Breast CarePub Date : 2022-02-01DOI: 10.1159/000522400
A. Schneeweiss, S. Loibl
{"title":"First-in-Class-Therapie mit Sacituzumab Govitecan","authors":"A. Schneeweiss, S. Loibl","doi":"10.1159/000522400","DOIUrl":"https://doi.org/10.1159/000522400","url":null,"abstract":"information@karger.com www.karger.com Sektion Gynäkologische Onkologie am Natio nalen Centrum für Tumorerkrankungen (NCT) [3–5]. Da das TNBC nicht nur eine hohe Resistenzrate unter Chemotherapie, sondern auch eine hohe genetische und im munhistochemische Heterogenität aufweist, sei eine gezielte Behandlung dieser Erkran kung schwierig. «Verschiedene TNBCSub gruppen haben eine komplett unterschiedli che Biologie, die wir therapeutisch kaum berücksichtigen», so Schneeweiss. Nur für 2 Subgruppen stehen derzeit stratifi zierte Therapiestrategien zur Verfügung: Bei Menschen mit positivem PDL1Status können ImmuncheckpointInhibitoren in Kombination mit Chemotherapie eingesetzt werden, bei nachgewiesener Keimbahnmutation im BRCA1/2Gen Inhibitoren der Poly (ADPRibose) Polymerase (PARP) [3]. «Die Hälfte der Pati enten mit TNBC weist aber keinen dieser Marker auf, sodass hier weiterhin nur die Che motherapie bleibt», so der Heidelberger Gynä koOnkologe. Neue zielgerichtete Behand lungsansätze seien daher dringend vonnöten. Positiv zu bewerten ist laut Schneeweiss, dass der hohe Medical Need beim vorbehandelten mTNBC nun durch ein neues Behandlungs konzept adressiert werden kann. Mit dem seit Ende November 2021 in der Europäischen Union zugelassenen Sacituzumab Govitecan sei eine neue zielgerichtete Therapie gegen das TNBC aus der Arzneimittelkategorie der An tikörperWirkstoffKonjugate (ADCs) verfüg bar. Schneeweiss verwies darauf, dass die The Das Antibody-Drug-Conjugate (ADC) Sacituzumab Govitecan (Trodelvy®) ist seit November 2021 als Monotherapie zur Behandlung von erwachsenen Patient*innen mit nicht resezierbarem oder metastasiertem TNBC (mTNBC) zugelassen, die zuvor zwei oder mehr systemische Therapien erhalten haben – davon mindestens eine gegen die fortgeschrittene Erkrankung. In der Zulassungsstudie ASCENT wurde unter dem Einfluss des ADC eine signifikante und klinisch relevante Verbesserung des Gesamtüberlebens (OS) und des progressionsfreien Überlebens (PFS) gegenüber der Kontrollgruppe dokumentiert [1, 2]. Die Zulassung des First-in-Class ADC ab der Zweitlinie kann dazu beitragen, den hohen medizinischen Bedarf beim vorbehandelten mTNBC zu decken, erklärten Expert*innen auf der Launch-Presse konferenz von Gilead.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"17 1","pages":"114 - 116"},"PeriodicalIF":2.1,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48482060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2021-12-01DOI: 10.1159/000521186
B. Gulluoglu
{"title":"Contents Vol. 16, 2021","authors":"B. Gulluoglu","doi":"10.1159/000521186","DOIUrl":"https://doi.org/10.1159/000521186","url":null,"abstract":"Marija Balic, MD – Department of Internal Medicine, Division of Oncology, Medical University of Graz, Graz, Austria Heba Gamal El Din Mohamed Mahmoud, MD – Surgical Oncology Department, National Cancer Institute, Cairo University, Cairo, Egypt Theodoros Foukakis, MD – Department of Oncology, Karolinska Institutet and University Hospital, Stockholm, Sweden Bahadir M. Gulluoglu, MD – Department of General Surgery, Marmara University School of Medicine, Istanbul, Turkey Thomas Helbich, MD – Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria Wolfgang Janni, MD – Department of Obstetrics and Gynecology, University Hospital Ulm, Ulm, Germany Marion Kiechle, MD – Department of Obstetrics and Gynecology, Technical University Munich, Munich, Germany Ludwig Kiesel, MD – Department of Gynecology and Obstetrics, University Hospital Münster, Münster, Germany Sibylle Loibl, MD – German Breast Group, Neu-Isenburg, Germany Martina Mittlböck, PhD – Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, Vienna, Austria Shani Paluch-Shimon, MD – Breast Oncology Unit, Department of Oncology, Shaare Zedek Medical Center, Jerusalem, Israel Angelo Paradiso, MD – Experimental Medical Oncology, Istituto Tumori G. Paolo II, IRCCS, National Cancer Institute, Bari, Italy Cristina Saura, MD – Breast Cancer Unit, Medical Oncology Service, Vall d’Hebron University Hospital, Barcelona, Spain Hans-Jörg Senn, MD – Tumor and Breast Center ZeTuP, St. Gallen, Switzerland Günther Steger, MD – Clinical Division of Oncology, Department of Medicine I, Comprehensive Cancer Center of the Medical University of Vienna, Vienna, Austria Janice Tsang, MD – Medical Oncology, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong Michael Untch, MD – Department of Gynecology, HELIOS Hospital Berlin Buch, Berlin, Germany","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"16 1","pages":"I - X"},"PeriodicalIF":2.1,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47813505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2021-12-01DOI: 10.1159/000521177
