fitzal, Florian, Potter, Shelley, Rubio, Isabel T., Cardoso, Maria Joao, Gentilini, Oreste Davide, Galimberti, Viviana, Sacchini, Virgilio, Rutgers, Emiel J.T., Benson, John, Allweis, Tanir M., Haug, Martin, Paulinelli, Regis R., Kovacs, Tibor, Harder, Yves, Gulluoglu, Bahadir M., Gonzalez, Eduardo, Faridi, Andree, Elder, Elisabeth, Dubsky, Peter, Blohmer, Jens Uwe, Bjelic-Radisic, Vesna, Barry, Mitchel, Hay, Susanne Dieroff, Bowles, Kimberly, French, James, Reitsamer, Roland, Koller, Rupert, Schrenk, Peter, Kauer-Dorner, Daniela, Biazus, Jorge, Brenelli, Fabricio, Letzkus, Jaime, Saccilotto, Ramon, Joukainen, Sarianna, Kauhanen, Susanna, Karhunen-Enckell, Ulla, Hoffmann, Juergen, Kneser, Ulrich, Kühn, Thorsten, Kontos, Michalis, Tampaki, Ekaterini Christina, Carmon, Moshe, Hadar, Tal, Catanuto, Giuseppe, Garcia-Etienne, Carlos A., Koppert, Linetta, Gouveia, Pedro F., Lagergren, Jakob, Svensjö, Tor, Maggi, Nadia, Kappos, Elisabeth A., Schwab, Fabienne D., Castrezana, Liliana, Steffens, Daniel, Krol, Janna, Tausch, Christoph, Günthert, Andreas, Knauer, Michael, Katapodi, Maria C., Bucher, Susanne, Hauser, Nik, Kurzeder, Christian, Mucklow, Rosine, Tsoutsou, Pelagia G., Sezer, Atakan, Çakmak, Güldeniz Karadeniz, Karanlik, Hasan, Fairbrother, Patricia, Romics, Laszlo, Montagna, Giacomo, Urban, Cicero, Walker, Melanie, Formenti, Silvia C., Gruber, Guenther, Zimmermann, Frank, Zwahlen, Daniel Rudolf, Kuemmel, Sherko, El-Tamer, Mahmoud, Vrancken Peeters, Marie Jeanne, Kaidar-Person, Orit, Gnant, Michael, Poortmans, Philip, and de Boniface, Jana
Abstract: Aim: Demand for nipple- and skin- sparing mastectomy (NSM/SSM) with immediate breast reconstruction (BR) has increased at the same time as indications for post-mastectomy radiation therapy (PMRT) have broadened. The aim of the Oncoplastic Breast Consortium initiative was to address relevant questions arising with this clinically challenging scenario. Methods: A large global panel of oncologic, oncoplastic and reconstructive breast surgeons, patient advocates and radiation oncologists developed recommendations for clinical practice in an iterative process based on the principles of Delphi methodology. Results: The panel agreed that surgical technique for NSM/SSM should not be formally modified when PMRT is planned with preference for autologous over implant-based BR due to lower risk of long-term complications and support for immediate and delayed-immediate reconstructive approaches. Nevertheless, it was strongly believed that PMRT is not an absolute contraindication for implant-based or other types of BR, but no specific recommendations regarding implant positioning, use of mesh or timing were made due to absence of high-quality evidence. The panel endorsed use of patient-reported outcomes in clinical practice. It was acknowledged that the shape and size of reconstructed breasts can hinder radiotherapy planning and attention to details of PMRT techniques is important in determining aesthetic outcomes after immediate BR.
Published: 2022

19. Retrospective, Multicenter Analysis Comparing Conventional with Oncoplastic Breast Conserving Surgery : Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Joerg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Baerbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Joerg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth K., Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Abstract: Introduction Recent data suggest that margins >= 2 mm after breast-conserving surgery may improve local control in invasive breast cancer (BC). By allowing large resection volumes, oncoplastic breast-conserving surgery (OBCII; Clough level II/Tubingen 5-6) may achieve better local control than conventional breast conserving surgery (BCS; Tubingen 1-2) or oncoplastic breast conservation with low resection volumes (OBCI; Clough level I/Tubingen 3-4). Methods Data from consecutive high-risk BC patients treated in 15 centers from the Oncoplastic Breast Consortium (OPBC) network, between January 2010 and December 2013, were retrospectively reviewed. Results A total of 3,177 women were included, 30% of whom were treated with OBC (OBCI n = 663; OBCII n = 297). The BCS/OBCI group had significantly smaller tumors and smaller resection margins compared with OBCII (pT1: 50% vs. 37%, p = 0.002; proportion with margin <1 mm: 17% vs. 6%, p < 0.001). There were significantly more re-excisions due to R1 ("ink on tumor") in the BCS/OBCI compared with the OBCII group (11% vs. 7%, p = 0.049). Univariate and multivariable regression analysis adjusted for tumor biology, tumor size, radiotherapy, and systemic treatment demonstrated no differences in local, regional, or distant recurrence-free or overall survival between the two groups. Conclusions Large resection volumes in oncoplastic surgery increases the distance from cancer cells to the margin of the specimen and reduces reexcision rates significantly. With OBCII larger tumors are resected with similar local, regional and distant recurrence-free as well as overall survival rates as BCS/OBCI.
Published: 2022
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20. ASO Visual Abstract : Retrospective Multicenter Analysis Comparing Conventional with Oncoplastic Breast-Conserving Surgery: Oncological and Surgical Outcomes in Women with High-Risk Breast Cancer from the OPBC-01/iTOP2 Study

Author: Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, Weber, Walter Paul, Fitzal, Florian, Bolliger, Michael, Dunkler, Daniela, Geroldinger, Angelika, Gambone, Luca, Heil, Jörg, Riedel, Fabian, de Boniface, Jana, André, Camilla, Matrai, Zoltan, Pukancsik, David, Paulinelli, Regis R., Ostapenko, Valerijus, Burneckis, Arvydas, Ostapenko, Andrej, Ostapenko, Edvin, Meani, Francesco, Harder, Yves, Bonollo, Marta, Alberti, Andrea S. M., Tausch, Christoph, Papassotiropoulos, Bärbel, Helfgott, Ruth, Heck, Dietmar, Fehrer, Hans-Jörg, Acko, Markus, Schrenk, Peter, Trapp, Elisabeth, Gunda, Pristauz-Telsnigg, Clara, Paliczek, Montagna, Giacomo, Ritter, Mathilde, Blohmer, Jens-Uwe, Steffen, Sander, Romics, Laszlo, Morrow, Elizabeth, Lorenz, Katharina, Fehr, Mathias, and Weber, Walter Paul
Published: 2022
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21. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2021

Author: Thill, Marc, Friedrich, Michael, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Wockel, Achim, Mueller, Volkmar, Janni, Wolfgang, Ditsch, Nina, Thill, Marc, Friedrich, Michael, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Wockel, Achim, Mueller, Volkmar, Janni, Wolfgang, and Ditsch, Nina
Published: 2021

22. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials

Author: Denkert, Carsten, Seither, Fenja, Schneeweiss, Andreas, Link, Theresa, Blohmer, Jens-Uwe, Just, Marianne, Wimberger, Pauline, Forberger, Almuth, Tesch, Hans, Jackisch, Christian, Schmatloch, Sabine, Reinisch, Mattea, Solomayer, Erich F., Schmitt, Wolfgang D., Hanusch, Claus, Fasching, Peter A., Luebbe, Kristina, Solbach, Christine, Huober, Jens, Rhiem, Kerstin, Marme, Frederik, Reimer, Toralf, Schmidt, Marcus, Sinn, Bruno, V, Janni, Wolfgang, Stickeler, Elmar, Michel, Laura, Stoetzer, Oliver, Hahnen, Eric, Furlanetto, Jenny, Seiler, Sabine, Nekljudova, Valentina, Untch, Michael, Loibl, Sibylle, Denkert, Carsten, Seither, Fenja, Schneeweiss, Andreas, Link, Theresa, Blohmer, Jens-Uwe, Just, Marianne, Wimberger, Pauline, Forberger, Almuth, Tesch, Hans, Jackisch, Christian, Schmatloch, Sabine, Reinisch, Mattea, Solomayer, Erich F., Schmitt, Wolfgang D., Hanusch, Claus, Fasching, Peter A., Luebbe, Kristina, Solbach, Christine, Huober, Jens, Rhiem, Kerstin, Marme, Frederik, Reimer, Toralf, Schmidt, Marcus, Sinn, Bruno, V, Janni, Wolfgang, Stickeler, Elmar, Michel, Laura, Stoetzer, Oliver, Hahnen, Eric, Furlanetto, Jenny, Seiler, Sabine, Nekljudova, Valentina, Untch, Michael, and Loibl, Sibylle
Abstract: Background The development of anti-HER2 antibody-drug conjugates opens new therapeutic options for patients with breast cancer, including patients with low expression of HER2. To characterise this new breast cancer subtype, we have compared the clinical and molecular characteristics of HER2-low-positive and HER2-zero breast cancer, including response to neoadjuvant chemotherapy and prognosis. Methods In this pooled analysis of individual patient data, we evaluated a cohort of 2310 patients with HER2non-amplified primary breast cancer that were treated with neoadjuvant combination chemotherapy in four prospective neoadjuvant clinical trials (GeparSepto, NCT01583426; GeparOcto, NCT02125344; GeparX, NCT02682693; Gain-2 neoadjuvant, NCT01690702) between July 30, 2012, and March 20, 2019. Central HER2 testing was done prospectively before random assignment of participants in all trials. HER2-low-positive status was defined as immunohistochemistry (IHC) 1+ or IHC2+/in-situ hybridisation negative and HER2-zero was defined as IHC0, based on the American Society of Clinical Oncology/College of American Pathologists guidelines. Disease-free survival and overall survival data were available for 1694 patients (from all trials except GeparX) with a median followup of 46.6 months (IQR 35.0-52.3). Bivariable and multivariable logistic regression models and Cox-proportional hazards models were performed based on a predefined statistical analysis plan for analysis of the endpoints pathological complete response, disease-free survival, and overall survival. Findings A total of 1098 (47.5%) of 2310 tumours were HER2-low-positive and 1212 (52.5%) were HER2-zero. 703 (64.0%) of 1098 patients with HER2-low-positive tumours were hormone receptor positive, compared with 445 (36.7%) of 1212 patients with HER2-zero tumours (p<0.0001). HER2-low-positive tumours had a significantly lower pathological complete response rate than HER2-zero tumours (321 [29.2%] of 1098 vs 473 [39.0%] of 1212, p=0
Published: 2021

23. AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2021

Author: Ditsch, Nina, Kolberg-Liedtke, Cornelia, Friedrich, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schutz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, Thill, Marc, Ditsch, Nina, Kolberg-Liedtke, Cornelia, Friedrich, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schutz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, and Thill, Marc
Published: 2021

24. Germline BRCA1/2 mutations and severe haematological toxicities in patients with breast cancer treated with neoadjuvant chemotherapy

Author: Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Hahnen, Eric, Loibl, Sibylle, Fasching, Peter A., Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Hahnen, Eric, Loibl, Sibylle, and Fasching, Peter A.
Abstract: Background: BRCA1 and BRCA2 play a central role in DNA repair. Therefore, patients harbouring germline (g) BRCA1/2 mutations (m) treated with chemotherapy might be at higher risk of haematological toxicities. Methods: Patients from German Breast Group (GBG) and Arbeitsgemeinschaft Gynakologische Onkologie-breast group studies with early triple-negative breast cancer (TNBC) and known gBRCA1/2m status treated with anthracycline-taxane-based neoadjuvant chemotherapy were analysed. Primary objective was the rate of neutropenia grade (G)III-IV in cycle 1 (C1). Secondary objectives included effects on overall and other haematological toxicities GIII-IV in C1, cumulative haematological toxicity across all cycles, relative total dose intensity, and granulocyte-colony stimulating factor prophylaxis. Haematological toxicities under taxanes, carboplatin, and cyclophosphamide were explored. Results: Two hundred nine of 1171 (17.8%) evaluated patients had gBRCA1/2m. In C1, 37.4% gBRCA1/2m versus 35.7% wild-type patients had neutropenia GIII-IV (P = 0.683). For C1, gBRCA1/2m predicted neither for neutropenia GIII-IV (odds ratio [OR]: 1.26, 95% confidence intervals [CI]: 0.87-1.82, P = 0.226) nor for other haematological toxicities GIII-IV (OR: 0.91, 95% CI: 0.64-1.31, P = 0.625) in multivariable regression models. Analyses of cumulative toxicities across all cycles yielded similar results except thrombocytopaenia GIII-IV, which was increased in gBRCA1m patients. In patients treated with taxanes, the rate of haematological toxicities GIII-IV was higher in gBRCA1/2m compared with wild-type (59.5% versus 43.1%; p < 0.001). No difference was seen under cyclophosphamide or platinum-containing chemotherapies. Conclusions: gBRCA1/2m was not associated with higher risk of overall severe haematological toxicities in the first cycle or cumulatively across all cycles under standard chemotherapy for TNBC. Under taxane, patients with gBRCA1/2m might have a higher risk of haematological toxici
Published: 2021

25. Utility of the CPS plus EG scoring system in triple-negative breast cancer treated with neoadjuvant chemotherapy

Author: Marme, Frederik, Solbach, Christine, Michel, Laura, Schneeweiss, Andreas, Blohmer, Jens-Uwe, Huober, Jens, Fasching, Peter A., Jackisch, Christian, Nekljudova, Valentina, Link, Theresa, Rhiem, Kerstin, Rey, Julia, Denkert, Carsten, Hanusch, Claus, Tesch, Hans, Lederer, Bianca, Loibl, Sibylle, Untch, Michael, Marme, Frederik, Solbach, Christine, Michel, Laura, Schneeweiss, Andreas, Blohmer, Jens-Uwe, Huober, Jens, Fasching, Peter A., Jackisch, Christian, Nekljudova, Valentina, Link, Theresa, Rhiem, Kerstin, Rey, Julia, Denkert, Carsten, Hanusch, Claus, Tesch, Hans, Lederer, Bianca, Loibl, Sibylle, and Untch, Michael
Abstract: Background: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is associated with superior survival. This association is strongest in triple negative breast cancer (TNBC). The CPS + EG system, based on pre-treatment clinical (CS) and post-treatment pathological stage (PS), oestrogen-receptor status (E) and grade (G), leads to a refined estimate of prognosis after NACT in all-comers and hormone receptor-positive/ human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here, we investigate if CPS + EG scoring provides a superior estimate of prognosis in TNBC to select patients for postneoadjuvant therapy. Methods: We calculated the CPS + EG score for 1795 patients with TNBC from 8 prospective German trials. Five-year disease-free survival (DFS) and overall survival estimates were calculated using the Kaplan-Meier method. Results: In TNBC, patients with pCR (ypT0/is ypN0, n = 822, 45.8%) had a 5-year DFS of 86%, whereas patients with residual American Joint Committee on Cancer stage I disease (n = 383; 21.3%) had a 5-year DFS of 77.5%.CPS + EG led to superior prognostic information compared with that provided by the clinical stage, but it was inferior to the prognostic information provided by the pathological stage (c-index statistics, p < 0.001). CPS + EG did not discriminate prognosis within the two best prognostic groups (score 1 and 2; n = 362; 37.2%). In contrast, pCR status added prognostic information beyond CPS + EG. Patients with a CPS + EG score of 3 had a 5-year DFS rate of 64% overall, but those with pCR had a 5-year DFS rate of 84%, and those without pCR had a 5-year DFS rate of only 49.7%. Conclusions: In TNBC, CPS + EG scoring provided inferior prognostic information compared with the pathological stage and was unable to identify patients without pCR and with a sufficiently good prognosis, who could avoid postneoadjuvant therapy. pCR remains the strongest and most clinically useful prognostic factor after NACT. Oth
Published: 2021

26. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2021

Author: Thill, Marc, Friedrich, Michael, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Wockel, Achim, Mueller, Volkmar, Janni, Wolfgang, Ditsch, Nina, Thill, Marc, Friedrich, Michael, Kolberg-Liedtke, Cornelia, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Jackisch, Christian, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schuetz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Wockel, Achim, Mueller, Volkmar, Janni, Wolfgang, and Ditsch, Nina
Published: 2021

27. AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2021

Author: Ditsch, Nina, Kolberg-Liedtke, Cornelia, Friedrich, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schutz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, Thill, Marc, Ditsch, Nina, Kolberg-Liedtke, Cornelia, Friedrich, Michael, Jackisch, Christian, Albert, Ute-Susann, Banys-Paluchowski, Maggie, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Harbeck, Nadia, Heil, Jorg, Huober, Jens, Kreipe, Hans-Heinrich, Krug, David, Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael P., Maass, Nicolai, Mundhenke, Christoph, Nitz, Ulrike, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Schutz, Florian, Sinn, Hans-Peter, Solbach, Christine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Untch, Michael, Witzel, Isabell, Woeckel, Achim, Mueller, Volkmar, Janni, Wolfgang, and Thill, Marc
Published: 2021

28. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials

Author: Denkert, Carsten, Seither, Fenja, Schneeweiss, Andreas, Link, Theresa, Blohmer, Jens-Uwe, Just, Marianne, Wimberger, Pauline, Forberger, Almuth, Tesch, Hans, Jackisch, Christian, Schmatloch, Sabine, Reinisch, Mattea, Solomayer, Erich F., Schmitt, Wolfgang D., Hanusch, Claus, Fasching, Peter A., Luebbe, Kristina, Solbach, Christine, Huober, Jens, Rhiem, Kerstin, Marme, Frederik, Reimer, Toralf, Schmidt, Marcus, Sinn, Bruno, V, Janni, Wolfgang, Stickeler, Elmar, Michel, Laura, Stoetzer, Oliver, Hahnen, Eric, Furlanetto, Jenny, Seiler, Sabine, Nekljudova, Valentina, Untch, Michael, Loibl, Sibylle, Denkert, Carsten, Seither, Fenja, Schneeweiss, Andreas, Link, Theresa, Blohmer, Jens-Uwe, Just, Marianne, Wimberger, Pauline, Forberger, Almuth, Tesch, Hans, Jackisch, Christian, Schmatloch, Sabine, Reinisch, Mattea, Solomayer, Erich F., Schmitt, Wolfgang D., Hanusch, Claus, Fasching, Peter A., Luebbe, Kristina, Solbach, Christine, Huober, Jens, Rhiem, Kerstin, Marme, Frederik, Reimer, Toralf, Schmidt, Marcus, Sinn, Bruno, V, Janni, Wolfgang, Stickeler, Elmar, Michel, Laura, Stoetzer, Oliver, Hahnen, Eric, Furlanetto, Jenny, Seiler, Sabine, Nekljudova, Valentina, Untch, Michael, and Loibl, Sibylle
Abstract: Background The development of anti-HER2 antibody-drug conjugates opens new therapeutic options for patients with breast cancer, including patients with low expression of HER2. To characterise this new breast cancer subtype, we have compared the clinical and molecular characteristics of HER2-low-positive and HER2-zero breast cancer, including response to neoadjuvant chemotherapy and prognosis. Methods In this pooled analysis of individual patient data, we evaluated a cohort of 2310 patients with HER2non-amplified primary breast cancer that were treated with neoadjuvant combination chemotherapy in four prospective neoadjuvant clinical trials (GeparSepto, NCT01583426; GeparOcto, NCT02125344; GeparX, NCT02682693; Gain-2 neoadjuvant, NCT01690702) between July 30, 2012, and March 20, 2019. Central HER2 testing was done prospectively before random assignment of participants in all trials. HER2-low-positive status was defined as immunohistochemistry (IHC) 1+ or IHC2+/in-situ hybridisation negative and HER2-zero was defined as IHC0, based on the American Society of Clinical Oncology/College of American Pathologists guidelines. Disease-free survival and overall survival data were available for 1694 patients (from all trials except GeparX) with a median followup of 46.6 months (IQR 35.0-52.3). Bivariable and multivariable logistic regression models and Cox-proportional hazards models were performed based on a predefined statistical analysis plan for analysis of the endpoints pathological complete response, disease-free survival, and overall survival. Findings A total of 1098 (47.5%) of 2310 tumours were HER2-low-positive and 1212 (52.5%) were HER2-zero. 703 (64.0%) of 1098 patients with HER2-low-positive tumours were hormone receptor positive, compared with 445 (36.7%) of 1212 patients with HER2-zero tumours (p<0.0001). HER2-low-positive tumours had a significantly lower pathological complete response rate than HER2-zero tumours (321 [29.2%] of 1098 vs 473 [39.0%] of 1212, p=0
Published: 2021

29. Germline BRCA1/2 mutations and severe haematological toxicities in patients with breast cancer treated with neoadjuvant chemotherapy

Author: Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Hahnen, Eric, Loibl, Sibylle, Fasching, Peter A., Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Hahnen, Eric, Loibl, Sibylle, and Fasching, Peter A.
Abstract: Background: BRCA1 and BRCA2 play a central role in DNA repair. Therefore, patients harbouring germline (g) BRCA1/2 mutations (m) treated with chemotherapy might be at higher risk of haematological toxicities. Methods: Patients from German Breast Group (GBG) and Arbeitsgemeinschaft Gynakologische Onkologie-breast group studies with early triple-negative breast cancer (TNBC) and known gBRCA1/2m status treated with anthracycline-taxane-based neoadjuvant chemotherapy were analysed. Primary objective was the rate of neutropenia grade (G)III-IV in cycle 1 (C1). Secondary objectives included effects on overall and other haematological toxicities GIII-IV in C1, cumulative haematological toxicity across all cycles, relative total dose intensity, and granulocyte-colony stimulating factor prophylaxis. Haematological toxicities under taxanes, carboplatin, and cyclophosphamide were explored. Results: Two hundred nine of 1171 (17.8%) evaluated patients had gBRCA1/2m. In C1, 37.4% gBRCA1/2m versus 35.7% wild-type patients had neutropenia GIII-IV (P = 0.683). For C1, gBRCA1/2m predicted neither for neutropenia GIII-IV (odds ratio [OR]: 1.26, 95% confidence intervals [CI]: 0.87-1.82, P = 0.226) nor for other haematological toxicities GIII-IV (OR: 0.91, 95% CI: 0.64-1.31, P = 0.625) in multivariable regression models. Analyses of cumulative toxicities across all cycles yielded similar results except thrombocytopaenia GIII-IV, which was increased in gBRCA1m patients. In patients treated with taxanes, the rate of haematological toxicities GIII-IV was higher in gBRCA1/2m compared with wild-type (59.5% versus 43.1%; p < 0.001). No difference was seen under cyclophosphamide or platinum-containing chemotherapies. Conclusions: gBRCA1/2m was not associated with higher risk of overall severe haematological toxicities in the first cycle or cumulatively across all cycles under standard chemotherapy for TNBC. Under taxane, patients with gBRCA1/2m might have a higher risk of haematological toxici
Published: 2021

