64 results on '"Solomayer EF"'
Search Results
2. Serum HER2 Verlauf und Therapieansprechen beim metastasierten Mammakarzinom
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Gebauer, G, Solomayer, EF, Jäger, W, Wallwiener, D, Sohn, C, Maul, H, and Fehm, TN
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- 2024
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3. Comparison of HER2 status between disseminated tumor cells (DTC) and corresponding tumors in breast cancer patients
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Fehm, T, Bachmann, R, Pergola-Becker, G, Vogel, U, Becker, S, Wallwiener, D, and Solomayer, EF
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- 2024
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4. Änderung des Her2 Status im postoperativen Verlauf von Mammakarzinompatientinnen
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Fehm, TN, Jäger, W, Kraemer, S, Sohn, C, Solomayer-Meyberg, G, Solomayer, EF, Kurek, R, Wallwiener, D, Maul, H, and Gebauer, G
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- 2024
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5. Evaluation of immunohistochemical TRPC3 and TRPC6 expression patterns in human endometriosis.
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Keller JM, Klamminger GG, Tschernig T, Linxweiler B, Korac L, Wagner M, Solomayer EF, and Kasoha M
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Background: Although to date the pathogenesis of endometriosis remains largely unexplained, it is known that processes of migration, proliferation and revascularization and thus calcium as a messenger substance play an important role. Consecutively, the present study examines the immunohistochemical expression of the calcium transient receptor potential channels 3 and 6 (TRPC3 and TRPC6) in ectopically located (outside the uterine cavity) endometrial tissue., Methods: Laparoscopically collected and histomorphologically verified endometriosis tissues from several different intraabdominal locations were examined (n = 20) and immunohistochemical stainings were performed with anti-TRPC3 and anti-TRPC6 antibodies (Alomone Labs, Jerusalem). Hereby, eutopic endometrium served as a healthy control cohort (n = 6). Staining patterns were evaluated using a modified immunoreactive score (IRS) and exploratory statistical analysis was performed, aiming to determine relations of staining intensities with associated clinical parameters such as rASRM stage and location., Results: We determined a strong cytoplasmatic TRPC3 and TRPC6 expression in all ectopic endometrial glandular formations, albeit with focally varying staining intensities. Within our cohort, we did not verify a statistically significant difference of TRPC3 and TRPC6 expression between endometriosis patients and a healthy control group or between different clinical affections (rASRM stages)., Conclusions: Our study confirms - to our knowledge for the first time - the successful immunohistochemical assessment of TRPC3 and TRPC6 in endometriosis, setting the basis for future studies aiming at evaluating not only clinical aspects of TRPC3 and TRPC6 expression but also shedding light on its function in the pathophysiological context of endometriosis., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier GmbH.. All rights reserved.)
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- 2024
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6. Comparison of different histomorphological grading systems in vulvar squamous cell carcinoma.
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Klamminger GG, Bitterlich A, Nigdelis MP, Hamoud BH, Solomayer EF, and Wagner M
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- Humans, Female, Middle Aged, Prognosis, Aged, Lymph Nodes pathology, Papillomavirus Infections pathology, Papillomavirus Infections complications, Adult, Vulvar Neoplasms pathology, Vulvar Neoplasms virology, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell virology, Neoplasm Grading, Lymphatic Metastasis pathology
- Abstract
Background: Histopathological biomarkers of carcinomas and their prognostic relevance, such as Broder's grading system (based on the total number of undifferentiated cells) or Bryne's grading system (rating morphological features at the tumor invasive front), have been repeatedly and successfully put to test. Since most studies focus on head and neck cancers or oral carcinomas, for squamous cell carcinoma of the vulva, no standardized and agreed on pathological tumor grading system, yielding prognostic significance, could be determined so far., Material and Methods: To determine prognostic associations of different grading systems with regard to groin lymph node metastasis, 73 cases of vulvar carcinomas (VC) were re-examined within our study and Broder's and Bryne's grading system individually performed. To sub-classify between HPV-associated or HPV-independent VC, immunohistochemical p16 stainings were performed. Statistical relationships were evaluated using Spearman correlation and logistic regression analysis, validation was achieved by employment of the likelihood ratio test (LRT) and assessment of ROC curves/AUC values., Results: Within our cohort, Broder's grade I (40≈55%) and Bryne's grade II (48≈66%) were the most frequently assigned histological gradings. We determined a positive correlation of Bryne's grading with the extent of lymph node involvement in HPV-associated tumors and demonstrated the feasibility of Bryne's grading to predict the presence of carcinoma cells within groin lymph nodes (LRT p = 0.0066; AUC value≈0.91) in this cohort. On the other hand, our data suggest that especially HPV-independent tumors may not sufficiently be characterized by current standardly performed grading approaches., Conclusion: Since only Bryne's grading system correlated positively with lymph node involvement in HPV-associated squamous cell carcinoma of the vulva, we propose to include it by name next to the distinct tumor entity on the histopathological report, allowing not only the interpretation of its prognostic relevance but also future research attempts., Competing Interests: Declarations. Conflict of interests: The authors have no relevant financial or non-financial interests to disclose pertaining to this study. Ethical approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Saarland (study identification number 249/23)., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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7. Correlation of preoperative sonographic staging and postoperative histopathologic staging in patients with invasive breast cancer.
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Mueller C, Zimmermann JSM, Radosa MP, Hahn AK, Kaya AC, Huwer S, Stotz L, Wagenpfeil G, Radosa CG, Solomayer EF, and Radosa JC
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- Humans, Female, Middle Aged, Aged, Retrospective Studies, Adult, Aged, 80 and over, Neoplasm Invasiveness, Preoperative Care, Preoperative Period, Breast Neoplasms pathology, Breast Neoplasms diagnostic imaging, Breast Neoplasms surgery, Neoplasm Staging, Ultrasonography, Mammary
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Purpose: To assess the accuracy of preoperative sonographic staging in patients with primary invasive breast cancer., Methods: We retrospectively analyzed a prospectively kept service database of patients with newly diagnosed, unifocal, cT1-3, invasive breast cancer. All patients were diagnosed at a single center institution between January 2013 and December 2021. Clinical T stage was assessed preoperatively by ultrasound and correlated with the definite postoperative pathologic T stage. Demographics, clinical and pathological characteristics were collected. Factors influencing accuracy, over- and underdiagnosis of sonographic staging were analyzed with multivariable regression analysis., Results: A total of 2478 patients were included in the analysis. Median patients' age was 65 years. 1577 patients (63.6%) had clinical T1 stage, 864 (34.9%) T2 and 37 (1.5%) T3 stage. The overall accuracy of sonography and histology was 76.5% (n = 1896), overestimation was observed in 9.1% (n = 225) of all cases, while underestimation occurred in 14.4% (n = 357) of all cases. Accuracy increased when clinical tumor stage cT was higher (OR 1.23; 95% CI 1.10-1.38, p ≤ 0.001). The highest accuracy was seen for patients with T2 stage (82.8%). The accuracy was lower in Luminal B tumors compared to Luminal A tumors (OR 0.71; 95% CI 0.59-0.87, p ≤ 0.001). We could not find any association between sonographic accuracy in HER2 positive patients, and demographic characteristics, or tumor-related factors., Conclusion: Our unicentric study showed a high accuracy of sonography in predicting T stage, especially for tumors with clinical T2 stage. Tumor stage and biological tumor factors do affect the accuracy of sonographic staging., (© 2024. The Author(s).)
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- 2024
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8. Access to Hysterectomy-What Is the Realistic Rate for Pure Vaginal Hysterectomy? A Single-Center Prospective Observational Study.
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Neis F, Ayguen A, Sima RM, Solomayer EF, Juhasz-Boess I, Wagenpfeil G, Brandner P, and Neis KJ
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Background/Objectives: Hysterectomy (HE) is the most common surgical procedure in gynecology worldwide. The guidelines of most countries unanimously recommend vaginal hysterectomy (VH) as the access of first choice. However, there are significant international differences in the implementation of this recommendation. Methods: In the consistent implementation of the national guidelines, the aim of this prospective observational cohort study was to evaluate how many hysterectomies can be performed vaginally under real-world conditions for benign indications excluding genital prolapse and extensive endometriosis. For this purpose, the requirements of the guidelines were implemented for all HE cases. All HEs were performed by a single, experienced surgeon. The aim was not to go to the limits of the method, but to develop a reproducible benchmark with the lowest possible complication rate. Results: From 2011 to 2020, 230 hysterectomies were performed for benign indications. A VH was performed in 146 cases (63.5%), and a laparoscopic hysterectomy (LH) in 75 cases (32.6%). An abdominal hysterectomy (AH) was only required in nine cases (3.9%). The decision for LH was made in half of the cases due to the assumed presence of endometriosis or a significantly enlarged uterus. The median duration of VH was 32 min (range 16-118 min), and the uterine weights were 15-540 g. The rate of postoperative complications of VH was 3.4%. Conclusions: In line with international guidelines, VH is possible in over 60% of cases with a short surgical time and a low complication rate. LH procedures are useful in the presence of assumed additional pathology in 35%. AH is reserved for huge uteri. A reduction in AH below 10% is possible. The global target could be a rate of 60-30-10% for VH, LH, and AH.
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- 2024
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9. Impact of low HER2 expression on response to CDK4/6 inhibitor treatment in advanced HR + /HER2- breast cancer: a multicenter real-world data analysis.
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Ralser DJ, Kiver V, Solomayer EF, Neeb C, Blohmer JU, Abramian AV, Maass N, Schütz F, Kolberg-Liedtke C, Müller C, and Rambow AC
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Purpose: CDK4/6 inhibitors (CDK4/6i) represent the first-line therapy approach of choice for patients with hormone receptor-positive, HER2-negative advanced breast cancer (HR + /HER-ABC). Approximately 50% of HR + /HER2-ABC displays low HER2 expression (HER2 low). Recent data emerging from the DESTINY-Breast04 trial demonstrated practice-changing efficacy of the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) in patients with low HER2 expression. Here, we aimed to analyze the impact of low HER2 expression on CDK4/6i therapy response in a well-characterized multicenter HR + /HER-ABC cohort., Methods: Patients diagnosed with HR + /HER2-ABC who were treated with CDK4/6i in clinical routine between November 2016 and December 2020 at four certified German Breast Cancer Centers were retrospectively identified. The cohort was stratified according to graduation of positivity in HER2 immunohistochemistry (IHC; HER2 zero = IHC score 0 and HER2 low = IHC score 1 + , 2 + /fluorescence in situ hybridization negative). Subgroups were analyzed with regard to progression-free survival (PFS) following CDK4/6i initiation., Findings: The study cohort comprised n = 448 patients. For n = 311 patients, HER2 status from the metastatic site was available. n = 91 (29.3%) cases were HER2 zero and n = 220 cases (70.7%) were HER2 low. There was no significant difference in PFS between the two groups (PFS: 17 months versus 18 months, log-rank p = 0.42). Further, we examined the influence of HER2 expression changes between primary and metastatic tissue (n = 171; HER2 gain/HER2 loss/HER2 stable expression) on CDK4/6i treatment response. Again, there was no significant difference between these three groups, respectively (PFS: 16 months versus 13 months versus 17 months, log-rank p = 0.86)., Conclusions: In our analysis, HER2 status did not have a significant impact on treatment response to CDK4/6i., (© 2024. The Author(s).)
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- 2024
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10. Limitations and perspectives of the novel salivary test for endometriosis: an open web-based survey study of German gynecologic healthcare providers.
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Nigdelis MP, Doerk M, Burghaus S, Sillem M, Hamoud BH, Solomayer EF, and Olmes GL
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Introduction: The description of a salivary miRNA signature for endometriosis has led to the development of a non-invasive diagnostic test. Current healthcare provider practices regarding the test remain uncaptured. The application of this test in practice was examined in a web-based survey, with the aim to provide their opinions on it., Methods: We conducted an open web-based survey study between November 2023 and January 2024. Members of the German society of gynecologic endoscopy (Arbeitsgemeinschaft gynäkologische Endoskopie, AGE), society of endometriosis (Arbeitsgemeinschaft Endometriose, AGEM), and the endometriosis research foundation (Stiftung Endometriose Forschung, SEF) were contacted per e-mail twice. Participants' data were anonymized. Differences in responses based on self-reported expertise in the field (basic knowledge, specialized knowledge, expert) were assessed using the χ
2 -test or Fisher's exact test. Statistical significance was set as p < 0.05., Results: In total 141 of 190 respondents completely responded to the survey (> 75% of the questions of the survey). Twenty-one physicians reported having experience with the test, while most participants had at least specialized knowledge on the field (112/141). In terms of specific questions, more than 90% found the costs high; almost 85% did not believe that the test replaces standard diagnostic tools (histology, clinical examination, and sonography). Eighty-six providers supported the use of the test in adolescents. Gynecologists with basic knowledge had a more positive attitude compared with more experienced ones in terms of usefulness (Fisher's exact test, p < 0.001). Significant differences were demonstrated between expertise groups regarding (not only) applicability in adolescents (Fisher's exact test, p = 0.004), and using the test for screening purposes (χ2 -test, p = 0.002)., Discussion: Despite the promising benefits of a salivary test for endometriosis, German healthcare providers would not change current practices. Nevertheless, less experienced colleagues were more positive towards the test., (© 2024. The Author(s).)- Published
- 2024
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11. Th17 cells target the metabolic miR-142-5p-succinate dehydrogenase subunit C/D (SDHC/SDHD) axis, promoting invasiveness and progression of cervical cancers.
