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3. Radiotherapy statements of the 18th St. Gallen International Breast Cancer Consensus Conference—a German expert perspective

Author

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

Published
2024
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4. On-treatment biopsies to predict response to neoadjuvant chemotherapy for breast cancer

Author

Bruno Valentin Sinn, Katharina Sychra, Michael Untch, Thomas Karn, Marion van Mackelenbergh, Jens Huober, Wolfgang Schmitt, Frederik Marmé, Christian Schem, Christine Solbach, Elmar Stickeler, Hans Tesch, Peter A. Fasching, Andreas Schneeweiss, Volkmar Müller, Johannes Holtschmidt, Valentina Nekljudova, Sibylle Loibl, and Carsten Denkert

Subjects
Breast cancer, Neoadjuvant therapy, Serial biopsies, TILs, Ki-67, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Patients with pathologic complete response (pCR) to neoadjuvant chemotherapy for invasive breast cancer (BC) have better outcomes, potentially warranting less extensive surgical and systemic treatments. Early prediction of treatment response could aid in adapting therapies. Methods On-treatment biopsies from 297 patients with invasive BC in three randomized, prospective neoadjuvant trials were assessed (GeparQuattro, GeparQuinto, GeparSixto). BC quantity, tumor-infiltrating lymphocytes (TILs), and the proliferation marker Ki-67 were compared to pre-treatment samples. The study investigated the correlation between residual cancer, changes in Ki-67 and TILs, and their impact on pathologic complete response (pCR) and disease-free survival (DFS). Results Among the 297 samples, 138 (46%) were hormone receptor-positive (HR+)/human epidermal growth factor 2-negative (HER2−), 87 (29%) were triple-negative (TNBC), and 72 (24%) were HER2+. Invasive tumor cells were found in 70% of on-treatment biopsies, with varying rates across subtypes (HR+/HER2−: 84%, TNBC: 62%, HER2+: 51%; p

Published
2024
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5. Expert Consensus Practice Recommendations of the North American Neuroendocrine Tumor Society for the management of high grade gastroenteropancreatic and gynecologic neuroendocrine neoplasms.

Author

Eads, Jennifer, Halfdanarson, Thorvardur, Asmis, Tim, Bellizzi, Andrew, Bergsland, Emily, Dasari, Arvind, El-Haddad, Ghassan, Frumovitz, Michael, Meyer, Joshua, Mittra, Erik, Myrehaug, Sten, Nakakura, Eric, Raj, Nitya, Soares, Heloisa, Untch, Brian, Vijayvergia, Namrata, and Chan, Jennifer

Subjects
high-grade, neuroendocrine carcinoma, neuroendocrine tumors, recommendations, Humans, Female, Neuroendocrine Tumors, Consensus, Neoplasm Grading, Carcinoma, Neuroendocrine, North America, Pancreatic Neoplasms
Abstract

High-grade neuroendocrine neoplasms are a rare disease entity and account for approximately 10% of all neuroendocrine neoplasms. Because of their rarity, there is an overall lack of prospectively collected data available to advise practitioners as to how best to manage these patients. As a result, best practices are largely based on expert opinion. Recently, a distinction was made between well-differentiated high-grade (G3) neuroendocrine tumors and poorly differentiated neuroendocrine carcinomas, and with this, pathologic details, appropriate imaging practices and treatment have become more complex. In an effort to provide practitioners with the best guidance for the management of patients with high-grade neuroendocrine neoplasms of the gastrointestinal tract, pancreas, and gynecologic system, the North American Neuroendocrine Tumor Society convened a panel of experts to develop a set of recommendations and a treatment algorithm that may be used by practitioners for the care of these patients. Here, we provide consensus recommendations from the panel on pathology, imaging practices, management of localized disease, management of metastatic disease and surveillance and draw key distinctions as to the approach that should be utilized in patients with well-differentiated G3 neuroendocrine tumors vs poorly differentiated neuroendocrine carcinomas.

Published
2023

6. On-treatment biopsies to predict response to neoadjuvant chemotherapy for breast cancer

Author

Sinn, Bruno Valentin, Sychra, Katharina, Untch, Michael, Karn, Thomas, van Mackelenbergh, Marion, Huober, Jens, Schmitt, Wolfgang, Marmé, Frederik, Schem, Christian, Solbach, Christine, Stickeler, Elmar, Tesch, Hans, Fasching, Peter A., Schneeweiss, Andreas, Müller, Volkmar, Holtschmidt, Johannes, Nekljudova, Valentina, Loibl, Sibylle, and Denkert, Carsten

Published
2024
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7. GAIN2 trial overall survival with intense versus tailored dose dense chemotherapy in early breast cancer

Author

Möbus, Volker, Lück, Hans-Joachim, Ladda, Ekkehart, Klare, Peter, Engels, Knut, Schmidt, Marcus, Schneeweiss, Andreas, Grischke, Eva-Maria, Wachsmann, Grischa, Forstbauer, Helmut, Untch, Michael, Marmé, Frederik, Blohmer, Jens-Uwe, Jackisch, Christian, Huober, Jens, Stickeler, Elmar, Reinisch, Mattea, Link, Theresa, Sinn, Bruno, Janni, Wolfgang, Denkert, Carsten, Seiler, Sabine, Solbach, Christine, Schmatloch, Sabine, Rey, Julia, and Loibl, Sibylle

Published
2024
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8. Susceptibility gene mutations in germline and tumors of patients with HER2-negative advanced breast cancer

