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1. A multicentre, randomised, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer (DESIREE)

Author

Schmidt, M., Lübbe, K., Decker, T., Thill, M., Bauer, L., Müller, V., Link, T., Furlanetto, J., Reinisch, M., Mundhenke, C., Hoffmann, O., Zahn, M.-O., Müller, L., Denkert, C., van Mackelenbergh, M., Fasching, P.A., Burchardi, N., Nekljudova, V., and Loibl, S.

Published
2022
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2. 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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4. 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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6. 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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7. 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

9. 132P Health economic properties of palbociclib in breast cancer patients with high risk of relapse following neoadjuvant therapy: Results from the Penelope-B trial

Author

Galactionova, K., primary, Loibl, S., additional, Salari, P., additional, Marmé, F., additional, Martin, M., additional, Untch, M., additional, Bonnefoi, H., additional, Kim, S-B., additional, Bear, H.D., additional, McCarthy, N., additional, Gelmon, K., additional, García-Saenz, J.A., additional, Kelly, C.M., additional, Reimer, T., additional, Toi, M., additional, Rugo, H.S., additional, Gnant, M., additional, Makris, A., additional, Burchardi, N., additional, and Schwenkglenks, M., additional

Published
2021
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10. LBA19 A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer (mBC) (DESIREE)

Author

Loibl, S., primary, Schmidt, M., additional, Lübbe, K., additional, Decker, T., additional, Thill, M., additional, Bauer, L., additional, Müller, V., additional, Link, T., additional, Furlanetto, J., additional, Kümmel, S., additional, Mundhenke, C., additional, Hoffmann, O., additional, Zahn, M-O., additional, Müller, L., additional, Denkert, C., additional, van Mackelenbergh, M., additional, Fasching, P.A., additional, Burchardi, N., additional, and Nekljudova, V., additional

Published
2021
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11. 122MO Quality of life from the Penelope-B study on high-risk HR+/HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib

Author

García-Saenz, J.A., primary, Marmé, F., additional, Rugo, H.S., additional, Untch, M., additional, Bonnefoi, H., additional, Kim, S-B., additional, Bear, H.D., additional, McCarthy, N., additional, Gelmon, K., additional, Martin, M., additional, Kelly, C.M., additional, Reimer, T., additional, Toi, M., additional, Law, E.H., additional, Gnant, M., additional, Makris, A., additional, Seiler, S., additional, Burchardi, N., additional, Nekljudova, V., additional, and Loibl, S., additional

Published
2021
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13. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

Author

Kos, Z., Roblin, E., Kim, R. S., Michiels, S., Gallas, B. D., Chen, W., van de Vijver, K. K., Goel, S., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S., Denkert, C., Loibl, S., Luen, S. J., Bartlett, J. M. S., Savas, P., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kok, M., Horlings, H. M., Madabhushi, A., van der Laak, J., Ciompi, F., Laenkholm, A. -V., Bellolio, E., Gruosso, T., Fox, S. B., Araya, J. C., Floris, G., Hudecek, J., Voorwerk, L., Beck, A. H., Kerner, J., Larsimont, D., Declercq, S., Van den Eynden, G., Pusztai, L., Ehinger, A., Yang, W., Abduljabbar, K., Yuan, Y., Singh, R., Hiley, C., Bakir, M., Lazar, A. J., Naber, S., Wienert, S., Castillo, M., Curigliano, G., Dieci, M. -V., Andre, F., Swanton, C., Reis-Filho, J., Sparano, J., Balslev, E., Chen, I. -C., Stovgaard, E. I. S., Pogue-Geile, K., Blenman, K. R. M., Penault-Llorca, F., Schnitt, S., Lakhani, S. R., Vincent-Salomon, A., Rojo, F., Braybrooke, J. P., Hanna, M. G., Soler-Monso, M. T., Bethmann, D., Castaneda, C. A., Willard-Gallo, K., Sharma, A., Lien, H. -C., Fineberg, S., Thagaard, J., Comerma, L., Gonzalez-Ericsson, P., Brogi, E., Loi, S., Saltz, J., Klaushen, F., Cooper, L., Amgad, M., Moore, D. A., Salgado, R., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Gown, A., Lo, A., Sapino, A., Moreira, A. M., Richardson, A., Vingiani, A., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Garrido-Castro, A. C., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Ballesteroes-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Solinas, C., Drubay, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Perez, E., Elgabry, E. A., Blackley, E. F., Reisenbichler, E., Chmielik, E., Gaire, F., F. -I., Lu, Azmoudeh-Ardalan, F., Peale, F., Hirsch, F. R., Acosta-Haab, G., Farshid, G., Broeckx, G., Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Cree, I., Nederlof, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Weseling, J., Giltnane, J., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Hartman, J., Hainfellner, J., Le Quesne, J., Juco, J. W., van den Berg, J., Sanchez, J., Cucherousset, J., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Sikorska, K., Weber, K., Steele, K. E., Emancipator, K., El Bairi, K., Allison, K. H., Korski, K., Buisseret, L., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Van Seijen, M., Lacroix-Triki, M., Sebastian, M. M., Balancin, M. L., Mathieu, M. -C., van de Vijver, M., Rebelatto, M. C., Piccart, M., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., de Maaker, M., Van Bockstal, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Kirtani, P., Watson, P. H., Jelinic, P., Francis, P. A., Russell, P. A., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Bedri, S., Irshad, S., Liu, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Luz, S., Gevaert, T., D'Alfons, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camaea, V. P., Tong, W., Tran, W. T., Wang, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Odense University Hospital, Unité de génétique et biologie des cancers (U830), Université Paris Descartes - Paris 5 (UPD5)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Breast Medical Oncology [Houston], The University of Texas M.D. Anderson Cancer Center [Houston], Helsingborg Hospital, Division of Experimental Therapeutics [Milan, Italy], Département de médecine oncologique [Gustave Roussy], Cancer Research UK Lung Cancer Centre of Excellence [Londres, Royaume-Uni], University College of London [London] (UCL), Memorial Sloane Kettering Cancer Center [New York], Herlev and Gentofte Hospital, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Southern Queensland (USQ), Pharmacogenomics Unit [Paris], Department of Genetics [Paris], Institut Curie [Paris]-Institut Curie [Paris], Instituto de Física Teórica UAM/CSIC (IFT), Universidad Autonoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Ctr Biomol Struct & Org, University of Maryland [College Park], University of Maryland System-University of Maryland System, The University of Sydney, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), Innovation North - Faculty of Information and Technology, Leeds Metropolitan University, Int Immuno-Oncology Biomarker, Graduate School, CCA - Cancer biology and immunology, Pathology, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), German Breast Group (GBG), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Universidad Autónoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Gallas, Brandon D [0000-0001-7332-1620], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, W Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Savas, Peter [0000-0001-5999-428X], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], van der Laak, Jeroen [0000-0001-7982-0754], Bellolio, Enrique [0000-0003-0079-5264], Araya, Juan Carlos [0000-0003-3501-8203], Floris, Giuseppe [0000-0003-2391-5425], Hudeček, Jan [0000-0003-1071-5686], Ehinger, Anna [0000-0001-9225-7396], Lazar, Alexander J [0000-0002-6395-4499], Castillo, Miluska [0000-0002-0111-3176], Curigliano, Giuseppe [0000-0003-1781-2518], Sparano, Joseph [0000-0002-9031-2010], Braybrooke, Jeremy P [0000-0003-1943-7360], Hanna, Matthew G [0000-0002-7536-1746], Willard-Gallo, Karen [0000-0002-1150-1295], Sharma, Ashish [0000-0002-1011-6504], Comerma, Laura [0000-0002-0249-4636], Gonzalez-Ericsson, Paula [0000-0002-6292-6963], Loi, Sherene [0000-0001-6137-9171], Cooper, Lee [0000-0002-3504-4965], Apollo - University of Cambridge Repository, Research Programs Unit, Heikki Joensuu / Principal Investigator, HUS Comprehensive Cancer Center, Department of Oncology, Medicum, Gallas, Brandon D. [0000-0001-7332-1620], van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Symmans, W. Fraser [0000-0002-1526-184X], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Lazar, Alexander J. [0000-0002-6395-4499], Braybrooke, Jeremy P. [0000-0003-1943-7360], and Hanna, Matthew G. [0000-0002-7536-1746]