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Pohlers M, Gies S, Taenzer T, Stroeder R, Theobald L, Ludwig N, Kim YJ, Bohle RM, Solomayer EF, Meese E, Hart M, and Walch-Rückheim B
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- Humans, Female, Epithelial-Mesenchymal Transition genetics, Cell Line, Tumor, Cell Movement genetics, Gene Expression Regulation, Neoplastic, MicroRNAs genetics, MicroRNAs metabolism, Uterine Cervical Neoplasms genetics, Uterine Cervical Neoplasms pathology, Uterine Cervical Neoplasms immunology, Succinate Dehydrogenase genetics, Succinate Dehydrogenase metabolism, Neoplasm Invasiveness, Disease Progression, Th17 Cells immunology, Th17 Cells metabolism
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During cervical carcinogenesis, T-helper (Th)-17 cells accumulate in the peripheral blood and tumor tissues of cancer patients. We previously demonstrated that Th17 cells are associated with therapy resistance as well as cervical cancer metastases and relapse; however, the underlying Th17-driven mechanisms are not fully understood. Here, using microarrays, we found that Th17 cells induced an epithelial-to-mesenchymal transition (EMT) phenotype of cervical cancer cells and promoted migration and invasion of 2D cultures and 3D spheroids via induction of microRNA miR-142-5p. As the responsible mechanism, we identified the subunits C and D of the succinate dehydrogenase (SDH) complex as new targets of miR-142-5p and provided evidence that Th17-miR-142-5p-dependent reduced expression of SDHC and SDHD mediated enhanced migration and invasion of cancer cells using small interfering RNAs (siRNAs) for SDHC and SDHD, and miR-142-5p inhibitors. Consistently, patients exhibited high levels of succinate in their serum associated with lymph node metastases and diminished expression of SDHD in patient biopsies correlated with increased numbers of Th17 cells. Correspondingly, a combination of weak or negative SDHD expression and a ratio of Th17/CD4
+ T cells > 43.90% in situ was associated with reduced recurrence-free survival. In summary, we unraveled a previously unknown molecular mechanism by which Th17 cells promote cervical cancer progression and suggest evaluation of Th17 cells as a potential target for immunotherapy in cervical cancer., (© 2023 The Authors. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.)- Published
- 2024
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12. Objective structured assessment of medical students' technical skills in second-degree perineal laceration repair with sponge model-based training.
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Olmes GL, Doerk M, Solomayer EF, Nigdelis MP, Sima RM, and Hamoud BH
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- Humans, Female, Obstetrics education, Suture Techniques education, Pregnancy, Cohort Studies, Surgical Sponges, Gynecology education, Educational Measurement, Education, Medical, Undergraduate methods, Adult, Perineum injuries, Perineum surgery, Clinical Competence, Lacerations surgery, Students, Medical, Simulation Training methods
- Abstract
Purpose: In this cohort study, we used a sponge simulator to train students in second-degree perineal laceration repair. We examined whether the training course improved the students' skills, as measured with an objective structured assessment of technical skills (OSATS) and by a senior physician. We also examined the correlation between these ratings to assess the validity of OSATS application in this context., Methods: Between April and July 2022, 40 medical students took part in gynecological/obstetrics training that included a lecture about perineal trauma and the viewing of a video that demonstrated second-degree perineal laceration repair using a sponge model. They then underwent initial evaluation by a senior physician and OSATS application, yielding two independent scores. After training with the sponge model, a second evaluation was performed. The OSATS assessed practical skills (8 items) and suture results (2 items). The senior physician assigned ratings on a five-point ordinal scale ranging from 1 (excellent) to 5 (poor)., Results: Training with the sponge simulator significantly increased students' OSATS (practical skills, p < 0.001; suture results, p < 0.05) and senior physician (p < 0.001) ratings. The OSATS and senior physician ratings correlated strongly (Spearman's r: first assessment, - 0.72; second assessment, - 0.74; p < 0.01)., Conclusion: The sponge-based training improves students' skills for the repair of a second-degree perineal laceration. The OSATS for the sponge model might be a valid option to examine medical students in an obstetrical course., (© 2023. The Author(s).)
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- 2024
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13. Impact of the COVID-19 Pandemic on Tumor Stage and Pathohistological Parameters of Vulvar Cancer.
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Klamminger GG, Bitterlich A, Nigdelis MP, Schnöder L, Hamoud BH, Solomayer EF, and Wagner M
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Background/Objectives : Vulvar cancer (VC) comprises a small fraction of female neoplasms with notable high-incidence clusters among German regions. Despite a proposed impact of nationwide lockdowns in response to the COVID-19 pandemic on oncological diseases, the effect on VC staging and tumor characteristics remains yet to be resolved; therefore, analyzing pathological data from patients with squamous cell VC pre-, during, and post-COVID in a high-incidence region may offer insights into potential epidemiological and clinical trends. Methods : We identified a total of 90 patients who were diagnosed at the Institute of Pathology, University Hospital Saarland, between 2018 and 2023, and defined three distinct cohorts: a pre-COVID cohort (2018-2019), a COVID cohort (2020-2021), and a post-COVID cohort (2022-2023). Histomorphological data were collected from the individual patient reports and statistically analyzed using Fisher's exact test or the Kruskal-Wallis test. Results : Although we found no statistically significant differences in age, T-stage, perineural infiltration, blood vessel infiltration, resection status, grading, or resection margin between our three cohorts, surprisingly, we determined a greater extent of lymphovascular infiltration (Fisher's exact test; p = 0.041), as well as deeper tumor infiltration depth (Kruskal-Wallis test; p < 0.001) before the COVID-19 pandemic. Furthermore, we did not identify any soft indications of abnormalities in patient care within our center (unchanged status of the resection margins across all three cohorts). Conclusions : Our results clearly do not support a negative affection of clinical or pathobiological characteristics of VC during or after the pandemic. However, final assessments regarding the pandemic's effect on VC require additional study approaches in various regions, preferably with future extended timeframes of a longer follow-up.
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- 2024
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14. A Plea for Monitoring Serum Selenium Levels in Breast Cancer Patients: Selenium Deficiency Is Rare during the First Year of Therapy, and Selenium Supplementation Is Associated with Elevated Risk of Overdosing.
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Altmayer LA, Lang M, Schleicher JT, Stuhlert C, Wörmann C, Scherer LS, Thul IC, Spenner LS, Simon JA, Wind A, Tokcan M, Kaiser E, Weber R, Goedicke-Fritz S, Wagenpfeil G, Zemlin M, Solomayer EF, Reichrath J, Müller C, and Zemlin C
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- Humans, Female, Middle Aged, Prospective Studies, Aged, Adult, Selenium blood, Selenium deficiency, Breast Neoplasms blood, Breast Neoplasms drug therapy, Dietary Supplements
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(1) Background: The role of selenium in cancer biology remains poorly understood. Our aim was to study the course of selenium serum levels and the use of selenium supplements during breast cancer therapy. (2) Methods: Serum selenium levels, clinical-pathological data, selenium supplementation, and lifestyle factors were monitored quarterly over one year. (3) Results: A total of 110 non-metastatic breast cancer patients were enrolled in the prospective observational "BEGYN-1" study. At baseline, 2.9% of patients were selenium-deficient (<50 ng/mL), 1.9% were overdosed (>120 ng/mL), and 6.4% received substitution. The median selenium level was 81.5 ng/mL and ranged between 78.7 and 84.5 ng/mL within the year. A total of 25.3% of the patients received supplementation, resulting in significantly higher selenium levels ( p < 0.05). A total of 8.7-28.6% of the patients using supplements were overdosed. Selenium levels strongly correlated with mushroom consumption ( p = 0.003), but no association was found with therapy or clinical characteristics. (4) Conclusions: Although selenium deficiency is rare, serum selenium levels should be assessed in breast cancer patients. Mushrooms and nuts should be preferred over supplements to correct selenium deficiency. Ruling out selenium deficiency helps prevent the risk of selenosis and avoid unnecessary, costly supplementation in patients who are often financially burdened due to their disease.
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- 2024
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15. Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2024.
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Thill M, Janni W, Albert US, Banys-Paluchowski M, Bauerfeind I, Blohmer J, Budach W, Dall P, Ditsch N, Fallenberg EM, Fasching PA, Fehm T, Friedrich M, Gerber B, Gluz O, Harbeck N, Hartkopf A, Heil J, Huober J, Jackisch C, Kolberg-Liedtke C, Kreipe HH, Krug D, Kühn T, Kümmel S, Loibl S, Lüftner D, Lux MP, Maass N, Mundhenke C, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schütz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Untch M, Witzel I, Wöckel A, Würstlein R, Müller V, and Park-Simon TW
- Abstract
The Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2024 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer., Competing Interests: Prof. Dr. med. Marc Thill was a member of advisory board Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm medical, Pierre Fabre, Roche, RTI Surgical, Seagen, Sirius Medical, and Sysmex; received manuscript support from Amgen, ClearCut, Clovis, Organon, pfm medical, Roche, and Servier; received travel expenses from Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Hexal, I-Med-Institute, Lilly, MCI, MSD, Neodynamics, Novartis, Pfizer, pfm medical, Roche, RTI Surgical, and Seagen; received congress support from Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Gilead, Hexal, Lilly, Neodynamics, Novartis, Pfizer, Pierre Fabre, Roche, and Sirius Medical; has received lecture honoraria from Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther et al. Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, pfm medical, Roche, Seagen, StreamedUp, Stemline, Sysmex, Vifor, Viatris, and ZP Therapeutics; has received trial funding from Endomag, Exact Sciences; and received trial honoraria (institutional) from AstraZeneca, Biom’Up, Cairn Surgical, Celgene, Clearcut, Neodynamics, Novartis, pfm medical, Roche, and RTI Surgical. Prof. Dr. med. Wolfgang Janni has received research grants and/or honoraria from AstraZeneca, Celgene, Chugai, Daiichi Sankyo, Eisai, ExactScience, GSK, Janssen, Lilly, Menarini, MSD, Novartis, Sanofi Aventis, Roche, Pfizer, Seagen, Gilead, Inivata, and Guardant Health. Prof. Dr. med. Ute-Susann Albert has received lectures from Pfizer, Novartis, AstraZeneca, was a member of advisory board Daiichi Sankyo, and Pfizer. Prof. Dr. Malgorzata Banys-Paluchowski has received honoraria for lectures and advisory from Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Stemline, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Medical, Syantra, Pierre Fabre, and ExactSciences; received study support from EndoMag, Mammotome, MeritMedical, Gilead, Hologic, and ExactSciences; and received travel/congress support from Eli Lilly, ExactSciences, Pierre Fabre, Pfizer, AstraZeneca, Daiichi Sankyo, and Roche. Dr. med. Ingo Bauerfeind has received honoraria and travel reimbursement from Brustkrebs Deutschland e.V., Krankenhaus Kempten, Akademie für Psychoonkologie, IF-Kongress Management. Prof. Dr. med. Jens-Uwe Blohmer has received honoraria for advisory boards and lectures from Astra Zeneca, Daiichi Sankyo, Eisai, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, and Seagen. Prof. Dr. med. Wilfried Budach has received honoraria for lectures and advisory boards from Merck, BMS, Jörg Eickeler Veranstaltungen, medpublico GmbH, and BVDST. Prof. Dr. med. Peter Dall has received honoraria for lectures and advisory boards from Novartis, Pierre Fabré, MSD, Lilly, and AstraZeneca. Prof. Dr. Nina Ditsch was a member of advisory boards and speakers bureaus AstraZeneca, Aurikamed, BGGF, Daiichi Sankyo, Elsevier Verlag, ESO, Exact Sciences, Gilead Sciences, GSK, if-Kongress, KelCon, Leopoldina Schweinfurt, Lilly, Lukon, Molekular Health, MSD, Novartis, onkowissen, Pfizer, RG-Ärztefortbildungen, Roche, and Seagen. Prof. Dr. med. Eva Maria Fallenberg has received research grant from DFG and speaker honorarium from GE Healthcare, Bayer Healthcare, Guerbet, Siemens, BD, Roche, EUSOBI, ESOR, ESMO, and B-Rayz. Prof. Dr. med. Peter A. Fasching participate on a data safety monitoring board or advisory board: Novartis, Pfizer, Roche, Daiichi Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, and Mylan; has received honoraria for lecture, speakers bureaus, manuscript writing, or educational events from Novartis, Pfizer, Roche, Daiichi Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, and Mylan; and has received consulting from Novartis, Pfizer, Roche, Daiichi Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, and Mylan. Medical Writing: Merck, to institution: Biontech, Cepheid, Pfizer. Prof. Dr. med. Tanja N. Fehm has receiverd honoraria from Onkowissen. Prof. Dr. med. Michael Friedrich was a member of advisory board: Gilead Sciences has received other honoraria from Roche, MSD. Prof. Dr. med. Bernd Gerber has received travel support from Pfizer. PD Dr. med. Oleg Gluz has received honoraria for lectures and/or consulting from Amgen, AstraZeneca, Daiichi Sanyko, Eisai, Gilead Science, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, Exact Sciences, Agendia, MedConcept, and GynUpdate, Minority share holder: Westdeutsche Studiengruppe (WSG). Prof. Nadia Harbeck, MD has received honoraria for lectures and/or consulting from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seagen, Viatris, and Zuelligpharma; received other from Co-Director West German Study Group (WSG). Prof. Dr. med. Andreas Daniel Hartkopf has received honoraria for consulting and speaking engagements from AstraZeneca, Agendia, Amgen, Clovis, Daichi Sankyo, Eisai, ExactScience, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Onkowissen, Pfizer, Roche, Pierre Fabre, Seagen, Stemline, and Verazyte. Prof. Dr. med. Jens Huober has received honoraria for lectures from Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Seagen, Gilead, and Daiichi; has received honoraria for consulting/advisory board from Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Daiichi, and Gilead; and has received travel grants from Roche, Pfizer, Daiichi, and Gilead. Prof. Dr. med. Christian Jackisch was a member of advisory board Astra Zeneca, Novartis, Lilly, Gilead, Exact Sciences, Pfizer, Roche, GSK, Pierre Fabre, Roche, and Seagen and received lecture from Art tempi, AstraZeneca, Lilly, Novartis, Roche, Amgen, Pierre Fabre, Exact Sciences, MSD, GynUpdate, and StreamedUp. Prof. Dr. med. Cornelia Kolberg-Liedtke was a member of advisory board: SeaGen, Exact Sciences, Pfizer, Novartis, AstraZeneca, Lilly, SeaGen, Daiichi Sankyo, Agendia, Gilead, and Onkowissen; has received lecture from NOGGO, CECOG, PINK, Pfizer, Roche, AstraZeneca, Carl Zeiss Meditec, Lilly, SeaGen, and Daiichi Sankyo; received other honoraria from Gilead Science and POMME; and stockholding Theraclion SA. Prof. Dr. med. Hans-Heinrich Kreipe was a member of advisory board: Lilly; has received lecture from AstraZeneca, Roche, Daiichi Sankyo, and Pfizer. PD Dr. David Krug has received lecture from Merck Sharp and Dohme, Pfizer, Astra Zeneca, onkowissen, med update; was a member of advisory board: Gilead; and has received research funding from Merch KGaA and Deutsche Krebshilfe. Prof. Dr.med. Thorsten Kühn was a member of advisory board/lecture Sysmex, Neodynamics, Pfizer, MSD, Merit Medical, Sirius Medical, Hologic, Endomag, Lilly; and has received trial funding from Merit Medical, Endomag, Mammotome. Prof. Dr. med. Sherko Kümmel has received lecture from Roche, Lilly, Exact Sciences, Novartis, Amgen, Daiichi Sankyo, AstraZeneca, MSD, Pfizer, Seagen, Gilead, Agendia; Hologic, PINK!, and Stemline; has received other honoraria from Roche, Daiichi Sankyo, and Sonoscape; was a member of advisory board Lilly, MSD, Roche, Astra Zeneca, Stemline, Novartis, Daiichi Sankyo, MSD, Seagen, Gilead, and Exact Science. Prof. Dr. med. Sibylle Loibl was a member of advisory board, institutional: Abbvie, Amgen, AstraZeneca, BMS, Celgene, DSI, Eirgenix, GSK, Gilead Science, Lilly, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeuticas, Puma, Roche, Seagen, and Stemline-Menarini; invited speaker, personal: Medscape; and has received trial funding/others from Astra Zeneca, Abbvie, Celgene, Daiichi Sankyo, Greenwich Life Sciences, GSK, Immunomedics/Gilead, Molecular Health, Novartis, Pfizer, Roche, Stemline-Menarini, and VM Scope GmbH. Prof. Dr. med. Diana Lüftner D.L. has received honoraria for advisory board activities and/or oral presentations from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, high5md, Loreal, MSD, Mundipharma, Novartis, onkowissen.de, Pfizer, Pierre Fabre, Roche, and TEVA. Prof. Dr. med. Michael Patrick Lux M.P.L. has received honoraria from Lilly, Pfizer, Roche, MSD, Hexal, Novartis, AstraZeneca, Eisai, Exact Sciences, Agendia, Daiichi Sankyo, Grünenthal, Gilead, Pierre Fabre, PharmaMar, Samantree, Endomag, and medac for advisory boards, lectures, and travel support. Prof. Dr. med. Nicolai Maass was a member of advisory board Amgen, AstraZeneca, Clovis, Daiichi Sankyo, GSK, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, and Seagen has received lecture from Astra Zeneca, Daiichi Sankyo, GSK, Lilly, Novartis, Pfizer, and Roche. Prof. Dr. med. Christoph Mundhenke was a member of advisory board AstraZeneca, Pfizer, Daiichi Sankyo, Seagen, and Novartis and has received lecture from Pfizer and Novartis. Prof. Dr. med. Toralf Reimer has received trial funding from German Cancer Aid and Else Kroener-Fresenius-Stiftungwas a member of advisory board MSD, Novartis, and Myriad; and has received lecture from Pfizer, Novartis, Roche, and AstraZeneca. Prof. Dr. med. Kerstin Rhiem has received honoraria from AstraZeneca, Roche, Novartis, streamed up. Prof. Dr. med. Achim Rody was a member of advisory board AstraZeneca, Novartis, Roche, Exact Sciences, Pierre Fabre, Lilly, Seagen, Amgen, MSD, Gilead; has received lecture from Pfizer, Celgene, Eisai; and has received trial funding from Eisai. Prof. Dr. med. Marcus Schmidt M.S. reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, GILEAD, Lilly, Menarini-Stemline, Molecular Health, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, and SeaGen, His institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, he has a patent for EP 2390370 B1 and a patent for EP 2951317 B1 issued. Prof. Dr. med. Andreas Schneeweiss has received research grants from Celgene, Roche; has received honoraria from Amgen, AstraZeneca, Aurikamed, Bayer, Celgene, ClinSol, Clovis Oncology, coma UroGyn, Connectmedica, Daiichi Sankyo, Gilead, GSK, if-kongress, I-MED, iOMEDICO, Lilly, MCI Deutschland, med publico, Metaplan, MSD, Mylan, NanoString Technologies, Novartis, onkowissen.de, Pfizer, Pierre Fabre, promedicis, Roche, Seagen, streamedup, and Tesaro; and has received travel support from AstraZeneca, Celgene, Daiichi Sankyo, Gilead, Pfizer, and Roche. Prof. Dr. med. Florian Schütz has received lecture from Amgen, AstraZeneca, Daiichi Sankyo, Eisai, ExactSciences, Gilead, Lilly, MSD, Novartis, ClinSol, Pfizer, and Roche Pharma; was a member of advisory board Lilly, MSD, Gilead, Atheneum Partners, and ClinSol; and received travel expenses from Lilly, Gilead. Prof. Dr. med. Hans-Peter Sinn was a member of advisory board Astra Zeneca, Exact Sciences, and Daiichi Sankyo; has received lecture from AstraZeneca and Diacentus; and has received trial funding from AstraZeneca. Prof. Dr. med. Christine Solbach has received lecture from DiaLog Service GmbH, Jörg Eickeler, Pfizer, Roche, AstraZeneca, MedConcept, I-Med, GBG, BVF Akademie, and LÄK Hessen Akademie was a member of advisory board: MSD, Roche. Prof. Dr. med. Erich Solomeyer has received honoraria from Roche, Amgen, Celgen, Tesaro, Astra Zeneca, Pfizer, Storz, Erbe, Gedeon Richter, Eisai, Medac, MSD, Vifor, Teva, Ethikon, Johnson Johnson, Daiichi Sankyo, Gilead, Exact Sciences, GSK, and Pierre Fabre. Prof. Dr. med. Elmar Stickeler was a member of advisory boards Amgen, Astra Zeneca, Gilead, Iomedico, Lilly, MSD, Novartis, Seagen, and Roche and received lecture from Astra Zeneca, BSH Düsseldorf, Gilead, Iomedico, MSD, Novartis, Onkowissen, Pfizer, PharmaMar, and Roche. Prof. Dr. med. Christoph Thomssen has received compensation for advisory boards, lectures or publications from Amgen, AstraZeneca, Aurikamed, Daiichi Sankyo, Forum Sanitas, Gilead, Jörg Eickeler, Hexal, Lilly, Medupdate, MSD, Nanostring, Novartis, Onkowissen, Pfizer, Roche, Seagen, Vifor. Prof. Dr. med. Michael Untch M. U. has received honoraria to travel support, lectures, and consulting or advisory role from AstraZeneca, Amgen, Daiichi Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Pierre Fabre, Sanofi Aventis, Myriad, Seagen, Novartis, Gilead, Stemline, Genzyme, Agendia, Onkowissen, and Eisai, all honoraria and fees to the employer/institution. Prof. Dr. Isabell Witzel has received lecture from Astra Zeneca, Lilly, Seagen, Daiichi Sankyo, Gilead, Pfizer and Novartis, and Onkowissen and has received Travel support from Roche and Lilly. Prof. Dr. med. Achim Wöckel has received compensation for advisory boards, lectures, trial funding advisory board from Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Exact Sciences, Pierre Fabre, Clovis, Organon, Daiji Sankyo, Seagen, Stemline, and Gilead. PD. Dr. Rachel Würstlein served as advisor, consultant, speaker, and travel grant Agendia, Amgen, Apogepha, Aristo, Astra Zeneca, Celgene, Clovis Oncology, Daiichi Sankyo, Eisai, Esteve, Exact Sciences, Gilead, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Mylan, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PINK, PumaBiotechnolgogy, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics/Seagen, Sidekick, Stemline, Tesaro Bio, Teva, Veracyte, Viatris, Wiley, FOMF, Aurikamed, Clinsol, Pomme Med, medconcept, MCI, and MediSeminar. Prof. Dr. med. Volkmar Müller has received speaker honoraria Astra Zeneca, Daiichi Sankyo, Eisai, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead, Pierre Fabre, and i-MED Institute; has received consultancy honoraria from Roche, Pierre Fabre, PINK, ClinSol, Novartis, MSD, Daiichi Sankyo, Eisai, Lilly, Seagen, Gilead, and Stemline; has received institutional research support from Novartis, Roche, Seagen, Genentech, and Astra Zeneca; and has received travel grants from Astra Zeneca, Roche, Pfizer, Daiichi Sankyo, and Gilead. Prof. Dr. Tjoung-Won Park-Simon has received honoraria for lectures and/or consulting from Roche, AstraZeneca, GSK, Pfizer, Lilly, MSD, Exact Sciences, Daiichi Sankyo, Seagen, Novartis, Gilead Science, NCO, Onkowissen, Exact Sciences, and Seagen and has received travel compensation from Roche, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Gilead, and Pierre Fabre. Prof. Dr. med. Jörg Heil has none to declare., (© 2024 S. Karger AG, Basel.)
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- 2024
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16. Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2024.
