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2. 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

3. 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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4. 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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7. Ten-year results of intense dose-dense chemotherapy show superior survival compared with a conventional schedule in high-risk primary breast cancer: final results of AGO phase III iddEPC trial

Author

Möbus, V, Jackisch, C, Lück, HJ, du Bois, A, Thomssen, C, Kuhn, W, Nitz, U, Schneeweiss, A, Huober, J, Harbeck, N, von Minckwitz, G, Runnebaum, IB, Hinke, A, Konecny, GE, Untch, M, Kurbacher, C, and Group, AGO Breast Study

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Cyclophosphamide, Disease-Free Survival, Dose-Response Relationship, Drug, Epirubicin, Female, Humans, Lymphatic Metastasis, Middle Aged, Paclitaxel, Risk Factors, Survival Rate, high-risk early breast cancer, dose-dense, intense dose-dense, AGO Breast Study Group, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundPrimary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis.Patients and methodsEnrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC → P) q3w. Event-free survival (EFS) was the primary end point.ResultsA total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC → P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC → P arm, respectively.ConclusionThe previously reported OS benefit of iddEPC in comparison to conventionally dosed EC → P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.

Published
2018

8. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE

Author

Mamounas, E.P., Untch, M., Mano, M.S., Huang, C.-S., Geyer Jr, C.E., von Minckwitz, G., Wolmark, N., Pivot, X., Kuemmel, S., DiGiovanna, M.P., Kaufman, B., Kunz, G., Conlin, A.K., Alcedo, J.C., Kuehn, T., Wapnir, I., Fontana, A., Hackmann, J., Polikoff, J., Saghatchian, M., Brufsky, A., Yang, Y., Zimovjanova, M., Boulet, T., Liu, H., Tesarowski, D., Lam, L.H., Song, C., Smitt, M., and Loibl, S.

Published
2021
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9. Reconstructing tumor history in breast cancer: signatures of mutational processes and response to neoadjuvant chemotherapy⋆

Author

Denkert, C., Untch, M., Benz, S., Schneeweiss, A., Weber, K.E., Schmatloch, S., Jackisch, C., Sinn, H.P., Golovato, J., Karn, T., Marmé, F., Link, T., Budczies, J., Nekljudova, V., Schmitt, W.D., Stickeler, E., Müller, V., Jank, P., Parulkar, R., Heinmöller, E., Sanborn, J.Z., Schem, C., Sinn, B.V., Soon-Shiong, P., van Mackelenbergh, M., Fasching, P.A., Rabizadeh, S., and Loibl, S.

Published
2021
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10. Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study)

Author

Fasching, P.A., Link, T., Hauke, J., Seither, F., Jackisch, C., Klare, P., Schmatloch, S., Hanusch, C., Huober, J., Stefek, A., Seiler, S., Schmitt, W.D., Uleer, C., Doering, G., Rhiem, K., Schneeweiss, A., Engels, K., Denkert, C., Schmutzler, R.K., Hahnen, E., Untch, M., Burchardi, N., Blohmer, J.-U., and Loibl, S.

Published
2021
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11. Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo

Author

Karn, T., Denkert, C., Weber, K.E., Holtrich, U., Hanusch, C., Sinn, B.V., Higgs, B.W., Jank, P., Sinn, H.P., Huober, J., Becker, C., Blohmer, J.-U., Marmé, F., Schmitt, W.D., Wu, S., van Mackelenbergh, M., Müller, V., Schem, C., Stickeler, E., Fasching, P.A., Jackisch, C., Untch, M., Schneeweiss, A., and Loibl, S.

Published
2020
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12. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study

Author

Loibl, S., Untch, M., Burchardi, N., Huober, J., Sinn, B.V., Blohmer, J.-U., Grischke, E.-M., Furlanetto, J., Tesch, H., Hanusch, C., Engels, K., Rezai, M., Jackisch, C., Schmitt, W.D., von Minckwitz, G., Thomalla, J., Kümmel, S., Rautenberg, B., Fasching, P.A., Weber, K., Rhiem, K., Denkert, C., and Schneeweiss, A.

