Stefan Lukac, Kerstin Pfister, Henning Schäffler, Elena Leinert, Angelina Fink, Brigitte Rack, Visnja Fink, Wolfgang Janni, Sabine Heublein
{"title":"Correction: Adjuvant Targeted Treatment of Early Hormone Receptor-positive HER2-negative Breast Cancer: Olaparib, Abemaciclib or Ribociclib - Which One, How and For Whom?","authors":"Stefan Lukac, Kerstin Pfister, Henning Schäffler, Elena Leinert, Angelina Fink, Brigitte Rack, Visnja Fink, Wolfgang Janni, Sabine Heublein","doi":"10.1055/a-2617-2084","DOIUrl":"https://doi.org/10.1055/a-2617-2084","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1055/a-2562-8469.].</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 6","pages":"e2"},"PeriodicalIF":2.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12158537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dominik Denschlag, Bastian Czogalla, Florian Heitz, Markus Kerkmann, Laura-Christin Fangmann, Philip H Klecker, Frederik A Stuebs, Linn Wölber, Julia Radosa, Pia C Lodde, Stephan Seitz, Christian George, Pawel Mach, Angelina Fink, Davit Bokhua, Nikolaus deGregorio, Björn Lampe, Franziska Hemptenmacher, Verena Friebe, Markus Fleisch, Pauline Wimberger, Anna Jaeger, Andreas Schnelzer, Suzana Mittelstadt, Dominik Ratiu, Michael Eichbaum, Adriana Haus, Matthias Kalder, Beyhan Ataseven, Willibald Schröder, Holger Bronger, Jens Kosse, Uwe Andreas Ulrich, Gabriele Elser, Philipp Harter
{"title":"Evaluation of Baseline Characteristics and Therapeutic Management Strategies in Metastatic Cervical Cancer in Germany: A Multicentric Retrospective Longitudinal Observational Study: A Quality Assurance Initiative of the AGO-Study Group and AGO-OK Uterus.","authors":"Dominik Denschlag, Bastian Czogalla, Florian Heitz, Markus Kerkmann, Laura-Christin Fangmann, Philip H Klecker, Frederik A Stuebs, Linn Wölber, Julia Radosa, Pia C Lodde, Stephan Seitz, Christian George, Pawel Mach, Angelina Fink, Davit Bokhua, Nikolaus deGregorio, Björn Lampe, Franziska Hemptenmacher, Verena Friebe, Markus Fleisch, Pauline Wimberger, Anna Jaeger, Andreas Schnelzer, Suzana Mittelstadt, Dominik Ratiu, Michael Eichbaum, Adriana Haus, Matthias Kalder, Beyhan Ataseven, Willibald Schröder, Holger Bronger, Jens Kosse, Uwe Andreas Ulrich, Gabriele Elser, Philipp Harter","doi":"10.1055/a-2520-5736","DOIUrl":"10.1055/a-2520-5736","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world data on treatment patterns and outcomes in recurrent or metastatic cervical cancer (r/mCC) are lacking.</p><p><strong>Methods: </strong>This first national quality assurance initiative was a retrospective analysis of patients with r/mCC diagnosed between 2018 and 2022, who were identified from medical records of 31 gynecologic cancer centers in Germany. Patient demographic and clinical characteristics, treatment patterns, and clinical outcomes were assessed descriptively. Progression-free (PFS) and overall survival (OS) were calculated using Kaplan-Meier analysis.</p><p><strong>Results: </strong>A total of 503 eligible patients (median age 55 years) were analyzed for r/mCC. 276/503 patients (55%) received first-line (1L) chemotherapy (platinum combination: 247/276; 79%) followed by targeted antibody therapy with bevacizumab (177/247; 72%), immunotherapy (19/247; 8%), or both combined (50/247; 20%). 111/503 (22%) received chemotherapy only (platinum combination: 64/111; 58%, platinum mono: 35/111; 31%, or platinum-free: 12/111; 11%), and 110/503 (22%) did not receive any systemic treatment (the remaining 6/503 patients received immunotherapy only). For these subgroups after a median follow-up of 16 months, the PFS was 12 months (95% CI 11-14), 8.8 months (95% CI 7.1-11), and 3 months (95% CI 2.3-4.8), and OS was 25 months (95% CI 21-31), 17 months (95% CI 14-22), and 3.6 months (95% CI 2.8-5.3), respectively. 176/283 (62%) patients who developed progressive disease (PD) were treated with second-line (2L) therapy.