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1. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C

Author

de Gregorio, Amelie, Janni, Wolfgang, Friedl, Thomas W. P., Nitz, Ulrike, Rack, Brigitte, Schneeweiss, Andreas, Kates, Ronald, Fehm, Tanja, Kreipe, Hans, Christgen, Matthias, Kümmel, Sherko, Trapp, Elisabeth, Wuerstlein, Rachel, Hartkopf, Andreas, Clemens, Michael, Reimer, Toralf, Häberle, Lothar, Fasching, Peter A., Gluz, Oleg, and Harbeck, Nadia

Published
2022
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2. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases

Author

de Boniface, Jana, Filtenborg Tvedskov, Tove, Ryden, Lisa, Szulkin, Robert, Reimer, Toralf, Kuehn, Thorsten, Kontos, Michalis, Gentilini, Oreste D., Olofsson Bagge, Roger, Sund, Malin, Lundstedt, Dan, Appelgren, Matilda, Ahlgren, Johan, Norenstedt, Sophie, Celebioglu, Fuat, Sackey, Helena, Scheel Andersen, Inge, Hoyer, Ute, Nyman, Per F., Vikhe Patil, Eva, Wieslander, Elinore, Dahl Nissen, Henrik, Alkner, Sara, Andersson, Yvette, Offersen, Birgitte V., Bergkvist, Leif, Frisell, Jan, Christiansen, Peer, de Boniface, Jana, Filtenborg Tvedskov, Tove, Ryden, Lisa, Szulkin, Robert, Reimer, Toralf, Kuehn, Thorsten, Kontos, Michalis, Gentilini, Oreste D., Olofsson Bagge, Roger, Sund, Malin, Lundstedt, Dan, Appelgren, Matilda, Ahlgren, Johan, Norenstedt, Sophie, Celebioglu, Fuat, Sackey, Helena, Scheel Andersen, Inge, Hoyer, Ute, Nyman, Per F., Vikhe Patil, Eva, Wieslander, Elinore, Dahl Nissen, Henrik, Alkner, Sara, Andersson, Yvette, Offersen, Birgitte V., Bergkvist, Leif, Frisell, Jan, and Christiansen, Peer

Abstract

Background Trials evaluating the omission of completion axillary-lymph-node dissection in patients with clinically node-negative breast cancer and sentinel-lymph-node metastases have been compromised by limited statistical power, uncertain nodal radiotherapy target volumes, and a scarcity of data on relevant clinical subgroups. Methods We conducted a noninferiority trial in which patients with clinically node-negative primary T1 to T3 breast cancer (tumor size, T1, <= 20 mm; T2, 21 to 50 mm; and T3, >50 mm in the largest dimension) with one or two sentinel-node macrometastases (metastasis size, >2 mm in the largest dimension) were randomly assigned in a 1:1 ratio to completion axillary-lymph-node dissection or its omission (sentinel-node biopsy only). Adjuvant treatment and radiation therapy were used in accordance with national guidelines. The primary end point was overall survival. We report here the per-protocol and modified intention-to-treat analyses of the prespecified secondary end point of recurrence-free survival. To show noninferiority of sentinel-node biopsy only, the upper boundary of the confidence interval for the hazard ratio for recurrence or death had to be below 1.44. Results Between January 2015 and December 2021, a total of 2766 patients were enrolled across five countries. The per-protocol population included 2540 patients, of whom 1335 were assigned to undergo sentinel-node biopsy only and 1205 to undergo completion axillary-lymph-node dissection (dissection group). Radiation therapy including nodal target volumes was administered to 1192 of 1326 patients (89.9%) in the sentinel-node biopsy-only group and to 1058 of 1197 (88.4%) in the dissection group. The median follow-up was 46.8 months (range, 1.5 to 94.5). Overall, 191 patients had recurrence or died. The estimated 5-year recurrence-free survival was 89.7% (95% confidence interval [CI], 87.5 to 91.9) in the sentinel-node biopsy-only group and 88.7% (95% CI, 86.3 to 91.

Published
2024
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3. Quality assessment of radiotherapy in the prospective randomized SENOMAC trial

Author

Alkner, Sara, Wieslander, Elinore, Lundstedt, Dan, Berg, Martin, Kristensen, Ingrid, Andersson, Yvette, Bergkvist, Leif, Frisell, Jan, Olofsson Bagge, Roger, Sund, Malin, Christiansen, Peer, Davide Gentilini, Oreste, Kontos, Michalis, Kühn, Thorsten, Reimer, Toralf, Rydén, Lisa, Filtenborg Tvedskov, Tove, Vrou Offersen, Birgitte, Dahl Nissen, Henrik, de Boniface, Jana, Alkner, Sara, Wieslander, Elinore, Lundstedt, Dan, Berg, Martin, Kristensen, Ingrid, Andersson, Yvette, Bergkvist, Leif, Frisell, Jan, Olofsson Bagge, Roger, Sund, Malin, Christiansen, Peer, Davide Gentilini, Oreste, Kontos, Michalis, Kühn, Thorsten, Reimer, Toralf, Rydén, Lisa, Filtenborg Tvedskov, Tove, Vrou Offersen, Birgitte, Dahl Nissen, Henrik, and de Boniface, Jana

Abstract

Background and purpose: Recommendations for regional radiotherapy (RT) of sentinel lymph node (SLN)-positive breast cancer are debated. We here report a RT quality assessment of the SENOMAC trial. Materials and Methods: The SENOMAC trial randomized clinically node-negative breast cancer patients with 1–2 SLN macrometastases to completion axillary lymph node dissection (cALND) or SLN biopsy only between 2015–2021. Adjuvant RT followed national guidelines. RT plans for patients included in Sweden and Denmark until June 2019 were collected (N = 1176) and compared to case report forms (CRF). Dose to level I (N = 270) and the humeral head (N = 321) was analyzed in detail. Results: CRF-data and RT plans agreed in 99.3 % (breast/chest wall) and in 96.6 % of patients (regional RT). Congruence for whether level I was an intended RT target was lower (78 %). In accordance with Danish national guidelines, level I was more often an intended target in the SLN biopsy only arm (N = 334/611, 55 %,) than in the cALND arm (N = 174/565, 31 %,). When an intended target, level I received prescribed dose to 100 % (IQR 98–100 %) of the volume. However, even when not an intended target, full dose was delivered to > 80 % of level I (IQR 75–90 %). The intentional inclusion of level I in the target volume more than doubled the dose received by ≥ 50 % of the humeral head. Conclusion: Congruence between CRF data and RT plans was excellent. Level I received a high dose coverage even when not intentionally included in the target. Including level I in target significantly increased dose to the humeral head.

