Introduction: Identifying non-invasive biomarkers which can predict the outcome of intracytoplasmic sperm injection (ICSI) is crucial, particularly in Germany where the challenges are intensified by the Embryo Protection Act. Recent research has highlighted biomarkers within the epidermal growth factor (EGF) family as central to follicular processes, although their predictive utility remains a subject of debate in the literature. Therefore, the primary objective of this study was to investigate the significance of amphiregulin concentrations in follicular fluid and gene expression in mural granulosa cells on oocyte maturation, fertilization, and embryo quality.
Patients and methods: A total of 33 women were recruited at the University Clinic of Saarland Fertility Center (Homburg, Germany). Follicular fluid aspiration consisted of single/individual aspiration of follicles, enabling a 1 : 1 correlation with retrieved oocytes. Follicular fluid and mural granulosa cell samples from 108 oocytes were analyzed. Amphiregulin levels were determined with enzyme-linked immunosorbent assay, while gene expression was analyzed with the StepOnePlus Real-Time PCR System using TaqMan Fast Advanced Master Mix assays.
Results: Results showed that amphiregulin concentrations affect oocyte maturation, fertilization, and embryo quality, while luteinizing hormone concentrations influence oocyte maturation, with significant differences identified between fertilized/unfertilized and good/poor embryo groups. Amphiregulin expression significantly impacts oocyte maturation, with downregulation observed in immature oocytes, while luteinizing hormone/chorionic gonadotropin receptor expression showed no significant differences between groups and did not influence maturation, fertilization, or embryo quality.
Conclusion: These findings are very important for advancing infertility treatment, especially in Germany. The results for amphiregulin may provide prognostic insights which could be useful when selecting viable oocytes and embryos. This research underscores the importance of non-invasive biomarkers for optimizing ICSI outcomes and potentially enhancing the success rates of assisted reproductive technology.
引言:鉴别能够预测胞浆内单精子注射(ICSI)结果的非侵入性生物标志物是至关重要的,特别是在德国,胚胎保护法加剧了挑战。最近的研究强调了表皮生长因子(EGF)家族中的生物标志物是卵泡过程的核心,尽管它们的预测效用在文献中仍然存在争议。因此,本研究的主要目的是探讨卵泡液双调节蛋白浓度和壁粒细胞基因表达对卵母细胞成熟、受精和胚胎质量的影响。患者和方法:在萨尔生育中心(Homburg, Germany)的大学诊所共招募了33名妇女。卵泡液抽吸包括单个/单个卵泡抽吸,使其与回收的卵母细胞呈1:1的相关性。对108个卵母细胞的卵泡液和壁粒细胞样本进行了分析。采用酶联免疫吸附法检测双调节蛋白水平,采用TaqMan Fast Advanced Master Mix检测StepOnePlus实时PCR系统分析基因表达。结果:双调节蛋白浓度影响卵母细胞成熟、受精和胚胎质量,黄体生成素浓度影响卵母细胞成熟,且在受精/未受精和良好/不良胚胎组之间存在显著差异。双调节蛋白的表达显著影响卵母细胞成熟,在未成熟卵母细胞中观察到下调,而黄体生成素/绒毛膜促性腺激素受体的表达在组间无显著差异,不影响成熟、受精或胚胎质量。结论:这些发现对推进不孕症治疗具有重要意义,尤其是在德国。双调节蛋白的结果可能为选择存活的卵母细胞和胚胎提供有用的预后见解。这项研究强调了非侵入性生物标志物对优化ICSI结果和潜在地提高辅助生殖技术成功率的重要性。
{"title":"Impact of Amphiregulin on Oocyte Maturation and Embryo Quality: Insights from Clinical and Molecular Perspectives.","authors":"Marija Kljajic, Jasmin Teresa Ney, Gudrun Wagenpfeil, Simona Baus, Erich-Franz Solomayer, Mariz Kasoha","doi":"10.1055/a-2384-9193","DOIUrl":"https://doi.org/10.1055/a-2384-9193","url":null,"abstract":"<p><strong>Introduction: </strong>Identifying non-invasive biomarkers which can predict the outcome of intracytoplasmic sperm injection (ICSI) is crucial, particularly in Germany where the challenges are intensified by the Embryo Protection Act. Recent research has highlighted biomarkers within the epidermal growth factor (EGF) family as central to follicular processes, although their predictive utility remains a subject of debate in the literature. Therefore, the primary objective of this study was to investigate the significance of amphiregulin concentrations in follicular fluid and gene expression in mural granulosa cells on oocyte maturation, fertilization, and embryo quality.