Subjects
Oncology, [SDV]Life Sciences [q-bio], THERAPY, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Prognostic markers, 0302 clinical medicine, Breast cancer, Medicine and Health Sciences, Pharmacology (medical), Lymphocytes, Stromal tumor, health care economics and organizations, 0303 health sciences, CHEMOTHERAPY, Sciences bio-médicales et agricoles, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], PROGNOSTIC VALUE, Clinical Practice, 030220 oncology & carcinogenesis, Educational resources, Immunosurveillance, medicine.medical_specialty, 3122 Cancers, [SDV.CAN]Life Sciences [q-bio]/Cancer, IMMUNITY, lcsh:RC254-282, Article, Limfòcits, Càncer de mama, 03 medical and health sciences, Gastrointestinal cancer, SDG 3 - Good Health and Well-being, Internal medicine, 692/53/2422, medicine, Radiology, Nuclear Medicine and imaging, Càncer gastrointestinal, 030304 developmental biology, Predictive biomarker, Tumor-infiltrating lymphocytes, business.industry, Médecine pathologie humaine, medicine.disease, Cancérologie, Human medicine, business, SYSTEM, 631/67/580/1884
Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are important prognostic and predictive biomarkers in triple-negative (TNBC) and HER2-positive breast cancer. Incorporating sTILs into clinical practice necessitates reproducible assessment. Previously developed standardized scoring guidelines have been widely embraced by the clinical and research communities. We evaluated sources of variability in sTIL assessment by pathologists in three previous sTIL ring studies. We identify common challenges and evaluate impact of discrepancies on outcome estimates in early TNBC using a newly-developed prognostic tool. Discordant sTIL assessment is driven by heterogeneity in lymphocyte distribution. Additional factors include: technical slide-related issues; scoring outside the tumor boundary; tumors with minimal assessable stroma; including lymphocytes associated with other structures; and including other inflammatory cells. Small variations in sTIL assessment modestly alter risk estimation in early TNBC but have the potential to affect treatment selection if cutpoints are employed. Scoring and averaging multiple areas, as well as use of reference images, improve consistency of sTIL evaluation. Moreover, to assist in avoiding the pitfalls identified in this analysis, we developed an educational resource available at www.tilsinbreastcancer.org/pitfalls., info:eu-repo/semantics/published

Published
2020
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14. 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, Loibl, S., 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.