Published
2019
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14. Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response—final results from GeparSixto

Author

Loibl, S., Weber, K.E., Timms, K.M., Elkin, E.P., Hahnen, E., Fasching, P.A., Lederer, B., Denkert, C., Schneeweiss, A., Braun, S., Salat, C.T., Rezai, M., Blohmer, J.U., Zahm, D.M., Jackisch, C., Gerber, B., Klare, P., Kümmel, S., Schem, C., Paepke, S., Schmutzler, R., Rhiem, K., Penn, S., Reid, J., Nekljudova, V., Hartman, A.-R., von Minckwitz, G., and Untch, M.

Published
2018
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15. Current and future role of neoadjuvant therapy for breast cancer

Author

Untch, M, Konecny, GE, Paepke, S, and von Minckwitz, G

Subjects
Breast cancer, Breast conserving surgery, Molecular subtypes, Neoadjuvant systemic therapy, Pathologic complete response, Oncology & Carcinogenesis, Clinical Sciences, Public Health and Health Services
Abstract

Neoadjuvant systemic chemotherapy is a possible therapeutic approach for the treatment of locally advanced operable, primarily non-operable or inflammatory breast cancer. Neoadjuvant systemic chemotherapy is an option for breast cancer patients who would require adjuvant chemotherapy otherwise based on clinical and histological examination and imaging. The use of neoadjuvant systemic therapy in operable breast cancer is currently increasing because of its advantages that include higher rates of breast conserving surgery and the possibility of measuring early in-vivo response to systemic treatment. The timing of axillary sentinel lymph node diagnosis (i.e. before or after neoadjuvant chemotherapy) is critical in that it may influence the likelihood of axillary preservation. It is not yet clear if neoadjuvant therapy might improve outcomes in certain subgroups of breast cancer patients. Neoadjuvant treatment modalities require a close collaboration between oncology professionals, including surgeons, gynecologists, medical oncologists, radiation oncologists, radiologists and pathologists. The most important parameter for treatment success and improved overall survival is the achievement of a pathologic complete response (pCR), although the role of pCR in patients with luminal A like tumours might be less informative. Identification of patient subgroups with high pCR rates may allow less invasive surgical or radiological interventions. Patients not achieving a pCR may be candidates for postoperative clinical trials exploring novel systemic treatments.

Published
2014

16. VP3-2023: Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2- early breast cancer (EBC)

Author

Fasching, P.A., primary, Slamon, D., additional, Nowecki, Z., additional, Kukielka-Budny, B.D., additional, Stroyakovskiy, D., additional, Yardley, D., additional, Huang, C., additional, Chan, A., additional, Chia, S., additional, Martin, M., additional, Rugo, H.S., additional, Loi, S., additional, Hurvitz, S.A., additional, Untch, M., additional, Afenjar, K., additional, Fresco, R., additional, Danyliv, A., additional, Ferrusi, I., additional, Li, Z., additional, and Hortobagyi, G.N., additional

Published
2023
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19. Dual HER2-blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: a subanalysis of data from the randomized phase III GeparSepto trial

Author

Loibl, S., Jackisch, C., Schneeweiss, A., Schmatloch, S., Aktas, B., Denkert, C., Wiebringhaus, H., Kümmel, S., Warm, M., Paepke, S., Just, M., Hanusch, C., Hackmann, J., Blohmer, J.-U., Clemens, M., Dan Costa, S., Gerber, B., Engels, K., Nekljudova, V., von Minckwitz, G., and Untch, M.

Published
2017
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20. 109P Updated long-term overall survival of older adjuvant ibandronate-treated patients with intermediate- or high-risk early breast cancer compared with additional adjuvant capecitabine treatment: The ICE randomized clinical trial

Author

Schmidt, M., primary, Nitz, U.A., additional, Reimer, T., additional, Schmatloch, S., additional, Graf, H., additional, Just, M., additional, Heinrich, G., additional, Stickeler, E., additional, Untch, M., additional, Huober, J., additional, Jackisch, C., additional, Nekljudova, V., additional, and Loibl, S., additional

Published
2023
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21. 129P Impact of TROP-2 and its cellular localization on prognosis of breast cancer in the GAIN cohort

Author

Westhoff, C., primary, Müller, S.K., additional, Schmatloch, S., additional, Henke, R-P., additional, Jank, P., additional, Hattesohl, A., additional, Janni, W., additional, Fasching, P.A., additional, Marmé, F., additional, Karn, T., additional, Schmidt, M., additional, Mueller, V., additional, Untch, M., additional, Schem, C., additional, Stickeler, E., additional, Van Mackelenbergh, M.V.M., additional, Forstbauer, H., additional, Nekljudova, V., additional, Loibl, S., additional, and Denkert, C., additional