</p><p><strong>Patients and methods: </strong>A total of 33 women were recruited at the University Clinic of Saarland Fertility Center (Homburg, Germany). Follicular fluid aspiration consisted of single/individual aspiration of follicles, enabling a 1 : 1 correlation with retrieved oocytes. Follicular fluid and mural granulosa cell samples from 108 oocytes were analyzed. Amphiregulin levels were determined with enzyme-linked immunosorbent assay, while gene expression was analyzed with the StepOnePlus Real-Time PCR System using TaqMan Fast Advanced Master Mix assays.</p><p><strong>Results: </strong>Results showed that amphiregulin concentrations affect oocyte maturation, fertilization, and embryo quality, while luteinizing hormone concentrations influence oocyte maturation, with significant differences identified between fertilized/unfertilized and good/poor embryo groups. Amphiregulin expression significantly impacts oocyte maturation, with downregulation observed in immature oocytes, while luteinizing hormone/chorionic gonadotropin receptor expression showed no significant differences between groups and did not influence maturation, fertilization, or embryo quality.</p><p><strong>Conclusion: </strong>These findings are very important for advancing infertility treatment, especially in Germany. The results for amphiregulin may provide prognostic insights which could be useful when selecting viable oocytes and embryos. This research underscores the importance of non-invasive biomarkers for optimizing ICSI outcomes and potentially enhancing the success rates of assisted reproductive technology.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"85 1","pages":"69-79"},"PeriodicalIF":2.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142931014","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}
Introduction: Induction of labor is indicated when benefits of delivery outweigh benefits of prolonged pregnancy, which is not always welcomed by women. Castor oil is accepted as an "old household remedy" for labor induction but is not yet part of the official guidelines. Nevertheless, it is often used, mostly even before the women are admitted to the hospital. Data on its actual benefits and safety are missing. Upon accepting the real-world practice of applying castor oil cocktail for labor induction we added castor oil as one option of labor induction in our clinical routine for multiparous women at term, with a history of at least one vaginal delivery. Here we aimed to generate data on the effectivity and safety of castor oil in labor induction by analyzing the real-world data generated in our cohort.
Methods: In our retrospective analysis we included data of a cohort of 148 multiparous women induced by castor oil cocktail and of 286 matched controls receiving established methods according to the current guidelines for labor induction. The castor oil cocktail was prepared following a standardized recipe with quality-tested castor oil. Statistical analysis was performed with SPSS 27.0.
Results: Perinatal outcome data including the rate of vaginal deliveries did not differ between groups, except significantly more neonates were admitted to the neonatal intensive care unit in the group receiving established methods for induction of labor (p = 0.01). In 39 women (26%), administration of castor oil cocktail alone failed to induce labor. The time from initiation of labor induction until delivery was significantly shorter in the castor oil cocktail group (p = 0.04).
Conclusion: Our study demonstrates the safety and effectivity of a castor oil cocktail induction in multiparous women at term in a hospital-based setting using quality-controlled castor oil in a standardized recipe.