</p><p><strong>Conclusion: </strong>Only half of the patients with r/mCC were treated 1L with platinum-combination therapy including antibody therapy according to national guidelines. Moreover, 22% at initial diagnosis and 38% of patients at PD were not treated with systemic therapy at all. This might reflect poor general performance status, patients' preference, and/or lack of effective therapies especially in 2L treatment.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 5","pages":"520-532"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12081097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diana Lüftner, Hans-Christian Kolberg, Andreas D Hartkopf, Tanja N Fehm, Manfred Welslau, Volkmar Müller, Florian Schütz, Peter A Fasching, Christian Jackisch, Frederik Marme, Katharina Keller, Manuel Hörner, Chloë Goossens, Erik Belleville, Michael Untch, Marc Thill, Hans Tesch, Nina Ditsch, Julia C Radosa, Maggie Banys-Paluchowski, Achim Wöckel, Nadia Harbeck, Elmar Stickeler, Rupert Bartsch, Bahriye Aktas, Andreas Schneeweiss, Johannes Ettl, Florin-Andrei Taran, Wolfgang Janni, Rachel Würstlein, Michael P Lux
{"title":"Update Breast Cancer 2024 Part 3 - Patients with Advanced Stage Breast Cancer.","authors":"Diana Lüftner, Hans-Christian Kolberg, Andreas D Hartkopf, Tanja N Fehm, Manfred Welslau, Volkmar Müller, Florian Schütz, Peter A Fasching, Christian Jackisch, Frederik Marme, Katharina Keller, Manuel Hörner, Chloë Goossens, Erik Belleville, Michael Untch, Marc Thill, Hans Tesch, Nina Ditsch, Julia C Radosa, Maggie Banys-Paluchowski, Achim Wöckel, Nadia Harbeck, Elmar Stickeler, Rupert Bartsch, Bahriye Aktas, Andreas Schneeweiss, Johannes Ettl, Florin-Andrei Taran, Wolfgang Janni, Rachel Würstlein, Michael P Lux","doi":"10.1055/a-2515-2366","DOIUrl":"10.1055/a-2515-2366","url":null,"abstract":"<p><p>The use of CDK4/6 inhibitors, the new PI3K/AKT-kinase inhibitors, selective estrogen receptor-degraders (SERDs), antibody-drug conjugates, immune therapies and PARP inhibitors in recent years has resulted in a marked change in the therapy landscape for patients with advanced stage breast cancer. CDK4/6 inhibitors, trastuzumab deruxtecan, and sacituzumab govitecan have all been shown to provide significant overall survival benefits compared to conventional chemotherapy. Other substances are also showing promising results and hold out the hope that further analysis of the overall survival benefits will be available in the near future. The speed at which studies are now being carried out has markedly increased, and conferences and specialist journals are now constant sources of new information. This review summarizes the most recent publications and conference presentations on the treatment of patients with advanced stage breast cancer.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 5","pages":"507-519"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12081098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Valerie Catherine Linz, Alina Breuer, Philipp Leppert, Nils Herm-Stapelberg, Katja Schwarzer, Annette Hasenburg
{"title":"First Analysis of the Incidence of Serous Tubal Intraepithelial Carcinoma (STIC) in Germany - Evaluation of the Cancer Registry of the Federal State of Rhineland-Palatinate from 2016 to 2023.","authors":"Valerie Catherine Linz, Alina Breuer, Philipp Leppert, Nils Herm-Stapelberg, Katja Schwarzer, Annette Hasenburg","doi":"10.1055/a-2555-4602","DOIUrl":"10.1055/a-2555-4602","url":null,"abstract":"<p><strong>Introduction: </strong>Serous tubal intraepithelial carcinomas (STIC) are classified as precursor lesions of high-grade serous carcinomas (HGSC) in women. STIC are rare and their incidence, prognosis and therapy remain unclear. Since 2021, all cases of isolated STIC in Germany must be reported, which means that all STICs in the German federal state of the Rhineland-Palatine (RLP) are available for evaluation.</p><p><strong>Material and methods: </strong>A systematic search of the pathology reports in the RLP cancer registry was carried out for the period 01/2016-12/2023 using keywords related to STIC, and the results of the search were evaluated.