5 results on '"Ziegler-Löhr K"'
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2. Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958).
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Thill M, Wimberger P, Grafe A, Klare P, Luedtke-Heckenkamp K, Reichert D, Zaiss M, Ziegler-Löhr K, Eckl T, and Schneeweiss A
- Subjects
- Humans, Adult, Middle Aged, Aged, Aged, 80 and over, Female, Trastuzumab adverse effects, Receptor, ErbB-2, Docetaxel therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Neoplasm Recurrence, Local pathology, Breast Neoplasms pathology, Neoplasms, Second Primary etiology
- Abstract
Purpose: NIS HELENA documented outcomes in clinical routine practice of first-line therapy with P plus T and docetaxel (D) of patients with advanced HER2-positive BC and prior (neo)adjuvant T., Methods: Between 06/2013 through 07/2016, 126 patients (in-label use of P at study start = full analysis set, FAS) in 81 German study sites were included. Intense documentation period was limited to 28 treatment cycles. Maximum follow-up (FU) was 24 months (mos). Safety was assessed in the safety set (SAF = eligible patients with at least one dose of P, n = 132). Median progression-free survival (PFS) was the main parameter of interest., Results: Mean age of FAS patients was 55.1 [30.7-80.2] years, 81.7% (95.2%) were < 65 (75) years of age. 51.6% of the FAS patients were hormone receptor-positive (HR+), 91.3% had distant, 73.0% visceral, and 18.3% non-visceral metastases. Median disease-free interval was 40.2 [6.6-95.9] mos. Effectiveness (FAS): Median PFS was 18.8 [15.1; 24.2] mos. Overall response rate was 64.3% (55.6; 72.1). Median overall survival was 55.9 mos [41.2, not reached]. Safety (SAF): 93.9% of patients had an adverse event (AE), 32.6% a serious AE (SAE). AEs related to P occurred in 53.8% of SAF, SAEs related to P in 13.6%. Diarrhea was the most frequently reported related (S)AE. There were 8 (6.1%) patients with a fatal AE., Conclusion: Based on the outcomes from NIS HELENA, results of dual blockade with P+T in patients relapsing after (neo)adjuvant T as reported from the CLEOPATRA study (NCT01777958) can be transferred to routine clinical practice. No new safety signals were detected., (© 2022. The Author(s).)
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- 2022
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3. Olaparib for metastatic breast cancer in a patient with a germline PALB2 variant.
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Kuemmel S, Harrach H, Schmutzler RK, Kostara A, Ziegler-Löhr K, Dyson MH, Chiari O, and Reinisch M
- Abstract
There is a strong biologic rationale that poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors may benefit a broader range of metastatic breast cancer (MBC) patients than covered by current approvals, which require a germline BRCA1/2 sequence variant affecting function. We report a patient with germline/somatic BRCA1/2 wild-type MBC, who had a dramatic response to the PARP inhibitor olaparib of at least 8 months' duration. The patient is a 37-year-old woman with recurrent, hormone receptor-positive, HER2-negative MBC that had progressed despite hormonal therapy and palbociclib. Sensitivity to olaparib was likely conferred by a germline sequence variant affecting function in PALB2 (exon 1, c.18G>T, p.(=)). This case documenting activity of olaparib monotherapy in germline/somatic BRCA1/2 wild-type MBC illustrates that the clinical potential of PARP inhibition in MBC extends beyond currently approved indications to additional patients whose tumors have (epi)genetic changes affecting homologous recombination repair., Competing Interests: Competing interestsS.K. reports receiving personal fees from Roche, Genomic Health, Novartis, Amgen, Celgene, Daiichi Sankyo, Astra Zeneca, Somatex, MSD, Pfizer, Puma Biotechnology, PFM Medical and Lilly, and nonfinancial support from Roche, Daiichi Sankyo, Somatex and Sonoscape (outside the submitted work). A.K. reports receiving personal fees from Astra Zeneca and nonfinancial support from Tesaro and MSD (outside the submitted work). M.H.D. reports receiving personal fees from Boehringer Ingelheim, Merck, Novartis, EUSA Pharma, AbbVie, Janssen, Biogen, Menarini, and Norgine (outside the submitted work). M.R. reports receiving personal fees from Novartis, Lilly, Roche, Pfizer, Astra Zeneca, MSD and Somatex, and travel grants from Novartis, Pfizer and Celgene. Other authors report no competing interests., (© The Author(s) 2020.)