Author

Fasching, Peter A., Hu, Chunling, Hart, Steven N., Ruebner, Matthias, Polley, Eric C., Gnanaolivu, Rohan D., Hartkopf, Andreas D., Huebner, Hanna, Janni, Wolfgang, Hadji, Peyman, Tesch, Hans, Uhrig, Sabrina, Ettl, Johannes, Lux, Michael P., Lüftner, Diana, Wallwiener, Markus, Wurmthaler, Lena A., Goossens, Chloë, Müller, Volkmar, Beckmann, Matthias W., Hein, Alexander, Anetsberger, Daniel, Belleville, Erik, Wimberger, Pauline, Untch, Michael, Ekici, Arif B., Kolberg, Hans-Christian, Hartmann, Arndt, Taran, Florin-Andrei, Fehm, Tanja N., Wallwiener, Diethelm, Brucker, Sara Y., Schneeweiss, Andreas, Häberle, Lothar, and Couch, Fergus J.

Published
2024
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9. Author Correction: Proteogenomic analysis reveals RNA as a source for tumor-agnostic neoantigen identification

Author

Tretter, Celina, de Andrade Krätzig, Niklas, Pecoraro, Matteo, Lange, Sebastian, Seifert, Philipp, von Frankenberg, Clara, Untch, Johannes, Zuleger, Gabriela, Wilhelm, Mathias, Zolg, Daniel P., Dreyer, Florian S., Bräunlein, Eva, Engleitner, Thomas, Uhrig, Sebastian, Boxberg, Melanie, Steiger, Katja, Slotta-Huspenina, Julia, Ochsenreither, Sebastian, von Bubnoff, Nikolas, Bauer, Sebastian, Boerries, Melanie, Jost, Philipp J., Schenck, Kristina, Dresing, Iska, Bassermann, Florian, Friess, Helmut, Reim, Daniel, Grützmann, Konrad, Pfütze, Katrin, Klink, Barbara, Schröck, Evelin, Haller, Bernhard, Kuster, Bernhard, Mann, Matthias, Weichert, Wilko, Fröhling, Stefan, Rad, Roland, Hiltensperger, Michael, and Krackhardt, Angela M.

Published
2024
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11. GAIN2 trial overall survival with intense versus tailored dose dense chemotherapy in early breast cancer

Author

Volker Möbus, Hans-Joachim Lück, Ekkehart Ladda, Peter Klare, Knut Engels, Marcus Schmidt, Andreas Schneeweiss, Eva-Maria Grischke, Grischa Wachsmann, Helmut Forstbauer, Michael Untch, Frederik Marmé, Jens-Uwe Blohmer, Christian Jackisch, Jens Huober, Elmar Stickeler, Mattea Reinisch, Theresa Link, Bruno Sinn, Wolfgang Janni, Carsten Denkert, Sabine Seiler, Christine Solbach, Sabine Schmatloch, Julia Rey, and Sibylle Loibl

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract GAIN-2 trial evaluated the optimal intense dose-dense (idd) strategy for high-risk early breast cancer. This study reports the secondary endpoints pathological complete response (pCR) and overall survival (OS). Patients (n = 2887) were randomized 1:1 between idd epirubicin, nab-paclitaxel, and cyclophosphamide (iddEnPC) versus leukocyte nadir-based tailored regimen of dose-dense EC and docetaxel (dtEC-dtD) as adjuvant therapy, with neoadjuvant therapy allowed after amendment. At median follow-up of 6.5 years (overall cohort) and 5.7 years (neoadjuvant cohort, N = 593), both regimens showed comparable 5-year OS rates (iddEnPC 90.8%, dtEC-dtD 90.0%, p = 0.320). In the neoadjuvant setting, iddEnPC yielded a higher pCR rate than dtEC-dtD (51.2% vs. 42.6%, p = 0.045). Patients achieving pCR had significantly improved 5-year iDFS (88.7% vs. 70.1%, HR 0.33, p

Published
2024
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12. Susceptibility gene mutations in germline and tumors of patients with HER2-negative advanced breast cancer

Author

Peter A. Fasching, Chunling Hu, Steven N. Hart, Matthias Ruebner, Eric C. Polley, Rohan D. Gnanaolivu, Andreas D. Hartkopf, Hanna Huebner, Wolfgang Janni, Peyman Hadji, Hans Tesch, Sabrina Uhrig, Johannes Ettl, Michael P. Lux, Diana Lüftner, Markus Wallwiener, Lena A. Wurmthaler, Chloë Goossens, Volkmar Müller, Matthias W. Beckmann, Alexander Hein, Daniel Anetsberger, Erik Belleville, Pauline Wimberger, Michael Untch, Arif B. Ekici, Hans-Christian Kolberg, Arndt Hartmann, Florin-Andrei Taran, Tanja N. Fehm, Diethelm Wallwiener, Sara Y. Brucker, Andreas Schneeweiss, Lothar Häberle, and Fergus J. Couch