</p><p><strong>Results: </strong>382 pathology reports were identified as relevant and screened. A total of seven patients with isolated STIC were reported to the RLP registry in the years 2020-2022. This corresponds to 0.014% of all reported cases of cancer in women in RLP in this period. Six patients had a diagnosis of isolated STIC, identified during risk-reducing salpingo-oophorectomy (RRSO). The mean patient age at the time of RRSO was 60.29 (± 7.09) years. RRSO was carried out on average 9.38 (± 6.75) years after a primary diagnosis of breast cancer/DCIS in five patients. No HGSC was reported for any of the patients with isolated STIC in the follow-up period until 01/2024. 43 synchronous STICs were reported for the period from 01/2016 to 12/2023.</p><p><strong>Conclusion: </strong>2-3 diagnoses of isolated STIC were recorded annually in RLP in the years 2020-2022. To date, there have been no reports of HGSC in these patients. In the future, the systematic recording of STICs will be expanded to include the cancer registries of other federal states of Germany and it will be possible to obtain valid data on the incidence of STIC in Germany. The collected data will also provide the basic information for a national STIC registry.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 5","pages":"541-547"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12081095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter to the editor on \"Effects of Systematically Guided vs. Self-Directed Laparoscopic Box Training on Learning Performances\".","authors":"Florian Recker, Ricarda Neubauer","doi":"10.1055/a-2539-5940","DOIUrl":"10.1055/a-2539-5940","url":null,"abstract":"","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 5","pages":"548-550"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12081093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wolfgang Janni, Hans-Christian Kolberg, Andreas D Hartkopf, Tanja N Fehm, Manfred Welslau, Volkmar Müller, Florian Schütz, Peter A Fasching, Christian Jackisch, Frederik Marme, Manuel Hörner, Katharina Keller, Chloë Goossens, Erik Belleville, Michael Untch, Marc Thill, Hans Tesch, Nina Ditsch, Michael P Lux, Maggie Banys-Paluchowski, Achim Wöckel, Nadia Harbeck, Elmar Stickeler, Rupert Bartsch, Bahriye Aktas, Andreas Schneeweiss, Johannes Ettl, Florin-Andrei Taran, Diana Lüftner, Rachel Würstlein, Julia C Radosa
{"title":"Update Breast Cancer 2024 Part 2 - Patients with Early Stage Breast Cancer.","authors":"Wolfgang Janni, Hans-Christian Kolberg, Andreas D Hartkopf, Tanja N Fehm, Manfred Welslau, Volkmar Müller, Florian Schütz, Peter A Fasching, Christian Jackisch, Frederik Marme, Manuel Hörner, Katharina Keller, Chloë Goossens, Erik Belleville, Michael Untch, Marc Thill, Hans Tesch, Nina Ditsch, Michael P Lux, Maggie Banys-Paluchowski, Achim Wöckel, Nadia Harbeck, Elmar Stickeler, Rupert Bartsch, Bahriye Aktas, Andreas Schneeweiss, Johannes Ettl, Florin-Andrei Taran, Diana Lüftner, Rachel Würstlein, Julia C Radosa","doi":"10.1055/a-2533-2783","DOIUrl":"10.1055/a-2533-2783","url":null,"abstract":"<p><p>This review summarizes the latest developments for the treatment of patients with early-stage breast cancer. Most of the clinically relevant changes were the result of using immune checkpoint inhibitors to treat patients with triple-negative breast cancer (TNBC) and CDK4/6 inhibitors to treat patients with hormone receptor-positive, HER2-negative (HRpos/HER2neg) tumors and a high risk of recurrence. Recent studies are presenting more and more data with long follow-up times and integrating translational analyses to evaluate new biomarkers such as circulating tumor DNA (ctDNA). This review article summarizes the latest developments published in recent months and puts the findings in context.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 5","pages":"493-506"},"PeriodicalIF":2.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12081099/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stefan Lukac, Kerstin Pfister, Henning Schäffler, Elena Leinert, Angelina Fink, Brigitte Rack, Visnja Fink, Wolfgang Janni, Sabine Heublein