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- 2020
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4. ABC5 International Consensus Conference on Advanced Breast Cancer, Lisbon, 16 November 2019: Commentary by the German panel of experts on the ABC5 voting results.
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Untch M, Würstlein R, Lüftner D, Haidinger R, Fasching PA, Augustin D, Briest S, Ettl J, Förster F, Kurbacher CM, Lück HJ, Marschner N, Müller L, Müller V, Radke I, Ruckhäberle E, Scheffen I, Schumacher-Wulf E, Schwoerer M, Steinfeld-Birg D, Ziegler-Löhr K, Thomssen C, and Harbeck N
- Abstract
The Advanced Breast Cancer Fifth International Consensus Conference (ABC5) which focuses on the diagnosis and treatment of advanced breast cancer was held in Lisbon on November 14 - 16, 2019. The aim of the conference is to standardize the treatment of advanced breast cancer worldwide using evidence-based data and to ensure that patients with advanced breast disease anywhere in the world are treated appropriately and have access to the latest therapies. This year, the emphasis was on new developments and study results from patients with advanced breast cancer as well as precision medicine. The collaboration with patient advocates from all over the globe is also an important goal of the ABC Conference, which is why the international ABC panel also included a number of patient advocates. We present a commentary on the voting results of the ABC5 panelists in Lisbon by a working group of German breast cancer specialists together with the implications for routine clinical care in Germany. The commentary is based on the recommendations of the Breast Commission of the German Gynecological Oncology Working Group (AGO). This commentary is useful, it includes country-specific features for the ABC consensus., Competing Interests: Conflict of Interest/Interessenkonflikt Prof. Michael Untch: honoraria paid to his employer (for adboard participation, presentations) and travel grants from Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Eisai, Janssen Cilag, Johnson & Johnson, Lilly Deutschland, Lilly International, MSD Merck, Mundipharma, Myriad Genetics, Odonate, Pfizer, PUMA Biotechnology, Riemser, Roche, Sanofi Aventis, Sividon Diagnostics, Teva Pharmaceuticals Ind. Ltd. PD Dr. med. Rachel Würstlein received honoraria from Agendia, Amgen, AstraZeneca, Boehringer Ingelheim, Carl Zeiss, Celgene, Daiichi Sankyo, Eisai, Genomic Health, GSK, Lilly, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Teva. Prof. Diana Lüftner received honoraria from Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Esai, Genomic Health, GSK, Lilly, MSD, Mundipharma, Novartis, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Tesaro Bio, Teva. Renate Haidinger has no conflict of interest. Prof. Peter A. Fasching received honoraria from Roche, Pfizer, Celgene, Daiichi Sankyo, Merck Sharp & Dohme, Myelo Therapeutics, Eisai, Puma, Lilly, Novartis, AstraZeneca, and his institution received research funding from BionTech and Cepheid. Prof. Christoph Thomssen received honoraria from Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Lilly, MSD, Mundipharma, MEDA, Novartis, Roche, Tesaro, Vifor. Prof. Nadia Harbeck received honoraria for lectures and/or consultancy work from Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Lilly, MSD, Novartis, Odonate, Pierre Fabre, Pfizer, Roche, Sandoz/Hexal, Seattle Genetics. Dr. med. Doris Augustin has no conflict of interest. Dr. med. Susanne Briest has no conflict of interest. Dr. med. Johannes Ettl received honoraria from AstraZeneca, Roche, Celgene, Novartis, Lilly, Pfizer, Pierre Fabre, Teva and travel grants from Celgene, Lily, Novartis, Pfizer, Teva, Pierre