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Germline mutations in BRCA1 and BRCA2 (gBRCA1/2) are required for a PARP inhibitor therapy in patients with HER2-negative (HER2−) advanced breast cancer (aBC). However, little is known about the prognostic impact of gBRCA1/2 mutations in aBC patients treated with chemotherapy. This study aimed to investigate the frequencies and prognosis of germline and somatic BRCA1/2 mutations in HER2- aBC patients receiving the first chemotherapy in the advanced setting. Patients receiving their first chemotherapy for HER2- aBC were retrospectively selected from the prospective PRAEGNANT registry (NCT02338167). Genotyping of 26 cancer predisposition genes was performed with germline DNA of 471 patients and somatic tumor DNA of 94 patients. Mutation frequencies, progression-free and overall survival (PFS, OS) according to germline mutation status were assessed. gBRCA1/2 mutations were present in 23 patients (4.9%), and 33 patients (7.0%) had mutations in other cancer risk genes. Patients with a gBRCA1/2 mutation had a better OS compared to non-mutation carriers (HR: 0.38; 95%CI: 0.17–0.86). PFS comparison was not statistically significant. Mutations in other risk genes did not affect prognosis. Two somatic BRCA2 mutations were found in 94 patients without gBRCA1/2 mutations. Most frequently somatic mutated genes were TP53 (44.7%), CDH1 (10.6%) and PTEN (6.4%). In conclusion, aBC patients with gBRCA1/2 mutations had a more favorable prognosis under chemotherapy compared to non-mutation carriers. The mutation frequency of ~5% with gBRCA1/2 mutations together with improved outcome indicates that germline genotyping of all metastatic patients for whom a PARP inhibitor therapy is indicated should be considered.

Published
2024
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15. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer

Author

Rugo, HS, Bianchini, G, Cortes, J, Henning, J-W, and Untch, M

Subjects
Clinical Trials and Supportive Activities, Breast Cancer, Patient Safety, Clinical Research, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Alopecia, Antibodies, Monoclonal, Humanized, Breast Neoplasms, Camptothecin, Fatigue, Female, Humans, Immunoconjugates, Lung Diseases, Interstitial, Nausea, Neutropenia, Trastuzumab, Ventricular Dysfunction, Left, Vomiting, trastuzumab deruxtecan, adverse event, breast cancer, nausea, vomiting, interstitial lung disease
Abstract

IntroductionThe antibody-drug conjugate trastuzumab deruxtecan (T-DXd) targets human epidermal growth factor receptor 2 (HER2) and has been evaluated in patients with HER2-positive unresectable/metastatic breast cancer in the phase II DESTINY-Breast01 trial (NCT03248492; DS8201-A-U201) and the randomized phase III DESTINY-Breast03 trial (NCT03529110; DS8201-A-U302). Approximately 20 additional studies are ongoing in breast cancer, including HER2-low breast cancer, and other solid tumor types within the DESTINY trial program. T-DXd has demonstrated a generally manageable safety profile, with low-grade hematologic and gastrointestinal adverse events (AEs) among the most common; interstitial lung disease (ILD)/pneumonitis has been observed in patients receiving T-DXd and can be severe. This review discusses the management of common AEs and AEs of special interest in patients with HER2-positive unresectable/metastatic breast cancer, including nausea and vomiting, neutropenia, infusion-related reactions, alopecia, fatigue, ILD/pneumonitis, and left ventricular dysfunction.MethodsExpert opinions, institutional protocols, and strategies to help optimize AE management and maximize the potential benefits of T-DXd in patients with breast cancer from five oncologists treating patients with T-DXd in North America and Europe are discussed.ResultsProphylaxis for nausea and vomiting and proactive management of ILD/pneumonitis are especially important in treating patients with T-DXd. Management strategies for other T-DXd-related AEs of interest (e.g. neutropenia, infusion-related reactions, alopecia, fatigue, and left ventricular dysfunction) are also discussed.ConclusionsThis review provides context for understanding the usage, monitoring, and management practices of other health care providers and institutions with experience using T-DXd to help with safe and effective management of T-DXd-related AEs, particularly since the duration of T-DXd treatment may be quite long. Proper management of T-DXd-related AEs will allow optimal exposure and benefit from T-DXd and will help avoid premature discontinuation or improper dose reductions.

Published
2022

18. Palbociclib combined with endocrine treatment in hormone receptor-positive, HER2-negative breast cancer patients with high relapse risk after neoadjuvant chemotherapy: subgroup analyses of premenopausal patients in PENELOPE-B

Author

Marmé, F., Martin, M., Untch, M., Thode, C., Bonnefoi, H., Kim, S.-B., Bear, H., Mc Carthy, N., Gelmon, K., García-Sáenz, J.A., Kelly, C.M., Reimer, T., Valota, O., Toi, M., Rugo, H.S., Gnant, M., Makris, A., Bassy, M., Zhang, Z., Furlanetto, J., Nekljudova, V., and Loibl, S.

Published
2024
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19. Long-term outcomes of a randomized, open-label, phase II study comparing cabazitaxel versus paclitaxel as neoadjuvant treatment in patients with triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)

Author

Meyer-Wilmes, P., Huober, J., Untch, M., Blohmer, J.-U., Janni, W., Denkert, C., Klare, P., Link, T., Rhiem, K., Bayer, C., Reinisch, M., Bjelic-Radisic, V., Zahm, D.M., Hanusch, C., Solbach, C., Heinrich, G., Hartkopf, A.D., Schneeweiss, A., Fasching, P., Filmann, N., Nekljudova, V., Holtschmidt, J., Stickeler, E., and Loibl, S.