{"title":"Adjuvant Targeted Treatment of Early Hormone Receptor-positive HER2-negative Breast Cancer: Olaparib, Abemaciclib or Ribociclib - Which One, How and For Whom?","authors":"Stefan Lukac, Kerstin Pfister, Henning Schäffler, Elena Leinert, Angelina Fink, Brigitte Rack, Visnja Fink, Wolfgang Janni, Sabine Heublein","doi":"10.1055/a-2562-8469","DOIUrl":"10.1055/a-2562-8469","url":null,"abstract":"<p><p>With around 70000 new cases every year, breast cancer (BC) continues to be the most prevalent form of cancer. Hormone receptor-positive, HER2-negative (HR+/HER2-) BC is the most common type and accounts for around 70% of cases of early BC (eBC). The development of new drugs in recent years has significantly improved the survival of patients with eBC. Alongside established endocrine therapy (ET) options such as tamoxifen, aromatase inhibitors (AI), and GnRH analogs, additional treatment options such as CDK 4/6 inhibitors (abemaciclib and ribociclib) and the PARP inhibitor (olaparib) are now also available. To facilitate their use in clinical practice, this article provides a summary of the current information on the use of these drugs in clinical practice. Abemaciclib was approved for the adjuvant treatment of HR+/HER2- eBC in cases with positive lymph node involvement in 2022. The MonarchE trial showed that the addition of abemaciclib to ET improved invasive disease-free survival (iDFS) after 5 years by around 7.6% in patients with a high risk of recurrence. Ribociclib, another CDK4/6 inhibitor, was recently approved based on the results of the NATALEE trial. When combined with non-steroidal AIs, ribociclib showed a significant iDFS benefit of 4.9% after 4 years in node-positive and node-negative patients with a high risk of recurrence. The PARP inhibitor olaparib may be used to treat patients with BRCA germline mutation and HR+/HER2- eBC and a high risk of recurrence (CPS-EG score ≥ 3). The OlympiA approval study showed an iDFS benefit of 7.3% after four years and a benefit of 3.4% for overall survival. In summary, targeted therapies are expanding the range of adjuvant treatment options for patients with HR+/HER2- eBC and a higher risk of recurrence. Treating physicians are increasingly facing the challenge of choosing the optimal therapy for their patients. To do so, it is essential to carefully weigh up potential side effects against the expected benefit of treatment on a case-by-case basis.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 6","pages":"590-598"},"PeriodicalIF":2.4,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12158540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Constantin Pixberg, Christian Maurer, Katharina Smetanay, Luise Straßl, Mario Hlevnjak, Marc Zapatka, Celina V Wagner, Haniyeh Yazdanparast, Johanna Kurzawa, Vanessa Erben, Fangyoumin Feng, Chen Hong, Daniel Hübschmann, Lars Buschhorn, Jan Philip Suppelna, Laura Michel, Sabine Heublein, Carlo Fremd, Oliver Zivanovic, Peter Sinn, Albrecht Stenzinger, Renate Haidinger, Eva Schumacher-Wulf, Nina Ditsch, Sibylle Loibl, Stefan Fröhling, Theresa Link, Pauline Wimberger, Jens-Uwe Blohmer, Hanna Huebner, Peter A Fasching, Wolfgang Janni, Richard F Schlenk, Verena Thewes, Peter Lichter, Andreas Schneeweiss
{"title":"COGNITION-GUIDE - Genomics-Guided Targeted Post-Neoadjuvant Therapy in Patients with Early Breast Cancer: Study Design of a Multicenter, Open-Label, Umbrella Phase II Study.","authors":"Constantin Pixberg, Christian Maurer, Katharina Smetanay, Luise Straßl, Mario Hlevnjak, Marc Zapatka, Celina V Wagner, Haniyeh Yazdanparast, Johanna Kurzawa, Vanessa Erben, Fangyoumin Feng, Chen Hong, Daniel Hübschmann, Lars Buschhorn, Jan Philip Suppelna, Laura Michel, Sabine Heublein, Carlo Fremd, Oliver Zivanovic, Peter Sinn, Albrecht Stenzinger, Renate Haidinger, Eva Schumacher-Wulf, Nina Ditsch, Sibylle Loibl, Stefan Fröhling, Theresa Link, Pauline Wimberger, Jens-Uwe Blohmer, Hanna Huebner, Peter A Fasching, Wolfgang Janni, Richard F Schlenk, Verena Thewes, Peter Lichter, Andreas Schneeweiss","doi":"10.1055/a-2557-1876","DOIUrl":"10.1055/a-2557-1876","url":null,"abstract":"<p><strong>Background: </strong>As part of the COGNITION diagnostic registry program, residual tumor material after neoadjuvant therapy (NAT) of patients with early breast cancer (eBC), who are still at high-risk for relapse after NAT, is analyzed by next generation sequencing to identify biomarkers and actionable alterations. This strategy aims to stratify patients for subsequent genomics-guided therapies to reduce the significant risk of metastatic dissemination and hence to improve disease-free survival.