{"title":"PharmaNews","authors":"","doi":"10.1159/000521177","DOIUrl":"https://doi.org/10.1159/000521177","url":null,"abstract":"Im Kampf gegen Krebs nehmen biotechnologisch hergestellte Arzneimittel an Bedeutung zu. Der Anteil von Biopharmazeutika in der Onkologie stieg im ver gangenen Jahr auf 43% (2019: 41%), so der aktuelle Branchenreport der In teressengruppe Biotechnologie im Verband der forschenden PharmaUnter nehmen (vfa). Dieser Trend wird sich voraussichtlich auch in den nächsten Jahren fortsetzen, denn der Schwerpunkt der biotechnologischen Forschung liegt auf der Onkologie: 286 Forschungsprojekte, das sind 39% der Wirkstoff pipeline, suchen aktuell nach neuen Therapieansätzen gegen Krebs [1]. «Die Daten zeigen nicht nur den besonderen Stellenwert von Biopharmazeutika im Kampf gegen Krebs, sie sind auch ein Beleg für sehr hohe und kontinuierliche Investitionen in die biotechnologische Krebsforschung», sagt Manfred Heinzer, Geschäftsführer der Amgen GmbH. Rund ein Drittel der in Deutschland zuge lassenen 339 Biopharmazeutika nutzen laut vfaBiotechReport rekombinante Antikörper als Wirkstoff. 1998 wurde der erste biotechnologisch hergestellte Antikörper zugelassen, heute basieren 107 Arzneimittel auf dieser Wirkstoff klasse und die Pipeline ist gut gefüllt [1]. Ein wesentliches Anwendungsgebiet ist die Krebstherapie.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"16 1","pages":"683 - 684"},"PeriodicalIF":2.1,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43704298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2021-12-01DOI: 10.1159/000521407
B. Gulluoglu, S. Corradini
{"title":"Front & Back Matter","authors":"B. Gulluoglu, S. Corradini","doi":"10.1159/000521407","DOIUrl":"https://doi.org/10.1159/000521407","url":null,"abstract":"","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46436423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2021-10-01DOI: 10.1159/000520067
B. Gulluoglu, S. Corradini
{"title":"Front & Back Matter","authors":"B. Gulluoglu, S. Corradini","doi":"10.1159/000520067","DOIUrl":"https://doi.org/10.1159/000520067","url":null,"abstract":"","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48876847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2021-08-20DOI: 10.1159/000518260
Yi Zhang, Miao Liu, Houpu Yang, Shu Wang
{"title":"Physicians’ Perception of the Evidence in Relation to Primary Endpoints of Clinical Trials on Breast Cancer","authors":"Yi Zhang, Miao Liu, Houpu Yang, Shu Wang","doi":"10.1159/000518260","DOIUrl":"https://doi.org/10.1159/000518260","url":null,"abstract":"Objective: To investigate physicians’ perception of the evidence of clinical trials on breast cancer. Methods: A survey was conducted by the Chinese Society of Breast Surgeons. We investigated the physicians’ perception of meaningful endpoints, appropriate follow-up duration, and clinically acceptable benefit through online questionnaires. Results: Among 278 validated questionnaires, the majority of the questions had no consistent answer. For local treatment, 30.6, 28.8, and 28.4% of participants regarded locoregional recurrence (LRR), disease-free survival (DFS), and overall survival (OS) as the most meaningful endpoint, respectively, 47.5% believed that 5-year follow-up can alter clinical practice, and 34.5% thought it should be >10 years. In the adjuvant setting, 45.7, 38.5, and 12.9% regarded DFS, OS, and LRR as the most meaningful endpoint, respectively, 52.5% thought that 10-year follow-up was solid, while 37.4% thought that 5-year follow-up was enough. In the advanced setting, 49.6, 24.1, and 23.7% considered progression-free survival, quality of life, and OS the most meaningful endpoint, respectively, and 39.6 and 28.8% considered that a follow-up of 1 year and 3 years, respectively, was meaningful. Similarly, the clinically acceptable absolute difference was inconsistent. Conclusion: Most Chinese oncologists advocated that surrogate endpoints could be used in certain circumstances, though OS was the most reliable one in breast cancer studies. Doctors’ perceptions of follow-up time and magnitude of benefit vary widely, reflecting the fact that there are many unanswered questions about supporting the use of new cancer treatments; a common understanding needs to be reached, such as a very consensual surrogate endpoint and a meaningful sufficiently large therapeutic benefit.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"17 1","pages":"180 - 187"},"PeriodicalIF":2.1,"publicationDate":"2021-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45190843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}