Published
2024
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22. Proteogenomic analysis reveals RNA as a source for tumor-agnostic neoantigen identification

Author

Tretter, Celina, de Andrade Krätzig, Niklas, Pecoraro, Matteo, Lange, Sebastian, Seifert, Philipp, von Frankenberg, Clara, Untch, Johannes, Zuleger, Gabriela, Wilhelm, Mathias, Zolg, Daniel P., Dreyer, Florian S., Bräunlein, Eva, Engleitner, Thomas, Uhrig, Sebastian, Boxberg, Melanie, Steiger, Katja, Slotta-Huspenina, Julia, Ochsenreither, Sebastian, von Bubnoff, Nikolas, Bauer, Sebastian, Boerries, Melanie, Jost, Philipp J., Schenck, Kristina, Dresing, Iska, Bassermann, Florian, Friess, Helmut, Reim, Daniel, Grützmann, Konrad, Pfütze, Katrin, Klink, Barbara, Schröck, Evelin, Haller, Bernhard, Kuster, Bernhard, Mann, Matthias, Weichert, Wilko, Fröhling, Stefan, Rad, Roland, Hiltensperger, Michael, and Krackhardt, Angela M.

Published
2023
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23. Identifying breast cancer patients at risk of relapse despite pathological complete response after neoadjuvant therapy

Author

Huober, Jens, van Mackelenbergh, Marion, Schneeweiss, Andreas, Seither, Fenja, Blohmer, Jens-Uwe, Denkert, Carsten, Tesch, Hans, Hanusch, Claus, Salat, Christoph, Rhiem, Kerstin, Solbach, Christine, Fasching, Peter A., Jackisch, Christian, Reinisch, Mattea, Lederer, Bianca, Mehta, Keyur, Link, Theresa, Nekljudova, Valentina, Loibl, Sibylle, and Untch, Michael

Published
2023
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24. Baseline CD4+ and expansion of γδ T cells correlate with response to durvalumab in triple‐negative breast cancer patients

Author

Chiara Massa, Thomas Karn, Karsten Weber, Andreas Schneeweiss, Claus Hanusch, Jens Uwe Blohmer, Dirk‐Michael Zahm, Christian Jackisch, Marion van Mackelenbergh, Jörg Thomalla, Frederik Marmé, Jens Huober, Volkmar Müller, Christian Schem, Anja Müller, Elmar Stickeler, Katharina Biehl, Peter A. Fasching, Michael Untch, Sibylle Loibl, Carsten Denkert, and Barbara Seliger

Subjects
Medicine (General), R5-920
Published
2024
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25. Breast-conserving surgery is not associated with increased local recurrence in patients with early-stage node-negative triple-negative breast cancer treated with neoadjuvant chemotherapy

Author

David Krug, Valentina Vladimirova, Michael Untch, Thorsten Kühn, Andreas Schneeweiss, Carsten Denkert, Beyhan Ataseven, Christine Solbach, Bernd Gerber, Hans Tesch, Michael Golatta, Sabine Seiler, Jörg Heil, Valentina Nekljudova, Johannes Holtschmidt, and Sibylle Loibl

Subjects
Breast-conserving surgery, Local recurrence, Primary systemic therapy, Mastectomy, Molecular subtype, Previous presentation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Neoadjuvant chemotherapy (NACT) is routinely used for patients with triple-negative breast cancer (TNBC). Upfront breast-conserving therapy (BCT) consisting of breast-conserving surgery (BCS) and adjuvant radiotherapy (RT) has been shown to be associated with improved outcome in patients with early TNBC as compared to mastectomy. Methods: We identified 2632 patients with early TNBC from the German Breast Group meta-database. Patients with cT1-2 cN0 and ypN0, available surgery and follow-up data were enrolled. Data of 1074 patients from 8 prospective NACT trials were available. Endpoints of interest were locoregional recurrence as first site of relapse (LRR), disease-free survival (DFS) and overall survival (OS). We performed univariate and multivariate Fine-Gray analysis and Cox regression models. Results: After a median follow-up of 64 months, there were 94 (8.8%) locoregional events as first site of relapse. Absence of pathologic complete response (pCR) was associated with increased LRR upon uni- and multivariate analysis (hazard ratio [HR] = 2.28; p

Published
2024
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26. Proteogenomic analysis reveals RNA as a source for tumor-agnostic neoantigen identification

Author

Celina Tretter, Niklas de Andrade Krätzig, Matteo Pecoraro, Sebastian Lange, Philipp Seifert, Clara von Frankenberg, Johannes Untch, Gabriela Zuleger, Mathias Wilhelm, Daniel P. Zolg, Florian S. Dreyer, Eva Bräunlein, Thomas Engleitner, Sebastian Uhrig, Melanie Boxberg, Katja Steiger, Julia Slotta-Huspenina, Sebastian Ochsenreither, Nikolas von Bubnoff, Sebastian Bauer, Melanie Boerries, Philipp J. Jost, Kristina Schenck, Iska Dresing, Florian Bassermann, Helmut Friess, Daniel Reim, Konrad Grützmann, Katrin Pfütze, Barbara Klink, Evelin Schröck, Bernhard Haller, Bernhard Kuster, Matthias Mann, Wilko Weichert, Stefan Fröhling, Roland Rad, Michael Hiltensperger, and Angela M. Krackhardt

Subjects
Science
Abstract

Abstract Systemic pan-tumor analyses may reveal the significance of common features implicated in cancer immunogenicity and patient survival. Here, we provide a comprehensive multi-omics data set for 32 patients across 25 tumor types for proteogenomic-based discovery of neoantigens. By using an optimized computational approach, we discover a large number of tumor-specific and tumor-associated antigens. To create a pipeline for the identification of neoantigens in our cohort, we combine DNA and RNA sequencing with MS-based immunopeptidomics of tumor specimens, followed by the assessment of their immunogenicity and an in-depth validation process. We detect a broad variety of non-canonical HLA-binding peptides in the majority of patients demonstrating partially immunogenicity. Our validation process allows for the selection of 32 potential neoantigen candidates. The majority of neoantigen candidates originates from variants identified in the RNA data set, illustrating the relevance of RNA as a still understudied source of cancer antigens. This study underlines the importance of RNA-centered variant detection for the identification of shared biomarkers and potentially relevant neoantigen candidates.