Published
2023
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22. 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

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

Published
2023
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23. Zoledronate for patients with invasive residual disease after anthracyclines-taxane-based chemotherapy for early breast cancer – The Phase III NeoAdjuvant Trial Add-oN (NaTaN) study (GBG 36/ABCSG 29)

Author

von Minckwitz, G., Rezai, M., Tesch, H., Huober, J., Gerber, B., Zahm, D.M., Hilfrich, J., Costa, S.D., Dubsky, P., Blohmer, J.U., Denkert, C., Hanusch, C., Jackisch, C., Kümmel, S., Fasching, P.A., Schneeweiss, A., Paepke, S., Untch, M., Burchardi, N., Mehta, K., and Loibl, S.

Published
2016
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25. Adjuvant bisphosphonates in early breast cancer: consensus guidance for clinical practice from a European Panel

Author

Hadji, P., Coleman, R.E., Wilson, C., Powles, T.J., Clézardin, P., Aapro, M., Costa, L., Body, J.-J., Markopoulos, C., Santini, D., Diel, I., Di Leo, A., Cameron, D., Dodwell, D., Smith, I., Gnant, M., Gray, R., Harbeck, N., Thurlimann, B., Untch, M., Cortes, J., Martin, M., Albert, U.-S., Conte, P.-F., Ejlertsen, B., Bergh, J., Kaufmann, M., and Holen, I.

Published
2016
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27. Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)

Author

von Minckwitz, G., Loibl, S., Untch, M., Eidtmann, H., Rezai, M., Fasching, P.A., Tesch, H., Eggemann, H., Schrader, I., Kittel, K., Hanusch, C., Huober, J., Solbach, C., Jackisch, C., Kunz, G., Blohmer, J.U., Hauschild, M., Fehm, T., Nekljudova, V., Gerber, B., Gnauert, K., Heinrich, B., Prätz, T., Groh, U., Tanzer, H., Villena, C., Tulusan, A., Liedtke, B., Blohmer, J.-U., Mau, C., Potenberg, J., Schilling, J., Just, M., Weiss, E., Bückner, U., Wolfgarten, M., Lorenz, R., Doering, G., Feidicker, S., Krabisch, P., Deichert, U., Augustin, D., Kast, K., Nestle-Krämling, C., Höß, C., Terhaag, J., Fasching, P., Staib, P., Aktas, B., Kühn, T., Khandan, F., Möbus, V., Stickeler, E., Heinrich, G., Wagner, H., Abdallah, A., Dewitz, T., Emons, G., Belau, A., Rethwisch, V., Lantzsch, T., Thomssen, C., Mattner, U., Nugent, A., Müller, V., Noesselt, T., Holms, F., Müller, T., Deuker, J.-U., Strumberg, D., Uleer, C., Solomayer, E., Runnebaum, I., Link, H., Tomé, O., Ulmer, H.-U., Conrad, B., Feisel-Schwickardi, G., Schumacher, C., Steinmetz, T., Bauerfeind, I., Kremers, S., Langanke, D., Kullmer, U., Ober, A., Fischer, D., Kohls, A., Weikel, W., Bischoff, J., Freese, K., Schmidt, M., Wiest, W., Sütterlin, M., Dietrich, M., Grießhammer, M., Burgmann, D.-M., Rack, B., Salat, C., Sattler, D., Tio, J., von Abel, E., Christensen, B., Burkamp, U., Köhne, C.-H., Meinerz, W., Graßhoff, S.-T., Decker, T., Overkamp, F., Thalmann, I., Sallmann, A., Beck, T., Reimer, T., Bartzke, G., Deryal, M., Weigel, M., Weder, P., Steffens, C.-C., Lemster, S., Stefek, A., Ruhland, F., Hofmann, M., Schuster, J., Simon, W., Kronawitter, U., Clemens, M., Janni, W., Latos, K., Bauer, W., Roßmann, A., Bauer, L., Lampe, D., Heyl, V., Hoffmann, G., Lorenz-Salehi, F., Hackmann, J., and Schlag, R.