{"title":"Induction of Labor Using Castor Oil Cocktail - an Analysis of Real-world Data.","authors":"Stefanie Mona Ziegler, Yvonne Heimann, Ekkehard Schleussner, Friederike Weschenfelder, Tanja Groten","doi":"10.1055/a-2397-1490","DOIUrl":"https://doi.org/10.1055/a-2397-1490","url":null,"abstract":"<p><strong>Introduction: </strong>Induction of labor is indicated when benefits of delivery outweigh benefits of prolonged pregnancy, which is not always welcomed by women. Castor oil is accepted as an \"old household remedy\" for labor induction but is not yet part of the official guidelines. Nevertheless, it is often used, mostly even before the women are admitted to the hospital. Data on its actual benefits and safety are missing. Upon accepting the real-world practice of applying castor oil cocktail for labor induction we added castor oil as one option of labor induction in our clinical routine for multiparous women at term, with a history of at least one vaginal delivery. Here we aimed to generate data on the effectivity and safety of castor oil in labor induction by analyzing the real-world data generated in our cohort.</p><p><strong>Methods: </strong>In our retrospective analysis we included data of a cohort of 148 multiparous women induced by castor oil cocktail and of 286 matched controls receiving established methods according to the current guidelines for labor induction. The castor oil cocktail was prepared following a standardized recipe with quality-tested castor oil. Statistical analysis was performed with SPSS 27.0.</p><p><strong>Results: </strong>Perinatal outcome data including the rate of vaginal deliveries did not differ between groups, except significantly more neonates were admitted to the neonatal intensive care unit in the group receiving established methods for induction of labor (p = 0.01). In 39 women (26%), administration of castor oil cocktail alone failed to induce labor. The time from initiation of labor induction until delivery was significantly shorter in the castor oil cocktail group (p = 0.04).</p><p><strong>Conclusion: </strong>Our study demonstrates the safety and effectivity of a castor oil cocktail induction in multiparous women at term in a hospital-based setting using quality-controlled castor oil in a standardized recipe.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 11","pages":"1050-1056"},"PeriodicalIF":2.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11543103/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618257","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}
Pub Date : 2024-09-05eCollection Date: 2024-12-01DOI: 10.1055/a-2378-3468
Nicole Rebecca Heinze, Teresa Götz, Nadine Rohloff, Lisa Schaller, Roman Spelsberg, Sebastian Daniel Schäfer
Endometriosis patients face a significant economic burden. In addition to the directly attributable costs of the diagnosis and therapy of endometriosis, such as drug treatment and multimodal pain therapy, various indirect follow-up costs can be expected, e.g., due to incapacity for work and reduced work performance. As already reported in previous publications, endometriosis is associated with considerable costs for the health care system and society as well as for the affected women and their families. In order to measure the extent of the costs associated with endometriosis patients, 250 patients with an average age of 32.80 years were recruited via social media and interviewed about their self-financed costs as part of an online survey. The assessed direct costs comprise inpatient treatments, outpatient or pain therapy, fertility treatments, hormone therapies, prescribed and privately paid medications and aids, other therapeutic procedures, and directly attributable travel costs for endometriosis treatments. This resulted in an average cost of € 2059.55 per year. Indirect costs were calculated based on loss of income, day-to-day support, care costs, costs due to follow-up illnesses and other costs. On average, the indirect costs were € 2174.25. The average costs resulting from the survey totalled € 4233.81 per year with a standard deviation of € 8240.31. An increase of out-of-pocket costs can be assumed. This may result from an improved range of services for alternative treatment methods and an increased awareness of the need for personal investment in health. However, further health economic studies are needed to validate the results.
{"title":"Self-reported Costs of Endometriosis Patients in Germany.","authors":"Nicole Rebecca Heinze, Teresa Götz, Nadine Rohloff, Lisa Schaller, Roman Spelsberg, Sebastian Daniel Schäfer","doi":"10.1055/a-2378-3468","DOIUrl":"10.1055/a-2378-3468","url":null,"abstract":"<p><p>Endometriosis patients face a significant economic burden. In addition to the directly attributable costs of the diagnosis and therapy of endometriosis, such as drug treatment and multimodal pain therapy, various indirect follow-up costs can be expected, e.g., due to incapacity for work and reduced work performance. As already reported in previous publications, endometriosis is associated with considerable costs for the health care system and society as well as for the affected women and their families. In order to measure the extent of the costs associated with endometriosis patients, 250 patients with an average age of 32.80 years were recruited via social media and interviewed about their self-financed costs as part of an online survey. The assessed direct costs comprise inpatient treatments, outpatient or pain therapy, fertility treatments, hormone therapies, prescribed and privately paid medications and aids, other therapeutic procedures, and directly attributable travel costs for endometriosis treatments. This resulted in an average cost of € 2059.55 per year. Indirect costs were calculated based on loss of income, day-to-day support, care costs, costs due to follow-up illnesses and other costs. On average, the indirect costs were € 2174.25. The average costs resulting from the survey totalled € 4233.81 per year with a standard deviation of € 8240.31. An increase of out-of-pocket costs can be assumed. This may result from an improved range of services for alternative treatment methods and an increased awareness of the need for personal investment in health. However, further health economic studies are needed to validate the results.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 12","pages":"1143-1149"},"PeriodicalIF":2.4,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11624002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142793918","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2369-1489
Therese Pross, Maria Margarete Karsten, Jens-Uwe Blohmer
Background: Standardized treatment pathways should make it easier for medical staff and patients to achieve the best possible individual treatment outcome by making sure all relevant information are taken into consideration. The aim of this paper is to identify gaps in care along the treatment pathway through semi-structured patient interviews. Subsequently, it will be discussed if mobile health applications can close these identified gaps in care.