Abstract

Background: The efficacy and toxicity of olaparib as combination therapy in early breast cancer (BC) patients with homologous recombinant deficiency (HRD) [score high and/or germline (g) or tumour (t) BRCA1/2 mutation] is not well described. GeparOLA (ClinicalTriais gov, NCT02789332) investigated olaparib in combination with paclitaxel in HER2-negative early BC with HRD. Patients and methods: Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN + or pNSIN + or cT1c and triple-negative breast cancer (TNBC) or cT1c and Ki-67>20% BC with HRD were randomised either to paclitaxel (P) 80 mg/m(2) weekly plus olaparib (0) 100 mg twice daily for 12 weeks or P plus carboplatinum (Cb) area under the curve 2 weekly for 12 weeks, both followed by epirubicin/cyclophosphamide (EC). Stratification factors were hormone receptor (HR) status (HR versus HR ) and age (<40 versus >= 40 years). The primary endpoint was pathological complete response (pCR; ypTO/is ypNO). A two-sided one-group chi(2)-test was planned to exclude a pCR rate of <= 55% in the PO-EC arm. Secondary end points were other pCR definitions, breast conservation rate, clinical/ imaging response, tolerability and safety. Results: A total of 107 patients were randomised between September 2016 and July 2018; 106 (PO N = 69; PCb N = 37) started treatment. Median age was 47.0 years (range 25.0-71.0); 36.2% had cT1, 61.0% cT2, 2.9% cT3, and 31.8% cN-positive tumours; grade 3 tumours: 86.8%; Ki-67>20%: 89.6%; TNBC: 72.6%; confirmed gBRCA1/2 mutation: 56.2%. The pCR rate with PO was 55.1% [90% confidence interval (CI) 44.5% to 65.3%] versus PCb 48.6% (90% CI 34.3% to 63.2%). Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR patients. Conclusion: GeparOLA could not exclude a pCR rate of <= 55% in the PO arm. PO was significantly better tolerated and the combination merits further evaluation.

Published
2021

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

Published
2021
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17. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Author

Hudecek, J., Voorwerk, L., van Seijen, M., Nederlof, I., de Maaker, M., van den Berg, J., van de Vijver, K. K., Sikorska, K., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Michiels, S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S. M., Denkert, C., Loibl, S., Loi, S., Bartlett, J. M. S., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kos, Z., Salgado, R., Kok, M., Horlings, H. M., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Lazar, A. J., Gown, A., Lo, A., Sapino, A., Madabhushi, A., Moreira, A., Richardson, A., Vingiani, A., Beck, A. H., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Ehinger, A., Garrido-Castro, A., Vincent-Salomon, A., Laenkholm, A. -V., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Gallas, B. D., Castaneda, C., Ballesteros-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Swanton, C., Solinas, C., Hiley, C., Drubay, D., Bethmann, D., Moore, D. A., Larsimont, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Brogi, E., Perez, E., Elgabry, E. A., Stovgaard, E. S., Blackley, E. F., Roblin, E., Reisenbichler, E., Bellolio, E., Balslev, E., Chmielik, E., Gaire, F., Andre, F., F. -I., Lu, Azmoudeh-Ardalan, F., Rojo, F., Gruosso, T., Ciompi, F., Peale, F., Hirsch, F. R., Klauschen, F., Penault-Llorca, F., Acosta Haab, G., Farshid, G., van den Eynden, G., Curigliano, G., Floris, G., Broeckx, G., Gonzalez-Ericsson, Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Lien, H. -C., Chen, I. -C., Cree, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Wesseling, J., Giltnane, J., Kerner, J. K., Thagaard, J., Braybrooke, J. P., van der Laak, J. A. W. M., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Saltz, J., Hartman, J., Hainfellner, J., Quesne, J. L., Juco, J. W., Reis-Filho, J., Sanchez, J., Sparano, J., Cucherousset, J., Araya, J. C., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Willard-Gallo, K., Weber, K., Pogue-Geile, K. L., Steele, K. E., Emancipator, K., Abduljabbar, K., El Bairi, K., Blenman, K. R. M., Allison, K. H., Korski, K., Pusztai, L., Comerma, L., Buisseret, L., Cooper, L. A. D., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Lacroix-Triki, M., Al Bakir, M., Sebastian, M. M., van de Vijver, M., Balancin, M. L., Dieci, M. V., Mathieu, M. -C., Rebelatto, M. C., Piccart, M., Hanna, M. G., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., van Bockstal, M., Castillo, M., Amgad, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Gonzalez-Ericsson, P., Kirtani, P., Jelinic, P., Watson, P. H., Savas, P., Francis, P. A., Russell, P. A., Singh, R., Kim, R. S., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., De Clercq, S., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Kim, S. -R., Bedri, S., Irshad, S., Liu, S. -W., Goel, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Wienert, S., Fox, S. B., Luen, S. J., Naber, S., Schnitt, S. J., Sua, L. F., Lakhani, S. R., Fineberg, S., Soler, T., Gevaert, T., D'Alfonso, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camara, V. P., Tong, W., Chen, W., Yang, W., Tran, W. T., Wang, Y., Yuan, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Hudeček, Jan [0000-0003-1071-5686], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Loi, Sherene [0000-0001-6137-9171], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], Apollo - University of Cambridge Repository, van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, German Breast Group (GBG), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, [SDV]Life Sciences [q-bio], medicine.medical_treatment, MEDLINE, [SDV.CAN]Life Sciences [q-bio]/Cancer, Review Article, lcsh:RC254-282, 631/67/1857, Tumour biomarkers, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 03 medical and health sciences, 0302 clinical medicine, Breast cancer, 692/53, Internal medicine, Medicine and Health Sciences, medicine, Pharmacology (medical), Radiology, Nuclear Medicine and imaging, 692/4028/67/580, Stromal tumor, Biomarkers, Tumour immunology, business.industry, Risk management framework, review-article, Médecine pathologie humaine, 631/67/1347, Immunotherapy, Sciences bio-médicales et agricoles, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], 3. Good health, Review article, Clinical trial, Cancérologie, 030104 developmental biology, 030220 oncology & carcinogenesis, Biomarker (medicine), business
Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting., info:eu-repo/semantics/published

