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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. 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

13. 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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15. 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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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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18. 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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19. 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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20. 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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22. 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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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. 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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28. 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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29. 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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30. 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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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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36. 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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39. 58O Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment

Author

Marmé, F., primary, Hanusch, C., additional, Furlanetto, J., additional, Morris, P., additional, Link, T., additional, Denkert, C., additional, Fasching, P.A., additional, Jackisch, C., additional, Antolín, S., additional, Solbach, C., additional, Aftimos, P., additional, Huober, J., additional, Untch, M., additional, Balic, M., additional, Reinisch, M., additional, Blohmer, J-U., additional, Gonçalves, A., additional, Rey, J., additional, Büchele, T., additional, and Loibl, S., additional

Published
2022
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40. 120P AXSANA (AXillary Surgery After NeoAdjuvant Treatment) EUBREAST-3: An international prospective multicenter cohort study to evaluate different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655)

Author

Ruf, F., primary, Kühn, T., additional, Hartmann, S., additional, de Boniface, J., additional, Gentilini, O.D., additional, Stickeler, E., additional, Cakmak, G.K., additional, Rubio, I., additional, Niinikoski, L., additional, Kontos, M., additional, Murawa, D., additional, Bonci, E-A., additional, Hauptmann, M., additional, Thill, M., additional, Markus, H., additional, Lux, M.P., additional, Appelgren, M., additional, Blohmer, J-U., additional, Untch, M., additional, and Banys-Paluchowski, M., additional

Published
2022
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41. 24P Intermediate biopsies during neoadjuvant chemotherapy for breast cancer to predict patient outcome

Author

Sinn, B.V., primary, Untch, M., additional, Karn, T., additional, van Mackelenbergh, M., additional, Huober, J., additional, Sychra, K., additional, Schmitt, W.D., additional, Marmé, F., additional, Schem, C., additional, Solbach, C., additional, Stickeler, E., additional, Tesch, H., additional, Fasching, P.A., additional, Schneeweiss, A., additional, Müller, V., additional, Nekljudova, V., additional, Loibl, S., additional, and Denkert, C., additional

Published
2022
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42. 94P 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., primary, Blohmer, J-U., additional, Link, T., additional, Just, M., additional, Untch, M., additional, Stötzer, O., additional, Fasching, P.A., additional, Schneeweiss, A., additional, Wimberger, P., additional, Seiler, S., additional, Huober, J., additional, Thill, M., additional, Jackisch, C., additional, Rhiem, K., additional, Solbach, C., additional, Hanusch, C., additional, Denkert, C., additional, Engels, K., additional, Nekljudova, V., additional, and Loibl, S., additional

Published
2022
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43. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial

Author

Geyer, C.E., primary, Sikov, W.M., additional, Huober, J., additional, Rugo, H.S., additional, Wolmark, N., additional, O’Shaughnessy, J., additional, Maag, D., additional, Untch, M., additional, Golshan, M., additional, Lorenzo, J. Ponce, additional, Metzger, O., additional, Dunbar, M., additional, Symmans, W.F., additional, Rastogi, P., additional, Sohn, J.H., additional, Young, R., additional, Wright, G.S., additional, Harkness, C., additional, McIntyre, K., additional, Yardley, D., additional, and Loibl, S., additional

Published
2022
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46. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase 3 trial

Author

Geyer CE Jr, Sikov WM, Huober J, Rugo HS, Wolmark N, O'Shaughnessy J, Maag D, Untch M, Golshan M, Ponce Lorenzo J, Metzger O, Dunbar M, Symmans WF, Rastogi P, Sohn J, Young R, Wright GS, Harkness C, McIntyre K, Yardley D, and Loibl S

Subjects
phase 3, triple-negative breast cancer, veliparib, carboplatin [(max 6)], neoadjuvant chemotherapy
Abstract

BACKGROUND: Primary analyses of the phase 3 BrighTNess trial showed addition of carboplatin with/without veliparib to neoadjuvant chemotherapy significantly improved pathological complete response (pCR) rates with manageable acute toxicity in patients with triple-negative breast cancer (TNBC). Here, we report 4.5-year follow-up data from the trial. DESIGN: Women with untreated stage II-III TNBC were randomized (2:1:1) to paclitaxel (weekly for 12 doses) plus either: (a) carboplatin (every 3 weeks for four cycles) plus veliparib (twice daily); (b) carboplatin plus veliparib placebo; or (c) carboplatin placebo plus veliparib placebo. All patients then received doxorubicin and cyclophosphamide (AC) every 2?3 weeks for four cycles. The primary endpoint was pCR. Secondary endpoints included event-free survival (EFS), overall survival (OS), and safety. Since the co-primary endpoint of increased pCR with carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel was not met, secondary analyses are descriptive. RESULTS: Of 634 patients, 316 were randomized to carboplatin plus veliparib with paclitaxel, 160 to carboplatin with paclitaxel, and 158 to paclitaxel. With median follow-up of 4.5 years, the hazard ratio [HR] for EFS for carboplatin plus veliparib with paclitaxel versus paclitaxel was 0.63 (95% confidence interval [CI] 0.43?0.92, P=0.02), but 1.12 (95% CI 0.72?1.72, P=0.62) for carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel. In post hoc analysis, HR for EFS was 0.57 (95% CI 0.36?0.91, P=0.02) for carboplatin with paclitaxel versus paclitaxel. OS did not differ significantly between treatment arms, nor did rates of myelodysplastic syndromes, acute myeloid leukemia, or other secondary malignancies. CONCLUSION: Improvement in pCR with addition of carboplatin was associated with long-term EFS benefit with a manageable safety profile, and without increasing the risk of second malignancies, while adding veliparib did not impact EFS. These findings support the addition of carboplatin to weekly paclitaxel followed by AC neoadjuvant chemotherapy for early stage TNBC.

Published
2022

47. 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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