Material and methods: Nine semi-structured interviews of patients with invasive lobular breast cancer were conducted in March 2023 in German at the breast cancer center at Charité Universitätsmedizin Berlin, which were subsequently transcribed word for word and processed using a thematic analysis approach.
Results: Eight recurring themes are identified in the patient interviews: 1. Limited capacity to absorb information, 2. Discrepancy between information needs and information provision, 3. Need for individual initiative, 4. Uncertainty, 5. not being seen and heard, 6. Patient's desires and suggestions for improvement, 7. Use of mobile health apps, 8. Support through an app for patients.
Conclusions: The identified gaps in care of breast cancer patients can be largely addressed through the use of digital health solutions after the establishment of regulatory frameworks, thus improving care for patients with early breast cancer.
Trial registration: The interviews were done within a registry for which ethical approval was obtained by the Ethics Committee of Charité Universitätsmedizin Berlin EA4/180/17.
{"title":"From Gaps to Solutions: Semi-Structured Interviews to Identify Care Gaps in Breast Cancer Care and How to Solve Them with Digital Solutions.","authors":"Therese Pross, Maria Margarete Karsten, Jens-Uwe Blohmer","doi":"10.1055/a-2369-1489","DOIUrl":"10.1055/a-2369-1489","url":null,"abstract":"<p><strong>Background: </strong>Standardized treatment pathways should make it easier for medical staff and patients to achieve the best possible individual treatment outcome by making sure all relevant information are taken into consideration. The aim of this paper is to identify gaps in care along the treatment pathway through semi-structured patient interviews. Subsequently, it will be discussed if mobile health applications can close these identified gaps in care.</p><p><strong>Material and methods: </strong>Nine semi-structured interviews of patients with invasive lobular breast cancer were conducted in March 2023 in German at the breast cancer center at Charité Universitätsmedizin Berlin, which were subsequently transcribed word for word and processed using a thematic analysis approach.</p><p><strong>Results: </strong>Eight recurring themes are identified in the patient interviews: 1. Limited capacity to absorb information, 2. Discrepancy between information needs and information provision, 3. Need for individual initiative, 4. Uncertainty, 5. not being seen and heard, 6. Patient's desires and suggestions for improvement, 7. Use of mobile health apps, 8. Support through an app for patients.</p><p><strong>Conclusions: </strong>The identified gaps in care of breast cancer patients can be largely addressed through the use of digital health solutions after the establishment of regulatory frameworks, thus improving care for patients with early breast cancer.</p><p><strong>Trial registration: </strong>The interviews were done within a registry for which ethical approval was obtained by the Ethics Committee of Charité Universitätsmedizin Berlin EA4/180/17.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"845-854"},"PeriodicalIF":2.4,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368466/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125349","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2375-5194
Henning Schäffler, Dorothee Jakob, Sophia Huesmann, Kerstin Pfister, Kristina Veselinovic, Fabienne Schochter, Elena Leinert, Visnja Fink, Brigitte Rack, Alexander Englisch, Lea-Louise Volmer, Tobias Engler, Marie Louise Frevert, Ingolf Juhasz-Böss, Sara Brucker, Sabine Heublein, Wolfgang Janni, Florin-Andrei Taran, Andreas Hartkopf, Dominik Dannehl
Introduction: The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.
Materials and methods: This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.
Results: 125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4-11.6) and 11.8 months for SG (95% CI: 8.0-14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8-12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8-6.3) with SG (TNBC 4.9; HR+/HER2-: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1-not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7-not estimable) with SG therapy (TNBC: 12.4, HR+/HER2-: not reached). 95.7% of the protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.
Conclusion: Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.