Published
2020
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19. Abstract PD2-07: mRNA signatures predict response to durvalumab therapy in triple negative breast cancer (TNBC)– Results of the translational biomarker programme of the neoadjuvant double-blind placebo controlled GeparNuevo trial

Author

Loibl, S, primary, Sinn, BV, additional, Karn, T, additional, Untch, M, additional, Treue, D, additional, Sinn, H-P, additional, Weber, KE, additional, Hanusch, CA, additional, Fasching, PA, additional, Huober, J, additional, Zahm, D-M, additional, Jackisch, C, additional, Thomalla, J, additional, Blohmer, J-U, additional, Marmé, F, additional, Klauschen, F, additional, Rhiem, K, additional, Felder, B, additional, von Minckwitz, G, additional, Burchardi, N, additional, Schneeweiss, A, additional, and Denkert, C, additional

Published
2019
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20. Abstract PD5-05: Pre-therapeutic PD-L1 expression and dynamics of Ki-67 and gene expression during neoadjuvant immune-checkpoint blockade and chemotherapy to predict response within the GeparNuevo trial

Author

Sinn, BV, primary, Loibl, S, additional, Karn, T, additional, Untch, M, additional, Kunze, CA, additional, Weber, KE, additional, Treue, D, additional, Wagner, K, additional, Hanusch, CA, additional, Klauschen, F, additional, Fasching, PA, additional, Huober, J, additional, Zahm, D-M, additional, Jackisch, C, additional, Thomalla, J, additional, Blohmer, J-U, additional, van Mackelenbergh, M, additional, Rhiem, K, additional, Felder, B, additional, von Minckwitz, G, additional, Burchardi, N, additional, Schneeweiss, A, additional, and Denkert, C, additional

Published
2019
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21. Abstract P4-08-26: Validation of different prognostic scores in breast cancer patients with brain metastases of the BMBC registry (GBG-79)

Author

Witzel, ID, primary, Riecke, K, additional, Laakmann, E, additional, Weide, R, additional, Neunhoeffer, T, additional, Park-Simon, T-W, additional, Schmidt, M, additional, Fasching, PA, additional, Hesse, T, additional, Polasik, A, additional, Mohrmann, S, additional, Würschmidt, F, additional, Schem, C, additional, Bechtner, C, additional, Würstlein, R, additional, Fehm, T, additional, Möbus, V, additional, Burchardi, N, additional, Loibl, S, additional, and Müller, V, additional

Published
2019
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22. Validierung des Breast-GPA Scores bei Patientinnen mit Hirnmetastasen eines Mammakarzinoms im BMBC-Register (GBG-79)

Author

Riecke, K, additional, Müller, V, additional, Laakmann, E, additional, Weide, R, additional, Park-Simon, TW, additional, Schmidt, M, additional, Fasching, P, additional, Hesse, T, additional, Schem, C, additional, Bechtner, C, additional, Würschmidt, F, additional, Würstlein, R, additional, Fehm, T, additional, Moebus, V, additional, Burchardi, N, additional, Loibl, S, additional, and Witzel, I, additional

Published
2018
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23. A randomized, open-label, phase IV study evaluating palbociclib plus endocrine treatment versus a chemotherapy-based treatment in patients with hormone receptor-positive, HER2-negative metastatic breast cancer (PADMA)

Author

Thill, M, additional, Seiler, S, additional, Decker, T, additional, Denkert, C, additional, Lübbe, K, additional, Furlanetto, J, additional, Müller, V, additional, Mundhenke, C, additional, Schmidt, M, additional, Uhlig, M, additional, Burchardi, N, additional, and Loibl, S, additional

Published
2018
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24. Abstract OT3-05-04: A randomized, open-label, multi-center phase IV study evaluating palbociclib plus endocrine treatment versus a chemotherapy-based treatment strategy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer in a real world setting (PADMA)

Author

Loibl, S, primary, Barinoff, J, additional, Seiler, S, additional, Decker, T, additional, Denkert, C, additional, Hardy-Bessard, A-C, additional, Senkus-Konefka, E, additional, Cognetti, F, additional, Palmieri, C, additional, Gelmon, K, additional, Luebbe, K, additional, Furlanetto, J, additional, Mueller, V, additional, Mundhenke, C, additional, Schmidt, M, additional, von Minckwitz, G, additional, Uhlig, M, additional, Burchardi, N, additional, and Thill, M, additional

Published
2018
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25. Abstract P5-20-09: Pharmacokinetic results of a subcutaneous injection of trastuzumab into the thigh versus into the abdominal wall in patients with HER2-positive primary breast cancer (BC) treated within the neo-/adjuvant GAIN-2 study

Author

Möbus, V, primary, Mahlberg, R, additional, Janni, W, additional, Tomé, O, additional, Marmé, F, additional, Forstbauer, H, additional, Reimer, T, additional, von der Assen, A, additional, Reinisch, M, additional, Lorenz, R, additional, Schmatloch, S, additional, Schmidt, M, additional, Sinn, B, additional, Klutinus, N, additional, Stickeler, E, additional, Untch, M, additional, Seiler, S, additional, Burchardi, N, additional, von Minckwitz, G, additional, and Loibl, S, additional