- Author
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Park-Simon TW, Müller V, Albert US, Banys Paluchowski M, Bauerfeind I, Blohmer JU, Budach W, Dall P, Ditsch N, Fallenberg EM, Fasching PA, Fehm T, Friedrich M, Gerber B, Gluz O, Harbeck N, Hartkopf AD, Heil J, Huober J, Jackisch C, Kolberg-Liedtke C, Kreipe HH, Krug D, Kühn T, Kümmel S, Loibl S, Lüftner D, Lux MP, Maass N, Mundhenke C, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schütz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Untch M, Witzel I, Wuerstlein R, Wöckel A, Janni W, and Thill M
- Abstract
Introduction: Each year the interdisciplinary AGO (Arbeitsgemeinschaft Gynäkologische Onkologie, German Gynecological Oncology Group) Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer., Methods: The updated evidence-based treatment recommendations for early and metastatic breast cancer have been released in March 2024., Results and Conclusion: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter., Competing Interests: Prof. Dr. Tjoung-Won Park-Simon has received honoraria for lectures and/or consulting from Roche, AstraZeneca, GSK, Pfizer, Lilly, MSD, ExactSciences, Daiichi Sankyo, Seagen, Novartis, Gilead Science, NCO, Onkowissen, Exact Sciences, Seagen. Travel compensation: Roche, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Gilead, and Pierre Fabre. Prof. Dr. med. Ute-Susann Albert has received honoraria for lectures from Pfizer, Novartis, AstraZeneca and is a member of advisory board Daiichi Sankyo, Pfizer. Prof. Dr. Malgorzata Banys-Paluchowski has received honoraria for lectures and advisory from Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Stemline, Samsung,Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Medical, Syantra, Pierre Fabre, ExactSciences, study support from EndoMag, Mammotome, Merit Medical, Gilead, Hologic, ExactSciences, and travel/congress support from Eli Lilly, ExactSciences, Pierre Fabre, Pfizer, AstraZeneca, Daiichi Sankyo, and Roche. Prof. Dr. med. Jens-Uwe Blohmer has received honoraria for advisory boards and lectures: AstraZeneca, Daiichi Sankyo, Eisai, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Seagen. Prof. Dr. med. Wilfried Budach has received honoraria for lectures and advisory boards: Merck, BMS, Jörg Eickeler Veranstaltungen, med publico GmbH, BVDST. Prof. Dr. med. Peter Dall has received honoraria for lectures and advisory boards from Novartis, Pierre Fabré, MSD, Lilly, AstraZeneca. Prof. Dr. Nina Ditsch was a member of advisory boards and speakers bureaus: AstraZeneca, Aurikamed, BGGF, Daiichi-Sankyo, Elsevier Verlag, ESO, Exact Sciences, Gilead Sciences, GSK, if-Kongress, KelCon, Leopoldina Schweinfurt, Lilly, Lukon, Molekular Health, MSD, Novartis, Onkowissen, Pfizer, RG-Ärztefortbildungen, Roche, Seagen. Prof. Dr. med. Eva Maria Fallenberg has received research grant from DFG and received speaker honorarium from GE Healthcare, Bayer Healthcare, Guerbet, Siemens, BD, Roche, EUSOBI, ESOR, ESMO, B-Rayz. Prof. Dr. med. Peter A. Fasching: participation on a data safety monitoring board or advisory board: Novartis, Pfizer, Roche, Daiichi-Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, Mylan, has received honoraria for lecture, speakers bureaus, manuscript writing, or educational events from Novartis, Pfizer, Roche, Daiichi-Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, Mylan, consulting from Novartis, Pfizer, Roche, Daiichi-Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp and Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead, Mylan. Medical Writing: Merck. To institution: Biontech, Cepheid, Pfizer. Prof. Dr. med. Michael Friedrich is a member of the advisory board Gilead Sciences and has received other honoraria from Roche, MSD. Prof. Dr. med. Bernd Gerber has received travel support from Pfizer. PD Dr. med. Oleg Gluz has received honoraria for lectures and/or consulting from Amgen, AstraZeneca, Daiichi Sanyko, Eisai, Gilead Science, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, Exact Sciences, Agendia, MedConcept, GynUpdate, and minority share holder: Westdeutsche Studiengruppe (WSG). Prof. Nadia Harbeck, MD has received honoraria for lectures and/or consulting from AstraZeneca, Daiichi-Sankyo, Gilead, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seagen, Viatris, Zuelligpharma, other are Co-Director West German Study Group (WSG). Prof. Dr. med. Andreas Daniel Hartkopf has received honoraria for consulting and speaking engagements from AstraZeneca, Agendia, Amgen, Clovis, DaichiiSankyo, Eisai, Exact Science, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Onkowissen, Pfizer, Roche, Pierre Fabre, Seagen, Stemline, and Verazyte. Prof. Dr. med. Jens Huober has received honoraria for lectures: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Seagen, Gilead, Daiichi and honoraria for consulting/advisory board: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Daiichi, Gilead and received travel grants: Roche, Pfizer, Daiichi, Gilead. Prof. Dr. med. Christian Jackisch is a member of advisory board: AstraZeneca, Novartis, Lilly, Gilead, Exact Sciences, Pfizer, Roche, GSK, Pierre Fabre, Roche, Seagen; Lecture: Art tempi, AstraZeneca, Lilly, Novartis, Roche, Amgen, Pierre Fabre, Exact Sciences, MSD, GynUpdate, StreamedUp. Prof. Dr. med. Cornelia Kolberg-Liedtke is a member of advisory board: SeaGen, Exact Sciences, Pfizer, Novartis, AstraZeneca, Lilly, SeaGen, Daiichi Sankyo, Agendia, Gilead, Onkowissen, has received honoraria for lectures from NOGGO, CECOG, PINK, Pfizer, Roche, AstraZeneca, Carl Zeiss Meditec, Lilly, SeaGen, Daiichi Sankyo. Other: Gilead Science, POMME. Stockholding: Theraclion SA. Prof. Dr. med. Hans-Heinrich Kreipe is a member of advisory board: Lilly, has received honoraria for lecture: AstraZeneca, Roche, Daiichi Sankyo, Pfizer. PD Dr. David Krug has received honoraria for lecture from Merck Sharp and Dohme, Pfizer, AstraZeneca, Onkowissen, med update is a member of advisory board: Gilead, has received research funding from Merch KGaA, Deutsche Krebshilfe. Prof. Dr. med. Thorsten Kühn is a member of advisory board/lecture: Sysmex, Neodynamics, Pfizer, MSD, Merit Medical, Sirius Medical, Hologic, Endomag, Lilly has received trial funding from Merit Medical, Endomag, Mammotome. Prof. Dr. med. Sherko Kümmel has received honoraria for lecture: Roche, Lilly, Exact Sciences, Novartis, Amgen, Daiichi Sankyo, AstraZeneca, MSD, Pfizer, Seagen, Gilead, Agendia; Hologic, PINK!; Stemline, other honoraria from Roche, Daiichi Sankyo, Sonoscape, is a member of advisory board: Lilly, MSD, Roche, AstraZeneca, Stemline, Novartis, Daiichi Sankyo, MSD, Seagen, Gilead, Exact Science. Prof. Dr. med. Sibylle Loibl is a member of advisory board, institutional: Abbvie, Amgen, AstraZeneca, BMS, Celgene, DSI, Eirgenix, GSK, Gilead Science, Lilly, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeuticas, Puma, Roche, Seagen, Stemline-Menarini, invited speaker, personal: Medscape received trial funding/others from: AstraZeneca, Abbvie, Celgene, Daiichi-Sankyo, Greenwich Life Sciences, GSK, Immunomedics/Gilead, Molecular Health, Novartis, Pfizer, Roche, Stemline-Menarini, VM Scope GmbH. Prof. Dr. med. Diana Lüftner has received honoraria for advisory board activities and/or oral presentations from Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, GSK, high5md, Loreal, MSD, Mundipharma, Novartis, onkowissen.de, Pfizer, Pierre Fabre, Roche and TEVA. Prof. Dr. med. Michael Patrick Lux has received honoraria from Lilly, Pfizer, Roche, MSD, Hexal, Novartis, AstraZeneca, Eisai, Exact Sciences, Agendia, Daiichi-Sankyo, Grünenthal, Gilead, Pierre Fabre, PharmaMar, Samantree, Endomag, and medac for advisory boards, lectures, and travel support. Prof. Dr. med. Nicolai Maass was a member of advisory board: Amgen, AstraZeneca, Clovis, Daiichi Sankyo, GSK, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seagen and has received honoraria for lectures from AstraZeneca, Daiichi Sankyo, GSK, Lilly, Novartis, Pfizer, Roche. Prof. Dr. med. Christoph Mundhenke was a member of advisory board: AstraZeneca, Pfizer, Daiichi Sankyo, Seagen, Novartis, has received honoraria for lecture: Pfizer, Novartis. Prof. Dr. med. Toralf Reimer has received trial funding from German Cancer Aid and Else Kroener-Fresenius-Stiftung, is a member of advisory board: MSD, Novartis, Myriad lecture from: Pfizer, Novartis, Roche, AstraZeneca. Prof. Dr. med. Achim Rody was a member of advisory board: AstraZeneca, Novartis, Roche, Exact Sciences, Pierre Fabre, Lilly, Seagen, Amgen, MSD, Gilead, lecture Pfizer, Celgene, Eisai, has received trial funding from Eisai. Prof. Dr. med. Marcus Schmidt reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, GILEAD, Lilly, Menarini-Stemline, Molecular Health, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, and SeaGen, his institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, he has a patent for EP 2390370 B1 and a patent for EP 2951317 B1 issued. Prof. Dr. med. Andreas Schneeweiss has received research grants from Celgene, Roche, honoraria from Amgen, AstraZeneca, Aurikamed, Bayer, Celgene, ClinSol, Clovis Oncology, coma UroGyn, Connect Medica, Daiichi Sankyo, Gilead, GSK, if-kongress, I-MED, iOMEDICO, Lilly, MCI Deutschland, med publico, Metaplan, MSD, Mylan, NanoString Technologies, Novartis, onkowissen.de, Pfizer, Pierre Fabre, promedicis, Roche, Seagen, StreamedUp, and Tesaro, received travel support from AstraZeneca, Celgene, Daiichi Sankyo, Gilead, Pfizer, Roche. Prof. Dr. med. Florian Schütz has received honoraria for lecture Amgen, AstraZeneca, Daiichi Sankyo, Eisai, ExactSciences, Gilead, Lilly, MSD, Novartis, ClinSol, Pfizer, Roche Pharma, was a member of advisory board: Lilly, MSD, Gilead, Atheneum Partners, ClinSol, has received travel expenses from Lilly, Gilead. Prof. Dr. med. Hans-Peter Sinn was a member of advisory board: AstraZeneca, Exact Sciences, Daiichi Sankyo, has received honoraria for lecture from AstraZeneca, Diacentus, has received trial funding from AstraZeneca. Prof. Dr. med. Christine Solbach has received honoraria for lecture: DiaLog Service GmbH, Jörg Eickeler, Pfizer, Roche, AstraZeneca, MedConcept, I-Med, GBG, BVF Akademie, LÄK Hessen Akademie, was a member of advisory board: MSD, Roche. Prof. Dr. med. Elmar Stickeler was a member of advisory boards Amgen, AstraZeneca, Gilead, Iomedico, Lilly, MSD, Novartis, Seagen, Roche; has received honoraria for lecture: AstraZeneca, BSH Düsseldorf, Gilead, Iomedico, MSD, Novartis, Onkowissen, Pfizer, PharmaMar, Roche. Prof. Dr. med. Christoph Thomssen: compensation for advisory boards, lectures or publications. Amgen, AstraZeneca, Aurikamed, Daiichi-Sankyo, Forum Sanitas, Gilead, Jörg Eickeler, Hexal, Lilly, med update, MSD, Nanostring, Novartis, Onkowissen, Pfizer, Roche, Seagen, Vifor. Prof. Dr. med. Michael Untch has received honoraria to travel support, lectures, and consulting or advisory role from AstraZeneca, Amgen, Daiichi Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Pierre Fabre, Sanofi-Aventis, Myriad, Seagen, Novartis, Gilead, Stemline, Genzyme, Agendia, Onkowissen, Eisai, all honoraria and fees to the employer/institution. Prof. Dr. Isabell Witzel has received honoraria for lecture: AstraZeneca, Lilly, Seagen, Daiichi Sankyo, Gilead, Pfizer and Novartis, Onkowissen. travel support from Roche and Lilly. Prof. Dr. med. Achim Wöckel compensation for advisory boards, lectures, trial funding Advisory board: Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Exact Sciences, Pierre Fabre, Clovis, Organon, Daiji Sankyo, Seagen, Stemline, Gilead. PD. Dr. Rachel Würstlein served as advisor, consultant, speaker, and travel grant from Agendia, Amgen, Apogepha, Aristo, AstraZeneca, Celgene, Clovis Oncology, Daiichi-Sankyo, Eisai, Esteve, Exact Sciences, Gilead, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Mylan, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PINK, PumaBiotechnolgogy, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics /Seagen, Sidekick, Stemline, Tesaro Bio, Teva, Veracyte, Viatris, Wiley, FOMF, Aurikamed, Clinsol, Pomme Med, medconcept, MCI, MediSeminar. Prof. Dr. med. Volkmar Müller has received speaker honoraria from: AstraZeneca, Daiichi-Sankyo, Eisai, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead, Pierre Fabre, iMED Institute, consultancy honoraria from Roche, Pierre Fabre, PINK, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Seagen, Gilead, Stemline, institutional research support from Novartis, Roche, Seagen, Genentech, AstraZeneca, travel grants form AstraZeneca, Roche, Pfizer, Daiichi Sankyo, Gilead. Prof. Dr. med. Wolfgang Janni has received research grants and/or honoraria from AstraZeneca, Celgene, Chugai, Daiichi Sankyo, Eisai, Exact Science, GSK, Janssen, Lilly, Menarini, MSD, Novartis, Sanofi-Aventis, Roche, Pfizer, Seagen, Gilead, Inivata, Guardant Health. Prof. Dr. med. Marc Thill is a member of advisory board: Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm Medical, Pierre Fabre, Roche, RTI Surgical, Seagen, Sirius Medical, Sysmex, has received manuscript support from Amgen, ClearCut, Clovis, Organon, pfm medical, Roche, Servier, has received travel expenses from Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Hexal, I-Med-Institute, Lilly, MCI, MSD, Neodynamics, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, Seagen; Congress support: Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Gilead, Hexal, Lilly, Neodynamics, Novartis, Pfizer, Pierre Fabre, Roche, Sirius Medical; Lecture honoraria: Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther et al., Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, pfm medical, Roche, Seagen, StreamedUp, Stemline, Sysmex, Vifor, Viatris, ZP Therapeutics has received trial funding from Endomag, Exact Sciences, and trial honoraria from AstraZeneca, Biom’Up, Celgene, Clearcut, Neodynamics, Novartis, pfm medical, Roche, RTI Surgical. Prof. Dr. med. Jörg Heil: none to disclose. Dr. I. Bauerfeind received speaker honoraria from Brustkrebs Deutschland e.V., Krankenhaus Kempten, Akademie für Psychoonkologie, IF Kongressmanagement. Prof. Dr. med. Kerstin Rhiem received honoraria for lectures from AstraZeneca, Roche, Novartis, streamed up. Prof. Dr. med. Tanja N. Fehm received honoraria for lectures from Onkowissen. Prof. Dr. med. Erich-Franz Solomayer received honoraria for lectures and/or consulting from Roche, Amgen, Celgen, Tesaro, Astra Zeneca, Pfizer, Storz, Erbe, Gedeon Richter, Eisai, Medac, MSD, Vifor, Teva, Ethikon, Johnson Johnson, Daiichi-Sankyo, Gilead, Exact Sciences, GSK, Pierre Fabre., (© 2024 S. Karger AG, Basel.)
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- 2024
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17. Training of young medical professionals: implementation of modern training concepts, taking into account the changed framework conditions for training-a pilot project for operational subjects.