{"title":"Novel Antibody-Drug-Conjugates in Routine Clinical Practice for the Treatment of Metastatic Breast Cancer: Adherence, Efficacy and Tolerability - Real-World Data from German Breast Centers.","authors":"Henning Schäffler, Dorothee Jakob, Sophia Huesmann, Kerstin Pfister, Kristina Veselinovic, Fabienne Schochter, Elena Leinert, Visnja Fink, Brigitte Rack, Alexander Englisch, Lea-Louise Volmer, Tobias Engler, Marie Louise Frevert, Ingolf Juhasz-Böss, Sara Brucker, Sabine Heublein, Wolfgang Janni, Florin-Andrei Taran, Andreas Hartkopf, Dominik Dannehl","doi":"10.1055/a-2375-5194","DOIUrl":"10.1055/a-2375-5194","url":null,"abstract":"<p><strong>Introduction: </strong>The third-generation antibody-drug conjugates (ADC), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), recently obtained approval for metastatic breast cancer treatment across various subtypes and therapeutic contexts.</p><p><strong>Materials and methods: </strong>This retrospective, multicentric study evaluated real-world tolerability, feasibility and efficacy in a pre-treated, real-world cohort at three major German breast cancer centers.</p><p><strong>Results: </strong>125 patients treated with T-DXd or SG from November 2020 to June 2023 were included (T-DXd: 77 patients; SG: 48 patients). The median treatment duration was 6.0 months for T-DXd and 3.5 months for SG therapy, with a median follow-up duration of 10.4 months for T-DXd (95% CI: 8.4-11.6) and 11.8 months for SG (95% CI: 8.0-14.4). Severe neutropenia (CTC ≥ III°) occurred in 33.3% during SG therapy, with a numerical reduction observed following primary, prophylactic use of G-CSF. T-DXd-associated pneumonitis occurred in 8 out of 77 patients (10.4 %). Median progression-free survival (mPFS) was 8.6 months (95% CI: 5.8-12.4) with T-DXd (HER2+: 10.8; HER2-low: 4.7) and 4.9 months (95% CI: 2.8-6.3) with SG (TNBC 4.9; HR+/HER2-: not reached). Median overall survival (OS) was 23.8 months (95% CI: 16.1-not estimable) with T-DXd (HER2+: 27.1; HER2-low: not reached), and 12.4 months (95% CI: 8.7-not estimable) with SG therapy (TNBC: 12.4, HR+/HER2-: not reached). 95.7% of the protocol-specified, therapeutic dose was administered for T-DXd and 89.6% for SG.</p><p><strong>Conclusion: </strong>Overall, this indicates good feasibility, tolerability, and effectiveness of ADC therapies in the real-world setting.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"855-865"},"PeriodicalIF":2.4,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125351","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2374-2270
Maximilian Heinz Beck, Karoline Barbara Stephanie Weiler, Anna Trelinska-Finger, Jens-Uwe Blohmer
Introduction: The impact of surgical margins on the prognosis of early breast cancer remains uncertain, particularly in the context of modern treatment approaches. This study aimed to investigate whether involved margins after surgery for early breast cancer affect overall survival.
Methods: We conducted a retrospective analysis of 3767 patients who underwent surgery for primary breast cancer or carcinoma in situ between 2006 and 2022 at Charité - University Hospital Berlin. Survival analysis based on margin status and a subsequent multivariate Cox regression analysis were conducted.
Results: With a median follow-up of 72.2 months, clear margins were achieved in 81.4% of patients (n = 3068) after primary surgery, while 16.2% (n = 610) required re-excision. Only 2.4% of patients (n = 89) had definitively involved margins. Margin involvement was more common in hormone receptor-positive disease, lobular subtype, carcinoma in situ, or locally advanced tumors, but less frequent in patients with previous neoadjuvant chemotherapy or triple-negative breast cancer. The Kaplan-Meier survival curves showed a significant separation with worse outcomes for patients with definitive R1 resections. However, the multivariate Cox regression analysis detected no statistically significant difference in overall survival based on margin status. Breast conserving surgery (HR 0.66; 95% CI 0.54-0.81) and HER2 overexpression (HR 0.65; 95% CI 0.48-0.89) were associated with improved survival.
Conclusion: Patients who underwent breast-conserving surgery in our study demonstrated favorable outcomes compared to patients after mastectomy. Although margin status did not significantly affect overall survival, larger multicenter studies are needed to evaluate the prognostic implications of margin involvement in breast cancer treatment in different tumor stages, tumor subtypes and local and systemic treatments.