Fabre. Prof. Frank Förster received honoraria from Roche, Novartis, AstraZeneca, Eisai, Lilly, Pfizer, Tesaro, MSD, Celgene. Dr. med. Christian Kurbacher received honoraria from Amgen, Axios, Eli Lilly, Hilotherm, Mundipharma, NewCo, Novartis, Pfizer, Riemser, Roche, Tesaro. Research funding from AstraZeneca, Axios, MSD Sharp & Dohme, NewCo, Novartis, Pfizer, PharmaMar, Riemser, Seattle Genetics. Honoraria from Amgen, Eli Lilly, Novartis, Mundipharma, Pfizer, PharmaMar, Riemser, Roche, Tesaro; travel grants and other expenses from Amgen, Hexal, Pfizer, PharmaMar, Tesaro, Teva Oncology. Prof. Hans-Joachim Lück has no conflict of interest. Dr. med. Norbert Marschner received speakerʼs fees from Lilly, Roche, Novartis, Clovis, GSK, Amgen, Mylan, Eisai, Mundipharma, Novella, SEAGEN, and travel grants from Lilly, Roche. Dr. med. Lothar Müller received travel grants from octapharm and Medac. Prof. Volkmar Müller received honoraria from Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, and honoraria for consultancy work from Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Tesaro, Nektar. Dr. med. Isabel Radke received honoraria and/or travel grants from Amgen, AstraZeneca, Celgene, Genomic Health, Novartis, Pierre Fabre, Pfizer, Roche, Teva. Prof. Eugen Ruckhäberle received honoraria from Amgen, AstraZeneca, Pharma Mar, Celgene, Daiichi Sankyo, Eisai, GSK, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Clovis Oncology, Teva. Dr. med. Iris Scheffen received honoraria from Amgen, Celgene, MSD, Novartis, Pfizer, Roche. Eva Schumacher-Wulf has no conflict of interest. Dr. med. Moritz Schwoerer received honoraria for adboard participation from Roche. Dr. med. Dieter Steinfeld-Birg received honoraria from Amgen, Hexal, Roche, Teva, Novartis. Dr. med. Katja Ziegler-Löhr received honoraria from Celgene, Novartis, Oncovis, Roche, Tesaro./ Prof. Michael Untch: Honorare an den Arbeitgeber (für Adboard-Teilnahme, Präsentationen) und Reiseunterstützung von Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Eisai, Janssen Cilag, Johnson & Johnson, Lilly Deutschland, Lilly International, MSD Merck, Mundipharma, Myriad Genetics, Odonate, Pfizer, PUMA Biotechnology, Riemser, Roche, Sanofi Aventis, Sividon Diagnostics, Teva Pharmaceuticals Ind. Ltd. PD Dr. med. Rachel Würstlein erhielt Honorar von Agendia, Amgen, AstraZeneca, Boehringer Ingelheim, Carl Zeiss, Celgene, Daiichi Sankyo, Eisai, Genomic Health, GSK, Lilly, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Teva. Prof. Diana Lüftner erhielt Honorar von Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Esai, Genomic Health, GSK, Lilly, MSD, Mundipharma, Novartis, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Tesaro Bio, Teva. Renate Haidinger hat keinen Interessenkonflikt. Prof. Peter A. Fasching erhielt Honorare von Roche, Pfizer, Celgene, Daiichi Sankyo, Merck Sharp & Dohme, Myelo Therapeutics, Eisai, Puma, Lilly, Novartis, AstraZeneca und seine Institution erhielt Forschungsunterstützung von BionTech und Cepheid. Prof. Christoph Thomssen erhielt Honorar von Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Lilly, MSD, Mundipharma, MEDA, Novartis, Roche, Tesaro, Vifor. Prof. Nadia Harbeck erhielt Honorare für Vorträge und/oder Beratung von Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Lilly, MSD, Novartis, Odonate, Pierre Fabre, Pfizer, Roche, Sandoz/Hexal, Seattle Genetics. Dr. med. Doris Augustin hat keinen Interessenkonflikt. Dr. med. Susanne Briest hat keinen Interessenkonflikt. Dr. med. Johannes Ettl erhielt Honorar von AstraZeneca, Roche, Celgene, Novartis, Lilly, Pfizer, Pierre Fabre, Teva und Reiseunterstützung von Celgene, Lily, Novartis, Pfizer, Teva, Pierre Fabre. Prof. Frank Förster