30. Utility of the CPS plus EG scoring system in triple-negative breast cancer treated with neoadjuvant chemotherapy

Author: Marme, Frederik, Solbach, Christine, Michel, Laura, Schneeweiss, Andreas, Blohmer, Jens-Uwe, Huober, Jens, Fasching, Peter A., Jackisch, Christian, Nekljudova, Valentina, Link, Theresa, Rhiem, Kerstin, Rey, Julia, Denkert, Carsten, Hanusch, Claus, Tesch, Hans, Lederer, Bianca, Loibl, Sibylle, Untch, Michael, Marme, Frederik, Solbach, Christine, Michel, Laura, Schneeweiss, Andreas, Blohmer, Jens-Uwe, Huober, Jens, Fasching, Peter A., Jackisch, Christian, Nekljudova, Valentina, Link, Theresa, Rhiem, Kerstin, Rey, Julia, Denkert, Carsten, Hanusch, Claus, Tesch, Hans, Lederer, Bianca, Loibl, Sibylle, and Untch, Michael
Abstract: Background: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is associated with superior survival. This association is strongest in triple negative breast cancer (TNBC). The CPS + EG system, based on pre-treatment clinical (CS) and post-treatment pathological stage (PS), oestrogen-receptor status (E) and grade (G), leads to a refined estimate of prognosis after NACT in all-comers and hormone receptor-positive/ human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here, we investigate if CPS + EG scoring provides a superior estimate of prognosis in TNBC to select patients for postneoadjuvant therapy. Methods: We calculated the CPS + EG score for 1795 patients with TNBC from 8 prospective German trials. Five-year disease-free survival (DFS) and overall survival estimates were calculated using the Kaplan-Meier method. Results: In TNBC, patients with pCR (ypT0/is ypN0, n = 822, 45.8%) had a 5-year DFS of 86%, whereas patients with residual American Joint Committee on Cancer stage I disease (n = 383; 21.3%) had a 5-year DFS of 77.5%.CPS + EG led to superior prognostic information compared with that provided by the clinical stage, but it was inferior to the prognostic information provided by the pathological stage (c-index statistics, p < 0.001). CPS + EG did not discriminate prognosis within the two best prognostic groups (score 1 and 2; n = 362; 37.2%). In contrast, pCR status added prognostic information beyond CPS + EG. Patients with a CPS + EG score of 3 had a 5-year DFS rate of 64% overall, but those with pCR had a 5-year DFS rate of 84%, and those without pCR had a 5-year DFS rate of only 49.7%. Conclusions: In TNBC, CPS + EG scoring provided inferior prognostic information compared with the pathological stage and was unable to identify patients without pCR and with a sufficiently good prognosis, who could avoid postneoadjuvant therapy. pCR remains the strongest and most clinically useful prognostic factor after NACT. Oth
Published: 2021

31. Surgical management of the axilla in clinically node-positive breast cancer patients converting to clinical node negativity through neoadjuvant chemotherapy: current status, knowledge gaps, and rationale for the EUBREAST-03 AXSANA study

Author: AXSANA Study Group, Banys-Paluchowski, Maggie, Gasparri, Maria Luisa, de Boniface, Jana, Gentilini, Oreste, Stickeler, Elmar, Hartmann, Steffi, Thill, Marc, Rubio, Isabel T., Di Micco, Rosa, Bonci, Eduard-Alexandru, Niinikoski, Laura, Kontos, Michalis, Cakmak, Guldeniz Karadeniz, Hauptmann, Michael, Peintinger, Florentia, Pinto, David, Matrai, Zoltan, Murawa, Dawid, Kadayaprath, Geeta, Dostalek, Lukas, Nina, Helidon, Krivorotko, Petr, Classe, Jean-Marc, Schlichting, Ellen, Appelgren, Matilda, Paluchowski, Peter, Solbach, Christine, Blohmer, Jens-Uwe, Kühn, Thorsten, AXSANA Study Group, Banys-Paluchowski, Maggie, Gasparri, Maria Luisa, de Boniface, Jana, Gentilini, Oreste, Stickeler, Elmar, Hartmann, Steffi, Thill, Marc, Rubio, Isabel T., Di Micco, Rosa, Bonci, Eduard-Alexandru, Niinikoski, Laura, Kontos, Michalis, Cakmak, Guldeniz Karadeniz, Hauptmann, Michael, Peintinger, Florentia, Pinto, David, Matrai, Zoltan, Murawa, Dawid, Kadayaprath, Geeta, Dostalek, Lukas, Nina, Helidon, Krivorotko, Petr, Classe, Jean-Marc, Schlichting, Ellen, Appelgren, Matilda, Paluchowski, Peter, Solbach, Christine, Blohmer, Jens-Uwe, and Kühn, Thorsten
Abstract: Simple Summary: Currently, it is unclear which kind of axillary staging surgery breast cancer patients with lymph node metastasis should receive after neoadjuvant chemotherapy. For decades, these patients have been treated with a full axillary lymph node dissection, even if they converted to clinical node negativity. However, the removal of a large number of lymph nodes during the procedure can increase arm morbidity and impact quality of life. Therefore, several studies investigated less radical surgical strategies in this setting, such as sentinel lymph node biopsy or targeted axillary dissection, i.e., removal of a previously marked node combined with sentinel node removal. In this review, we summarize current evidence on the different surgical techniques and compare national and international recommendations. We show that many questions regarding oncological safety of different surgery types and the optimal marking technique remain unanswered and present the multinational prospective cohort study AXSANA that will address these open issues. Abstract: In the last two decades, surgical methods for axillary staging in breast cancer patients have become less extensive, and full axillary lymph node dissection (ALND) is confined to selected patients. In initially node-positive patients undergoing neoadjuvant chemotherapy, however, the optimal management remains unclear. Current guidelines vary widely, endorsing different strategies. We performed a literature review on axillary staging strategies and their place in international recommendations. This overview defines knowledge gaps associated with specific procedures, summarizes currently ongoing clinical trials that address these unsolved issues, and provides the rationale for further research. While some guidelines have already implemented surgical de-escalation, replacing ALND with, e.g., sentinel lymph node biopsy (SLNB) or targeted axillary dissection (TAD) in cN+ patients converting to clinical node negativity, ot
Published: 2021

32. Chemotherapy (CT)-Induced Anaemia in Patients (PTS) Treated with Dose-Dense Regimen: Results of the Prospectively Randomised Anaemia Substudy from the Neoadjuvant Geparocto Study

Author: Tesch, Hans, Loibl, Sibylle, Kast, Karin, Jackisch, Christian, Mobuss, Volker, Buchen, Stefanie, Untch, Michael, Hanusch, Claus, Seiler, Sabine, Weigel, Michael, Fasching, Peter A., Rhiem, Kerstin, Huober, Jens, Blohmer, Jens-Uwe, Solbach, Christine, Denkert, Carsten, Nekljudova, Valentina, Link, Theresa, Schneeweiss, Andreas, Tesch, Hans, Loibl, Sibylle, Kast, Karin, Jackisch, Christian, Mobuss, Volker, Buchen, Stefanie, Untch, Michael, Hanusch, Claus, Seiler, Sabine, Weigel, Michael, Fasching, Peter A., Rhiem, Kerstin, Huober, Jens, Blohmer, Jens-Uwe, Solbach, Christine, Denkert, Carsten, Nekljudova, Valentina, Link, Theresa, and Schneeweiss, Andreas
Published: 2020