Published
2023
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28. Breast-conserving surgery is not associated with increased local recurrence in patients with early-stage node-negative triple-negative breast cancer treated with neoadjuvant chemotherapy

Author

Krug, David, Vladimirova, Valentina, Untch, Michael, Kühn, Thorsten, Schneeweiss, Andreas, Denkert, Carsten, Ataseven, Beyhan, Solbach, Christine, Gerber, Bernd, Tesch, Hans, Golatta, Michael, Seiler, Sabine, Heil, Jörg, Nekljudova, Valentina, Holtschmidt, Johannes, and Loibl, Sibylle

Published
2024
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29. Patient-reported outcomes in high-risk HR+ /HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib within the randomized PENELOPEB study

Author

García-Sáenz, José Angel, Marmé, Frederik, Untch, Michael, Bonnefoi, Hervé, Kim, Sung-Bae, Bear, Harry, Mc Carthy, Nicole, Gelmon, Karen, Martin, Miguel, Kelly, Catherine M., Reimer, Toralf, Toi, Masakazu, Law, Ernest, Bhattacharyya, Helen, Gnant, Michael, Makris, Andreas, Seiler, Sabine, Burchardi, Nicole, Nekljudova, Valentina, Loibl, Sibylle, and Rugo, Hope S.

Published
2024
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30. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate – The ICE randomized clinical trial

Author

Schmidt, Marcus, Nitz, Ulrike, Reimer, Toralf, Schmatloch, Sabine, Graf, Heiko, Just, Marianne, Stickeler, Elmar, Untch, Michael, Runnebaum, Ingo, Belau, Antje, Huober, Jens, Jackisch, Christian, Hofmann, Manfred, Krocker, Jutta, Nekljudova, Valentina, and Loibl, Sibylle

Published
2023
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31. Identifying breast cancer patients at risk of relapse despite pathological complete response after neoadjuvant therapy

Author

Jens Huober, Marion van Mackelenbergh, Andreas Schneeweiss, Fenja Seither, Jens-Uwe Blohmer, Carsten Denkert, Hans Tesch, Claus Hanusch, Christoph Salat, Kerstin Rhiem, Christine Solbach, Peter A. Fasching, Christian Jackisch, Mattea Reinisch, Bianca Lederer, Keyur Mehta, Theresa Link, Valentina Nekljudova, Sibylle Loibl, and Michael Untch

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract This retrospective pooled analysis aims to identify factors predicting relapse despite a pathologic complete response (pCR) in patients with breast cancer (BC). 2066 patients with a pCR from five neoadjuvant GBG/AGO-B trials fulfill the inclusion criteria of this analysis. Primary endpoint is disease-free survival (DFS); secondary endpoints is distant DFS (DDFS) and overall survival (OS). After a median follow-up of 57.6 months, DFS is significantly worse for patients with positive lymph nodes (cN+ vs cN0 hazard ratio [HR] 1.94, 95%CI 1.48–2.54; p

Published
2023
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32. Return of individual genomic research results within the PRAEGNANT multicenter registry study

Author

Huebner, Hanna, Ruebner, Matthias, Kurbacher, Christian, Hadji, Peyman, Hartkopf, Andreas D., Lux, Michael P., Huober, Jens, Uhrig, Sabrina, Taran, Florin-Andrei, Overkamp, Friedrich, Tesch, Hans, Häberle, Lothar, Lüftner, Diana, Wallwiener, Markus, Müller, Volkmar, Beckmann, Matthias W., Hein, Alexander, Belleville, Erik, Untch, Michael, Janni, Wolfgang, Fehm, Tanja N., Kolberg, Hans-Christian, Wallwiener, Diethelm, Brucker, Sara Y., Schneeweiss, Andreas, Ettl, Johannes, Fasching, Peter A., and Michel, Laura L.

Published
2023
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33. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy—a sub-analysis of the ALTTO study

Author

Nader-Marta, Guilherme, Debien, Véronique, Eiger, Daniel, Tsourti, Zoi, Caparica, Rafael, Kassapian, Marie, Napoleone, Sylvia, Hultsch, Susanne, Korde, Larissa, Wang, Yingbo, Chumsri, Saranya, Pritchard, Kathleen I., Untch, Michael, Bellet-Ezquerra, Meritxell, Dornelles Rosa, Daniela, Moreno-Aspitia, Alvaro, Piccart, Martine, Dafni, Urania, and de Azambuja, Evandro

Published
2022
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34. Author Correction: Proteogenomic analysis reveals RNA as a source for tumor-agnostic neoantigen identification