Published
2014
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29. Gene expression profile at week 2 of neoadjuvant therapy course predicts outcome in HER2-positive breast cancer patients: an explorative analysis from NeoALTTO

Author

Di Cosimo, S., primary, Pizzamiglio, S., additional, Sotiriou, C., additional, Ciniselli, C.M., additional, Triulzi, T., additional, de Cecco, L., additional, El-Abed, S., additional, Izquierdo, M., additional, de Azambuja, E., additional, Saura, C., additional, Huober, J., additional, Untch, M., additional, Lang, I., additional, Loi, S., additional, Tagliabue, E., additional, Rubio, I.T., additional, Vingiani, A., additional, Colombo, M.P., additional, Verderio, P., additional, and Pruneri, G., additional

Published
2022
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30. Cytokine identification in seroma fluid after mastectomy in breast cancer patients – first results of SerMa pilot study subgroup

Author

Ditsch, N., primary, Pochert, N., additional, Schneider, M., additional, Köpke, M., additional, Mattmer, A., additional, Hunstiger, S., additional, Sagasser, J., additional, Kahl, H., additional, Metz, A., additional, Reiger, M., additional, Neumann, A., additional, Banys-Paluchowski, M., additional, Untch, M., additional, Dannecker, C., additional, Jeschke, U., additional, Traidl-Hoffmann, C., additional, and Kühn, T., additional

Published
2022
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31. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response

Author

Loibl, S., primary, Schneeweiss, A., additional, Huober, J., additional, Braun, M., additional, Rey, J., additional, Blohmer, J.-U., additional, Furlanetto, J., additional, Zahm, D.-M., additional, Hanusch, C., additional, Thomalla, J., additional, Jackisch, C., additional, Staib, P., additional, Link, T., additional, Rhiem, K., additional, Solbach, C., additional, Fasching, P.A., additional, Nekljudova, V., additional, Denkert, C., additional, and Untch, M., additional

Published
2022
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32. 168P Long-term survival of a randomised, open-label, phase II study comparing the efficacy and safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)

Author

Huober, J., primary, Janni, W., additional, Untch, M., additional, Blohmer, J-U., additional, Zahm, D-M., additional, Hanusch, C., additional, Jackisch, C., additional, Heinrich, G., additional, Schneeweiss, A., additional, Denkert, C., additional, Link, T., additional, Rhiem, K.E., additional, Furlanetto, J., additional, Solbach, C., additional, Klare, P., additional, Nekljudova, V., additional, Filmann, N., additional, and Loibl, S., additional

Published
2022
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33. 68MO Generalization of a deep learning model for HER2 status predictions on H&E-stained whole slide images derived from 3 neoadjuvant clinical studies

Author

Hägele, M., primary, Müller, K-R., additional, Denkert, C., additional, Schneeweiss, A., additional, Sinn, B.V., additional, Untch, M., additional, Van Mackelenbergh, M.T., additional, Jackisch, C., additional, Nekljudova, V., additional, Karn, T., additional, Alber, M., additional, Marmé, F., additional, Schem, C., additional, Stickeler, E., additional, Fasching, P.A., additional, Mueller, V., additional, Weber, K.E., additional, Lederer, B., additional, Loibl, S., additional, and Klauschen, F., additional

Published
2022
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34. 135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

Author

Dent, R.A., primary, Cortés, J., additional, Pusztai, L., additional, McArthur, H.L., additional, Kuemmel, S., additional, Bergh, J., additional, Denkert, C., additional, Park, Y.H., additional, Hui, R., additional, Harbeck, N., additional, Takahashi, M., additional, Untch, M., additional, Fasching, P.A., additional, Cardoso, F., additional, Haiderali, A., additional, Jia, L., additional, Nguyen, A.M., additional, Pan, W., additional, O'Shaughnessy, J., additional, and Schmid, P., additional

Published
2022
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35. 200TiP A randomized, open-label, phase II trial comparing neoadjuvant trastuzumab, pertuzumab and endocrine therapy +/- the PI3K inhibitor inavolisib in patients (pts) with HER2+/HR+, PIK3CA mutant early breast cancer (BC)- GeparPiPPa

Author

Loibl, S., primary, Reinisch, M., additional, Denkert, C., additional, Fasching, P.A., additional, Seiler, S., additional, Link, T., additional, Hanusch, C., additional, Bjelic-Radisic, V., additional, Schneeweiss, A., additional, Huober, J., additional, Jackisch, C., additional, Rhiem, K.E., additional, Untch, M., additional, Solbach, C., additional, Blohmer, J-U., additional, Buechele, T., additional, Nekljudova, V., additional, and Loi, S., additional