Published
2018
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26. Abstract P6-15-01: Withdrawn

Author

Loibl, S, primary, Untch, M, additional, Denkert, C, additional, Huober, J, additional, Blohmer, JU, additional, Grischke, E-M, additional, Furlanetto, J, additional, Tesch, H, additional, Hanusch, C, additional, Rezai, M, additional, Jackisch, C, additional, Schmitt, WD, additional, von Minckwitz, G, additional, Thomalla, J, additional, Kümmel, S, additional, Rautenberg, B, additional, Fasching, PA, additional, Rhiem, K, additional, Burchardi, N, additional, and Schneeweiss, A, additional

Published
2018
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27. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non-Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors.

Author

Hendry, Shona, Salgado, Roberto, Gevaert, Thomas, Russell, PA, John, T, Thapa, B, Christie, M, Van De Vijver, Kristin Inneke, Estrada, Mónica Valeria, Gonzales-Ericsson, PI, Sanders, Melinda M.E., Solomon, B, Solinas, Cinzia, Van den Eynden, Gert, Allory, Y, Preusser, Matthias, Hainfellner, J, Pruneri, Giancarlo, Vingiani, Andrea, Demaria, S, Symmans, Fraser, Nuciforo, Paolo, Comerma, L, Thompson, E A, Lakhani, Sunil S.R., Kim, Su Ryang, Schnitt, S, Colpaert, S, Sotiriou, Christos, Ignatiadis, Michail, Badve, S, Pierce, RH, Viale, G, Sirtaine, N., Pénault-Llorca, Frederique, Sugie, T, Fineberg, Daniel, Paik, Soon, Srinivasa, A, Richardson, A L, Wang, Y, Chmielik, E, Johnson, Douglas D.B., Balko, Justin J.M., Wienert, S, Bossuyt, V, Michiels, S, Ternest, N, Burchardi, N, Luen, SJ, Savas, P, Klauschen, F, Watson, PH, Nelson, BH, Criscitiello, Carmen, O'Toole, S, Larsimont, Denis, De Wind, Roland, Curigliano, G, André, F, Lacroix-Triki, M, Van de Vijver, Marc J, Rojo Fernandez, José Manuel, Floris, Giuseppe, Svatos, Bedrich, Sparano, Joseph, Rimm, David D.L., Nielsen, T, Kos, Z, Hewitt, Stephen M, Singh, Bal Ram, Farshid, G, Loibl, Sibylle, Allison, K H, Tung Ngu, Chan, Adams, S., Willard-Gallo, Karen, Horlings, HM, Gandhi, L, Moreira, A., Hirsch, F, Dieci, Maria V, Urbanowicz, M, Brcic, I, Korski, K, Gaire, F, Koeppen, A.H., Lo, A., Giltnane, Jennifer J.M., Rebelatto, MC, Steele, KE, Zha, J, Emancipator, K, Juco, JW, Denkert, Carsten, Reis-Filho, Jorge Sergio, Loi, Sherene, Fox, Stephen B, Hendry, Shona, Salgado, Roberto, Gevaert, Thomas, Russell, PA, John, T, Thapa, B, Christie, M, Van De Vijver, Kristin Inneke, Estrada, Mónica Valeria, Gonzales-Ericsson, PI, Sanders, Melinda M.E., Solomon, B, Solinas, Cinzia, Van den Eynden, Gert, Allory, Y, Preusser, Matthias, Hainfellner, J, Pruneri, Giancarlo, Vingiani, Andrea, Demaria, S, Symmans, Fraser, Nuciforo, Paolo, Comerma, L, Thompson, E A, Lakhani, Sunil S.R., Kim, Su Ryang, Schnitt, S, Colpaert, S, Sotiriou, Christos, Ignatiadis, Michail, Badve, S, Pierce, RH, Viale, G, Sirtaine, N., Pénault-Llorca, Frederique, Sugie, T, Fineberg, Daniel, Paik, Soon, Srinivasa, A, Richardson, A L, Wang, Y, Chmielik, E, Johnson, Douglas D.B., Balko, Justin J.M., Wienert, S, Bossuyt, V, Michiels, S, Ternest, N, Burchardi, N, Luen, SJ, Savas, P, Klauschen, F, Watson, PH, Nelson, BH, Criscitiello, Carmen, O'Toole, S, Larsimont, Denis, De Wind, Roland, Curigliano, G, André, F, Lacroix-Triki, M, Van de Vijver, Marc J, Rojo Fernandez, José Manuel, Floris, Giuseppe, Svatos, Bedrich, Sparano, Joseph, Rimm, David D.L., Nielsen, T, Kos, Z, Hewitt, Stephen M, Singh, Bal Ram, Farshid, G, Loibl, Sibylle, Allison, K H, Tung Ngu, Chan, Adams, S., Willard-Gallo, Karen, Horlings, HM, Gandhi, L, Moreira, A., Hirsch, F, Dieci, Maria V, Urbanowicz, M, Brcic, I, Korski, K, Gaire, F, Koeppen, A.H., Lo, A., Giltnane, Jennifer J.M., Rebelatto, MC, Steele, KE, Zha, J, Emancipator, K, Juco, JW, Denkert, Carsten, Reis-Filho, Jorge Sergio, Loi, Sherene, and Fox, Stephen B