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Findeklee S, Hamoud BH, Diedrich K, Sima RM, Solomayer EF, and Spüntrup C
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- Pilot Projects, Humans, Female, Simulation Training methods, Laparoscopy education, Clinical Competence, Suture Techniques education, Education, Medical, Undergraduate methods, Gynecology education, Obstetrics education, Students, Medical, Curriculum
- Abstract
Introduction: For years, generations of medical students have complained that practice-oriented learning is neglected in medical studies. Further training assistants also complain about limited opportunities to learn subject-specific practical activities., Material and Techniques: We are presenting a pilot project at the University Women's Hospital in Homburg, in which medical students complete an endoscopic hands-on course as part of the block internship gynaecology and obstetrics. During the course the students perform classic skills training and hand-eye coordination exercises and learn the first steps in endoscopic suturing (suture and rows of knots). The training concepts used can be implemented on simple boxing trainers and can therefore also be reproduced in clinics or in a private setting., Outcome: Altogether, 73 medical students did participate in the laparoscopy course. We were able to prove that the knotting time for a simple knot can be reduced from an average of 247 s to 40 s (80%) after completing our training programme. Based on the evaluation sheet that the students filled out after the course, we found a very-high acceptance for surgical simulation training within the student cohort., Discussion: Practical surgical exercises can complement the curriculum well and, as we can show with our work, are rated very positively by the students. For students in higher semesters, such practical courses can also provide an insight into the respective subject area and thus counteract the lack of skilled workers in surgical subjects. The practical year should not be the first contact with these practical courses, as at this timepoint a certain favoured subject has often already being chosen by the students., (© 2024. The Author(s).)
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- 2024
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18. Retrospective Evaluation of Bone Turnover Markers in Serum for the Prediction of Metastases Development in Breast Cancer Patients: A Cohort Study.
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Kasoha M, Findeklee S, Nigdelis MP, Schmidt G, Solomayer EF, and Haj Hamoud B
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Background: Serum bone turnover markers might play a role in the prediction of the development of bone metastases in breast cancer (BC) patients. We conducted a retrospective cohort study to address the association of serum bone turnover markers with oncologic outcomes., Methods: We included 80 women with BC, who were operated on at the Department of Gynecology, Obstetrics and Reproductive Medicine, Homburg/Saar, Germany. Serum samples were obtained prior to surgery and were used for estimation of the concentration of tumor and bone turnover markers using enzyme-linked immunosorbent assay (ELISA) and radioimmunoassay (RIA)., Results: At baseline, pyridinoline cross-linked carboxy-terminal telopeptide of type-1 collagen (ICTP) concentrations were higher in nodal positive vs. negative tumors (Mann-Whitney test p = 0.04). After a median follow-up of 79.4 months, 17 patients developed metastases, with 9 demonstrating, among other organs, osseous metastases. ICTP demonstrated the best area under the curve in the predection of osseous metastases in our cohort (AUC = 0.740, DeLong Test p = 0.005). Univariable Cox proportional hazard models failed to demonstrate significant associations between serum bone turnover markers and oncologic outcomes (progression-free survival, overall survival)., Conclusions: Serum bone turnover markers (e.g., ICTP) were able to predict the development of osseous metastases but were not associated with oncologic outcomes. Further investigation and validation are required for the use of such markers in clinical practice.
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- 2024
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19. Prediction of lymph node status in patients with surgically treated head and neck squamous cell carcinoma via neck lavage cytology: A pilot study.
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Rimbach H, Linxweiler M, Körner S, Smola S, Linxweiler B, Speicher S, Helfrich J, Solomayer EF, Wagner M, Schick B, and Kühn JP
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- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Cytodiagnosis methods, Lymph Nodes pathology, Lymph Nodes surgery, Pilot Projects, Predictive Value of Tests, Prognosis, ROC Curve, Head and Neck Neoplasms pathology, Head and Neck Neoplasms surgery, Head and Neck Neoplasms diagnosis, Lymphatic Metastasis pathology, Neck Dissection, Squamous Cell Carcinoma of Head and Neck pathology, Squamous Cell Carcinoma of Head and Neck surgery, Therapeutic Irrigation methods
- Abstract
Background: Neck dissection is a standardized surgical procedure for patients with head and neck squamous cell carcinoma (HNSCC) and plays a critical role in the choice of adjuvant treatment based on histopathological findings. Saline irrigation is routinely performed at the end of surgery. However, this irrigant is not used for diagnostic purposes., Methods: Intraoperative irrigation of the neck dissection wound was performed in 56 patients with HNSCC (N = 93 neck dissections), and the cytological suspension obtained was processed via the liquid-based cytology (LBC) technique, Papanicolaou staining, and immunocytochemical staining. Microscopic preparations were screened for the presence of tumor cells and classified as positive, borderline, or negative. These results were correlated with the histopathological and clinical data., Results: Neck lavage LBC demonstrated high diagnostic value in detecting lymph node metastases (N+) with extracapsular spread (ECS), with a specificity, sensitivity, negative predictive value, and positive predictive value of 93.1%, 100%, 100%, and 80%, respectively. Tumor cells were detected in 4.8% of N- cases, 20% of N+ cases without ECS, and 100% of N+ cases with ECS. Receiver operating characteristic curve analysis showed an area under the curve of 0.8429 for the prediction of N+ (p < .0001) and 0.9658 for the prediction of N+ with ECS (p < .0001)., Conclusions: Differential lavage cytology can provide valid and rapid information on the lymph node status in patients with HNSCC and showed an excellent correlation with histopathology. Thus, neck lavage LBC may facilitate faster and more reasonable planning of adjuvant treatment and help improve the therapeutic management of patients with HNSCC., (© 2024 The Authors. Cancer Cytopathology published by Wiley Periodicals LLC on behalf of American Cancer Society.)
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- 2024
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20. Towards clinical adherence monitoring of oral endocrine breast cancer therapies by LC-HRMS-method development, validation, comparison of four sample matrices, and proof of concept.
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Jacobs CM, Radosa JC, Wagmann L, Zimmermann JSM, Kaya AC, Aygün A, Edel T, Stotz L, Ismaeil M, Solomayer EF, and Meyer MR
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- Humans, Female, Chromatography, Liquid methods, Administration, Oral, Mass Spectrometry methods, Letrozole blood, Medication Adherence, Limit of Detection, Tamoxifen therapeutic use, Tamoxifen blood, Tamoxifen analysis, Tamoxifen urine, Saliva chemistry, Androstadienes urine, Androstadienes analysis, Androstadienes administration & dosage, Androstadienes therapeutic use, Androstadienes blood, Anastrozole, Reproducibility of Results, Breast Neoplasms drug therapy, Antineoplastic Agents, Hormonal blood, Antineoplastic Agents, Hormonal therapeutic use, Antineoplastic Agents, Hormonal urine, Drug Monitoring methods
- Abstract
Oral endocrine therapies (OET) for breast cancer treatment need to be taken over a long period of time and are associated with considerable side effects. Therefore, adherence to OET is an important issue and of high clinical significance for breast cancer patients' caregivers. We hypothesized that a new bioanalytical strategy based on liquid chromatography and high-resolution mass spectrometry might be suitable for unbiased adherence monitoring (AM) of OET. Four different biomatrices (plasma, urine, finger prick blood by volumetric absorptive microsampling (VAMS), oral fluid (OF)) were evaluated regarding their suitability for AM of the OET abemaciclib, anastrozole, exemestane, letrozole, palbociclib, ribociclib, tamoxifen, and endoxifen. An analytical method was developed and validated according to international recommendations. The analytical procedures were successfully validated in all sample matrices for most analytes, even meeting requirements for therapeutic drug monitoring. Chromatographic separation of analytes was achieved in less than 10 min and limits of quantification ranged from 1 to 1000 ng/mL. The analysis of 25 matching patient samples showed that AM of OET is possible using all four matrices with the exception of, e.g., letrozole and exemestane in OF. We were able to show that unbiased bioanalytical AM of OET was possible using different biomatrices with distinct restrictions. Sample collection of VAMS was difficult in most cases due to circulatory restraints and peripheral neuropathy in fingers and OF sampling was hampered by dry mouth syndrome in some cases. Although parent compounds could be detected in most of the urine samples, metabolites should be included when analyzing urine or OF. Plasma is currently the most suitable matrix due to available reference concentrations., (© 2024. The Author(s).)
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- 2024
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21. Will I soon be out of my job? Quality and guideline conformity of ChatGPT therapy suggestions to patient inquiries with gynecologic symptoms in a palliative setting.
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Braun EM, Juhasz-Böss I, Solomayer EF, Truhn D, Keller C, Heinrich V, and Braun BJ
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- Humans, Female, Artificial Intelligence, Patient Compliance, Guideline Adherence, Genital Neoplasms, Female drug therapy, Gynecology
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Purpose: The market and application possibilities for artificial intelligence are currently growing at high speed and are increasingly finding their way into gynecology. While the medical side is highly represented in the current literature, the patient's perspective is still lagging behind. Therefore, the aim of this study was to evaluate the recommendations of ChatGPT regarding patient inquiries about the possible therapy of gynecological leading symptoms in a palliative situation by experts., Methods: Case vignettes were constructed for 10 common concomitant symptoms in gynecologic oncology tumors in a palliative setting, and patient queries regarding therapy of these symptoms were generated as prompts for ChatGPT. Five experts in palliative care and gynecologic oncology evaluated the responses with respect to guideline adherence and applicability and identified advantages and disadvantages., Results: The overall rating of ChatGPT responses averaged 4.1 (5 = strongly agree; 1 = strongly disagree). The experts saw an average guideline conformity of the therapy recommendations with a value of 4.0. ChatGPT sometimes omits relevant therapies and does not provide an individual assessment of the suggested therapies, but does indicate that a physician consultation is additionally necessary., Conclusions: Language models, such as ChatGPT, can provide valid and largely guideline-compliant therapy recommendations in their freely available and thus in principle accessible version for our patients. For a complete therapy recommendation, an evaluation of the therapies, their individual adjustment as well as a filtering of possible wrong recommendations, a medical expert's opinion remains indispensable., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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22. Diagnostic performance of additional imaging tests for staging purposes in a bicentric German series of low-risk early breast cancer patients.
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Jung L, Huwer SI, Taran FA, Unger C, Müller C, Solomayer EF, Juhasz-Böss I, and Neubauer J
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- Humans, Female, Retrospective Studies, Tomography, X-Ray Computed, Ultrasonography, Risk, Neoplasm Staging, Breast Neoplasms pathology
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Purpose: Low-risk early breast cancer rarely leads to the development of metastatic disease, and in these patients, additional imaging test is controversial. The aim of our study was to evaluate the conventional staging procedures in a bicentric German series of low-risk breast carcinoma patients., Methods: Retrospective evaluation of all patients diagnosed with early, low-risk breast cancer at Saarland University Hospital and Freiburg University Hospital in 2017 was performed. Clinical patient characteristics, the number and type of additional imaging examinations, follow-up examinations, and results were evaluated. The detection rate of metastases and the rate of false-positive findings were analyzed., Results: A total of 203 patients were included, with all patients received at least one additional imaging test. Initially, a total of 562 additional imaging examinations were performed: 166 chest X-rays, 169 upper abdominal ultrasounds, 199 bone scans, 27 computer tomographies (CT) chest and abdomen, and 1 CT abdomen. 6.8% of patients had abnormal findings reported, requiring 38 additional imaging examinations. One patient (0.5%) was found to have bone metastases. The rate of false-positive findings in the performed additional imaging procedures was 6.6%., Conclusion: Metastatic disease was detected in one of 203 patients with low-risk early breast cancer. A total of 562 examinations and additional 38 follow-up examinations were performed without detection of metastasis (this corresponds to approximately 3 examinations/patient). The rate of false-positive findings was 6.6%. The performance of additional imaging procedures for detection of distant metastases should be critically reconsidered in patients with low-risk early breast cancer., (© 2023. The Author(s).)
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- 2024
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23. Course of Vitamin D Levels in Newly Diagnosed Non-Metastatic Breast Cancer Patients over One Year with Quarterly Controls and Substitution.
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Zemlin C, Altmayer L, Lang M, Schleicher JT, Stuhlert C, Wörmann C, Scherer LS, Thul IC, Spenner LS, Simon JA, Wind A, Kaiser E, Weber R, Goedicke-Fritz S, Wagenpfeil G, Zemlin M, Solomayer EF, Reichrath J, and Müller C
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- Humans, Female, Vitamin D, Magnesium therapeutic use, Vitamins, Dietary Supplements, Breast Neoplasms drug therapy, Vitamin D Deficiency
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(1) Background: Vitamin D levels in patients remain inadequately understood, with research yielding inconsistent findings. Breast cancer patients, particularly due to oncological therapies, face an increased risk of osteopenia, which can be exacerbated by a vitamin D deficiency. (2) Methods: The prospective observational "BEGYN-1" study assessed serum 25(OH)D levels at baseline and quarterly thereafter. Clinical, pathological, nutritional, vitamin supplementation, and lifestyle data were recorded. (3) Results: Before treatment, 68.5% of patients were vitamin D deficient (<30 ng/mL), with 4.6% experiencing severe deficiency (<10 ng/mL). The median baseline 25(OH)D levels were 24 ng/mL (range: 4.8 to 64.7 ng/mL). Throughout the study, the median vitamin D levels increased to 48 ng/mL (range: 22.0 to 76.7 ng/mL). Before diagnosis, 16.7% received vitamin D substitution, and 97.8% received vitamin D substitution throughout the year with a median weekly dose of 20,000 IU. It took at least three quarterly assessments for 95% of patients to reach the normal range. A multiple GEE analysis identified associations between 25(OH)D levels and supplementation, season, age, VLDL, magnesium levels, and endocrine therapy. (4) Conclusions: Physicians should monitor 25(OH)D levels before, during, and after oncological therapy to prevent vitamin D deficiency and to adjust substitution individually. While variables such as seasons, age, VLDL, magnesium, diet, and oncological interventions affect 25(OH)D levels, supplementation has the greatest impact.