Published
2022
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38. 241P Overall survival and updated invasive disease free survival results from the Penelope-B trial investigating palbociclib vs placebo for patients with high-risk HR+/HER2- breast cancer and residual disease after NACT

Author

Loibl, S., Jimenez, M. Martin, Bonnefoi, H., Untch, M., Kim, S-B., Bear, H.D., McCarthy, N.J., Gelmon, K.A., Saenz, J.Á. García, Kelly, C.M., Reimer, T., Zhang, Z., Toi, M., Rugo, H.S., Gnant, M.I., Makris, A., Debiasi, M., Hirmas, N., Nekljudova, V., and Marmé, F.

Published
2024
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40. LBA4 Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study

Author

Schmid, P., Cortés, J., Dent, R.A., McArthur, H.L., Pusztai, L., Kummel, S., Denkert, C., Park, Y.H., Hui, R., Harbeck, N., Takahashi, M., Im, S-A., Untch, M., Fasching, P.A., Cardoso, F., Zhao, J., Zhou, X., Tryfonidis, K.E., Aktan, G., and O'Shaughnessy, J.

Published
2024
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41. Corrigendum to “A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study”

Author

Loibl, S., primary, Untch, M., additional, Burchardi, N., additional, Huober, J., additional, Sinn, B.V., additional, Blohmer, J.-U., additional, Grischke, E.-M., additional, Furlanetto, J., additional, Tesch, H., additional, Hanusch, C., additional, Engels, K., additional, Rezai, M., additional, Jackisch, C., additional, Schmitt, W.D., additional, von Minckwitz, G., additional, Thomalla, J., additional, Kümmel, S., additional, Rautenberg, B., additional, Fasching, P.A., additional, Weber, K., additional, Rhiem, K., additional, Denkert, C., additional, and Schneeweiss, A., additional

Published
2022
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44. Physical activity, sedentary time and breast cancer risk: a Mendelian randomisation study