Author

Celina Tretter, Niklas de Andrade Krätzig, Matteo Pecoraro, Sebastian Lange, Philipp Seifert, Clara von Frankenberg, Johannes Untch, Gabriela Zuleger, Mathias Wilhelm, Daniel P. Zolg, Florian S. Dreyer, Eva Bräunlein, Thomas Engleitner, Sebastian Uhrig, Melanie Boxberg, Katja Steiger, Julia Slotta-Huspenina, Sebastian Ochsenreither, Nikolas von Bubnoff, Sebastian Bauer, Melanie Boerries, Philipp J. Jost, Kristina Schenck, Iska Dresing, Florian Bassermann, Helmut Friess, Daniel Reim, Konrad Grützmann, Katrin Pfütze, Barbara Klink, Evelin Schröck, Bernhard Haller, Bernhard Kuster, Matthias Mann, Wilko Weichert, Stefan Fröhling, Roland Rad, Michael Hiltensperger, and Angela M. Krackhardt

Subjects
Science
Published
2024
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35. Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer – A single-arm phase II trial (NeoImmunoboost, AGO-B-041)

Author

Fasching, Peter A., Hein, Alexander, Kolberg, Hans-Christian, Häberle, Lothar, Uhrig, Sabrina, Rübner, Matthias, Belleville, Erik, Hack, Carolin C., Fehm, Tanja N., Janni, Wolfang, Hartmann, Arndt, Erber, Ramona, Theuser, Anna-Katharin, Brucker, Sara Y., Hartkopf, Andreas D., and Untch, Michael

Published
2023
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36. 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

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

Subjects
Breast cancer, Trastuzumab subcutaneous, patients' preference, Pharmacokinetic, Thigh or abdominal wall, Safety, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Trastuzumab given intravenously in combination with chemotherapy is standard of care for patients with early HER2-positive breast cancer (BC). Different randomised studies have shown equivalent efficacy of a subcutaneous injection into the thigh compared to the intravenous formulation. Other body regions for injection have not been investigated but might be more convenient for patients. Methods: After surgery, patients were randomised to receive either subcutaneous trastuzumab into the thigh or into the abdominal wall (AW). Patient preferences were evaluated using validated questionnaires (PINT). Primary objectives of this multicentre, non-blinded, randomised substudy of the GAIN-2 study were to investigate pharmacokinetics of the injection into the thigh versus AW and to determine patients' preferences of either administration site versus the previously received intravenous application. Results: 226 patients were randomised and 219 patients (thigh: N = 110; AW: N = 109) formed the modified intent-to-treat (mITT). Overall, 83.5% (out of N = 182 with information about patients’ preference) preferred subcutaneous over previous intravenous application or had no preference. Preference was similar between both administration sites (thigh: 80.6%; AW: 86.5; p = 0.322). Pharmacokinetic analysis included 30 patients. Geometric means of Cmax and AUC0-21d were higher in thigh than in AW group (geometric mean ratio with body weight adjustment: Cmax: 1.291, 90%-CI 1.052–1.584; AUC0-21d: 1.291, 90%-CI 1.026–1.626). Safety profile was in line with previous reports of subcutaneous trastuzumab. Conclusion: Subcutaneous trastuzumab into the thigh showed an approximately 30% higher bioavailability. Injections were well tolerated and preferred over intravenous administration. The subcutaneous injection into the thigh should remain the standard of care.

Published
2022
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38. Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE

Author

Sibylle Loibl, Chiun-Sheng Huang, Max S. Mano, Eleftherios P. Mamounas, Charles E. Geyer, Michael Untch, Jean-Christophe Thery, Ingo Schwaner, Steven Limentani, Niklas Loman, Kristina Lübbe, Jenny C. Chang, Thomas Hatschek, David Tesarowski, Chunyan Song, Sanne Lysbet de Haas, Thomas Boulet, Chiara Lambertini, and Norman Wolmark

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Following chemotherapy and human epidermal growth factor 2 (HER2)-targeted neoadjuvant therapy for HER2-positive early breast cancer, residual invasive breast cancer at surgery may be HER2-negative on retesting in some patients. We evaluated outcomes with T-DM1 and trastuzumab in patients randomized in the phase III KATHERINE trial based on HER2-positive central testing of the pre-treatment core biopsy with HER2-negative central testing on their corresponding surgical specimen after neoadjuvant treatment. In the 70/845 (8.3%) patients with HER2-negative residual disease on retesting at surgery, there were 11 IDFS events in the 42 trastuzumab-treated patients (26.2%) and none in the 28 T-DM1-treated patients, suggesting that T-DM1 should not be withheld in this patient population.

Published
2022
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39. An analysis of PIK3CA hotspot mutations and response to neoadjuvant therapy in breast cancer patients from four prospective clinical trials

Author

Jank, Paul, primary, Karn, Thomas, additional, van Mackelenbergh, Marion, additional, Lindner, Judith, additional, Treue, Denise, additional, Huober, Jens, additional, Engels, Knut, additional, Solbach, Christine, additional, Diebold, Kurt, additional, Marme, Frederik, additional, Müller, Volkmar, additional, Schneeweiss, Andreas, additional, Sinn, Hans-Peter, additional, Fehm, Tanja, additional, Schem, Christian, additional, Stickeler, Elmar, additional, Fasching, Peter A., additional, Budczies, Jan, additional, Felder, Bärbel, additional, Nekljudova, Valentina, additional, Holtschmidt, Johannes, additional, Untch, Michael, additional, Denkert, Carsten, additional, and Loibl, Sibylle, additional

Published
2024
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40. Relationship of adaptive subtyping and tumour heterogeneity of treatment response to neoadjuvant therapy in hormone receptor–positive HER2-negative early breast cancer: PENELOPE-B.