erhielt Honorar von Roche, Novartis, AstraZeneca, Eisai, Lilly, Pfizer, Tesaro, MSD, Celgene. Dr. med. Christian Kurbacher erhielt Honorar von Amgen, Axios, Eli Lilly, Hilotherm, Mundipharma, NewCo, Novartis, Pfizer, Riemser, Roche, Tesaro. Forschungsunterstützung von AstraZeneca, Axios, MSD Sharp & Dohme, NewCo, Novartis, Pfizer, PharmaMar, Riemser, Seattle Genetics. Honorare von Amgen, Eli Lilly, Novartis, Mundipharma, Pfizer, PharmaMar, Riemser, Roche, Tesaro; Reiseunterstützung und sonstige Ausgaben von Amgen, Hexal, Pfizer, PharmaMar, Tesaro, Teva Oncology. Prof. Hans-Joachim Lück hat keinen Interessenkonflikt. Dr. med. Norbert Marschner erhielt Vortragshonorare von Lilly, Roche, Novartis, Clovis, GSK, Amgen, Mylan, Eisai, Mundipharma, Novella, SEAGEN und Reisekostenerstattung von Lilly, Roche. Dr. med. Lothar Müller erhielt Reiseunterstützung von octapharm und Medac. Prof. Volkmar Müller erhielt Honorar von Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, und Beratungshonorar von Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Tesaro, Nektar. Dr. med. Isabel Radke erhielt Honorar und/oder Reiseunterstützung von Amgen, AstraZeneca, Celgene, Genomic Health, Novartis, Pierre Fabre, Pfizer, Roche, Teva. Prof. Eugen Ruckhäberle erhielt Honorar von Amgen, AstraZeneca, Pharma Mar, Celgene, Daiichi Sankyo, Eisai, GSK, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Clovis Oncology, Teva. Dr. med. Iris Scheffen erhielt Honorar von Amgen, Celgene, MSD, Novartis, Pfizer, Roche. Eva Schumacher-Wulf hat keinen Interessenkonflikt. Dr. med. Moritz Schwoerer erhielt Honorar für Adboard-Teilnahme von Roche. Dr. med. Dieter Steinfeld-Birg erhielt Honorar von Amgen, Hexal, Roche, Teva, Novartis. Dr. med. Katja Ziegler-Löhr erhielt Honorar von Celgene, Novartis, Oncovis, Roche, Tesaro.
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- 2020
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5. International Consensus Conference for Advanced Breast Cancer, Lisbon 2019: ABC5 Consensus - Assessment by a German Group of Experts.
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Thomssen C, Lüftner D, Untch M, Haidinger R, Würstlein R, Harbeck N, Augustin D, Briest S, Ettl J, Fasching PA, Förster F, Kurbacher CM, Lück HJ, Marschner N, Müller L, Müller V, Perlova-Griff L, Radke I, Ruckhäberle E, Scheffen I, Schumacher-Wulf E, Schwoerer M, Steinfeld-Birg D, and Ziegler-Löhr K
- Abstract
The 5th International Consensus Conference for Advanced Breast Cancer (ABC5) took place on November 14-16, 2019, in Lisbon, Portugal. Its aim is to standardize the treatment of advanced breast cancer based on the available evidence and to ensure that all breast cancer patients worldwide receive adequate treatment and access to new therapies. This year, the conference focused on developments and study results in the treatment of patients with hormone receptor-positive/HER2-negative breast cancer as well as precision medicine. As in previous years, patient advocates from around the world were integrated into the ABC conference and had seats on the ABC consensus panel. In the present paper, a working group of German breast cancer experts comments on the results of the on-site ABC5 consensus votes by ABC panelists regarding their applicability for routine treatment in Germany. These comments take the recommendations of the Breast Committee of the Gynecological Oncology Working Group ( Arbeitsgemeinschaft Gynäkologische Onkologie ; AGO) into account. The report and assessment presented here pertain to the preliminary results of the ABC5 consensus. The final version of the statements will be published in Annals of Oncology and The Breast ., Competing Interests: Prof. Christoph Thomssen received