Abstract

info:eu-repo/semantics/published

Published
2017

28. A randomized phase II study to investigate the addition of PD-L1 antibody MEDI4673 (durvalumab) to a taxane-anthracycline containing chemotherapy in triple negative breast cancer (GeparNuevo)

Author

Loibl, S., primary, Schneeweiss, A., additional, Burchardi, N., additional, Blohmer, J.-U., additional, Hanusch, C., additional, Costa, S.D., additional, Huober, J., additional, Jackisch, C., additional, von Minckwitz, G., additional, Kümmel, S., additional, Paepke, S., additional, Denkart, C., additional, and Untch, M., additional

Published
2016
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29. The LaLiMo Trial: lamotrigine compared with levetiracetam in the initial 26 weeks of monotherapy for focal and generalised epilepsy—an open-label, prospective, randomised controlled multicenter study

Author

Rosenow, F., Schade-Brittinger, C., Burchardi, N., Arnold, Stephan, and LaLiMo Study Group

Subjects
610 Medizin
Abstract

Background: Of the newer antiepileptic drugs, lamotrigine (LTG) and levetiracetam (LEV) are popular first choice drugs for epilepsy. The authors compared these drugs with regard to their efficacy and tolerability in the initial monotherapy for epilepsy. Methods: A randomised, open-label, controlled, parallel group, multicenter trial was conducted to test the superiority of the LEV arm over the LTG arm. The primary endpoint was the rate of seizure-free patients in the first 6 weeks (two-sided Fisher's exact test, α=0.05, intent-to-treat set). Furthermore, efficacy, tolerability and quality of life were evaluated. The authors included 409 patients aged ≥12 years with newly diagnosed focal or generalised epilepsy defined by either two or more unprovoked seizures or one first seizure with high risk for recurrence. Patients were titrated to 2000 mg/day of LEV or 200 mg/day of LTG reached on day 22 or 71, respectively. Two dose adjustments by 500/50 mg were allowed. Results: The proportions of seizure-free patients were 67.5% (LEV) versus 64.0% (LTG) 6 weeks after randomisation (p=0.47), and 45.2% (LEV) versus 47.8% (LTG) during the whole treatment period of 26 weeks. The HR (LEV vs LTG) for seizure-free time was 0.86 (95% CI, 0.61 to 1.22). Adverse events occurred in 74.5% (LEV) versus 70.6% (LTG) of the patients (p=0.38). Adverse events associated with study discontinuation occurred in 17/204 (LEV) versus 8/201 (LTG) patients (p=0.07). Conclusions: There were no significant differences with regard to efficacy and tolerability of LEV and LTG in newly diagnosed focal and generalised epilepsy despite more rapid titration in the LEV arm. Clinical trial registration number: ClinicalTrials.gov identifier NCT00242606.

Published
2012
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30. Abstract P1-13-05: GAIN-2: Adjuvant phase III trial to compare intense dose-dense (idd) treatment with EnPC to tailored dose-dense (dt) therapy with dtEC-dtD for patients with high-risk early breast cancer: Results of the second safety interim analyses

Author

Möbus, V, primary, Lück, H-J, additional, Forstbauer, H, additional, Wachsmann, G, additional, Ober, A, additional, Schneeweiss, A, additional, Christensen, B, additional, von Abel, E, additional, Grischke, E-M, additional, Höffkes, H-G, additional, Klare, P, additional, Yon-Dschun, K, additional, Schmatloch, S, additional, Furlanetto, J, additional, Burchardi, N, additional, von Minckwitz, G, additional, and Loibl, S, additional

Published
2016
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31. Abstract P6-17-08: Brain metastases in breast cancer network Germany (BMBC, GBG 79): First analysis of 548 patients from the multicenter registry

Author

Witzel, I, primary, Loibl, S, additional, Laakmann, E, additional, Augustin, D, additional, Flock, F, additional, Dohmen, H-H, additional, Durmus, G, additional, Frank, M, additional, Hesse, T, additional, Ignatov, A, additional, Kühn, T, additional, Neunhöffer, T, additional, Park-Simon, T-W, additional, Schmidt, M, additional, Stefek, A, additional, Weide, R, additional, Würschmidt, F, additional, Fehm, T, additional, Moebus, V, additional, von Minckwitz, G, additional, Burchardi, N, additional, and Mueller, V, additional

Published
2016
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32. Abstract OT1-03-08: DESIREE - A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer

Author

Loibl, S, primary, Furlanetto, J, additional, Barinoff, J, additional, Bauerschlag, D, additional, Herr, D, additional, Lübbe, K, additional, Maass, N, additional, Müller, V, additional, Mundhenke, C, additional, Schmidt, M, additional, Schwedler, K, additional, Thill, M, additional, Gkantiragas, I, additional, Burchardi, N, additional, and von Minckwitz, G, additional

Published
2016
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33. DESIREE – Eine multizentrische, randomisierte doppelblinde, Phase-II-Studie zum Vergleich der Verträglichkeit bei vorgeschalteter ansteigender Everolimus Dosierung bei Patienten mit metastasiertem Brustkrebs

Author

Loibl, S, primary, Furlanetto, J, additional, Barinoff, J, additional, Bauerschlag, D, additional, Herr, D, additional, Lübbe, K, additional, Maass, N, additional, Müller, V, additional, Mundhenke, C, additional, Schmidt, M, additional, Schwedler, K, additional, Thill, M, additional, Gkantiragas, I, additional, Burchardi, N, additional, and Minckwitz, G von, additional