Published
2024
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4. Association of TILs with clinical parameters, Recurrence Score® results, and prognosis in patients with early HER2-negative breast cancer (BC)—a translational analysis of the prospective WSG PlanB trial

Author

Cornelia Kolberg-Liedtke, Gluz Oleg, Heinisch Fred, Feuerhake Friedrich, Kreipe Hans, Clemens Michael, Nuding Benno, Malter Wolfram, Reimer Toralf, Wuerstlein Rachel, Graeser Monika, Shak Steve, Nitz Ulrike, Kates Ronald, Christgen Matthias, and Harbeck Nadia

Subjects
Tumor-infiltrating lymphocytes (TILs), Adjuvant chemotherapy, Breast cancer, Disease-free survival, Hormone receptor status, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background The presence of tumor-infiltrating lymphocytes has been associated with prognosis and chemotherapy response, particularly in high-risk breast cancer subtypes. There is limited data so far as to (i) how tumor-infiltrating lymphocyte (TIL) measurements correlate with genomic measurements such as the Oncotype DX Recurrence Score® and (ii) whether the survival impact of TIL measurements varies according to different adjuvant systemic therapies. Methods The WSG PlanB trial compared an anthracycline-free chemotherapy regimen (6x docetaxel/cyclophosphamide, TC) to an anthracycline-taxane sequence (4xEC followed by 4x docetaxel) in patients with intermediate-risk, HER2-negative early breast cancer (EBC). Patients with HR-positive HER2-negative EBC were further stratified to receive endocrine therapy alone vs. chemotherapy followed by endocrine therapy based on Recurrence Score results and nodal status. In this analysis, three independent observers quantified and categorized the presence of TILs among tumor samples from patients in PlanB. TIL measurements were correlated with clinical/pathological parameters and treatment outcome overall and according to the treatment arm. Results Disease-free survival (DFS) rates were significantly better (p = .04) in HR-negative patients with high vs. intermediate TIL levels and were higher in low vs. intermediate TIL patients, however with borderline significance only (p = .06). There were no significant differences among TIL categories in HR+ patients. High RS categories, HR-negative status, and high KI67 were independently and significantly associated with high TIL categories. There was no significant impact of TIL category on DFS in patients treated by endocrine therapy only; however, in patients receiving chemotherapy, DFS in the intermediate TIL category was lower than that in the other categories. Conclusion Although the presence of high TILs is associated with negative prognostic parameters such as high KI67 and HR-negative status among patients with HR-positive HER2-negative EBC, patients with high TILs show a favorable 5-year DFS in both HR-positive/HER2-negative and triple-negative breast cancer.

Published
2020
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5. Treatment of Early Breast Cancer

Author

Untch, Michael, additional, Banys-Paluchowski, Maggie, additional, Brucker, Sara Y., additional, Budach, Wilfried, additional, Denkert, Carsten, additional, Ditsch, Nina, additional, Fasching, Peter A., additional, Haidinger, Renate, additional, Heil, Jörg, additional, Jackisch, Christian, additional, Janni, Wolfgang, additional, Kolberg, Hans-Christian, additional, Krug, David, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, van Mackelenbergh, Marion, additional, Radosa, Julia C., additional, Reimer, Toralf, additional, Welslau, Manfred, additional, Würstlein, Rachel, additional, Harbeck, Nadia, additional, and Huober, Jens, additional

Published
2023
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6. Abstract OT1-07-01: Omission of SLNB in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after NAST: a single-arm, prospective surgical trial (EUBREAST-01 trial, GBG 104)

Author

Reimer, Toralf, primary, Kuehn, Thorsten, additional, Stachs, Angrit, additional, Kleine-Tebbe, Anke, additional, Bangemann, Nikola, additional, Stefek, Andrea, additional, Hammerle, Carolin, additional, Heil, Jörg, additional, Nixdorf, Antje, additional, Bonatz, Gabriele, additional, Nolte, Agnieszka, additional, Rubio, Isabel T., additional, Peintinger, Florentia, additional, Mehta, Keyur, additional, Loibl, Sibylle, additional, Botteri, Edoardo, additional, and Gentilini, Oreste Davide, additional

Published
2023
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7. Abstract PD17-06: Immunohistochemical markers and determinants of clinical response in the Penelope-B trial

Author

Knudsen, Erik S., primary, Rachakonda, Sivaramakrishna, additional, Marmé, Frederik, additional, Martín, Miguel, additional, Untch, Michael, additional, Bonnefoi, Hervé R., additional, Schmitt, Wolfgang D., additional, Kim, Sung-Bae, additional, Bear, Harry D., additional, Witkiewicz, Agnieszka, additional, Im, Seock-Ah, additional, DeMichele, Angela, additional, Van’t Veer, Laura, additional, McCarthy, Nicole, additional, Sinn, Bruno V., additional, Gelmon, Karen, additional, García-Sáenz, José Ángel, additional, Kelly, Catherine M., additional, Reimer, Toralf, additional, Turner, Nicholas, additional, Rojo, Federico, additional, Filipits, Martin, additional, Fasching, Peter A., additional, Schem, Christian, additional, Martin, Lesley-Ann, additional, Liu, Yuan, additional, Toi, Masakazu, additional, Rugo, Hope, additional, Gnant, Michael, additional, Makris, Andreas, additional, Furlanetto, Jenny, additional, Weber, Karsten, additional, Denkert, Carsten, additional, and Loibl, Sibylle, additional