Author

Dixon-Suen, SC, Lewis, SJ, Martin, RM, English, DR, Boyle, T, Giles, GG, Michailidou, K, Bolla, MK, Wang, Q, Dennis, J, Lush, M, Ahearn, TU, Ambrosone, CB, Andrulis, IL, Anton-Culver, H, Arndt, V, Aronson, KJ, Augustinsson, A, Auvinen, P, Beane Freeman, LE, Becher, H, Beckmann, MW, Behrens, S, Bermisheva, M, Blomqvist, C, Bogdanova, N, Bojesen, SE, Bonanni, B, Brenner, H, Bruening, T, Buys, SS, Camp, NJ, Campa, D, Canzian, F, Castelao, JE, Cessna, MH, Chang-Claude, J, Chanock, SJ, Clarke, CL, Conroy, DM, Couch, FJ, Cox, A, Cross, SS, Czene, K, Daly, MB, Devilee, P, Doerk, T, Dwek, M, Eccles, DM, Eliassen, AH, Engel, C, Eriksson, M, Evans, DG, Fasching, PA, Fletcher, O, Flyger, H, Fritschi, L, Gabrielson, M, Gago-Dominguez, M, Garcia-Closas, M, Garcia-Saenz, JA, Goldberg, MS, Guenel, P, Guendert, M, Hahnen, E, Haiman, CA, Haeberle, L, Hakansson, N, Hall, P, Hamann, U, Hart, SN, Harvie, M, Hillemanns, P, Hollestelle, A, Hooning, MJ, Hoppe, R, Hopper, J, Howell, A, Hunter, DJ, Jakubowska, A, Janni, W, John, EM, Jung, A, Kaaks, R, Keeman, R, Kitahara, CM, Koutros, S, Kraft, P, Kristensen, VN, Kubelka-Sabit, K, Kurian, AW, Lacey, J, Lambrechts, D, Le Marchand, L, Lindblom, A, Loibl, S, Lubinski, J, Mannermaa, A, Manoochehri, M, Margolin, S, Martinez, ME, Mavroudis, D, Menon, U, Mulligan, AM, Murphy, RA, Nevanlinna, H, Nevelsteen, I, Newman, WG, Offit, K, Olshan, AF, Olsson, H, Orr, N, Patel, A, Peto, J, Plaseska-Karanfilska, D, Presneau, N, Rack, B, Radice, P, Rees-Punia, E, Rennert, G, Rennert, HS, Romero, A, Saloustros, E, Sandler, DP, Schmidt, MK, Schmutzler, RK, Schwentner, L, Scott, C, Shah, M, Shu, X-O, Simard, J, Southey, MC, Stone, J, Surowy, H, Swerdlow, AJ, Tamimi, RM, Tapper, WJ, Taylor, JA, Terry, MB, Tollenaar, RAEM, Troester, MA, Truong, T, Untch, M, Vachon, CM, Joseph, V, Wappenschmidt, B, Weinberg, CR, Wolk, A, Yannoukakos, D, Zheng, W, Ziogas, A, Dunning, AM, Pharoah, PDP, Easton, DF, Milne, RL, Lynch, BM, Dixon-Suen, SC, Lewis, SJ, Martin, RM, English, DR, Boyle, T, Giles, GG, Michailidou, K, Bolla, MK, Wang, Q, Dennis, J, Lush, M, Ahearn, TU, Ambrosone, CB, Andrulis, IL, Anton-Culver, H, Arndt, V, Aronson, KJ, Augustinsson, A, Auvinen, P, Beane Freeman, LE, Becher, H, Beckmann, MW, Behrens, S, Bermisheva, M, Blomqvist, C, Bogdanova, N, Bojesen, SE, Bonanni, B, Brenner, H, Bruening, T, Buys, SS, Camp, NJ, Campa, D, Canzian, F, Castelao, JE, Cessna, MH, Chang-Claude, J, Chanock, SJ, Clarke, CL, Conroy, DM, Couch, FJ, Cox, A, Cross, SS, Czene, K, Daly, MB, Devilee, P, Doerk, T, Dwek, M, Eccles, DM, Eliassen, AH, Engel, C, Eriksson, M, Evans, DG, Fasching, PA, Fletcher, O, Flyger, H, Fritschi, L, Gabrielson, M, Gago-Dominguez, M, Garcia-Closas, M, Garcia-Saenz, JA, Goldberg, MS, Guenel, P, Guendert, M, Hahnen, E, Haiman, CA, Haeberle, L, Hakansson, N, Hall, P, Hamann, U, Hart, SN, Harvie, M, Hillemanns, P, Hollestelle, A, Hooning, MJ, Hoppe, R, Hopper, J, Howell, A, Hunter, DJ, Jakubowska, A, Janni, W, John, EM, Jung, A, Kaaks, R, Keeman, R, Kitahara, CM, Koutros, S, Kraft, P, Kristensen, VN, Kubelka-Sabit, K, Kurian, AW, Lacey, J, Lambrechts, D, Le Marchand, L, Lindblom, A, Loibl, S, Lubinski, J, Mannermaa, A, Manoochehri, M, Margolin, S, Martinez, ME, Mavroudis, D, Menon, U, Mulligan, AM, Murphy, RA, Nevanlinna, H, Nevelsteen, I, Newman, WG, Offit, K, Olshan, AF, Olsson, H, Orr, N, Patel, A, Peto, J, Plaseska-Karanfilska, D, Presneau, N, Rack, B, Radice, P, Rees-Punia, E, Rennert, G, Rennert, HS, Romero, A, Saloustros, E, Sandler, DP, Schmidt, MK, Schmutzler, RK, Schwentner, L, Scott, C, Shah, M, Shu, X-O, Simard, J, Southey, MC, Stone, J, Surowy, H, Swerdlow, AJ, Tamimi, RM, Tapper, WJ, Taylor, JA, Terry, MB, Tollenaar, RAEM, Troester, MA, Truong, T, Untch, M, Vachon, CM, Joseph, V, Wappenschmidt, B, Weinberg, CR, Wolk, A, Yannoukakos, D, Zheng, W, Ziogas, A, Dunning, AM, Pharoah, PDP, Easton, DF, Milne, RL, and Lynch, BM