33. Investigating denosumab as an add-on treatment to neoadjuvant chemotherapy and two different nab-paclitaxel schedules in a 2x2 design in primary breast cancer - First results of the GeparX study

Author: Blohmer, Jens-Uwe, Link, Theresa, Kuemmel, Sherko, Untch, Michael, Just, Marianne, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Stoetzer, Oliver, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Hanusch, Claus, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, Loibl, Sibylle, Blohmer, Jens-Uwe, Link, Theresa, Kuemmel, Sherko, Untch, Michael, Just, Marianne, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Stoetzer, Oliver, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Hanusch, Claus, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, and Loibl, Sibylle
Published: 2020

34. A Randomized, Double-Blind, Phase III Trial of Neoadjuvant Chemotherapy (NACT) with atezolizumab/Placebo in Patients with Triple-Negative Breast Cancer (TNBC) Followed by Adjuvant Continuation of atezolizumab/Placebo (Gepardouze)

Author: Loibl, Sibylle, Jackisch, Christian, Seiler, Sabine, Rastogi, Priya, Huober, Lens, Denkert, Carsten, Schneeweiss, Andreas, Hanusch, Claus, Fasching, Peter A., Blohmer, Jens-Uwe, Untch, Michael, Rhiem, Kerstin, Solbach, Christine, Nekljudova, Valentina, Costantino, Joseph, Wolmark, Norman, Geyer, Charles, Loibl, Sibylle, Jackisch, Christian, Seiler, Sabine, Rastogi, Priya, Huober, Lens, Denkert, Carsten, Schneeweiss, Andreas, Hanusch, Claus, Fasching, Peter A., Blohmer, Jens-Uwe, Untch, Michael, Rhiem, Kerstin, Solbach, Christine, Nekljudova, Valentina, Costantino, Joseph, Wolmark, Norman, and Geyer, Charles
Published: 2020

35. Germline (G)BRCA1/2 Mutations (M) and Hematological Toxicities in Patients (PTS) with Triple Negative Breast Cancer (TNBC) Treated with Neoadjuvant Chemotherapy (NACT)

Author: Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Loibl, Sibylle, Fasching, Peter A., Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Loibl, Sibylle, and Fasching, Peter A.
Published: 2020

36. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2020

Author: Ditsch, Nina, Untch, Michael, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Friedrich, Michael, Janni, Wolfgang, Mueller, Volkmar, Albert, Ute-Susann, Banys-Paluchowski, Malgorzata, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Diel, Ingo, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans H., Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael, Maass, Nicolai, Moebus, Volker, Mundhenke, Christoph, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Solbach, Chistine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Woeckel, Achim, Thill, Marc, Ditsch, Nina, Untch, Michael, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Friedrich, Michael, Janni, Wolfgang, Mueller, Volkmar, Albert, Ute-Susann, Banys-Paluchowski, Malgorzata, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Diel, Ingo, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans H., Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael, Maass, Nicolai, Moebus, Volker, Mundhenke, Christoph, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Solbach, Chistine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Woeckel, Achim, and Thill, Marc
Published: 2020

37. Dihydropyrimidine Dehydrogenase Testing prior to Treatment with 5-Fluorouracil, Capecitabine, and Tegafur: A Consensus Paper

Author: Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, Hofheinz, Ralf-Dieter, Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, and Hofheinz, Ralf-Dieter
Abstract: Background: 5-Fluorouracil (FU) is one of the most commonly used cytostatic drugs in the systemic treatment of cancer. Treatment with FU may cause severe or life-threatening side effects and the treatment-related mortality rate is 0.2–1.0%. Summary: Among other risk factors associated with increased toxicity, a genetic deficiency in dihydropyrimidine dehydrogenase (DPD), an enzyme responsible for the metabolism of FU, is well known. This is due to variants in the DPD gene (DPYD). Up to 9% of European patients carry a DPD gene variant that decreases enzyme activity, and DPD is completely lacking in approximately 0.5% of patients. Here we describe the clinical and genetic background and summarize recommendations for the genetic testing and tailoring of treatment with 5-FU derivatives. The statement was developed as a consensus statement organized by the German Society for Hematology and Medical Oncology in cooperation with 13 medical associations from Austria, Germany, and Switzerland. Key Messages: (i) Patients should be tested for the 4 most common genetic DPYD variants before treatment with drugs containing FU. (ii) Testing forms the basis for a differentiated, risk-adapted algorithm with recommendations for treatment with FU-containing drugs. (iii) Testing may optionally be supplemented by therapeutic drug monitoring
Published: 2020

38. Dihydropyrimidine Dehydrogenase Testing prior to Treatment with 5-Fluorouracil, Capecitabine, and Tegafur: A Consensus Paper

Author: Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, Hofheinz, Ralf-Dieter, Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, and Hofheinz, Ralf-Dieter
Abstract: Background: 5-Fluorouracil (FU) is one of the most commonly used cytostatic drugs in the systemic treatment of cancer. Treatment with FU may cause severe or life-threatening side effects and the treatment-related mortality rate is 0.2–1.0%. Summary: Among other risk factors associated with increased toxicity, a genetic deficiency in dihydropyrimidine dehydrogenase (DPD), an enzyme responsible for the metabolism of FU, is well known. This is due to variants in the DPD gene (DPYD). Up to 9% of European patients carry a DPD gene variant that decreases enzyme activity, and DPD is completely lacking in approximately 0.5% of patients. Here we describe the clinical and genetic background and summarize recommendations for the genetic testing and tailoring of treatment with 5-FU derivatives. The statement was developed as a consensus statement organized by the German Society for Hematology and Medical Oncology in cooperation with 13 medical associations from Austria, Germany, and Switzerland. Key Messages: (i) Patients should be tested for the 4 most common genetic DPYD variants before treatment with drugs containing FU. (ii) Testing forms the basis for a differentiated, risk-adapted algorithm with recommendations for treatment with FU-containing drugs. (iii) Testing may optionally be supplemented by therapeutic drug monitoring
Published: 2020

39. Investigating denosumab as an add-on treatment to neoadjuvant chemotherapy and two different nab-paclitaxel schedules in a 2x2 design in primary breast cancer - First results of the GeparX study

Author: Blohmer, Jens-Uwe, Link, Theresa, Kuemmel, Sherko, Untch, Michael, Just, Marianne, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Stoetzer, Oliver, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Hanusch, Claus, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, Loibl, Sibylle, Blohmer, Jens-Uwe, Link, Theresa, Kuemmel, Sherko, Untch, Michael, Just, Marianne, Fasching, Peter A., Schneeweiss, Andreas, Wimberger, Pauline, Stoetzer, Oliver, Huober, Jens, Thill, Marc, Jackisch, Christian, Rhiem, Kerstin, Hanusch, Claus, Denkert, Carsten, Engels, Knut, Nekljudova, Valentina, and Loibl, Sibylle
Published: 2020

40. Germline (G)BRCA1/2 Mutations (M) and Hematological Toxicities in Patients (PTS) with Triple Negative Breast Cancer (TNBC) Treated with Neoadjuvant Chemotherapy (NACT)