Published
2023
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8. Abstract P4-01-01: RIBANNA 5th interim analysis: Matched-pair analysis of progression-free survival (PFS) across treatment cohorts and comparison of frontline ribociclib + endocrine therapy PFS data from RIBANNA vs MONALEESA trials, in HR+, HER2– ABC

Author

Jackisch, Christian, primary, Brucker, Cosima, additional, Decker, Thomas, additional, Engel, Anne, additional, Fasching, Peter A., additional, Göhler, Thomas, additional, Janssen, Jan, additional, Köhler, Andreas, additional, Lüdtke-Heckenkamp, Kerstin, additional, Lüftner, Diana, additional, van Mackelenbergh, Marion, additional, Marmé, Frederik, additional, Nusch, Arnd, additional, Rautenberg, Beate, additional, Reimer, Toralf, additional, Schmidt, Marcus, additional, Weide, Rudolf, additional, Wimberger, Pauline, additional, Roos, Christian, additional, and Wöckel, Achim, additional

Published
2023
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9. Abstract P4-01-03: Progression-free survival and patient-reported outcomes in HR+, HER2– ABC patients treated with first-line ribociclib + endocrine therapy (ET) or ET monotherapy or chemotherapy in real world setting: 5th interim analysis of RIBANNA

Author

Fasching, Peter A., primary, Brucker, Cosima, additional, Decker, Thomas, additional, Engel, Anne, additional, Göhler, Thomas, additional, Jackisch, Christian, additional, Janssen, Jan, additional, Köhler, Andreas, additional, Lüdtke-Heckenkamp, Kerstin, additional, Lüftner, Diana, additional, van Mackelenbergh, Marion, additional, Marmé, Frederik, additional, Nusch, Arnd, additional, Rautenberg, Beate, additional, Reimer, Toralf, additional, Schmidt, Marcus, additional, Weide, Rudolf, additional, Wimberger, Pauline, additional, Roos, Christian, additional, and Wöckel, Achim, additional

Published
2023
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10. Abstract HER2-06: HER2-06 Outcome analysis of HER2-zero or HER2-low hormone receptor-positive (HR+) breast cancer patients - characterization of the molecular phenotype in combination with molecular subtyping

Author

Denkert, Carsten, primary, Martín, Miguel, additional, Untch, Michael, additional, Bonnefoi, Hervé R., additional, Knudsen, Erik S., additional, Im, Seock-Ah, additional, DeMichele, Angela, additional, Witkiewicz, Agnieszka, additional, Van ’t Veer, Laura, additional, Kim, Sung-Bae, additional, Bear, Harry D., additional, McCarthy, Nicole, additional, Gelmon, Karen, additional, Marmé, Frederik, additional, García-Sáenz, José Ángel, additional, Turner, Nicholas, additional, Rojo, Federico, additional, Filipits, Martin, additional, Martin, Lesley-Ann, additional, Fasching, Peter A., additional, Schem, Christian, additional, Kelly, Catherine M., additional, Reimer, Toralf, additional, Toi, Masakazu, additional, Rugo, Hope, additional, Gnant, Michael, additional, Makris, Andreas, additional, Liu, Yuan, additional, Weber, Karsten, additional, Rachakonda, Sivaramakrishna, additional, and Loibl, Sibylle, additional

Published
2023
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12. Standardized evaluation of tumor-infiltrating lymphocytes in breast cancer: results of the ring studies of the international immuno-oncology biomarker working group

Author

Denkert, Carsten, Wienert, Stephan, Poterie, Audrey, Loibl, Sibylle, Budczies, Jan, Badve, Sunil, Bago-Horvath, Zsuzsanna, Bane, Anita, Bedri, Shahinaz, Brock, Jane, Chmielik, Ewa, Christgen, Matthias, Colpaert, Cecile, Demaria, Sandra, Van den Eynden, Gert, Floris, Giuseppe, Fox, Stephen B, Gao, Dongxia, Ingold Heppner, Barbara, Kim, S Rim, Kos, Zuzana, Kreipe, Hans H, Lakhani, Sunil R, Penault-Llorca, Frederique, Pruneri, Giancarlo, Radosevic-Robin, Nina, Rimm, David L, Schnitt, Stuart J, Sinn, Bruno V, Sinn, Peter, Sirtaine, Nicolas, O'Toole, Sandra A, Viale, Giuseppe, Van de Vijver, Koen, de Wind, Roland, von Minckwitz, Gunter, Klauschen, Frederick, Untch, Michael, Fasching, Peter A, Reimer, Toralf, Willard-Gallo, Karen, Michiels, Stefan, Loi, Sherene, and Salgado, Roberto

Published
2016
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13. Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023

Author

Park-Simon, Tjoung-Won, primary, Müller, Volkmar, additional, Jackisch, Christian, additional, Albert, Ute-Susann, additional, Banys-Paluchowski, Maggie, additional, Bauerfeind, Ingo, additional, Blohmer, Jens-Uwe, additional, Budach, Wilfried, additional, Dall, Peter, additional, Ditsch, Nina, additional, Fallenberg, Eva Maria, additional, Fasching, Peter A., additional, Fehm, Tanja, additional, Friedrich, Michael, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Harbeck, Nadia, additional, Hartkopf, Andreas D., additional, Heil, Joerg, additional, Huober, Jens, additional, Kolberg-Liedtke, Cornelia, additional, Kreipe, Hans H., additional, Krug, David, additional, Kühn, Thorsten, additional, Kümmel, Sherko, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Mundhenke, Christoph, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, Wöckel, Achim, additional, Wuerstlein, Rachel, additional, Janni, Wolfgang, additional, and Thill, Marc, additional

Published
2023
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14. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2023