Abstract

OBJECTIVES: Physical inactivity and sedentary behaviour are associated with higher breast cancer risk in observational studies, but ascribing causality is difficult. Mendelian randomisation (MR) assesses causality by simulating randomised trial groups using genotype. We assessed whether lifelong physical activity or sedentary time, assessed using genotype, may be causally associated with breast cancer risk overall, pre/post-menopause, and by case-groups defined by tumour characteristics. METHODS: We performed two-sample inverse-variance-weighted MR using individual-level Breast Cancer Association Consortium case-control data from 130 957 European-ancestry women (69 838 invasive cases), and published UK Biobank data (n=91 105-377 234). Genetic instruments were single nucleotide polymorphisms (SNPs) associated in UK Biobank with wrist-worn accelerometer-measured overall physical activity (nsnps=5) or sedentary time (nsnps=6), or accelerometer-measured (nsnps=1) or self-reported (nsnps=5) vigorous physical activity. RESULTS: Greater genetically-predicted overall activity was associated with lower breast cancer overall risk (OR=0.59; 95% confidence interval (CI) 0.42 to 0.83 per-standard deviation (SD;~8 milligravities acceleration)) and for most case-groups. Genetically-predicted vigorous activity was associated with lower risk of pre/perimenopausal breast cancer (OR=0.62; 95% CI 0.45 to 0.87,≥3 vs. 0 self-reported days/week), with consistent estimates for most case-groups. Greater genetically-predicted sedentary time was associated with higher hormone-receptor-negative tumour risk (OR=1.77; 95% CI 1.07 to 2.92 per-SD (~7% time spent sedentary)), with elevated estimates for most case-groups. Results were robust to sensitivity analyses examining pleiotropy (including weighted-median-MR, MR-Egger). CONCLUSION: Our study provides strong evidence that greater overall physical activity, greater vigorous activity, and lower sedentary time are likely to reduce breast cancer r

Published
2022

45. A randomized, open-label, phase II trial comparing neoadjuvant trastuzumab, pertuzumab and endocrine therapy +/- the PI3K inhibitor inavolisib in patients (pts) with HER2+/HR+, PIK3CA mutant early breast cancer (BC)-GeparPiPPa

Author

Loibl, S., Reinisch, M., Denkert, C., Fasching, P. A., Seiler, S., Link, T., Hanusch, C., Bjelic-Radisic, V., Schneeweiss, A., Huober, J., Jackisch, C., Rhiem, K. E., Untch, M., Solbach, C., Blohmer, J-U., Buechele, T., Nekljudova, V., Loi, S., Loibl, S., Reinisch, M., Denkert, C., Fasching, P. A., Seiler, S., Link, T., Hanusch, C., Bjelic-Radisic, V., Schneeweiss, A., Huober, J., Jackisch, C., Rhiem, K. E., Untch, M., Solbach, C., Blohmer, J-U., Buechele, T., Nekljudova, V., and Loi, S.

Published
2022

46. Long-term survival of a randomised, open-label, phase II study comparing the efficacy and safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE)

Author

Huober, J., Janni, W., Untch, M., Blohmer, J-U., Zahm, D-M., Hanusch, C., Jackisch, C., Heinrich, G., Schneeweiss, A., Denkert, C., Link, T., Rhiem, K. E., Furlanetto, J., Solbach, C., Klare, P., Nekljudova, V., Filmann, N., Loibl, S., Huober, J., Janni, W., Untch, M., Blohmer, J-U., Zahm, D-M., Hanusch, C., Jackisch, C., Heinrich, G., Schneeweiss, A., Denkert, C., Link, T., Rhiem, K. E., Furlanetto, J., Solbach, C., Klare, P., Nekljudova, V., Filmann, N., and Loibl, S.

Published
2022

47. Patient quality of life (QoL) from the GeparX trial on the addition of denosumab (Dmab) added to two different nab-paclitaxel (nP) regimens as neoadjuvant chemotherapy (NACT) in primary breast cancer (BC)

Author

Reinisch, M., Blohmer, J-U., Link, T., Just, M., Untch, M., Stoetzer, O., Fasching, P. A., Schneeweiss, A., Wimberger, P., Seiler, S., Huober, J., Thill, M., Jackisch, C., Rhiem, K., Solbach, C., Hanusch, C., Denkert, C., Engels, K., Nekljudova, V., Loibl, S., Reinisch, M., Blohmer, J-U., Link, T., Just, M., Untch, M., Stoetzer, O., Fasching, P. A., Schneeweiss, A., Wimberger, P., Seiler, S., Huober, J., Thill, M., Jackisch, C., Rhiem, K., Solbach, C., Hanusch, C., Denkert, C., Engels, K., Nekljudova, V., and Loibl, S.