Published
2015
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34. GAIN2: Adjuvante Phase III Studie zum Vergleich einer intensivierten dosisdichten adjuvanten Therapie mit EnPC im Vergleich zu einer dosisdichten, adaptierten Therapie mit dtEC-dtD bei Patienten mit einem frühen Hochrisiko-Brustkrebs: Ergebnisse der zweiten Sicherheitsanalyse

Author

Möbus, V, primary, Lück, H, additional, Forstbauer, H, additional, Wachsmann, G, additional, Ober, A, additional, Schneeweiss, A, additional, Christensen, B, additional, Abel, E von, additional, Grischke, E, additional, Hoeffkes, H, additional, Klare, P, additional, Ko, Y, additional, Schmatloch, S, additional, Burchardi, N, additional, Loibl, S, additional, and Minckwitz, G von, additional

Published
2015
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37. Breaking bad news

Author

Schildmann, J, Härlein, J, Burchardi, N, Schlögl, M, and Vollmann, J

Subjects
Teamwork, ddc: 610, interprofessional education, communication skills, kommunikative Kompetenzen, interprofessionelle Ausbildung, breaking bad news, Schlechte Nachrichten überbringen
Abstract

Background: Breaking bad news is a frequent and difficult communication situation in clinical practice. Informing patients about bad news is part of physicians' tasks. Nurses may support patients during the process of realising bad news on a cognitive as well as emotional level. Empirical studies show that experiential courses are effective measures to train communication skills. This paper presents the course concept of an interprofessional teaching session for medical and nursing students on the communication with seriously ill patients. Description of the project: Since 2002, 54 participants took part in seven courses. Teaching aims are the development of competences to provide feedback as well as communication skills with respect to discussions with seriously ill patients. In addition students get to know the specific tasks both professions encounter in the context of discussions with patients who had been diagnosed with a serious illness. Role plays with simulated patients, small group discussions as well as a session with clinically experienced physicians and nurses are the main teaching methods. Conclusion: The optional course has been well accepted by both student groups. In addition to the analysis of individual communication skills participants use the collaborative teaching sessions to discuss the options of an interprofessional approach of breaking bad news. There is a lack of scientific literature regarding the criteria of interprofessional concepts of breaking bad news. Such research is necessary to define specific teaching aims of collaborative courses on disclosing bad news and will serve as a fundament for future evaluation studies. Hintergrund: Das Überbringen schlechter Nachrichten ist eine häufige und schwierige Gesprächssituation im klinischen Alltag. Während das Aufklärungsgespräch ärztliche Aufgabe ist, unterstützen Mitarbeiter der Krankenpflege1, 2 die Patienten im Verlauf des Aufklärungsprozesses bei der kognitiven und emotionalen Verarbeitung einer schlechten Nachricht. Empirische Untersuchungen belegen die Effektivität erfahrungsorientierter Lehrveranstaltungen zur Ausbildung kommunikativer Fertigkeiten. In dieser Arbeit wird das Kurskonzept einer interprofessionellen Lehrveranstaltung für Medizinstudenten und Krankenpflegeschüler zur Kommunikation mit schwer kranken Patienten im Aufklärungsprozess vorgestellt. Projektbeschreibung: Die fakultative Lehrveranstaltung wurde seit 2002 sieben Mal mit insgesamt 54 Kursteilnehmenden durchgeführt. Lernziele der Lehrveranstaltung sind die Weiterentwicklung kommunikativer Kompetenzen für Gespräche mit schwer kranken Patienten sowie der Erwerb von Kompetenzen zur konstruktiven Rückmeldung (Feedback). In Ergänzung dazu sollen im Rahmen des interprofessionellen Ansatzes Kenntnisse der berufsgruppenspezifischen Aufgaben im Aufklärungsprozess erworben werden. Gespräche mit Simulationspatienten, Diskussionen in Kleingruppen sowie der Austausch mit klinisch erfahrenen Ärzten und Krankenpflegern sind die Wichtigsten in der Lehrveranstaltung eingesetzten Lehrmethoden. Schlussfolgerung: Das Kursangebot wird von Medizinstudenten und Krankenpflegeschülern gut angenommen. Neben der Analyse des individuellen Gesprächsverhaltens wird die Veranstaltung von den Teilnehmern genutzt, um Möglichkeiten der interprofessionellen Zusammenarbeit bei der Patientenaufklärung zu identifizieren. Es besteht ein Mangel an wissenschaftlichen Arbeiten zur Konzeptionalisierung interprofessioneller Ansätze bei der Patientenaufklärung. Dies ist Voraussetzung für die Definition spezifischer Lehr- und Lernziele interprofessioneller Kursveranstaltungen zum Überbringen schlechter Nachrichten und bildet die Grundlage für zukünftige Evaluationsstudien.