Author

Thill, Marc, primary, Kolberg-Liedtke, Cornelia, additional, Albert, Ute-Susann, additional, Banys-Paluchowski, Maggie, additional, Bauerfeind, Ingo, additional, Blohmer, Jens-Uwe, additional, Budach, Wilfried, additional, Dall, Peter, additional, Ditsch, Nina, additional, Fallenberg, Eva Maria, additional, Fasching, Peter A., additional, Fehm, Tanja, additional, Friedrich, Michael, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Harbeck, Nadia, additional, Hartkopf, Andreas D., additional, Heil, Joerg, additional, Huober, Jens, additional, Jackisch, Christian, additional, Kreipe, Hans H., additional, Krug, David, additional, Kühn, Thorsten, additional, Kümmel, Sherko, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Mundhenke, Christoph, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, Wöckel, Achim, additional, Wuerstlein, Rachel, additional, Müller, Volkmar, additional, Janni, Wolfgang, additional, and Park-Simon, Tjoung-Won, additional

Published
2023
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15. Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): a randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer

Author

Reimer, Toralf, primary, Stachs, Angrit, additional, Veselinovic, Kristina, additional, Polata, Silke, additional, Müller, Thomas, additional, Kühn, Thorsten, additional, Heil, Jörg, additional, Ataseven, Beyhan, additional, Reitsamer, Roland, additional, Hildebrandt, Guido, additional, Knauer, Michael, additional, Golatta, Michael, additional, Stefek, Andrea, additional, Zahm, Dirk-Michael, additional, Thill, Marc, additional, Nekljudova, Valentina, additional, Krug, David, additional, Loibl, Sibylle, additional, and Gerber, Bernd, additional

Published
2023
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16. Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study

Author

Reinisch, Mattea, primary, Untch, Michael, additional, Mahlberg, Rolf, additional, Reimer, Toralf, additional, Hitschold, Thomas, additional, Marmé, Frederik, additional, Aydogdu, Mustafa, additional, Schmatloch, Sabine, additional, Lück, Hans-Joachim, additional, Schmidt, Marcus, additional, Ladda, Ekkehart, additional, Sinn, Bruno Valentin, additional, Klare, Peter, additional, Janni, Wolfgang, additional, Jackisch, Christian, additional, Denkert, Carsten, additional, Seiler, Sabine, additional, Göhler, Thomas, additional, Michel, Laura, additional, Burchardi, Nicole, additional, Stickeler, Elmar, additional, Rey, Julia, additional, Klutinus, Nicole, additional, Möbus, Volker, additional, and Loibl, Sibylle, additional

Published
2022
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17. Impact of RNA Signatures on pCR and Survival after 12-Week Neoadjuvant Pertuzumab plus Trastuzumab with or without Paclitaxel in the WSG-ADAPT HER2+/HR− Trial

Author

Graeser, Monika, primary, Gluz, Oleg, additional, Biehl, Claudia, additional, Ulbrich-Gebauer, Daniel, additional, Christgen, Matthias, additional, Palatty, Jenci, additional, Kuemmel, Sherko, additional, Grischke, Eva-Maria, additional, Augustin, Doris, additional, Braun, Michael, additional, Potenberg, Jochem, additional, Wuerstlein, Rachel, additional, Krauss, Katja, additional, Schumacher, Claudia, additional, Forstbauer, Helmut, additional, Reimer, Toralf, additional, Stefek, Andrea, additional, Fischer, Hans Holger, additional, Pelz, Enrico, additional, zu Eulenburg, Christine, additional, Kates, Ronald, additional, Ni, Hua, additional, Kolberg-Liedtke, Cornelia, additional, Feuerhake, Friedrich, additional, Kreipe, Hans Heinrich, additional, Nitz, Ulrike, additional, and Harbeck, Nadia, additional

Published
2022
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18. Impact of RNA Signatures on pCR and Survival after 12-Week Neoadjuvant Pertuzumab plus Trastuzumab with or without Paclitaxel in the WSG-ADAPT HER2+/HR− Trial

Author

Graeser, Monika, Gluz, Oleg, Biehl, Claudia, Ulbrich-Gebauer, Daniel, Christgen, Matthias, Palatty, Jenci, Kuemmel, Sherko, Grischke, Eva-Maria, Augustin, Doris, Braun, Michael, Potenberg, Jochem, Wuerstlein, Rachel, Krauss, Katja, Schumacher, Claudia, Forstbauer, Helmut, Reimer, Toralf, Stefek, Andrea, Fischer, Hans Holger, Pelz, Enrico, Zu Eulenburg, Christine, Kates, Ronald, Ni, Hua, Kolberg-Liedtke, Cornelia, Feuerhake, Friedrich, Kreipe, Hans Heinrich, Nitz, Ulrike, Harbeck, Nadia, and WSG-ADAPT Investigators

Subjects
Cancer Research, Oncology, Medizin
Abstract

Clinical cancer research 29(4), 805-814 (2023). doi:10.1158/1078-0432.CCR-22-1587, Published by AACR, Philadelphia, Pa. [u.a.]

Published
2023
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19. AGO Recommendations for the Surgical Therapy of Breast Cancer: Update 2022

Author

Banys-Paluchowski, Maggie, additional, Thill, Marc, additional, Kühn, Thorsten, additional, Ditsch, Nina, additional, Heil, Jörg, additional, Wöckel, Achim, additional, Fallenberg, Eva, additional, Friedrich, Michael, additional, Kümmel, Sherko, additional, Müller, Volkmar, additional, Janni, Wolfgang, additional, Albert, Ute-Susann, additional, Bauerfeind, Ingo, additional, Blohmer, Jens-Uwe, additional, Budach, Wilfried, additional, Dall, Peter, additional, Fasching, Peter, additional, Fehm, Tanja, additional, Gluz, Oleg, additional, Harbeck, Nadia, additional, Huober, Jens, additional, Jackisch, Christian, additional, Kolberg-Liedtke, Cornelia, additional, Kreipe, Hans H., additional, Krug, David, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Mundhenke, Christoph, additional, Nitz, Ulrike, additional, Park-Simon, Tjoung Won, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, H. Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, and Gerber, Bernd, additional

Published
2022
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20. Cost-effectiveness of palbociclib in early breast cancer patients with a high risk of relapse: Results from the PENELOPE-B trial