{"title":"Prognostic Impact of Surgical Margin Status on Overall Survival of Patients with Early Breast Cancer: A Retrospective Analysis from the Department for Women's Medicine at Charité - University Hospital Berlin.","authors":"Maximilian Heinz Beck, Karoline Barbara Stephanie Weiler, Anna Trelinska-Finger, Jens-Uwe Blohmer","doi":"10.1055/a-2374-2270","DOIUrl":"10.1055/a-2374-2270","url":null,"abstract":"<p><strong>Introduction: </strong>The impact of surgical margins on the prognosis of early breast cancer remains uncertain, particularly in the context of modern treatment approaches. This study aimed to investigate whether involved margins after surgery for early breast cancer affect overall survival.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of 3767 patients who underwent surgery for primary breast cancer or carcinoma in situ between 2006 and 2022 at Charité - University Hospital Berlin. Survival analysis based on margin status and a subsequent multivariate Cox regression analysis were conducted.</p><p><strong>Results: </strong>With a median follow-up of 72.2 months, clear margins were achieved in 81.4% of patients (n = 3068) after primary surgery, while 16.2% (n = 610) required re-excision. Only 2.4% of patients (n = 89) had definitively involved margins. Margin involvement was more common in hormone receptor-positive disease, lobular subtype, carcinoma in situ, or locally advanced tumors, but less frequent in patients with previous neoadjuvant chemotherapy or triple-negative breast cancer. The Kaplan-Meier survival curves showed a significant separation with worse outcomes for patients with definitive R1 resections. However, the multivariate Cox regression analysis detected no statistically significant difference in overall survival based on margin status. Breast conserving surgery (HR 0.66; 95% CI 0.54-0.81) and HER2 overexpression (HR 0.65; 95% CI 0.48-0.89) were associated with improved survival.</p><p><strong>Conclusion: </strong>Patients who underwent breast-conserving surgery in our study demonstrated favorable outcomes compared to patients after mastectomy. Although margin status did not significantly affect overall survival, larger multicenter studies are needed to evaluate the prognostic implications of margin involvement in breast cancer treatment in different tumor stages, tumor subtypes and local and systemic treatments.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"837-844"},"PeriodicalIF":2.4,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368467/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125362","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2342-5218
Richard Berger, Patrick Stelzl, Holger Maul
{"title":"Reply to: Letter to the Editor: Administration of Antenatal Corticosteroids: Optimal Timing.","authors":"Richard Berger, Patrick Stelzl, Holger Maul","doi":"10.1055/a-2342-5218","DOIUrl":"10.1055/a-2342-5218","url":null,"abstract":"","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"877"},"PeriodicalIF":2.4,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125363","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2328-9427
Themistoklis Dagklis, Cihat Sen
{"title":"Letter to the Editor: Administration of Antenatal Corticosteroids: Optimal Timing.","authors":"Themistoklis Dagklis, Cihat Sen","doi":"10.1055/a-2328-9427","DOIUrl":"10.1055/a-2328-9427","url":null,"abstract":"","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"876"},"PeriodicalIF":2.4,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125350","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}
Pub Date : 2024-09-02eCollection Date: 2024-09-01DOI: 10.1055/a-2344-5269
Eugen Ruckhäberle, Marcus Schmidt, Anja Welt, Nadia Harbeck, Achim Wöckel, Oleg Gluz, Tjoung-Won Park-Simon, Michael Untch, Michael P Lux
Endocrine-based combination therapy with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6 inhibitors) is currently the first-line therapy of choice for patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer (mBC). The efficacy and safety of the treatment with palbociclib, the first CDK4/6 inhibitor approved for this indication, have been confirmed in large randomized controlled clinical trials (RCTs) with strictly defined patient cohorts. Since then, many relevant questions about CDK4/6 inhibition with palbociclib for mBC have been investigated in RCTs and real-world studies. Based on this evidence, palbociclib is widely used in clinical practice since many years because of its efficacy and good tolerability. The aim of this review is to summarize findings from RCTs and RWE considering clinically relevant aspects such as safety, tolerability, quality of life and efficacy with a focus on specific questions and patient characteristics. A critical discussion and review of the overall evidence for endocrine-based therapy with the CDK4/6 inhibitor palbociclib can contribute to support therapy decisions in daily clinical practice.