Published
2022

48. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response

Author

Loibl, S., Schneeweiss, A., Huober, J., Braun, M., Rey, J., Blohmer, J. U., Furlanetto, J., Zahm, D. M., Hanusch, C., Thomalla, J., Jackisch, C., Staib, P., Link, T., Rhiem, K., Solbach, C., Fasching, P. A., Nekljudova, V., Denkert, C., Untch, M., Loibl, S., Schneeweiss, A., Huober, J., Braun, M., Rey, J., Blohmer, J. U., Furlanetto, J., Zahm, D. M., Hanusch, C., Thomalla, J., Jackisch, C., Staib, P., Link, T., Rhiem, K., Solbach, C., Fasching, P. A., Nekljudova, V., Denkert, C., and Untch, M.

Abstract

Background: Addition of immune checkpoint inhibitors to neoadjuvant chemotherapy (NACT) is a promising strategy in early breast cancer, but the optimal duration of therapy is currently unknown. In the GeparNuevo (NCT02685059) trial, addition of durvalumab to NACT as previously reported led to a moderate increase in pathological complete response (pCR) rate by an absolute 9% (P = 0.287). Patients and methods: Patients with cT1b-cT4a-d triple-negative breast cancer (TNBC) received durvalumab 1.5 g or placebo every 4 weeks added to nab-paclitaxel 125 mg/m2 weekly for 12 weeks, followed by durvalumab/placebo every 4 weeks plus epirubicin/cyclophosphamide every 2 weeks followed by surgery. Durvalumab was not continued after surgery. The primary objective was pCR. Secondary endpoints included invasive disease-free survival (iDFS), distant disease-free survival (DDFS) and overall survival (OS). Results: A total of 174 patients were randomised between June 2016 and October 2017. After a median follow-up of 43.7 months, 34 events had occurred. Despite a non-significant increase in the pCR rate, significant differences were observed for 3-year iDFS, DDFS and OS: iDFS was 85.6% with durvalumab versus 77.2% with placebo [hazard ratio (HR) 0.48, 95% confidence interval (CI) 0.24-0.97, stratified log-rank P = 0.036]; DDFS 91.7% versus 78.4% (HR 0.31, 95% CI 0.13-0.74, P = 0.005); OS 95.2% versus 83.5% (HR 0.24, 95% CI 0.08-0.72, P = 0.006). pCR patients had 3 -year iDFS of 95.5% with durvalumab and 86.1% without (HR 0.22, 95% CI 0.05-1.06). In the non-pCR cohort 3-year iDFS was 76.3% versus 69.7% (HR 0.67, 95% CI 0.29-1.54). Multivariable analysis confirmed a durvalumab effect independent of the pCR effect. No new safety signals occurred. Conclusions: Durvalumab added to NACT in TNBC significantly improved survival despite a modest pCR increase and no adjuvant component of durvalumab. Additional studies are needed to clarify the optimal duration and sequence of checkpoint inhibit

Published
2022

49. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study (vol 30, pg 1279, 2019)

Author

Loibl, S., Untch, M., Burchardi, N., Huober, J., Sinn, B. V., Blohmer, J. -U., Grischke, E. -M., Furlanetto, J., Tesch, H., Hanusch, C., Engels, K., Rezai, M., Jackisch, C., Schmitt, W. D., von Minckwitz, G., Thomalla, J., Kuemmel, S., Rautenberg, B., Fasching, P. A., Weber, K., Rhiem, K., Denkert, C., Schneeweiss, A., Loibl, S., Untch, M., Burchardi, N., Huober, J., Sinn, B. V., Blohmer, J. -U., Grischke, E. -M., Furlanetto, J., Tesch, H., Hanusch, C., Engels, K., Rezai, M., Jackisch, C., Schmitt, W. D., von Minckwitz, G., Thomalla, J., Kuemmel, S., Rautenberg, B., Fasching, P. A., Weber, K., Rhiem, K., Denkert, C., and Schneeweiss, A.

Published
2022

50. Nationales Enantone®-Gyn Symposium

Author

Kiesel, L., Schindler, A. E., Schweppe, K.-W., Römer, Th., Deckhardt, R., Bühler, K., Untch, M., Berg, Dietrich, editor, Diedrich, Klaus, editor, and Rauskolb, Rüdiger, editor

Published
2000
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