</p><p><strong>Patients and methods: </strong>COGNITION-GUIDE is a multicenter umbrella phase-II-trial to translate molecular biomarker profiles generated in the COGNITION platform into six molecular-guided post-neoadjuvant therapeutic options in addition to standard-of-care treatment. Patients can be allocated toimmune checkpoint inhibition (PD-L1-antibody),PI3K inhibition,AKT inhibition,PARP inhibition,anti-Trop-2 antibody-drug-conjugate,HER2 inhibition or, in case of missing biomarkers, to observation for 12 months.The primary endpoint is invasive disease-free survival (IDFS) four years after surgery. Secondary endpoints include IDFS in each study arm separately, distant disease-free survival, overall survival and safety. 240 patients will be enrolled within four years.</p><p><strong>Conclusions: </strong>The COGNITION-GUIDE trial, which was activated in June 2023 and will recruit in different centers in Germany, empowers a risk-adapted, biomarker-guided therapy escalation algorithm in eBC patients who are still at high risk of metastasis.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 6","pages":"611-619"},"PeriodicalIF":2.4,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12158538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diana Lüftner, Maggie Banys-Paluchowski, Andreas D Hartkopf, Manuel Hörner, Wolfgang Janni, Dagmar Langanke, Volkmar Müller, Andreas Schneeweiss, Marcus Schmidt, Marc Thill, Michael Untch, Achim Wöckel, Lukas Höllrich, Julia Kreuzeder, Almuth Marx, Julia Meinzinger, Hanna Regus-Leidig, Christian Roos, Hien Wohlgemuth, Stephanie Sussmann, Peter A Fasching
{"title":"Indirect Treatment Comparison between Ribociclib Combined with Non-Steroidal Aromatase Inhibitors and Ovarian Function Suppression vs. Tamoxifen in Premenopausal Women with Early Breast Cancer.","authors":"Diana Lüftner, Maggie Banys-Paluchowski, Andreas D Hartkopf, Manuel Hörner, Wolfgang Janni, Dagmar Langanke, Volkmar Müller, Andreas Schneeweiss, Marcus Schmidt, Marc Thill, Michael Untch, Achim Wöckel, Lukas Höllrich, Julia Kreuzeder, Almuth Marx, Julia Meinzinger, Hanna Regus-Leidig, Christian Roos, Hien Wohlgemuth, Stephanie Sussmann, Peter A Fasching","doi":"10.1055/a-2561-6640","DOIUrl":"10.1055/a-2561-6640","url":null,"abstract":"<p><strong>Background: </strong>This study provides an indirect treatment comparison of ribociclib combined with non-steroidal aromatase inhibitors and ovarian function suppression (ribociclib + NSAI + OFS) vs. a frequently used treatment option in German clinical routine (tamoxifen ± OFS) in premenopausal patients with HR-positive (HR+), HER2-negative (HER2-) early breast cancer (BC).</p><p><strong>Material and methods: </strong>Data on premenopausal women treated with ribociclib and tamoxifen were derived from the NATALEE clinical trial (NCT03701334) and the retrospective German data collection CLEAR-B, respectively. NATALEE trial eligibility criteria were applied to the CLEAR-B dataset. Standardized mortality ratio weights were used for propensity score (PS) adjustment to balance study populations. All hazard ratios (HR) were calculated based on a 4-year-observation period for both treatment arms. Effectiveness endpoints comprised invasive and distant disease-free survival (iDFS, dDFS), recurrence-free survival (RFS), and overall survival (OS). Safety-related endpoints were treatment termination (TT) and toxicity-related TT (TTtox). For safety comparisons, the ribociclib arm was divided into groups that discontinued ribociclib + NSAI + OFS or ribociclib only.