honoraria from Amgen, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, Lilly, MSD, Mundipharma, MEDA, Novartis, Roche, Tesaro, and Vifor. Prof. Diana Lüftner received honoraria from AstraZeneca, Celgene, Pfizer, Novartis, Amgen, Roche, Loreal, Teva, Tesaro, and Eli Lilly. Prof. Michael Untch received honoraria to the employer (for AdBoard participation, presentations) and travel grants from Amgen, AstraZeneca, BMS, Celgene, Daiichi Sankyo, Eisai, Janssen Cilag, Johnson & Johnson, Lilly Deutschland, Lilly International, MSD Merck, Mundipharma, Myriad Genetics, Odonate, Pfizer, PUMA Biotechnology, Riemser, Roche, Sanofi Aventis, Sividon Diagnostics, and TEVA Pharmaceuticals Ind. Ltd. Renate Haidinger, Dr. med. Doris Augustin, Dr. med. Susanne Briest, Dr. med. Lidia Perlova-Griff, Prof. Hans-Joachim Lück, Dr. med. Norbert Marschner, and Eva Schumacher-Wulf have no conflict of interests. PD Dr. med. Rachel Würstlein received honoraria from Agendia, Amgen, AstraZeneca, Boehringer Ingelheim, Carl Zeiss, Celgene, Daiichi Sankyo, Eisai, Genomic Health, GSK, Lilly, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, and Teva. Prof. Nadia Harbeck received honoraria for consulting and/or lectures from Agendia, Amgen, Astra Zeneca Celgene, Genomic Health, Lilly, MSD, Novartis, Odonate, Pfizer, Roche, Sandoz/Hexal, and Seattle Genetics. Dr. med. Johannes Ettl received honoraria from Astra Zeneca, Roche, Celgene, Novartis, Lilly, Pfizer, Pierre Fabre, TEVA and travel support from Celgene, Lily, Novartis, Pfizer, TEVA, and Pierre Fabre. Prof. Peter A. Fasching received honoraria from Roche, Pfizer, Celgene, Daiichi-Sankyo, TEVA, Marck Sharp and Dohme, Myelo Therapeutics, Macrogenics, Eisai, Puma, Lilly, Novartis, and AstraZeneca and he received grant from BioTech, Cepheid, and Novartis. Prof. Frank Förster received honoraria for consulting and/or lectures from Roche, Novartis, AstraZeneca, Eisai, Lilly, Pfizer, Tesaro, MSD, and Celgene. Dr. med. Christian Kurbacher received honoraria for a consulting or advisory role from Amgen, Axios, Eli Lilly, Hilotherm, Mundipharma, NewCo, Novartis, Pfizer, Riemser, Roche, Tesaro; research funding from AstraZeneca, Axios, MSD Sharp and Dohme, NewCo, Novartis, Pfizer, PharmaMar, Riemser, and Seattle Genetics; honoraria from Amgen, Eli Lilly, Novartis, Mundipharma, Pfizer, PharmaMar, Riemser, Roche, and Tesaro; and a travel grant, accommodations and expenses from Amgen, Hexal, Pfizer, PharmaMar, Tesaro, and TEVA Oncology. Dr. med. Lothar Müller received travel grants from octapharm and Medac. Prof. Volkmar Müller received honoraria from Amgen, Astra Zeneca, Celgene, Daiichi-Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, and Teva and consultancy honoraria from Genomic Health, Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Tesaro, and Nektar. Dr. med. Isabel Radke received honoraria and/or travel grants from Amgen, Astra Zeneca, Celgene, Genomic Health, Novartis, Pierre Fabre, Pfizer, Roche, and Teva. Prof. Eugen Ruckhäberle received honoraria from Amgen, AstraZeneca, Pharma Mar, Celgene, Daiichi Sankyo, Eisai, GSK, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Clovis Oncology, and Teva. Dr. med. Iris Scheffen received honoraria from Amgen, Celgene, MSD, Novartis, Pfizer, and Roche. Dr. med. Moritz Schwoerer received honoraria for adboard participation from Roche. Dr. med. Dieter Steinfeld-Birg received honoraria for studies and/or consulting from Amgen, Hexal, Roche, Teva, and Novartis. Dr. med. Katja Ziegler-Löhr received honoraria from Celgene, Novartis, Oncovis, Roche, Tesaro., (Copyright © 2020 by S. Karger AG, Basel.)
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- 2020
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