Author

Galactionova, Katya, primary, Loibl, Sibylle, additional, Salari, Paola, additional, Marmé, Frederik, additional, Martin, Miguel, additional, Untch, Michael, additional, Bonnefoi, Hervé R., additional, Kim, Sung-Bae, additional, Bear, Harry D., additional, McCarthy, Nicole, additional, Gelmon, Karen A., additional, García-Sáenz, José A., additional, Kelly, Catherine M., additional, Reimer, Toralf, additional, Toi, Masakazu, additional, Rugo, Hope S., additional, Gnant, Michael, additional, Makris, Andreas, additional, Burchardi, Nicole, additional, and Schwenkglenks, Matthias, additional

Published
2022
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21. RESPONDER – diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial

Author

Heil, Joerg, Sinn, Peter, Richter, Hannah, Pfob, André, Schaefgen, Benedikt, Hennigs, André, Riedel, Fabian, Thomas, Bettina, Thill, Marc, Hahn, Markus, Blohmer, Jens-Uwe, Kuemmel, Sherko, Karsten, Maria Margarete, Reinisch, Mattea, Hackmann, John, Reimer, Toralf, Rauch, Geraldine, and Golatta, Michael

Published
2018
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24. 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

25. 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

26. 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

27. 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

28. De-escalated neoadjuvant pertuzumab plus trastuzumab therapy with or without weekly paclitaxel in HER2-positive, hormone receptor-negative, early breast cancer (WSG-ADAPT-HER2+/HR-): survival outcomes from a multicentre, open-label, randomised, phase 2 trial

Author

Nitz, Ulrike, Gluz, Oleg, Graeser, Monika, Christgen, Matthias, Kuemmel, Sherko, Grischke, Eva-Maria, Braun, Michael, Augustin, Doris, Potenberg, Jochem, Krauss, Katja, Schumacher, Claudia, Forstbauer, Helmut, Reimer, Toralf, Stefek, Andrea, Fischer, Hans Holger, Pelz, Enrico, Zu Eulenburg, Christine, Kates, Ronald, Wuerstlein, Rachel, Kreipe, Hans Heinrich, Harbeck, Nadia, Nitz, Ulrike, Gluz, Oleg, Graeser, Monika, Christgen, Matthias, Kuemmel, Sherko, Grischke, Eva-Maria, Braun, Michael, Augustin, Doris, Potenberg, Jochem, Krauss, Katja, Schumacher, Claudia, Forstbauer, Helmut, Reimer, Toralf, Stefek, Andrea, Fischer, Hans Holger, Pelz, Enrico, Zu Eulenburg, Christine, Kates, Ronald, Wuerstlein, Rachel, Kreipe, Hans Heinrich, and Harbeck, Nadia

Abstract

Background Several de-escalation neoadjuvant strategies have been investigated to reduce the use of chemotherapy in HER2-positive early breast cancer using pathological complete response as a surrogate endpoint; there are few survival data from these trials. Here, we report 5-year survival data in the WSG-ADAPT-HER2+/HR- trial and address the effect of pathological complete response, early therapy response, and molecular subtype. Methods WSG-ASAPT-HER2+/ HR-, a part of the ADAPT umbrella trial performed in patients with different subtypes of early breast cancer, was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 40 Breast Cancer Centres in Germany. Eligible patients were aged 18 years or older with histologically confirmed, unilateral, primary invasive, non-inflammatory early breast cancer, hormone receptor-negative and HER2-positive status, and an Eastern Cooperative Oncology Group performance status of 0 or 1 or a Karnofsky performance status of at least 80%. Patients were randomly assigned (5:2, block size 21, stratified by centre and clinical nodal status) to 12 weeks of either trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks) plus pertuzumab (840 mg loading dose, then 420 mg every 3 weeks) or trastuzumab plus pertuzumab plus paclitaxel (80 mg/m (2) weekly); all drugs were administered intravenously. The primary objective of the trial was to compare the number of patients with a pathological complete response at surgery (ie, no invasive tumour cells in breast and lymph nodes [ypT0/is ypN0], the primary endpoint) in early responders (ie, low cellularity or Ki67 decrease =30% after 3 weeks) in the trastuzumab plus pertuzumab group versus all patients (irrespective of an early response) in the trastuzumab plus pertuzumab plus paclitaxel group. Non-inferiority was defined as a pathological complete response no worse than 23% lower in the early-responder proportion of patients in the trastuzumab plus pertuzumab grou

Published
2022

29. 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

30. Cost-effectiveness of palbociclib in early breast cancer patients with a high risk of relapse: Results from the PENELOPE-B trial

Author

Galactionova, Katya, Loibl, Sibylle, Salari, Paola, Marmé, Frederik, Martin, Miguel, Untch, Michael, Bonnefoi, Hervé R, Kim, Sung-Bae, Bear, Harry D, McCarthy, Nicole, Gelmon, Karen A, García-Sáenz, José A, Kelly, Catherine M, Reimer, Toralf, Toi, Masakazu, Rugo, Hope S, Gnant, Michael, Makris, Andreas, Burchardi, Nicole, Schwenkglenks, Matthias; https://orcid.org/0000-0001-7217-1173, Galactionova, Katya, Loibl, Sibylle, Salari, Paola, Marmé, Frederik, Martin, Miguel, Untch, Michael, Bonnefoi, Hervé R, Kim, Sung-Bae, Bear, Harry D, McCarthy, Nicole, Gelmon, Karen A, García-Sáenz, José A, Kelly, Catherine M, Reimer, Toralf, Toi, Masakazu, Rugo, Hope S, Gnant, Michael, Makris, Andreas, Burchardi, Nicole, and Schwenkglenks, Matthias; https://orcid.org/0000-0001-7217-1173