Published
2006

42. Dual Blockade with Afatinib and Trastuzumab As Neoadjuvant Treatment for Patients with Locally Advanced or Operable Breast Cancer Receiving Taxane-Anthracycline Containing Chemotherapy (Dafne)-Gbg70 – Efficacy and Safety Analysis

Author

Hanusch, C., primary, Schneeweiss, A., additional, Untch, M., additional, Paepke, S., additional, Kümmel, S., additional, Jackisch, C., additional, Huober, J., additional, Hilfrich, J., additional, Gerber, B., additional, Eidtmann, H., additional, Denkert, C., additional, Costa, S., additional, Blohmer, J.U., additional, Loibl, S., additional, Burchardi, N., additional, and von Minckwitz, G., additional

Published
2014
Full Text
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43. Gain2: Adjuvant Phase III Trial Comparing an Intensified Dose-Dense Adjuvant Therapy with Enpc Compared with a Dose-Dense, Dose-Adapted Therapy with Dtec Dtdocetaxel in Patients with Primary Breast Cancer and a High Risk of Recurrence

Author

Noeding, S., primary, Forstbauer, H., additional, Wachsmann, G., additional, Ober, A., additional, Schneeweiss, A., additional, Christensen, B., additional, von Abel, E., additional, Grischke, E., additional, Höffkes, H., additional, Klare, P., additional, Ko, Y., additional, Schmatloch, S., additional, Burchardi, N., additional, Loibl, S., additional, von Minckwitz, G., additional, and Möbus, V., additional

Published
2014
Full Text
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44. GAIN2: Adjuvante Phase III Studie zum Vergleich einer intensivierten dosisdichten adjuvanten Therapie mit EnPC im Vergleich zu einer dosisdichten, adaptierten Die Therapie mit dtEC-dtD bei Patienten mit einem frühen Hochrisiko-Brustkrebs

Author

Noeding, S, primary, Forstbauer, H, additional, Wachsmann, G, additional, Ober, A, additional, Schneeweiss, A, additional, Christensen, B, additional, Abel, E von, additional, Grischke, EM, additional, Höffkes, H, additional, Klare, P, additional, Ko, Y, additional, Schmatloch, S, additional, Burchardi, N, additional, Loibl, S, additional, Minckwitz, G von, additional, and Möbus, V, additional

Published
2014
Full Text
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48. Die Aufklärung schwer kranker Patienten im interprofessionellen Kontext

Author

Schildmann, J, Härlein, J, Burchardi, N, Schlögl, M, Vollmann, J, Schildmann, J, Härlein, J, Burchardi, N, Schlögl, M, and Vollmann, J

Abstract

Background: Breaking bad news is a frequent and difficult communication situation in clinical practice. Informing patients about bad news is part of physicians' tasks. Nurses may support patients during the process of realising bad news on a cognitive as well as emotional level. Empirical studies show that experiential courses are effective measures to train communication skills. This paper presents the course concept of an interprofessional teaching session for medical and nursing students on the communication with seriously ill patients. Description of the project: Since 2002, 54 participants took part in seven courses. Teaching aims are the development of competences to provide feedback as well as communication skills with respect to discussions with seriously ill patients. In addition students get to know the specific tasks both professions encounter in the context of discussions with patients who had been diagnosed with a serious illness. Role plays with simulated patients, small group discussions as well as a session with clinically experienced physicians and nurses are the main teaching methods. Conclusion: The optional course has been well accepted by both student groups. In addition to the analysis of individual communication skills participants use the collaborative teaching sessions to discuss the options of an interprofessional approach of breaking bad news. There is a lack of scientific literature regarding the criteria of interprofessional concepts of breaking bad news. Such research is necessary to define specific teaching aims of collaborative courses on disclosing bad news and will serve as a fundament for future evaluation studies., Hintergrund: Das Überbringen schlechter Nachrichten ist eine häufige und schwierige Gesprächssituation im klinischen Alltag. Während das Aufklärungsgespräch ärztliche Aufgabe ist, unterstützen Mitarbeiter der Krankenpflege1, 2 die Patienten im Verlauf des Aufklärungsprozesses bei der kognitiven und emotionalen Verarbeitung einer schlechten Nachricht. Empirische Untersuchungen belegen die Effektivität erfahrungsorientierter Lehrveranstaltungen zur Ausbildung kommunikativer Fertigkeiten. In dieser Arbeit wird das Kurskonzept einer interprofessionellen Lehrveranstaltung für Medizinstudenten und Krankenpflegeschüler zur Kommunikation mit schwer kranken Patienten im Aufklärungsprozess vorgestellt. Projektbeschreibung: Die fakultative Lehrveranstaltung wurde seit 2002 sieben Mal mit insgesamt 54 Kursteilnehmenden durchgeführt. Lernziele der Lehrveranstaltung sind die Weiterentwicklung kommunikativer Kompetenzen für Gespräche mit schwer kranken Patienten sowie der Erwerb von Kompetenzen zur konstruktiven Rückmeldung (Feedback). In Ergänzung dazu sollen im Rahmen des interprofessionellen Ansatzes Kenntnisse der berufsgruppenspezifischen Aufgaben im Aufklärungsprozess erworben werden. Gespräche mit Simulationspatienten, Diskussionen in Kleingruppen sowie der Austausch mit klinisch erfahrenen Ärzten und Krankenpflegern sind die Wichtigsten in der Lehrveranstaltung eingesetzten Lehrmethoden. Schlussfolgerung: Das Kursangebot wird von Medizinstudenten und Krankenpflegeschülern gut angenommen. Neben der Analyse des individuellen Gesprächsverhaltens wird die Veranstaltung von den Teilnehmern genutzt, um Möglichkeiten der interprofessionellen Zusammenarbeit bei der Patientenaufklärung zu identifizieren. Es besteht ein Mangel an wissenschaftlichen Arbeiten zur Konzeptionalisierung interprofessioneller Ansätze bei der Patientenaufklärung. Dies ist Voraussetzung für die Definition spezifischer Lehr- und Lernziele interprofessioneller Kursveranstaltungen zum Überbringen schlechter Nac

Published
2006

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