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- 2024
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24. A Metastasis of Ovarian Cancer in the Bartholin Gland: A Case Report with Systematic Literature Review.
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Olmes GL, Breitbach GP, Tepikin A, Nistor A, Solomayer EF, and Hamoud BH
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- Humans, Female, Middle Aged, Bartholin's Glands pathology, Bartholin's Glands surgery, Ovarian Neoplasms surgery, Ovarian Neoplasms pathology, Breast Neoplasms pathology, Gynecology
- Abstract
The metastasis of a gynecological malignancy to the Bartholin gland is rare. We report the case of a 62-year-old patient who had undergone extensive treatment of metastatic ovarian cancer that involved the liver, spleen, and peritoneum. She presented with painful swelling of the left vulva. Clinical and sonographic examinations showed a solid tumor in loco typico of the Bartholin gland. Surgical excision was performed. The patient died 3 months after the diagnosis of this metastasis. We performed a systematic search of PubMed, which yielded 453 entries. We selected those with at least an abstract available in English that described metastatic lesions on the Bartholin gland (n = 5). The review showed that a variety of primary cancers (colorectal, medullary thyroid, breast cancer, and endometrial cancers) metastasize to this location. Some patients showed signs of visceral metastasis. Bartholin gland metastases appeared as initial and metachronous manifestations. Most patients were symptomatic, with painful swelling or abscess. Genetic alterations were mentioned in some cases. The main pathways of metastasis discussed were lymphatic, but the mechanism of such metastasis remains unclear. Surgical resection was the preferred treatment option. The literature review indicated that Bartholin gland metastasis of ovarian cancer is rare and associated with poor prognosis. Oncological reasons for vulvar pathologies should be taken into consideration in patients with metastases., (© 2023. The Author(s).)
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- 2024
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25. Dkk1 as a Prognostic Marker for Neoadjuvant Chemotherapy Response in Breast Cancer Patients.
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Kasoha M, Steinbach AK, Bohle RM, Linxweiler B, Haj Hamoud B, Doerk M, Nigdelis MP, Stotz L, Zimmermann JSM, Solomayer EF, Kaya AC, and Radosa JC
- Abstract
Purpose: To investigate the role of Dkk1 as a predictor of response to NACT in BC patients., Methods: This retrospective monocentric study included 145 women who had undergone NACT followed by breast surgery. Dkk1 protein expression was assessed using immunohistochemistry staining in core needle biopsies and mammary carcinoma specimens., Results: Dkk1 levels were lower in treated BC tumours than in untreated tumours. The outcomes of 68 matched pre- and post-therapy tissues showed that Dkk1 levels in mammary carcinoma tissues were significantly predicted by levels in core needle biopsies and that Dkk1 expression was reduced in 83% of cases. Smaller cT stage, positive Her2 expression, and decreased Dkk1-IRS in core needle biopsy tissues were all independent predictors of regression grade (R4), according to Sinn. However, the percentage of Dkk1 expression differences prior to and following NACT had no effect on PFS or OS., Conclusions: In this study, we demonstrated for the first time that Dkk1 could be identified as an independent predictor of NACT response in BC patients, particularly those with TNBC. Further research with a multicentric expanded (pre-/post-therapy) sample set and better-defined populations in terms of molecular subtypes, therapy modality, and long-term follow-up is recommended to obtain more solid evidence.
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- 2024
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26. Immune landscape of vulvar cancer patients treated with surgery and adjuvant radiotherapy revealed restricted T cell functionality and increased IL-17 expression associated with cancer relapse.
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Gies S, Melchior P, Stroeder R, Tänzer T, Theobald L, Pohlers M, Glombitza B, Sester M, Solomayer EF, and Walch-Rückheim B
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- Female, Humans, CD8-Positive T-Lymphocytes, Perforin metabolism, Radiotherapy, Adjuvant, Prospective Studies, Programmed Cell Death 1 Receptor metabolism, Neoplasm Recurrence, Local metabolism, Th17 Cells metabolism, Interleukin-17 metabolism, Vulvar Neoplasms therapy
- Abstract
For vulvar cancers, radiotherapy is targeting cancer cells, but also affects the host immune system. As this may affect treatment outcome, in this prospective study, we characterized the individual T cell immune milieu induced by surgery and adjuvant radio +/- chemotherapy (aRT) systemically in the blood of vulvar cancer patients and found increased frequencies of Interleukin (IL)-17-producing CD4
+ and CD8+ T cells after aRT while frequencies of Th1 and perforin-producing CD8+ killer cells were strongly diminished. Phenotypic characterization revealed enhanced expression of the ectonucleotidase CD39 on Th17 and Tc17 cells as well as CD8+ perforin+ cells after aRT. Furthermore, the aRT cohort exhibited increased proportions of Programmed Cell Death Protein (PD-1) expressing cells among Th1 and CD8+ perforin+ cells, but not among Th17 and Tc17 cells. High post-therapeutic levels of Th17 and Tc17 cells and low proportions of Th1 and CD8+ perforin+ cells expressing PD-1 was associated with reduced recurrence free survival on follow-up. In conclusion, our study defines individual therapy-induced changes in the cellular immune milieu of patients and their association with cancer relapse. Our results may help to explain differences in the individual courses of disease of vulvar cancer patients and suggest PD-1 and IL-17 as targets for immunotherapy in vulvar cancer., (© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)- Published
- 2024
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27. Dual Sec62/Ki67 immunocytochemistry of liquid-based cytological preparations represents a highly valid biomarker for non-invasive detection of head and neck squamous cell carcinomas.
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Kühn JP, Speicher S, Linxweiler B, Körner S, Rimbach H, Wagner M, Solomayer EF, Schick B, and Linxweiler M
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- Humans, Squamous Cell Carcinoma of Head and Neck diagnosis, Ki-67 Antigen metabolism, Immunohistochemistry, Head and Neck Neoplasms diagnosis, Papilloma
- Abstract
Background: Head and neck squamous cell carcinomas (HNSCC) are frequently diagnosed in advanced stages, which limits therapeutic options and results in persistently poor patient outcomes. The aim of this study was to use liquid-based swab cytology (LBC) in combination with dual immunocytochemical detection of migration and proliferation markers Sec62 and Ki67 in order to allow non-invasive early detection of HNSCC as well as to analyse the diagnostic validity of this method for predicting the malignancy of suspicious oral lesions., Methods: 104 HNSCC patients and 28 control patients, including healthy patients (n = 17), papilloma (n = 1) and leukoplakia patients (n = 10), were included in this study. For all patients, an LBC swab followed by simultaneous immunocytochemical detection of Sec62 and Ki67 was performed. Immunocytochemical as well as cytopathological results were correlated with histological diagnoses and clinical findings., Results: All HNSCC patients (100%) showed dual Sec62/Ki67 positivity, and all control patients except for the papilloma patient were negative for Sec62/Ki67 (96.4%), resulting in a 100% sensitivity and 96.4% specificity of Sec62/Ki67 dual stain for non-invasive detection of HNSCC. The positive predictive value was 99% and the negative predictive value was 100%. Sec62 expression levels showed a positive correlation with tumour de-differentiation (p = 0.0489)., Conclusion: Simultaneous immunocytochemical detection of Sec62/Ki67 using LBC represents a promising non-invasive and easy-to-apply tool for the early detection of HNSCC in routine clinical practice. This novel technique can help to avoid incisional biopsies and reduce the frequency with which general anaesthesia is used in diagnostic procedures in patients with suspicious oral lesions., (© 2023 The Authors. Cytopathology published by John Wiley & Sons Ltd.)
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- 2024
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28. Unusual Case of Splenic Metastasis in Adenosquamous Carcinoma of the Cervix Uteri: Diagnosis and Treatment Considerations.
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Klamminger GG, Burgard C, Rosar F, Altmeyer K, Malinowski M, Nigdelis MP, Stahl PR, Solomayer EF, and Haj Hamoud B
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- Female, Humans, Adult, Cervix Uteri pathology, Splenectomy methods, Tumor Microenvironment, Splenic Neoplasms diagnosis, Splenic Neoplasms therapy, Carcinoma, Adenosquamous diagnosis, Carcinoma, Adenosquamous therapy
- Abstract
BACKGROUND Due to several factors such as its specific cellular and biochemical microenvironment, the spleen is not a predestined organ of frequent metastatic colonization in the case of primary solid carcinoma. Hence, the mode of diagnosis and the preferred treatment of a lesion highly suspicious of splenic metastasis must be decided on a case-by-case basis, considering not only the biological tumor entity but also the stage of the primary disease. CASE REPORT In the present case, we demonstrate the clinical course of a 37-year-old female patient who initially presented to our clinic with irregular vaginal bleeding. A consecutive gynecological examination revealed a 3×3-cm large mass of the cervix uteri, and the subsequent histomorphological workup led to the diagnosis of an adenosquamous carcinoma of the cervix uteri. Therapeutically, the patient received multimodal treatment, namely radical hysterectomy with adjuvant radio-chemotherapy. After 1.5 years, the patient presented to our Emergency Department with intermittent left-sided abdominal pain. Subsequent abdominal imaging (computed tomography scan, magnetic resonance imaging, positron emission tomography) determined a metabolically active splenic lesion with a central necrosis - signs of malignancy in line with a splenic metastasis. Presentation and discussion of the case within our interdisciplinary tumor board led to the decision of splenectomy followed by chemotherapy, a procedure that could be considered as therapeutic treatment in such exceptional cases. CONCLUSIONS The collection and reporting of atypical clinical courses remains a key factor in precision medicine to enable the most evidence-based decision making in such cases.
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- 2023
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29. Obstetric practice differences between Syrian refugees and non-Syrian nonrefugee gravidae: A retrospective cross-sectional study.
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Kasoha M, Nigdelis MP, Bishara L, Wagenpfeil G, Solomayer EF, and Haj Hamoud B
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- Infant, Newborn, Adolescent, Pregnancy, Female, Humans, Retrospective Studies, Pregnancy Outcome, Cross-Sectional Studies, Prenatal Care, Syria, Cesarean Section, Refugees
- Abstract
Objective: To assess differences in obstetric practices between Syrian war refugees (SRs) and non-Syrian nonrefugees (NSRs) in a tertiary care provider in Germany., Methods: This was a retrospective study of SRs (n = 356) and NSRs (n = 5836) giving birth between January 2015 and December 2018. Data on medical history, birth mode, complications, and neonatal parameters was extracted. Group differences were evaluated using Mann-Whitney and χ
2 test. Logistic regression models were fitted to investigate the association of refugee status with mode of birth in conditions associated with increased risk of cesarean section (CS)., Results: SRs had higher rates of adolescent pregnancies (1.7% versus 0.6%, P = 0.020) but fewer maternal diseases compared with NSRs (1.7% versus 3.9%, P = 0.035). The rate of CS was higher in the NSR group (43.9% versus 36%, P = 0.003), as well as the rates of premature rupture of membranes (P = 0.006) and steroid administration for lung maturation (P = 0.012). Cases of umbilical artery pH ≤7.0 were more common in SRs (0.4% versus 1.1%, P = 0.027). Women with previous CS had similar odds of CS in the current pregnancy irrespective of study group (odds ratio, 0.94 [95% confidence interval, 0.50-1.75])., Conclusion: SR women had lower rates of CS but higher rates of adolescent pregnancies and neonatal pH ≤7.0 at birth compared with NSR women., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)- Published
- 2023
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30. Efficacy and Safety of Platelet-Rich Plasma Injections for the Treatment of Female Sexual Dysfunction and Stress Urinary Incontinence: A Systematic Review.
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Dankova I, Pyrgidis N, Tishukov M, Georgiadou E, Nigdelis MP, Solomayer EF, Marcon J, Stief CG, and Hatzichristou D
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Introduction: There is no clear evidence in the literature that platelet-rich plasma (PRP) injections improve female sexual dysfunction (FSD) and female stress urinary incontinence (SUI). Objectives: A systematic review was performed to study the efficacy and safety of PRP injections in women with the above pathologies, as well as to explore the optimal dosing, frequency and area of injections, and duration of treatment. Methods: A systematic search on PubMed, Embase and the Cochrane Library database was performed, as well as sources of grey literature from the date of database or source creation to January 2023. After title/abstract and full-text screening, clinical studies on humans evaluating the efficacy of PRP in gynecological disorders using standardized tools were included. Risk of bias was undertaken with RoB-2 for randomized-controlled trials (RCT) and the Newcastle-Ottawa Scale (NOS) for observational studies. Results: Four prospective and one retrospective study explored FSD, while six prospective and one RCT evaluated female SUI. A total of 327 women with a mean age of 51 ± 12 years were included. For FSD, PRP significantly improved the Female Sexual Function Index (FSFI), the Vaginal Health Index (VHI) and the Female Sexual Distress score (FSDS). For SUI, PRP led to a significant improvement in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the Urogenital Distress Inventory (UDI-6). The identified RCT reported a significantly higher mean score of ICIQ-SF ( p < 0.05) and UDI-6 ( p < 0.01) in the midurethral sling group compared to the PRP injections group. Regarding the risk of bias, the RCT was characterized by high risk, whereas the observational studies were of moderate risk. The protocol for PRP injections for FSD is the injection of 2 mL of PRP into the distal anterior vaginal wall once a month for 3 months. For female SUI, 5-6 mL of PRP should be injected into the periurethral area once a month for 3 months. Conclusions: Despite the promising initial results of PRP injections, the level of current evidence is low due to methodological issues in the available studies. It becomes clear that there is an emerging need for high-quality research examining PRP injections for the treatment of FSD and female SUI.