Abstract

BACKGROUND Patients with hormone receptor-positive, HER2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) are at a high risk of relapse. PENELOPE-B was a double-blind, placebo-controlled, phase III trial that investigated adding palbociclib (PAL) for thirteen 28-day cycles to adjuvant endocrine therapy (ET) in these patients. Clinical results showed no significant improvement in invasive disease-free survival with PAL. METHODS We performed a pre-planned cost-effectiveness analysis of PAL within PENELOPE-B from the perspective of the German statutory health insurance. Health-related quality of life scores, collected in the trial using the EQ-5D-3L instrument, were converted to utilities based on the German valuation algorithm. Resource use was valued using German price weights. Outcomes were discounted at 3% and modeled with mixed-level linear models to adjust for attrition, repeated measurements, and residual baseline imbalances. Subgroup analyses were performed for key prognostic risk factors. Scenario analyses addressed data limitations and evaluated the robustness of the estimated cost-effectiveness of PAL to methodological choices. RESULTS The effects of PAL on quality-adjusted life years (QALYs) were marginal during the active treatment phase, increasing thereafter to 0.088 (95% confidence interval: -0.001; 0.177) QALYs gained over the 4 years of follow-up. The incremental costs were dominated by PAL averaging EUR 33,000 per patient; costs were higher in the PAL arm but not significantly different after the second year. At an incremental cost-effectiveness ratio of EUR 380,000 per QALY gained, PAL was not cost-effective compared to the standard-of-care ET. Analyses restricted to Germany and other subgroups were consistent with the main results. Findings were robust in the scenarios evaluated. CONCLUSIONS One year of PAL added to ET is not cost-effective in women with residual invasive disease after NACT in Germany.

Published
2022

31. Abstract P5-13-36: Germline BRCA1/2 and other predisposition genes in high-risk early-stage HR+/HER2- breast cancer (BC) patients treated with endocrine therapy (ET) with or without palbociclib: A secondary analysis from the PENELOPE-B study

Author

Loibl, Sibylle, primary, Hauke, Jan, additional, Gelmon, Karen, additional, Marmé, Frederik, additional, Ernst, Corinna, additional, Martin, Miguel, additional, Untch, Michael, additional, Bonnefoi, Hervé, additional, Knudsen, Erik, additional, Im, Seock-Ah, additional, DeMichele, Angela, additional, Van’t Veer, Laura, additional, Kim, Sung-Bae, additional, Bear, Harry, additional, McCarthy, Nicole, additional, Turner, Nicholas, additional, Witkiewicz, Agnieszka, additional, Rojo, Federico, additional, Fasching, Peter A, additional, García-Sáenz, José A, additional, Kelly, Catherine M, additional, Reimer, Toralf, additional, Toi, Masakazu, additional, Rugo, Hope S, additional, Denkert, Carsten, additional, Gnant, Michael, additional, Makris, Andreas, additional, Liu, Yuan, additional, Valota, Olga, additional, Felder, Bärbel, additional, Weber, Karsten, additional, Nekljudova, Valentina, additional, and Hahnen, Eric, additional

Published
2022
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32. Abstract PD7-02: Intelligent vacuum-assisted breast biopsy to identify breast cancer patients with pathologic complete response after neoadjuvant systemic treatment for omission of breast and axillary surgery

Author

Pfob, André, primary, Sidey-Gibbons, Chris, additional, Rauch, Geraldine, additional, Thomas, Bettina, additional, Schaefgen, Benedikt, additional, Kuemmel, Sherko, additional, Reimer, Toralf, additional, Hahn, Markus, additional, Thill, Marc, additional, Blohmer, Jens-Uwe, additional, Hackmann, John, additional, Malter, Wolfram, additional, Bekes, Inga, additional, Friedrichs, Kay, additional, Wojcinski, Sebastian, additional, Joos, Sylvie, additional, Paepke, Stefan, additional, Degenhardt, Tom, additional, Rom, Joachim, additional, Rody, Achim, additional, Große, Regina, additional, van Mackelenbergh, Marion, additional, Reinisch, Mattea, additional, Karsten, Maria, additional, Golatta, Michael, additional, and Heil, Joerg, additional

Published
2022
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33. Abstract GS4-03: Patient-reported outcomes (PROs) for the intergroup sentinel mamma study (INSEMA, GBG75, ABCSG43): Persistent impact of axillary surgery on arm and breast symptoms in early breast cancer

Author

Gerber, Bernd, primary, Stachs, Angrit, additional, Veselinovic, Kristina, additional, Polata, Silke, additional, Müller, Thomas, additional, Kühn, Thorsten, additional, Heil, Jörg, additional, Ataseven, Beyhan, additional, Reitsamer, Roland, additional, Hildebrandt, Guido, additional, Knauer, Michael, additional, Golatta, Michael, additional, Stefek, Andrea, additional, Zahm, Dirk-Michael, additional, Thill, Marc, additional, Nekljudova, Valentina, additional, Krug, David, additional, Seither, Fenja, additional, Loibl, Sibylle, additional, and Reimer, Toralf, additional

Published
2022
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34. Abstract PD2-04: Molecular plasticity of luminal breast cancer and response to CDK 4/6 inhibition - The biomarker program of the PENELOPE-B trial investigating post-neoadjuvant palbociclib

Author

Denkert, Carsten, primary, Marmé, Frederik, additional, Martin, Miguel, additional, Untch, Michael, additional, Bonnefoi, Hervé, additional, Kim, Sung-Bae, additional, Bear, Harry, additional, Witkiewicz, Agnieszka, additional, Im, Seock-Ah, additional, DeMichele, Angela, additional, Van’t Veer, Laura, additional, McCarthy, Nicole, additional, Stiewe, Thorsten, additional, Gelmon, Karen A., additional, García-Sáenz, José A., additional, Kelly, Catherine M., additional, Reimer, Toralf, additional, Knudsen, Erik, additional, Turner, Nicholas, additional, Rojo, Federico, additional, Fasching, Peter A., additional, Teply-Szymanski, Julia, additional, Liu, Yuan, additional, Toi, Masakazu, additional, Rugo, Hope S., additional, Gnant, Michael, additional, Makris, Andreas, additional, Felder, Bärbel, additional, Weber, Karsten, additional, and Loibl, Sibylle, additional

Published
2022
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35. Abstract OT1-02-01: Phase III postneoadjuvant study evaluating sacituzumab govitecan (SG), an antibody drug conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA

Author

Marmé, Frederik, primary, Schmidt, Marcus, additional, Furlanetto, Jenny, additional, Denkert, Carsten, additional, Goncalves, Anthony, additional, Stickeler, Elmar, additional, Reinisch, Mattea, additional, Antolín, Silvia, additional, Reimer, Toralf, additional, Janni, Wolfgang, additional, Aftimos, Philippe, additional, Untch, Michael, additional, Michel, Laura, additional, Balic, Marija, additional, Sinn, Bruno, additional, Möbus, Volker, additional, Morris, Patrick, additional, Schöllhorn, Laura, additional, Schmatloch, Sabine, additional, Rey, Julia, additional, and Loibl, Sibylle, additional

Published
2022
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36. Abstract P1-18-15: Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) locally advanced or metastatic breast cancer: Fourth interim analysis from the RIBANNA study

Author

Lüftner, Diana, primary, Brucker, Cosima, additional, Decker, Thomas, additional, Fasching, Peter, additional, Göhler, Thomas, additional, Jackisch, Christian, additional, Janssen, Jan, additional, Köhler, Andreas, additional, Lüdtke-Heckenkamp, Kerstin, additional, van Mackelenbergh, Marion, additional, Marmé, Frederik, additional, Nusch, Arnd, additional, Rautenberg, Beate, additional, Reimer, Toralf, additional, Schmidt, Marcus, additional, Weide, Rudolf, additional, Wimberger, Pauline, additional, Nabieva, Naiba, additional, Roos, Christian, additional, and Wöckel, Achim, additional

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

Author

Ditsch, Nina, primary, Wöcke, Achim, additional, Untch, Michael, additional, Jackisch, Christian, additional, Albert, Ute-Susann, additional, Banys-Paluchowski, Maggie, additional, Bauerfeind, Ingo, additional, Blohmer, Jens-Uwe, additional, Budach, Wilfried, additional, Dall, Peter, additional, Fallenberg, Eva Maria, additional, Fasching, Peter A., additional, Fehm, Tanja N., additional, Friedrich, Michael, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Harbeck, Nadia, additional, Heil, Jörg, additional, Huober, Jens, additional, Kreipe, Hans H., additional, Krug, David, additional, Kühn, Thorsten, additional, Kümmel, Sherko, additional, Kolberg-Liedtke, Cornelia, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Mundhenke, Christoph, additional, Nitz, Ulrike, additional, Park-Simon, Tjoung-Won, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans-Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Witzel, Isabell, additional, Müller, Volkmar, additional, Janni, Wolfgang, additional, and Thill, Marc, additional

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

Author

Thill, Marc, primary, Lüftner, Diana, additional, Kolberg-Liedtke, Cornelia, additional, Albert, Ute-Susann, additional, Banys-Paluchowski, Maggie, additional, Bauerfeind, Ingo, additional, Blohmer, Jens-Uwe, additional, Budach, Wilfried, additional, Dall, Peter, additional, Fallenberg, Eva Maria, additional, Fasching, Peter A., additional, Fehm, Tanja, additional, Friedrich, Michael, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Harbeck, Nadia, additional, Heil, Jörg, additional, Huober, Jens, additional, Jackisch, Christian, additional, Kreipe, Hans-Heinrich, additional, Krug, David, additional, Kühn, Thorsten, additional, Kümmel, Sherko, additional, Loibl, Sibylle, additional, Lux, Michael, additional, Maass, Nicolai, additional, Mundhenke, Christoph, additional, Nitz, Ulrike, additional, Park-Simon, Tjoung-Won, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans-Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, Wöckel, Achim, additional, Müller, Volkmar, additional, Janni, Wolfgang, additional, and Ditsch, Nina, additional

Published
2022
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39. Expert Discussion: Ductal Carcinoma in situ

Author

Dall, Peter, primary, Heil, Jörg, additional, Banys-Paluchowski, Maggie, additional, Krug, David, additional, Budach, Wilfried, additional, Kolberg-Liedtke, Cornelia, additional, and Reimer, Toralf, additional

Published
2021
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41. AGO Recommendations for the Surgical Therapy of the Axilla After Neoadjuvant Chemotherapy: 2021 Update

Author

Friedrich, Michael, additional, Kühn, Thorsten, additional, Janni, Wolfgang, additional, Müller, Volkmar, additional, Banys-Paluchowski, Maggie, additional, Kolberg-Liedtke, Cornelia, additional, Jackisch, Christian, additional, Krug, David, additional, Albert, Ute-Susann, additional, Bauerfeind, Ingo, additional, Blohmer, Jens, additional, Budach, Wilfried, additional, Dall, Peter, additional, Fallenberg, Eva M., additional, Fasching, Peter A., additional, Fehm, Tanja, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Hanf, Volker, additional, Harbeck, Nadia, additional, Heil, Jörg, additional, Huober, Jens, additional, Kreipe, Hans-Heinrich, additional, Kümmel, Sherko, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Möbus, Volker, additional, Mundhenke, Christoph, additional, Nitz, Ulrike, additional, Park-Simon, Tjoung-Won, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans-Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, Wöckel, Achim, additional, Thill, Marc, additional, and Ditsch, Nina, additional

Published
2021
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42. Correction: AGO Recommendations for the Surgical Therapy of the Axilla After Neoadjuvant Chemotherapy: 2021 Update

Author

Friedrich, Michael, additional, Kühn, Thorsten, additional, Janni, Wolfgang, additional, Müller, Volkmar, additional, Banys-Paluchowski, Maggie, additional, Kolberg-Liedtke, Cornelia, additional, Jackisch, Christian, additional, Krug, David, additional, Albert, Ute-Susann, additional, Bauerfeind, Ingo, additional, Blohmer, Jens, additional, Budach, Wilfried, additional, Dall, Peter, additional, Fallenberg, Eva M., additional, Fasching, Peter A., additional, Fehm, Tanja, additional, Gerber, Bernd, additional, Gluz, Oleg, additional, Hanf, Volker, additional, Harbeck, Nadia, additional, Heil, Jörg, additional, Huober, Jens, additional, Kreipe, Hans-Heinrich, additional, Kümmel, Sherko, additional, Loibl, Sibylle, additional, Lüftner, Diana, additional, Lux, Michael Patrick, additional, Maass, Nicolai, additional, Möbus, Volker, additional, Mundhenke, Christoph, additional, Nitz, Ulrike, additional, Park-Simon, Tjoung-Won, additional, Reimer, Toralf, additional, Rhiem, Kerstin, additional, Rody, Achim, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schütz, Florian, additional, Sinn, Hans-Peter, additional, Solbach, Christine, additional, Solomayer, Erich-Franz, additional, Stickeler, Elmar, additional, Thomssen, Christoph, additional, Untch, Michael, additional, Witzel, Isabell, additional, Wöckel, Achim, additional, Thill, Marc, additional, and Ditsch, Nina, additional