{"title":"Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer.","authors":"Eugen Ruckhäberle, Marcus Schmidt, Anja Welt, Nadia Harbeck, Achim Wöckel, Oleg Gluz, Tjoung-Won Park-Simon, Michael Untch, Michael P Lux","doi":"10.1055/a-2344-5269","DOIUrl":"10.1055/a-2344-5269","url":null,"abstract":"<p><p>Endocrine-based combination therapy with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6 inhibitors) is currently the first-line therapy of choice for patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer (mBC). The efficacy and safety of the treatment with palbociclib, the first CDK4/6 inhibitor approved for this indication, have been confirmed in large randomized controlled clinical trials (RCTs) with strictly defined patient cohorts. Since then, many relevant questions about CDK4/6 inhibition with palbociclib for mBC have been investigated in RCTs and real-world studies. Based on this evidence, palbociclib is widely used in clinical practice since many years because of its efficacy and good tolerability. The aim of this review is to summarize findings from RCTs and RWE considering clinically relevant aspects such as safety, tolerability, quality of life and efficacy with a focus on specific questions and patient characteristics. A critical discussion and review of the overall evidence for endocrine-based therapy with the CDK4/6 inhibitor palbociclib can contribute to support therapy decisions in daily clinical practice.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 9","pages":"813-836"},"PeriodicalIF":1.9,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11368471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125361","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}
Background: Effective healthcare relies on well-trained professionals, and the quality of their training is dependent on appropriate learning methods and assessment techniques. Gamification, the use of game mechanics in non-game environments, has emerged as a promising strategy in medical education. This review explores the applicability and effectiveness of gamification in obstetrics and gynecology education.
Methods: Adhering to PRISMA guidelines, a comprehensive search was conducted on PubMed, Google Scholar, Embase, and Medline databases from January to March 2023. The search terms included "medical students OR residents OR physicians OR midwives AND games OR educational games OR serious games AND gynecology OR obstetrics". The inclusion criteria encompassed studies published in English or German from 1990 to March 2023, focusing on gamification in gynecology and obstetrics education. Data extraction and analysis were structured using the PICOS framework.
Results: The review identified various studies demonstrating the effectiveness of gamification in obstetrics and gynecology education. Gaming shows like Jeopardy significantly boosted knowledge retention and engagement. VR technologies, such as Second Life, enhanced emergency and surgical training. Improvisational games improved empathy skills, though requiring reinforcement. Video games and laparoscopy trainers showed promise in enhancing surgical skills, with gamers performing better in initial tasks. Custom-developed games like Play and Learn for Surgeons significantly improved procedural skills.
Discussion: Gamification in obstetrics and gynecology education boosts learner engagement, knowledge retention, and practical skills. VR technologies and video games are effective for surgical training, while custom games can enhance specific procedural skills. Further research is needed to optimize and integrate gamification strategies into standard curricula, offering a modern approach to equip healthcare professionals with essential skills and knowledge.
{"title":"How to Play a Game Properly - Enhancing Obstetrics and Gynecology Education through Gamification: A Scoping Review.","authors":"Melissa Neubacher, Pauline Siebers, Agnes Wittek, Florian Recker","doi":"10.1055/a-2379-8729","DOIUrl":"10.1055/a-2379-8729","url":null,"abstract":"<p><strong>Background: </strong>Effective healthcare relies on well-trained professionals, and the quality of their training is dependent on appropriate learning methods and assessment techniques. Gamification, the use of game mechanics in non-game environments, has emerged as a promising strategy in medical education. This review explores the applicability and effectiveness of gamification in obstetrics and gynecology education.</p><p><strong>Methods: </strong>Adhering to PRISMA guidelines, a comprehensive search was conducted on PubMed, Google Scholar, Embase, and Medline databases from January to March 2023. The search terms included \"medical students OR residents OR physicians OR midwives AND games OR educational games OR serious games AND gynecology OR obstetrics\". The inclusion criteria encompassed studies published in English or German from 1990 to March 2023, focusing on gamification in gynecology and obstetrics education. Data extraction and analysis were structured using the PICOS framework.</p><p><strong>Results: </strong>The review identified various studies demonstrating the effectiveness of gamification in obstetrics and gynecology education. Gaming shows like Jeopardy significantly boosted knowledge retention and engagement. VR technologies, such as Second Life, enhanced emergency and surgical training. Improvisational games improved empathy skills, though requiring reinforcement. Video games and laparoscopy trainers showed promise in enhancing surgical skills, with gamers performing better in initial tasks. Custom-developed games like Play and Learn for Surgeons significantly improved procedural skills.</p><p><strong>Discussion: </strong>Gamification in obstetrics and gynecology education boosts learner engagement, knowledge retention, and practical skills. VR technologies and video games are effective for surgical training, while custom games can enhance specific procedural skills. Further research is needed to optimize and integrate gamification strategies into standard curricula, offering a modern approach to equip healthcare professionals with essential skills and knowledge.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 12","pages":"1126-1134"},"PeriodicalIF":2.4,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11623999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142793910","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}