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- 2023
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31. Laparoscopic Fertility-Sparing Surgery for Early Ovarian Malignancies.
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Zimmermann JSM, Ramisch P, Radosa MP, Radosa CG, Kaya AC, Brucker SY, Taran FA, Ulrich UA, Hackethal A, Deeken M, Sütterlin M, Tuschy B, Solomayer EF, and Radosa JC
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The demand for fertility-sparing surgery (FSS) has increased in the last decade due to increased maternal age, increased incidence of ovarian malignancies in younger patients, and technical advances in surgery. Data on oncological safety and fertility outcomes of patients with ovarian cancer after laparoscopic FSS are sparse, but some retrospective studies have shown that open FSS may be offered to selected patients. We assessed the role of minimally invasive FSS in comparison with radical surgery (RS) in terms of oncological safety and reproductive outcomes after FSS in this multicenter study. Eighty patients with FIGO stage I/II ovarian cancer treated with laparoscopic FSS or RS between 01/2000 and 10/2018 at the participating centers (comprehensive gynecological cancer centers with minimally invasive surgical expertise) were included in this retrospective analysis of prospectively kept data. Case-control ( n = 40 each) matching according to the FIGO stage was performed. Progression-free survival [150 (3-150) and 150 (5-150) months; p = 0.61] and overall survival [36 (3-150) and 50 (1-275) months; p = 0.65] did not differ between the FSS and RS groups. Eight (25.8%) women became pregnant after FSS, resulting in seven (22.5%) deliveries; three (37.5%) patients conceived after in vitro fertilization, and five (62.5%) conceived spontaneously. Laparoscopic FSS seems to be applicable and oncologically safe for patients with early-stage ovarian cancer, with adequate fertility outcomes.
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- 2023
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32. Diagnostics and Therapy of Venous Thrombosis and Pulmonary Embolism. The revised AWMF S2k Guideline
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Linnemann B, Blank W, Doenst T, Erbel C, Isfort P, Janssens U, Kalka C, Klamroth R, Kotzerke J, Ley S, Meyer J, Mühlberg K, Müller OJ, Noppeney T, Opitz C, Riess H, Solomayer EF, Volk T, and Beyer-Westendorf J
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- Humans, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism therapy, Venous Thrombosis diagnostic imaging, Venous Thrombosis drug therapy
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- 2023
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33. The Therapy of Vulvar Carcinoma-Evaluation of Surgical Options in a Retrospective Monocentric Study.
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Jankowski P, Findeklee S, Georgescu MT, Sima RM, Nigdelis MP, Solomayer EF, Klamminger GG, and Hamoud BH
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(1) Background: Surgical-oncological treatment methods are continuously put to the test in times of evidence-based medicine-notably, a constant reevaluation remains key, especially for tumor entities with increasing incidence such as vulvar carcinoma. (2) Methods: In order to determine the postoperative clinical course of different methods of vulvar excision (vulvectomy, hemivulvectomy) as well as inguinal lymph node removal (lymphadenectomy, sentinel lymph node biopsy) with regard to postoperative wound-healingprocess, perioperative hemorrhage, and re-resection rates, we retrospectively analyzed surgical, morphological and laboratory data of 76 patients with a pathological diagnosed vulvar cancer. (3) Results: Analysis of our data from a single center revealed a comparable perioperative clinical course regardless of the chosen method of vulvar excision and inguinal lymph node removal. (4) Conclusions: Thus, our results emphasize the current multimodality in surgical therapy of vulvar carcinoma, in which consideration of known prognostic factors together with the individual patient's clinical situation allow guideline-based therapy aimed at maximizing surgical safety.
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- 2023
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34. Accuracy of Breast Ultrasonography and Mammography in Comparison with Postoperative Histopathology in Breast Cancer Patients after Neoadjuvant Chemotherapy.
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Schmidt G, Findeklee S, Del Sol Martinez G, Georgescu MT, Gerlinger C, Nemat S, Klamminger GG, Nigdelis MP, Solomayer EF, and Hamoud BH
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Introduction: Nowadays chemotherapy in breast cancer patients is optionally applied neoadjuvant, which allows for testing of tumor response to the chemotherapeutical treatment in vivo, as well as allowing a greater number of patients to benefit from a subsequent breast-conserving surgery., Material and Methods: We compared breast ultrasonography, mammography, and clinical examination (palpation) results with postoperative histopathological findings after neoadjuvant chemotherapy, aiming to determine the most accurate prediction of complete remission and tumor-free resection margins. To this end, clinical and imaging data of 184 patients (193 tumors) with confirmed diagnosis of breast cancer and neoadjuvant therapy were analyzed., Results: After chemotherapy, tumors could be assessed by palpation in 91.7%, by sonography in 99.5%, and by mammography in 84.5% (chi-square p < 0.0001) of cases. Although mammography proved more accurate in estimating the exact neoadjuvant tumor size than breast sonography in total numbers (136/163 (83.44%) vs. 142/192 (73.96%), n.s.), 29 tumors could be assessed solely by means of breast sonography. A sonographic measurement was feasible in 192 cases (99.48%) post-chemotherapy and in all cases prior to chemotherapy., Conclusions: We determined a superiority of mammography and breast sonography over clinical palpation in predicting neoadjuvant tumor size. However, neither examination method can predict either pCR or tumor margins with high confidence.
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- 2023
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35. Improved awareness of physical activities is associated with a gain of fitness and a stable body weight in breast cancer patients during the first year of antineoplastic therapy: the BEGYN-1 study.
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Zemlin C, Schleicher JT, Altmayer L, Stuhlert C, Wörmann C, Lang M, Scherer LS, Thul IC, Spenner LS, Simon JA, Wind A, Kaiser E, Weber R, Goedicke-Fritz S, Wagenpfeil G, Zemlin M, Steffgen G, Solomayer EF, and Müller C
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Background: Breast cancer is the most frequent cancer in women. Reduced physical activity and overweight are associated with poor prognosis. Breast cancer patients have a high risk to gain weight, lose muscle mass and reduce physical activity during therapy. Concepts are urgently needed to motivate patients to engage in physical activity., Methods: 110 non-metastatic breast cancer patients were included in the prospective observational BEGYN-1 study. Physiological parameters and body composition were measured before the start of therapy and then quarterly for one year. Patients used a fitness tracker and documented their physical activity in a diary throughout the study., Results: Although the patients were not offered any guided exercise, and despite the restrictions during the COVID-19 pandemic, they increased their physical activity (metabolic equivalent of task (MET) -minutes): p<0.001), physical fitness (decreasing resting heart rate: p=0.001) and did not gain weight (median - 0.4kg) over the course of the study., Conclusion: Improved awareness of physical activity is associated with an increase in physical activity, fitness, and a stable weight during the first year of therapy in breast cancer patients. Counselling at diagnosis should motivate patients to engage in physical activity, wear a fitness tracker and document activities., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Zemlin, Schleicher, Altmayer, Stuhlert, Wörmann, Lang, Scherer, Thul, Spenner, Simon, Wind, Kaiser, Weber, Goedicke-Fritz, Wagenpfeil, Zemlin, Steffgen, Solomayer and Müller.)
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- 2023
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36. Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023.
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Park-Simon TW, Müller V, Jackisch C, Albert US, Banys-Paluchowski M, Bauerfeind I, Blohmer JU, Budach W, Dall P, Ditsch N, Fallenberg EM, Fasching PA, Fehm T, Friedrich M, Gerber B, Gluz O, Harbeck N, Hartkopf AD, Heil J, Huober J, Kolberg-Liedtke C, Kreipe HH, Krug D, Kühn T, Kümmel S, Loibl S, Lüftner D, Lux MP, Maass N, Mundhenke C, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schütz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Untch M, Witzel I, Wöckel A, Wuerstlein R, Janni W, and Thill M
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Background: Each year the interdisciplinary Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), German Gynecological Oncology Group Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer., Summary: The updated evidence-based treatment recommendation for early and metastatic breast cancer has been released in March 2023., Key Messages: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter., Competing Interests: Prof. Dr. Tjoung-Won Park-Simon. Honoraria for lectures and/or consulting: Roche, AstraZeneca, GSK, Pfizer, Lilly, MSD, Exact Sciences, Daiichi Sankyo, Seagen, Novartis, Gilead Science, NCO, Onkowissen, Exact Sciences, Seagen. Travel compensation: Roche, AstraZeneca, Pfizer. Prof. Dr. med. Ute-Susann Albert. Lectures: Pfizer, Novartis, AstraZeneca. Advisory board: Daiichi Sankyo. PD. Dr. Malgorzata Banys-Paluchowski. M.B. has received honoraria for lectures and advisory from Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Pintuition, Pierre Fabre and ExactSciences, study support from EndoMag, Mammotome, MeritMedical, Gilead, Hologic, ExactSciences, and travel/congress support from Eli Lilly, ExactSciences, Pierre Fabre, Pfizer, Daiichi Sankyo and Roche. Dr. med. Ingo Bauerfeind. Honoraria for lectures: Pfizer, Roche, Seagen. Prof. Dr. med. Jens-Uwe Blohmer. Honoraria for advisory boards and lectures: Astrazeneca, Daiichi Sankyo, Eisai, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Seagen Prof. Dr. med. Wilfried Budach. Lecture: Merck, BMS, Jörg Eickeler Veranstaltungen, medpublico GmbH, BVDST. Prof. Dr. med. Peter Dall, Honoraria for lectures and advisory boards: Novartis, Pierre Fabre, Gilead, MSD, Daiichi Sankyo, Lilly, AstraZeneca, Pfizer, Roche. Prof. Dr. Nina Ditsch. Advisory Boards and speakers bureaus. AstraZeneca, Aurikamed, BGGF, Daiichi-Sankyo, Elsevier Verlag, ESO, Exact Sciences, Gilead, GSK, if-Kongress, KelCon, Leopoldina Schweinfurt, Lilly, Lukon, Molekular Health, MSD, Novartis, onkowissen, Pfizer, RG-Ärztefortbildungen, Roche, Seagen Prof. Dr. med. Eva Maria Fallenberg. Research grant: DFG. Speaker honorarium: GE Healthcare, Bayer Healthcare, Guerbet, Siemens, BD, Roche, EUSOBI, ESOR, ESMO. Prof. Dr. med. Peter A. Fasching. Advisory board: Pfizer, Novartis, Roche, Daiichi Sankyo, Eisai, AstraZeneca, Lilly, MSD, Seagen, Agendia, Pierre Fabre, Sanofi Aventis, Gilead Science. Lecture: Pfizer, Novartis, Roche, Daiichi Sankyo, Eisai, AstraZeneca, Lilly, MSD, Seagen, Gilead Sciences. Other: Onkowissen, art tempi. Prof. Dr. med. Tanja N. Fehm. Onkowissen Prof. Dr. med. Michael Friedrich. Advisory Board: Gilead Sciences. Other honoraria: Roche, MSD. Prof. Dr. med. Bernd Gerber. Lecture honoraria: Roche, AstraZeneca, Seagen, Novartis, Pfizer, MedConcept. Others: Pfizer. PD Dr. med. Oleg Gluz. Honoraria for lectures and/or consulting: Amgen, AstraZeneca, Daiichi Sanyko, Gilead Science, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, Exact Sciences, Agendia. Minority share holder: Westdeutsche Studiengruppe (WSG). Prof. Dr. med. Nadia Harbeck. Honoraria for lectures and/or consulting: Amgen, AstraZeneca, Daiichi Sanyko, Gilead, Lilly, MSD, Novartis, Pierre-Fabre, Pfizer, Roche, Sandoz, Sanofi, Seagen, Viatris, Zuelligpharma Minority share holder: Westdeutsche Studiengruppe (WSG). Prof. Dr. med. Andreas Hartkopf. Honoraria for consulting and speaking engagements from AstraZeneca, Agendia, Amgen, Clovis, DaichiiSankyo, Eisai, ExactScience, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Onkowissen, Pfizer, Roche, Pierre-Fabre, Seagen, Stemline