Author: Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Loibl, Sibylle, Fasching, Peter A., Furlanetto, Jenny, Moebus, Volker, Schneeweiss, Andreas, Rhiem, Kerstin, Tesch, Hans, Blohmer, Jens-Uwe, Luebbe, Kristina, Untch, Michael, Salat, Christoph, Huober, Jens, Klare, Peter, Schmutzler, Rita, Couch, Fergus J., Lederer, Bianca, Gerber, Bernd, Zahm, Dirk-Michael, Bauerfeind, Ingo, Nekljudova, Valentina, Hanusch, Claus, Jackisch, Christian, Link, Theresa, Loibl, Sibylle, and Fasching, Peter A.
Published: 2020

41. A Randomized, Double-Blind, Phase III Trial of Neoadjuvant Chemotherapy (NACT) with atezolizumab/Placebo in Patients with Triple-Negative Breast Cancer (TNBC) Followed by Adjuvant Continuation of atezolizumab/Placebo (Gepardouze)

Author: Loibl, Sibylle, Jackisch, Christian, Seiler, Sabine, Rastogi, Priya, Huober, Lens, Denkert, Carsten, Schneeweiss, Andreas, Hanusch, Claus, Fasching, Peter A., Blohmer, Jens-Uwe, Untch, Michael, Rhiem, Kerstin, Solbach, Christine, Nekljudova, Valentina, Costantino, Joseph, Wolmark, Norman, Geyer, Charles, Loibl, Sibylle, Jackisch, Christian, Seiler, Sabine, Rastogi, Priya, Huober, Lens, Denkert, Carsten, Schneeweiss, Andreas, Hanusch, Claus, Fasching, Peter A., Blohmer, Jens-Uwe, Untch, Michael, Rhiem, Kerstin, Solbach, Christine, Nekljudova, Valentina, Costantino, Joseph, Wolmark, Norman, and Geyer, Charles
Published: 2020

42. Chemotherapy (CT)-Induced Anaemia in Patients (PTS) Treated with Dose-Dense Regimen: Results of the Prospectively Randomised Anaemia Substudy from the Neoadjuvant Geparocto Study

Author: Tesch, Hans, Loibl, Sibylle, Kast, Karin, Jackisch, Christian, Mobuss, Volker, Buchen, Stefanie, Untch, Michael, Hanusch, Claus, Seiler, Sabine, Weigel, Michael, Fasching, Peter A., Rhiem, Kerstin, Huober, Jens, Blohmer, Jens-Uwe, Solbach, Christine, Denkert, Carsten, Nekljudova, Valentina, Link, Theresa, Schneeweiss, Andreas, Tesch, Hans, Loibl, Sibylle, Kast, Karin, Jackisch, Christian, Mobuss, Volker, Buchen, Stefanie, Untch, Michael, Hanusch, Claus, Seiler, Sabine, Weigel, Michael, Fasching, Peter A., Rhiem, Kerstin, Huober, Jens, Blohmer, Jens-Uwe, Solbach, Christine, Denkert, Carsten, Nekljudova, Valentina, Link, Theresa, and Schneeweiss, Andreas
Published: 2020

43. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2020

Author: Ditsch, Nina, Untch, Michael, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Friedrich, Michael, Janni, Wolfgang, Mueller, Volkmar, Albert, Ute-Susann, Banys-Paluchowski, Malgorzata, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Diel, Ingo, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans H., Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael, Maass, Nicolai, Moebus, Volker, Mundhenke, Christoph, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Solbach, Chistine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Woeckel, Achim, Thill, Marc, Ditsch, Nina, Untch, Michael, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Friedrich, Michael, Janni, Wolfgang, Mueller, Volkmar, Albert, Ute-Susann, Banys-Paluchowski, Malgorzata, Bauerfeind, Ingo, Blohmer, Jens-Uwe, Budach, Wilfried, Dall, Peter, Diel, Ingo, Fallenberg, Eva Maria, Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans H., Kuehn, Thorsten, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael, Maass, Nicolai, Moebus, Volker, Mundhenke, Christoph, Park-Simon, Tjoung-Won, Reimer, Toralf, Rhiem, Kerstin, Rody, Achim, Schmidt, Marcus, Schneeweiss, Andreas, Solbach, Chistine, Solomayer, Erich-Franz, Stickeler, Elmar, Thomssen, Christoph, Witzel, Isabell, Woeckel, Achim, and Thill, Marc
Published: 2020

44. High-risk breast cancer surveillance with MRI: 10-year experience from the German consortium for hereditary breast and ovarian cancer

Author: Bick, Ulrich, Engel, Christoph, Krug, Barbara, Heindel, Walter, Fallenberg, Eva M., Rhiem, Kerstin, Maintz, David, Golatta, Michael, Speiser, Dorothee, Rjosk-Dendorfer, Dorothea, Laemmer-Skarke, Irina, Dietzel, Frederic, Schaefer, Karl Werner Fritz, Leinert, Elena, Weigel, Stefanie, Sauer, Stephanie, Pertschy, Stefanie, Hofmockel, Thomas, Hagert-Winkler, Anne, Kast, Karin, Quante, Anne, Meindl, Alfons, Kiechle, Marion, Loeffler, Markus, Schmutzler, Rita K., Blohmer, Jens-Uwe, Horn, Denise, Varon-Mateeva, Raymonda, Huebbel, Verena, Herold, Natalie, Puesken, Michael, Wimberger, Pauline, Meisel, Cornelia, Keller, Katja, Antoch, Gerald, Vesper, Anne-Sophie, Fehm, Tanja N., Schlegelberger, Brigitte, Auber, Bernd, Wallaschek, Hannah, Heil, Joerg, Schott, Sarah, Dikow, Nicola, Mundhenke, Christoph, Arnold, Norbert, Caliebe, Almuth, Briest, Susanne, Lemke, Johannes, Gril, Sabine, Pfeifer, Katharina, Ramser, Juliane, Mahner, Sven, Ditsch, Nina, Zeder-Goess, Christine, Tio, Joke, Burg, Matthias, Horvath, Judith, Siebert, Reiner, Bartholomae, Jasmin, Janni, Wolfgang, Bley, Thorsten, Woeckel, Achim, Haaf, Thomas, Zachariae, Silke, Bucksch, Karolin, Enders, Ute, Bick, Ulrich, Engel, Christoph, Krug, Barbara, Heindel, Walter, Fallenberg, Eva M., Rhiem, Kerstin, Maintz, David, Golatta, Michael, Speiser, Dorothee, Rjosk-Dendorfer, Dorothea, Laemmer-Skarke, Irina, Dietzel, Frederic, Schaefer, Karl Werner Fritz, Leinert, Elena, Weigel, Stefanie, Sauer, Stephanie, Pertschy, Stefanie, Hofmockel, Thomas, Hagert-Winkler, Anne, Kast, Karin, Quante, Anne, Meindl, Alfons, Kiechle, Marion, Loeffler, Markus, Schmutzler, Rita K., Blohmer, Jens-Uwe, Horn, Denise, Varon-Mateeva, Raymonda, Huebbel, Verena, Herold, Natalie, Puesken, Michael, Wimberger, Pauline, Meisel, Cornelia, Keller, Katja, Antoch, Gerald, Vesper, Anne-Sophie, Fehm, Tanja N., Schlegelberger, Brigitte, Auber, Bernd, Wallaschek, Hannah, Heil, Joerg, Schott, Sarah, Dikow, Nicola, Mundhenke, Christoph, Arnold, Norbert, Caliebe, Almuth, Briest, Susanne, Lemke, Johannes, Gril, Sabine, Pfeifer, Katharina, Ramser, Juliane, Mahner, Sven, Ditsch, Nina, Zeder-Goess, Christine, Tio, Joke, Burg, Matthias, Horvath, Judith, Siebert, Reiner, Bartholomae, Jasmin, Janni, Wolfgang, Bley, Thorsten, Woeckel, Achim, Haaf, Thomas, Zachariae, Silke, Bucksch, Karolin, and Enders, Ute
Abstract: Purpose To report on 10 years of high-risk service screening with annual MRI in the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC). Methods A cohort of 4,573 high-risk, previously unaffected women (954 BRCA1 carriers, 598 BRCA2 carriers, 3021 BRCA1/2 non-carriers) participating in the GC-HBOC surveillance program was prospectively followed. Screening outcomes for 14,142 screening rounds with MRI between 2006 and 2015 were analyzed and stratified by risk group, type of screening round, and age. Results A total of 221 primary breast cancers (185 invasive, 36 in situ) were diagnosed within 12 months of an annual screening round with MRI. Of all cancers, 84.5% (174/206, 15 unknown) were stage 0 or I. In BRCA1 carriers, 16.9% (10/59, 5 unknown) of all incident cancers (screen-detected and interval cancers combined) and in BRCA2 carriers 12.5% (3/24, 4 unknown) were stage IIA or higher, compared to only 4.8% (2/42, 2 unknown) in high-risk BRCA1/2 non-carriers. Program sensitivity was 89.6% (95% CI 84.9-93.0) with no significant differences in sensitivity between risk groups or by age. Specificity was significantly lower in the first screening round (84.6%, 95% CI 83.6-85.7) than in subsequent screening rounds (91.1%, 95% CI 90.6-91.7), p < 0.001. Cancer detection rates (CDRs) and as a result positive predictive values were strongly dependent on type of screening round, risk group and patient age. CDRs ranged from 43.5 (95% CI 29.8-62.9) for the first screening round in BRCA2 carriers to 2.9 parts per thousand (95% CI 1.3-6.3) for subsequent screening rounds in high-risk non-carriers in the age group 30 to 39 years. Conclusions High-risk screening with MRI was successfully implemented in the GC-HBOC with high sensitivity and specificity. Risk prediction and inclusion criteria in high-risk non-carriers need to be adjusted to improve CDRs and thus screening efficacy in these patients.
Published: 2019

45. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto

Author: Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, Loibl, Sibylle, Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, and Loibl, Sibylle
Abstract: PURPOSE The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes. METHODS Patients with histologically confirmed primary BC were randomly assigned in a 1: 1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m(2) (after study amendment, 125 mg/m(2)) or weekly sb-paclitaxel 80 mg/m(2) followed in both arms by four times epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year. RESULTS A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m(2) compared with NAB-paclitaxel 150 mg/m(2). CONCLUSION The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improve
Published: 2019

46. Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto-GBG 84): A randomised phase III trial

Author: Schneeweiss, Andreas, Moebus, Volker, Tesch, Hans, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Huober, Jens, Klare, Peter, Kuemmel, Sherko, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Ingold-Heppner, Barbara, Blohmer, Jens-Uwe, Rezai, Mahdi, Frank, Matthias, Engels, Knut, Rhiem, Kerstin, Fasching, Peter Andreas, Nekljudova, Valentina, von Minckwitz, Gunter, Loibl, Sibylle, Schneeweiss, Andreas, Moebus, Volker, Tesch, Hans, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Huober, Jens, Klare, Peter, Kuemmel, Sherko, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Ingold-Heppner, Barbara, Blohmer, Jens-Uwe, Rezai, Mahdi, Frank, Matthias, Engels, Knut, Rhiem, Kerstin, Fasching, Peter Andreas, Nekljudova, Valentina, von Minckwitz, Gunter, and Loibl, Sibylle
Abstract: Background: GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet (R)) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). Patients and methods: Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER) 2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m(2)) followed by P (225 mg/m(2)) followed by C (2000 mg/m(2)), each q2w for 3 cycles or weekly P (80 mg/m(2)) plus M (20 mg/m(2)) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w) with all P and C cycles. Primary end-point was pathological complete response (pCR, ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344. Results: 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77-1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died. Conclusions: In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective
Published: 2019

47. High-risk breast cancer surveillance with MRI: 10-year experience from the German consortium for hereditary breast and ovarian cancer

Author: Bick, Ulrich, Engel, Christoph, Krug, Barbara, Heindel, Walter, Fallenberg, Eva M., Rhiem, Kerstin, Maintz, David, Golatta, Michael, Speiser, Dorothee, Rjosk-Dendorfer, Dorothea, Laemmer-Skarke, Irina, Dietzel, Frederic, Schaefer, Karl Werner Fritz, Leinert, Elena, Weigel, Stefanie, Sauer, Stephanie, Pertschy, Stefanie, Hofmockel, Thomas, Hagert-Winkler, Anne, Kast, Karin, Quante, Anne, Meindl, Alfons, Kiechle, Marion, Loeffler, Markus, Schmutzler, Rita K., Blohmer, Jens-Uwe, Horn, Denise, Varon-Mateeva, Raymonda, Huebbel, Verena, Herold, Natalie, Puesken, Michael, Wimberger, Pauline, Meisel, Cornelia, Keller, Katja, Antoch, Gerald, Vesper, Anne-Sophie, Fehm, Tanja N., Schlegelberger, Brigitte, Auber, Bernd, Wallaschek, Hannah, Heil, Joerg, Schott, Sarah, Dikow, Nicola, Mundhenke, Christoph, Arnold, Norbert, Caliebe, Almuth, Briest, Susanne, Lemke, Johannes, Gril, Sabine, Pfeifer, Katharina, Ramser, Juliane, Mahner, Sven, Ditsch, Nina, Zeder-Goess, Christine, Tio, Joke, Burg, Matthias, Horvath, Judith, Siebert, Reiner, Bartholomae, Jasmin, Janni, Wolfgang, Bley, Thorsten, Woeckel, Achim, Haaf, Thomas, Zachariae, Silke, Bucksch, Karolin, Enders, Ute, Bick, Ulrich, Engel, Christoph, Krug, Barbara, Heindel, Walter, Fallenberg, Eva M., Rhiem, Kerstin, Maintz, David, Golatta, Michael, Speiser, Dorothee, Rjosk-Dendorfer, Dorothea, Laemmer-Skarke, Irina, Dietzel, Frederic, Schaefer, Karl Werner Fritz, Leinert, Elena, Weigel, Stefanie, Sauer, Stephanie, Pertschy, Stefanie, Hofmockel, Thomas, Hagert-Winkler, Anne, Kast, Karin, Quante, Anne, Meindl, Alfons, Kiechle, Marion, Loeffler, Markus, Schmutzler, Rita K., Blohmer, Jens-Uwe, Horn, Denise, Varon-Mateeva, Raymonda, Huebbel, Verena, Herold, Natalie, Puesken, Michael, Wimberger, Pauline, Meisel, Cornelia, Keller, Katja, Antoch, Gerald, Vesper, Anne-Sophie, Fehm, Tanja N., Schlegelberger, Brigitte, Auber, Bernd, Wallaschek, Hannah, Heil, Joerg, Schott, Sarah, Dikow, Nicola, Mundhenke, Christoph, Arnold, Norbert, Caliebe, Almuth, Briest, Susanne, Lemke, Johannes, Gril, Sabine, Pfeifer, Katharina, Ramser, Juliane, Mahner, Sven, Ditsch, Nina, Zeder-Goess, Christine, Tio, Joke, Burg, Matthias, Horvath, Judith, Siebert, Reiner, Bartholomae, Jasmin, Janni, Wolfgang, Bley, Thorsten, Woeckel, Achim, Haaf, Thomas, Zachariae, Silke, Bucksch, Karolin, and Enders, Ute
Abstract: Purpose To report on 10 years of high-risk service screening with annual MRI in the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC). Methods A cohort of 4,573 high-risk, previously unaffected women (954 BRCA1 carriers, 598 BRCA2 carriers, 3021 BRCA1/2 non-carriers) participating in the GC-HBOC surveillance program was prospectively followed. Screening outcomes for 14,142 screening rounds with MRI between 2006 and 2015 were analyzed and stratified by risk group, type of screening round, and age. Results A total of 221 primary breast cancers (185 invasive, 36 in situ) were diagnosed within 12 months of an annual screening round with MRI. Of all cancers, 84.5% (174/206, 15 unknown) were stage 0 or I. In BRCA1 carriers, 16.9% (10/59, 5 unknown) of all incident cancers (screen-detected and interval cancers combined) and in BRCA2 carriers 12.5% (3/24, 4 unknown) were stage IIA or higher, compared to only 4.8% (2/42, 2 unknown) in high-risk BRCA1/2 non-carriers. Program sensitivity was 89.6% (95% CI 84.9-93.0) with no significant differences in sensitivity between risk groups or by age. Specificity was significantly lower in the first screening round (84.6%, 95% CI 83.6-85.7) than in subsequent screening rounds (91.1%, 95% CI 90.6-91.7), p < 0.001. Cancer detection rates (CDRs) and as a result positive predictive values were strongly dependent on type of screening round, risk group and patient age. CDRs ranged from 43.5 (95% CI 29.8-62.9) for the first screening round in BRCA2 carriers to 2.9 parts per thousand (95% CI 1.3-6.3) for subsequent screening rounds in high-risk non-carriers in the age group 30 to 39 years. Conclusions High-risk screening with MRI was successfully implemented in the GC-HBOC with high sensitivity and specificity. Risk prediction and inclusion criteria in high-risk non-carriers need to be adjusted to improve CDRs and thus screening efficacy in these patients.
Published: 2019

48. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto

Author: Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, Loibl, Sibylle, Untch, Michael, Jackisch, Christian, Schneeweiss, Andreas, Schmatloch, Sabine, Aktas, Bahriye, Denkert, Carsten, Schem, Christian, Wiebringhaus, Hermann, Kuemmel, Sherko, Warm, Mathias, Fasching, Peter A., Just, Marianne, Hanusch, Claus, Hackmann, John, Blohmer, Jens-Uwe, Rhiem, Kerstin, Schmitt, Wolfgang D., Furlanetto, Jenny, Gerber, Bernd, Huober, Jens, Nekljudova, Valentina, von Minckwitz, Gunter, and Loibl, Sibylle
Abstract: PURPOSE The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes. METHODS Patients with histologically confirmed primary BC were randomly assigned in a 1: 1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m(2) (after study amendment, 125 mg/m(2)) or weekly sb-paclitaxel 80 mg/m(2) followed in both arms by four times epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year. RESULTS A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m(2) compared with NAB-paclitaxel 150 mg/m(2). CONCLUSION The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improve
Published: 2019

49. Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto-GBG 84): A randomised phase III trial

Author: Schneeweiss, Andreas, Moebus, Volker, Tesch, Hans, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Huober, Jens, Klare, Peter, Kuemmel, Sherko, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Ingold-Heppner, Barbara, Blohmer, Jens-Uwe, Rezai, Mahdi, Frank, Matthias, Engels, Knut, Rhiem, Kerstin, Fasching, Peter Andreas, Nekljudova, Valentina, von Minckwitz, Gunter, Loibl, Sibylle, Schneeweiss, Andreas, Moebus, Volker, Tesch, Hans, Hanusch, Claus, Denkert, Carsten, Luebbe, Kristina, Huober, Jens, Klare, Peter, Kuemmel, Sherko, Untch, Michael, Kast, Karin, Jackisch, Christian, Thomalla, Joerg, Ingold-Heppner, Barbara, Blohmer, Jens-Uwe, Rezai, Mahdi, Frank, Matthias, Engels, Knut, Rhiem, Kerstin, Fasching, Peter Andreas, Nekljudova, Valentina, von Minckwitz, Gunter, and Loibl, Sibylle
Abstract: Background: GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet (R)) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). Patients and methods: Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER) 2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m(2)) followed by P (225 mg/m(2)) followed by C (2000 mg/m(2)), each q2w for 3 cycles or weekly P (80 mg/m(2)) plus M (20 mg/m(2)) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w) with all P and C cycles. Primary end-point was pathological complete response (pCR, ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344. Results: 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77-1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died. Conclusions: In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective
Published: 2019

50. Development of central nervous system metastases as a first site of metastatic disease in breast cancer patients treated in the neoadjuvant trials GeparQuinto and GeparSixto

Author: Laakmann, Elena, Witzel, Isabell, Fasching, Peter Andreas, Rezai, Mahdi, Schem, Christian, Solbach, Christine, Tesch, Hans, Klare, Peter, Schneeweiss, Andreas, Salat, Christoph, Zahm, Dirk-Michael, Blohmer, Jens-Uwe, Ingold Heppner, Barbara, Huober, Jens, Hanusch, Claus, Jackisch, Christian, Reinisch, Mattea, Untch, Michael, Minckwitz, Gunter von, Nekljudova, Valentina, Müller, Volkmar, Loibl, Sibylle, Laakmann, Elena, Witzel, Isabell, Fasching, Peter Andreas, Rezai, Mahdi, Schem, Christian, Solbach, Christine, Tesch, Hans, Klare, Peter, Schneeweiss, Andreas, Salat, Christoph, Zahm, Dirk-Michael, Blohmer, Jens-Uwe, Ingold Heppner, Barbara, Huober, Jens, Hanusch, Claus, Jackisch, Christian, Reinisch, Mattea, Untch, Michael, Minckwitz, Gunter von, Nekljudova, Valentina, Müller, Volkmar, and Loibl, Sibylle
Abstract: Background: The incidence of central nervous system (CNS) metastases in breast cancer patients is rising and has become a major clinical challenge. Only few data are published concerning risk factors for the development of CNS metastases as a first site of metastatic disease in breast cancer patients. Moreover, the incidence of CNS metastases after modern neoadjuvant treatment is not clear. Methods: We analyzed clinical factors associated with the occurrence of CNS metastases as the first site of metastatic disease in breast cancer patients after neoadjuvant treatment in the trials GeparQuinto and GeparSixto (n = 3160) where patients received targeted treatment in addition to taxane and anthracycline-based chemotherapy. Results: After a median follow-up of 61 months, 108 (3%) of a total of 3160 patients developed CNS metastases as the first site of recurrence and 411 (13%) patients had metastatic disease outside the CNS. Thirty-six patients (1%) developed both CNS metastases and other distant metastases as the first site of metastatic disease. Regarding subtypes of the primary tumor, 1% of luminal A-like (11/954), 2% of luminal B-like (7/381), 4% of HER2-positive (34/809), and 6% of triple-negative patients (56/1008) developed CNS metastases as the first site of metastatic disease. In multivariate analysis, risk factors for the development of CNS metastases were larger tumor size (cT3–4; HR 1.63, 95% CI 1.08–2.46, p = 0.021), node-positive disease (HR 2.57, 95% CI 1.64–4.04, p < 0.001), no pCR after neoadjuvant chemotherapy (HR 2.29, 95% CI 1.32–3.97, p = 0.003), and HER2-positive (HR 3.80, 95% CI 1.89–7.64, p < 0.001) or triple-negative subtype (HR 6.38, 95% CI 3.28–12.44, p < 0.001). Conclusions: Especially patients with HER2-positive and triple-negative tumors are at risk of developing CNS metastases despite effective systemic treatment. A better understanding of the underlying mechanisms is required in order to develop potential preventive strategies.
Published: 2019

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