</p><p><strong>Results: </strong>Significant beneficial effects favoring ribociclib + NSAI + OFS (n = 1115) over tamoxifen ± OFS (n = 822) were observed for all effectiveness outcomes (iDFS [HR = 0.5 (95% CI 0.35; 0.71); p < 0.01]; dDFS [HR = 0.52 (95% CI 0.35; 0.77); p = 0.01], RFS [HR = 0.42 (95% CI 0.29; 0.62); p < 0.01], OS [HR = 0.34 (95% CI 0.18; 0.63); p = 0.01]) during the 4-year-observation period. The effect of early treatment discontinuation showed no significant differences between ribociclib + NSAI + OFS and tamoxifen ± OFS (TT-a: HR = 1.2 [95% CI: 0.71; 2.01], p = 0.48; TTtox-a: HR = 0.54 [95% CI 0.22; 1.30], p = 0.23).</p><p><strong>Conclusion: </strong>In this retrospective analysis, ribociclib + NSAI + OFS demonstrated advantages across all effectiveness endpoints, including OS, in premenopausal women with HR+, HER2- early BC, without increasing overall treatment discontinuation rates compared to tamoxifen ± OFS.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 6","pages":"599-610"},"PeriodicalIF":2.4,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12158542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Markus Wallwiener, Marco Johannes Battista, Eike-Christian Burandt, Wolfgang Cremer, Gerlinde Egerer, Mathias K Fehr, Markus Follmann, Paul Gass, Heidemarie Haase, Philipp Harter, Florian Heitz, Simone Hettmer, Lars-Christian Horn, Ingolf Juhasz-Böss, Karin Kast, Günther Köhler, Thomas Kröncke, Katja Lindel, Alexander Mustea, Jan Philipp Novotny, Edgar Petru, Peter Reichardt, Kerstin Rhiem, Hans-Georg Strauß, Clemens Tempfer, Falk C Thiel, Uwe Andreas Ulrich, Thomas Vogl, Dirk Vordermark, Dominik Denschlag
{"title":"Sarcoma of the Uterus. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/074, June 2024).","authors":"Markus Wallwiener, Marco Johannes Battista, Eike-Christian Burandt, Wolfgang Cremer, Gerlinde Egerer, Mathias K Fehr, Markus Follmann, Paul Gass, Heidemarie Haase, Philipp Harter, Florian Heitz, Simone Hettmer, Lars-Christian Horn, Ingolf Juhasz-Böss, Karin Kast, Günther Köhler, Thomas Kröncke, Katja Lindel, Alexander Mustea, Jan Philipp Novotny, Edgar Petru, Peter Reichardt, Kerstin Rhiem, Hans-Georg Strauß, Clemens Tempfer, Falk C Thiel, Uwe Andreas Ulrich, Thomas Vogl, Dirk Vordermark, Dominik Denschlag","doi":"10.1055/a-2496-2591","DOIUrl":"10.1055/a-2496-2591","url":null,"abstract":"<p><p><b>Purpose</b> This is an official, recently updated guideline published and coordinated by the German Society of Gynecology and Obstetrics ( <i>Deutsche Gesellschaft für Gynäkologie und Geburtshilfe</i> , DGGG) together with the Austrian Society of Gynecology and Obstetrics ( <i>Österreichische Gesellschaft für Gynäkologie und Geburtshilfe</i> , OEGGG) and the Swiss Society of Gynecology and Obstetrics ( <i>Schweizerische Gesellschaft für Gynäkologie und Geburtshilfe</i> , SGGG) as part of the guidelines program. Because of their rarity and heterogeneous histopathology, uterine sarcomas are challenging in terms of their clinical management, and treatment requires a multidisciplinary approach. <b>Methods</b> This S2k guideline was first published in 2015. The update published here is again the result of a structured consensus of a representative interdisciplinary group of mandate holders and experts who carried out a selective search of the literature on uterine sarcomas. Members of the participating professional societies achieved a formal consensus on recommendations and statements after a structured consensus process. <b>Recommendations</b> Recommendations were made about the epidemiology, classification, staging of uterine sarcomas, symptoms, general diagnostic workup, general pathology and genetic predisposition for uterine sarcomas, leiomyosarcomas, endometrial stromal sarcomas (low-grade and high-grade), undifferentiated uterine sarcomas, adenosarcomas, and rhabdomyosarcoma of the uterus in children and adolescents. The guideline also discusses the follow-up of uterine sarcomas, the management of morcellated uterine sarcomas, and the information provided to patients.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 4","pages":"378-394"},"PeriodicalIF":2.4,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}