Author

Denkert, Carsten, primary, Rachakonda, Krishna, additional, Filipits, Martin, additional, Weber, Karsten, additional, Marmé, Frederik, additional, Untch, Michael, additional, Witkiewicz, Agnieszka K, additional, Im, Seock-Ah, additional, DeMichele, Angela, additional, Pehl, Anika, additional, van 't Veer, Laura, additional, Jank, Paul, additional, Schem, Christian, additional, Fasching, Peter A., additional, Reimer, Toralf, additional, Knudsen, Erik S., additional, Liu, Yuan, additional, Rojo Todo, Federico Gustavo, additional, Turner, Nicholas C., additional, and Loibl, Sibylle, additional

Published
2024
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42. Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC): NATALEE trial.

Author

Yardley, Denise A., primary, Untch, Michael, additional, Barrios, Carlos H., additional, Bardia, Aditya, additional, Kalinsky, Kevin, additional, Im, Seock-Ah, additional, Chia, Stephen K. L., additional, Ring, Alistair E., additional, McAndrew, Nicholas Patrick, additional, Valero, Vicente, additional, Ruiz-Borrego, Manuel, additional, Fresco, Rodrigo, additional, Sum, Eleanor, additional, Chattar, Yogesh, additional, Waters, Sorcha, additional, and Harbeck, Nadia, additional

Published
2024
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43. Update Breast Cancer 2024 Part 1 – Expert Opinion on Advanced Breast Cancer

Author

Würstlein, Rachel, additional, Kolberg, Hans-Christian, additional, Hartkopf, Andreas D., additional, Fehm, Tanja N., additional, Welslau, Manfred, additional, Schütz, Florian, additional, Fasching, Peter A., additional, Janni, Wolfgang, additional, Witzel, Isabell, additional, Thomssen, Christoph, additional, Krückel, Annika, additional, Belleville, Erik, additional, Lüftner, Diana, additional, Untch, Michael, additional, Thill, Marc, additional, Hörner, Manuel, additional, Tesch, Hans, additional, Ditsch, Nina, additional, Lux, Michael P., additional, Aktas, Bahriye, additional, Banys-Paluchowski, Maggie, additional, Taran, Florin-Andrei, additional, Wöckel, Achim, additional, Harbeck, Nadia, additional, Stickeler, Elmar, additional, Bartsch, Rupert, additional, Schneeweiss, Andreas, additional, Ettl, Johannes, additional, Krug, David, additional, and Müller, Volkmar, additional

Published
2024
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44. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy endocrine therapy alone in patients with HR+/HER2− early breast cancer

Author

Dennis J. Slamon, Peter A. Fasching, Sara Hurvitz, Stephen Chia, John Crown, Miguel Martín, Carlos H. Barrios, Aditya Bardia, Seock-Ah Im, Denise A. Yardley, Michael Untch, Chiun-Sheng Huang, Daniil Stroyakovskiy, Binghe Xu, Rebecca L. Moroose, Sherene Loi, Frances Visco, Valerie Bee-Munteanu, Karen Afenjar, Rodrigo Fresco, Tetiana Taran, Arunava Chakravartty, Juan Pablo Zarate, Agnes Lteif, and Gabriel N. Hortobagyi

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer. New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET) versus ET alone in patients with HR+/HER2− early nonmetastatic breast cancer (EBC). Methods/design: NATALEE is a multicenter, randomized, open-label, Phase III trial in patients with HR+/HER2− EBC. Eligible patients include women, regardless of menopausal status, and men aged ⩾18 years. Select patients with stage IIA, stage IIB, or stage III disease (per the anatomic classification in the AJCC Cancer Staging Manual , 8th edition) with an initial diagnosis ⩽18 months prior to randomization are eligible. Patients receiving standard (neo)adjuvant ET are eligible if treatment was initiated ⩽12 months before randomization. Patients undergo 1:1 randomization to ribociclib 400 mg/day (3 weeks on/1 week off) +ET (letrozole 2.5 mg/day or anastrozole 1 mg/day [investigator’s discretion] plus goserelin [men or premenopausal women]) or ET alone. Ribociclib treatment duration is 36 months; ET treatment duration is ⩾60 months. The primary end point is invasive disease-free survival. Discussion: The 36-month treatment duration of ribociclib in NATALEE is extended compared with that in other adjuvant cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor trials and is intended to maximize efficacy due to longer duration of CDK4/6 inhibition. Compared with the 600-mg/day dose used in advanced breast cancer, the reduced ribociclib dose used in NATALEE may improve tolerability while maintaining efficacy. NATALEE includes the broadest population of patients with HR+/HER2− EBC of any Phase III trial currently evaluating adjuvant CDK4/6 inhibitor treatment. Trial registration: ClinicalTrials.gov identifier: NCT03701334 ( https://clinicaltrials.gov/ct2/show/NCT03701334 )

Published
2023
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45. CDK4/6 Inhibition – Therapy Sequences and the Quest to Find the Best Biomarkers – an Overview of Current Programs