Published
2021
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44. Primary Therapy of Early Breast Cancer: Evidence, Controversies, Consensus

Author

Untch, Michael, Thomssen, Christoph, Bauerfeind, Ingo, Braun, Michael, Brucker, Sara Y., Felberbaum, Ricardo, Hagemann, Friederike, Haidinger, Renate, Hönig, Arnd, Huober, Jens, Jackisch, Christian, Kolberg, Hans-Christian, Kolberg-Liedtke, Cornelia, Kühn, Thorsten, Lüftner, Diana, Maass, Nicolai, Reimer, Toralf, Schneeweiss, Andreas, Schumacher-Wulf, Eva, Schütz, Florian, Thill, Marc, Wuerstlein, Rachel, Fasching, Peter A., and Harbeck, Nadia

Subjects
neoadjuvant treatment, axilla, lokoregionäre Therapie, Systemtherapie, St.-Gallen-Konsensus 2019, St. Gallen consensus 2019, locoregional therapy, Review/Übersicht, GebFra Science, early breast cancer, neoadjuvante Therapie, frühes Mammakarzinom, systemic therapy
Abstract

The results of the international St. Gallen Consensus Conference for the treatment of patients with primary breast cancer were discussed this year by a working group of leading breast cancer experts in view of the therapy recommendations for everyday clinical practice in Germany. Three of the breast cancer experts are also members of this year's St. Gallen panel. The comparison of the St. Gallen recommendations with the annually updated treatment recommendations of the AGO 2019 as well as the S3 guideline is useful, since the recommendations of the St. Gallen panel represent the opinions of experts from various countries and disciplines. The recommendations of the S3 guideline and AGO are based on evidence-based research of the literature. This year's 16th St. Gallen conference featured the motto "Magnitude of clinical benefit". In addition to the evidence-based data, each therapeutic decision must also undergo a benefit/risk assessment of the patient's individual situation and be discussed with the patient.

Published
2019

46. Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer : Third interim analysis from the RIBANNA study

Author

Wöckel, Achim, Brucker, Cosima, Decker, Thomas, Falbrede, Jörg, Forstbauer, Helmut, Göhler, Thomas, Hoffmann, Oliver, Jackisch, Christian, Janssen, Jan, Köhler, Andreas, Lüdtke-Heckenkamp, Kerstin, Lüftner, Diana, Marmé, Frederik, Nusch, Arnd, Reimer, Toralf, Roos, Christian, Schmidt, Marcus, Weide, Rudolf, and Fasching, Peter

Subjects
Medizin, ComputingMethodologies_GENERAL
Abstract

Poster-Abstract

Published
2021

47. 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

48. 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

49. AGO Recommendations for the Surgical Therapy of the Axilla After Neoadjuvant Chemotherapy: 2021 Update

Author

Friedrich, Michael, Kuehn, Thorsten, Janni, Wolfgang, Mueller, Volkmar, Banys-Pachulowski, Maggie, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Albert, Ute-Susann, Bauerfeind, Ingo, Blohmer, Jens, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans-Heinrich, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Moebus, Volker, 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, Thill, Marc, Ditsch, Nina, Friedrich, Michael, Kuehn, Thorsten, Janni, Wolfgang, Mueller, Volkmar, Banys-Pachulowski, Maggie, Kolberg-Liedtke, Cornelia, Jackisch, Christian, Krug, David, Albert, Ute-Susann, Bauerfeind, Ingo, Blohmer, Jens, Budach, Wilfried, Dall, Peter, Fallenberg, Eva M., Fasching, Peter A., Fehm, Tanja, Gerber, Bernd, Gluz, Oleg, Hanf, Volker, Harbeck, Nadia, Heil, Joerg, Huober, Jens, Kreipe, Hans-Heinrich, Kuemmel, Sherko, Loibl, Sibylle, Lueftner, Diana, Lux, Michael Patrick, Maass, Nicolai, Moebus, Volker, 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, Thill, Marc, and Ditsch, Nina

Abstract

For many decades, the standard procedure to treat breast cancer included complete dissection of the axillary lymph nodes. The aim was to determine histological node status, which was then used as the basis for adjuvant therapy, and to ensure locoregional tumour control. In addition to the debate on how to optimise the therapeutic strategies of systemic treatment and radiotherapy, the current discussion focuses on improving surgical procedures to treat breast cancer. As neoadjuvant chemotherapy is becoming increasingly important, the surgical procedures used to treat breast cancer, whether they are breast surgery or axillary dissection, are changing. Based on the currently available data, carrying out SLNE prior to neoadjuvant chemotherapy is not recommended. In contrast, surgical axillary management after neoadjuvant chemotherapy is considered the procedure of choice for axillary staging and can range from SLNE to TAD and ALND. To reduce the rate of false negatives during surgical staging of the axilla in pN+(CNB) stage before NACT and ycN0 after NACT, targeted axillary dissection (TAD), the removal of > 2 SLNs (SLNE, no untargeted axillary sampling), immunohistochemistry to detect isolated tumour cells and micro-metastases, and marking positive lymph nodes before NACT should be the standard approach. This most recent update on surgical axillary management describes the significance of isolated tumour cells and micro-metastasis after neoadjuvant chemotherapy and the clinical consequences of low volume residual disease diagnosed using SLNE and TAD and provides an overview of this year's AGO recommendations for surgical management of the axilla during primary surgery and in relation to neoadjuvant chemotherapy.

Published
2021

50. 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

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