Author

Schneeweiss, Andreas, additional, Brucker, Sara Y., additional, Huebner, Hanna, additional, Volmer, Lea L., additional, Hack, Carolin C., additional, Seitz, Katharina, additional, Ruebner, Matthias, additional, Heublein, Sabine, additional, Thewes, Verena, additional, Lüftner, Diana, additional, Lux, Michael P., additional, Jurhasz-Böss, Ingolf, additional, Taran, Florin-Andrei, additional, Wimberger, Pauline, additional, Anetsberger, Daniel, additional, Beierlein, Milena, additional, Schmidt, Marcus, additional, Radosa, Julia, additional, Müller, Volkmar, additional, Janni, Wolfgang, additional, Rack, Brigitte, additional, Belleville, Erik, additional, Untch, Michael, additional, Thill, Marc, additional, Ditsch, Nina, additional, Aktas, Bahriye, additional, Nel, Ivonne, additional, Kolberg, Hans-Christian, additional, Engerle, Tobias, additional, Tesch, Hans, additional, Roos, Christian, additional, Budden, Christina, additional, Neubauer, Hans, additional, Hartkopf, Andreas D., additional, Fehm, Tanja N., additional, and Fasching, Peter A., additional

Published
2024
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46. Discussion of ABC7 Consensus and German Recommendations

Author

Untch, Michael, additional, Ditsch, Nina, additional, Fasching, Peter A., additional, Busch, Steffi, additional, Ettl, Johannes, additional, Haidinger, Renate, additional, Harbeck, Nadia, additional, Jackisch, Christian, additional, Lüftner, Diana, additional, Müller, Lothar, additional, Ruckhäberle, Eugen, additional, Schumacher-Wulf, Eva, additional, Thomssen, Christoph, additional, Wuerstlein, Rachel, additional, and Müller, Volkmar, additional

Published
2024
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47. Attrition in the First Three Therapy Lines in Patients with Advanced Breast Cancer in the German Real-World PRAEGNANT Registry

Author

Hartkopf, Andreas D., primary, Walter, Christina B., primary, Kolberg, Hans-Christian, additional, Hadji, Peyman, additional, Tesch, Hans, additional, Fasching, Peter A., additional, Ettl, Johannes, additional, Lüftner, Diana, additional, Wallwiener, Markus, additional, Müller, Volkmar, additional, Beckmann, Matthias W., additional, Belleville, Erik, additional, Huebner, Hanna, additional, Uhrig, Sabrina, additional, Goossens, Chloë, additional, Link, Theresa, additional, Hielscher, Carsten, additional, Mundhenke, Christoph, additional, Kurbacher, Christian, additional, Wuerstlein, Rachel, additional, Untch, Michael, additional, Janni, Wolfgang, additional, Taran, Florin-Andrei, additional, Michel, Laura L., additional, Lux, Michael P., additional, Wallwiener, Diethelm, additional, Brucker, Sara Y., additional, Fehm, Tanja N., additional, Häberle, Lothar, additional, and Schneeweiss, Andreas, additional

Published
2024
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48. Clinical sequencing of soft tissue and bone sarcomas delineates diverse genomic landscapes and potential therapeutic targets

Author

Benjamin A. Nacev, Francisco Sanchez-Vega, Shaleigh A. Smith, Cristina R. Antonescu, Evan Rosenbaum, Hongyu Shi, Cerise Tang, Nicholas D. Socci, Satshil Rana, Rodrigo Gularte-Mérida, Ahmet Zehir, Mrinal M. Gounder, Timothy G. Bowler, Anisha Luthra, Bhumika Jadeja, Azusa Okada, Jonathan A. Strong, Jake Stoller, Jason E. Chan, Ping Chi, Sandra P. D’Angelo, Mark A. Dickson, Ciara M. Kelly, Mary Louise Keohan, Sujana Movva, Katherine Thornton, Paul A. Meyers, Leonard H. Wexler, Emily K. Slotkin, Julia L. Glade Bender, Neerav N. Shukla, Martee L. Hensley, John H. Healey, Michael P. La Quaglia, Kaled M. Alektiar, Aimee M. Crago, Sam S. Yoon, Brian R. Untch, Sarah Chiang, Narasimhan P. Agaram, Meera R. Hameed, Michael F. Berger, David B. Solit, Nikolaus Schultz, Marc Ladanyi, Samuel Singer, and William D. Tap

Subjects
Science
Abstract

Sarcomas are rare tumours with many different subtypes and clinical outcomes; a broader knowledge of their genetic features is required. Here, the authors analyse 2138 soft tissue and bone sarcomas across 45 subtypes using MSK-IMPACT targeted sequencing and find genomic groups that are distinct from histological subgroups.

Published
2022
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49. P125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study

Author

S. Kümmel, P. Schmid, N. Harbeck, M. Takahashi, M. Untch, J.-F. Boileau, J. Cortes, H. McArthur, R. Dent, J. O’Shaughnessy, L. Pusztai, T. Foukakis, Y.H. Park, R. Hui, F. Cardoso, C. Denkert, Y. Zhu, W. Pan, V. Karantza, and P. Fasching

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Published
2023
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50. Adjuvant trastuzumab emtansine in HER2-positive breast cancer patients with HER2-negative residual invasive disease in KATHERINE

Author

Loibl, Sibylle, Huang, Chiun-Sheng, Mano, Max S., Mamounas, Eleftherios P., Geyer, Jr, Charles E., Untch, Michael, Thery, Jean-Christophe, Schwaner, Ingo, Limentani, Steven, Loman, Niklas, Lübbe, Kristina, Chang, Jenny C., Hatschek, Thomas, Tesarowski, David, Song, Chunyan, Lysbet de Haas, Sanne, Boulet, Thomas, Lambertini, Chiara, and Wolmark, Norman

Published
2022
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