and Verazyte. Prof. Dr. med. Jörg Heil. None. Prof. Dr. med. Jens Huober. Trial funding: Novartis, Lilly. Honoraria for lectures: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene; Abbvie, Seagen, Gilead, Daiichi. Honoraria for consulting/advisory board: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Abbvie, Daiichi, Gilead. Travel grants: Roche, Pfizer, Daiichi, Gilead. Prof. Dr. med. Christian Jackisch. Advisory board: Astra Zeneca, Novartis, Lilly, Gilead, Exact Sciences, Pfizer, Roche, GSK, Pierre-Fabre, Roche, Seagen; Lecture: Art tempi, AstraZeneca, Lilly, Novartis, Roche, Amgen, Pierre-Fabre, Exact Sciences, MSD, GynUpdate, StreamedUp. Prof. Dr. med. Cornelia Kolberg-Liedtke. Advisory board: SeaGen, Exact Sciences, Pfizer, Novartis, AstraZeneca, Lilly, SeaGen, Daiichi Sankyo, Agendia, Gilead, Onkowissen; Lecture: Novartis Ireland, NOGGO, CECOG, PINK, Pfizer, Roche, AstraZeneca, Carl Zeiss Meditec, Lilly, SeaGen, Daiichi Sankyo. Other: Gilead Science, POMME. Stockholding: Phaon Scientific, Theraclion SA. Trial Funding: Gilead Science. Prof. Dr. med. Hans-Heinrich Kreipe. Advisory board: Lilly. Lecture: AstraZeneca, Roche, Daiichi Sankyo, Pfizer. PD Dr. David Krug. Lecture: Merck Sharp & Dohme, onkowissen, Pfizer. Research funding: Merck KGaA. Advisory Board: Gilead. Prof. Dr.med. Thorsten Kühn. Advisory Board: Sysmex, Neodynamics. Trial funding: Merit Medical, Endomag, Mammotome. Lecture: Pfizer. Prof. Dr. med. Sherko Kümmel. Lecture: Roche, Lilly, Exact Sciences, Novartis, Amgen, Daiichi Sankyo, AstraZeneca, Somatex, MSD, Pfizer, pfm medical, Seagen, Gilead Science, Agendia. Other honoraria: Roche, Daiichi Sankyo, Sonoscape Advisory board: Lilly, MSD, Roche. Prof. Dr. med. Sibylle Loibl. Advisory Board, institutional: Abbvie, Amgen, AstraZeneca, BMS, Celgene, DSI, Eirgenix, GSK, Gilead Science, Lilly, Merck, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeuticas, Puma, Roche, Samsung, Sanofi, Seagen Invited speaker, institutional: Astra Zeneca, DSI, Gilead, Novartis, Pfizer, Pierre Fabre, Roche, Seagen Invited speaker, personal: Medscape, Stemline-Menarini. Trial funding/others: Astra Zeneca, Abbvie, Celgene, Daiichi-Sankyo, Greenwich Life Sciences, Immunomedics/Gilead, Molecular Health, Novartis, Pfizer, Roche, Seagen, VM Scope GmbH. Prof. Dr. med. Diana Lüftner. Lecture: Lilly, Roche, MSD, Onkowissen, Novartis, Pfizer, Daiichi Sankyo, Gilead, AstraZeneca, Loreal, high4md. Advisory board: Lilly, Roche, MSD, Novartis, Pfizer, Daiichi Sankyo, Gilead, AstraZeneca, Other: Novartis. Prof. Dr. med. Michael Patrick Lux. M.P.L. has participated on advisory boards for AstraZeneca, Lilly, MSD, Novartis, Pfizer, Eisai, Gilead, Exact Sciences, Pierre Fabre, Grünenthal, Daiichi-Sankyo, PharmaMar, Roche, SamanTree, Sysmex and Hexal and has received honoraria for lectures from MSD, Lilly, Roche, Novartis, Pfizer, Exact Sciences, Daiichi-Sankyo, Grünenthal, pfm, Gilead, AstraZeneca, and Eisai. Prof. Dr. med. Nicolai Maass. Advisory board: Amgen, AstraZeneca, Clovis, Daiichi Sankyo, GSK, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seagen Lecture: AstraZeneca, Daiichi Sankyo, GSK, Lilly, Novartis, Pfizer, Roche. Prof. Dr. med. Christoph Mundhenke. Advisory board: AstraZeneca, Pfizer, Daiichi Sankyo, Seagen, Novartis. Lecture: Pfizer, Novartis. Prof. Dr. med. Toralf Reimer. Trial funding: German Cancer Aid and Else Kroener-Fresenius-Stiftung. Advisory board: MSD, Novartis, Myriad. Lecture: Pfizer, Novartis, Roche, AstraZeneca. Prof. Dr. med. Kerstin Rhiem. Lecture: AstraZeneca, Amgen, Roche. Prof. Dr. med. Achim Rody. Advisory board: AstraZeneca, Novartis, Roche, Exact Sciences, Pierre Fabre, Lilly, Seagen, Amgen, MSD. Lecture: Pfizer, Celgene, Eisai. Trial funding: Eisai. Prof. Dr. med. Marcus Schmidt. MS reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, and SeaGen, His institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, he has a patent for EP 2390370 B1 and a patent for EP 2951317 B1 issued. Prof. Dr. med. Andreas Schneeweiss. Lecture: Amgen, AstraZeneca, Aurikamed, Clinsol, ConnectMedica, Gilead Science, GSK, I-Med, Lilly, MSD, Nanostring, Novartis, Onkowissen, Promedicis, Pfizer, Pierre Fabre, Roche, Seagen, StreamedUp. Other: Thieme. Prof. Dr. med. Florian Schütz. Lecture: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, ExactSciences, Gilead, Pfizer, MSD, Novartis, Onkowissen, Roche Pharma. Advisory board: Lilly, MSD, Atheneum Partners. Travel expanses: Lilly, Daiichi-Sankyo, Amgen, Prof. Dr. med. Hans-Peter Sinn. Advisory board: Exact Sciences, Daiichi Sankyo. Lecture: AstraZeneca. Trial Funding: AstraZeneca. Prof. Dr. med. Christine Solbach. Lecture: DiaLog Service GmbH, Jörg Eickeler, Pfizer, MedConcept, Medicultus, GBG, Dt. Röntgengesellschaft, BVF Akademie, LÄK Hessen Akademie, Meet the Expert Academy. Advisory board: MSD, Roche. Prof. Dr. med. Erich-Franz Solomayer. Roche, Amgen, Celgen, Tesaro, Astra Zeneca, Pfizer, Storz, Erbe, Gedeon Richter, Eisai, Medac, MSD, Vifor, Teva, Ethikon, Johnson Johnson, Daiichi-Sankyo, Gilead, Exact Sciences, GSK, Pierre Fabre. Prof. Dr. med. Elmar Stickeler. Advisory boards: Gilead, Iomedico, Lilly, MSD, Seagen Lecture: Pfizer, Bsh Düsseldorf, Gilead, Iomedico, PharmaMar, Onkowissen, Roche. Prof. Dr. med. Christoph Thomssen. Compensation for advisory boards, lectures or publications. Amgen, AstraZeneca, Aurikamed, Daiichi-Sankyo, Forum Sanitas, Gilead, Jörg Eickeler, Hexal, Lilly, Medupdate, MSD, Nanostring, Novartis, Onkowissen, Pfizer, Roche, Seagen, Vifor Prof. Dr. med. Michael Untch. M.U. has received honoraria for lectures and consulting or advisory role from AstraZeneca, Art tempi, Amgen, Daiji Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Pierre Fabre, Sanofi-Aventis, Myriad, Seagen, Novartis, Gilead, Stemline, Genzyme, Agendia, Onkowissen, Eisai, All honoraria and fees to the employer/institution. Prof. Dr. Isabell Witzel. Lecture: Daiichi Sankyo, Pfizer, Roche, MSD, Lilly, Seagen, AstraZeneca, Gilead. Other: Onkowissen Prof. Dr. med. Achim Wöckel. Advisory board: Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Genomic Health, Pierre Fabre, Clovis, Organon. PD. Dr. Rachel Würstlein. Agendia, Amgen, Aristo, Astra Zeneca, Aurikamed, Celgene, Clinsol, Clovis Oncology, Daiichi-Sankyo, Eisai, Exact Sciences, FOMF, Gilead, Glaxo Smith Kline, Hexal, Lilly, MCI, medconcept, Medstrom Medical, MSD, Mundipharma, Mylan, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PINK, Pomme Med, PumaBiotechnolgogy, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics/Seagen, Stemline, Tesaro Bio, Teva, Veracyte, Viatris Prof. Dr. med. Volkmar Müller. V.M. received speaker honoraria from Amgen, Astra Zeneca, Daiichi-Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, Seattle Genetics, Genomic Health, Hexal, Roche, Pierre Fabre, ClinSol, Daiichi-Sankyo, Eisai, Lilly, Tesaro, Seattle Genetics and Nektar. Institutional research support from Novartis, Roche, Seattle Genetics, Genentech. Travel grants: Roche, Pfizer, Daiichi Sankyo. Prof. Dr. med. Wolfgang Janni. Lecture: Amgen, AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, Gilead Science. Trial Funding: Amgen, AstraZeneca, Lilly, Novartis, Roche. Prof. Dr. med. Marc Thill. M.T. received personal fees for consulting from Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Norgine, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm Medical, Pierre-Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, Sysmex, for manuscript support from Amgen, ClearCut, Clovis, pfm medical, Roche, Servier, for travel expenses from Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, Neodynamics, Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, Seagen, for congress support Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Hexal, Neodynamics, Novartis, Pfizer, Roche, Sirius Medical, for lectures from Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther et al. Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, pfm medical, Roche, Seagen, StreamedUp, Sysmex, Vifor, Viatris, for trial funding from Endomag, Exact Sciences and institutional fees from AstraZeneca, Biom’Up, Celgene, Clearcut, Neodynamics, Novartis, pfm medical, Roche, RTI Surgical., (© 2023 The Author(s). Published by S. Karger AG, Basel.)
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- 2023
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37. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2023.
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Thill M, Kolberg-Liedtke C, Albert US, Banys-Paluchowski M, Bauerfeind I, Blohmer JU, Budach W, Dall P, Ditsch N, Fallenberg EM, Fasching PA, Fehm T, Friedrich M, Gerber B, Gluz O, Harbeck N, Hartkopf AD, Heil J, Huober J, Jackisch C, Kreipe HH, Krug D, Kühn T, Kümmel S, Loibl S, Lüftner D, Lux MP, Maass N, Mundhenke C, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Schütz F, Sinn HP, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Untch M, Witzel I, Wöckel A, Müller V, Würstlein R, Janni W, and Park-Simon TW
- Abstract
The Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2023 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer (mBC)., Competing Interests: The authors have the following conflicts of interest: Prof. Dr. Med. Marc Thill: MT received personal fees for consulting from Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom‘Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grünenthal, GSK, Lilly, MSD, Norgine, NeoDynamics, Novartis, Onkowissen, Organon, Pfizer, pfm Medical, Pierre Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, and Sysmex; for manuscript support from Amgen, ClearCut, Clovis, pfm medical, Roche, and Servier; for travel expenses from Amgen, Art Tempi, AstraZeneca, ClearCut, Clovis, ConnectMedica, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, NeoDynamics, Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, and Seagen; for congress support Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Hexal, NeoDynamics, Novartis, Pfizer, Roche, and Sirius Medical; for lectures from Amgen, Art Tempi, AstraZeneca, Clovis, ConnectMedica, Eisai, Exact Sciences, Gedeon Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jörg Eickeler, Laborarztpraxis Walther, Lilly, MCI, Medscape, MSD, Medtronic, Novartis, Onkowissen, Pfizer, pfm medical, Roche, Seagen, STREAMED UP, Sysmex, Vifor, and Viatris; for trial funding from Endomag, Exact Sciences; and institutional fees from AstraZeneca, Biom’Up, Celgene, ClearCut, NeoDynamics, Novartis, pfm medical, Roche, and RTI Surgical. Prof. Dr. Med. Ute-Susann Albert, lectures: Pfizer, Novartis, and AstraZeneca; advisory board: Daiichi Sankyo. PD Dr. Malgorzata Banys-Paluchowski: M.B. has received honoraria for lectures and advisory from Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Pintuition, Pierre Fabre, and Exact Sciences; study support from Endomag, Mammotome, Merit Medical, Gilead, Hologic, and Exact Sciences; and travel/congress support from Eli Lilly, Exact Sciences, Pierre Fabre, Pfizer, Daiichi Sankyo, and Roche. Dr. Med. Ingo Bauerfeind, honoraria for lectures: Pfizer, Roche, and Seagen. Prof. Dr. Med. Jens-Uwe Blohmer, honoraria for advisory boards and lectures: AstraZeneca, Daiichi Sankyo, Eisai, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, and Seagen. Prof. Dr. Med. Wilfried Budach, lecture: Merck, BMS, Jörg Eickeler Veranstaltungen, medpublico GmbH, and BVDST. Prof. Dr. Med. Peter Dall, honoraria for lectures and advisory boards: Novartis, Pierre Fabre, Gilead, MSD, Daiichi Sankyo, Lilly, AstraZeneca, Pfizer, and Roche. Prof. Dr. Nina Ditsch, advisory boards and speakers bureaus advisory boards and speakers bureaus: AstraZeneca, Aurikamed, BGGF, Daiichi Sankyo, Elsevier Verlag, ESO, Exact Sciences, Gilead, GSK, if-Kongress, KelCon, Leopoldina Schweinfurt, Lilly, Lukon, Molecular Health, MSD, Novartis, Onkowissen, Pfizer, RG-Ärztefortbildungen, Roche, and Seagen. Prof. Dr. Med. Eva Maria Fallenberg, research grant: DFG; speaker honorarium: GE Healthcare, Bayer Healthcare, Guerbet, Siemens, BD, Roche, EUSOBI, ESOR, ESMO. Prof. Dr. Med. Peter A. Fasching, advisory board: Pfizer, Novartis, Roche, Daiichi Sankyo, Eisai, AstraZeneca, Lilly, MSD, Seagen, Agendia, Pierre Fabre, Sanofi-Aventis, and Gilead Science; lecture: Pfizer, Novartis, Roche, Daiichi Sankyo, Eisai, AstraZeneca, Lilly, MSD, Seagen, and Gilead Sciences; and other: Onkowissen, art tempi. Prof. Dr. Med. Tanja N. Fehm, Onkowissen. Prof. Dr. Med. Michael Friedrich, advisory board: Gilead Sciences; other honoraria: Roche and MSD. Prof. Dr. Med. Bernd Gerber, lecture honoraria: Roche, AstraZeneca, Seagen, Novartis, Pfizer, and MedConcept; and others: Pfizer. PD Dr. Med. Oleg Gluz, honoraria for lectures and/or consulting: Amgen, AstraZeneca, Daiichi Sankyo, Gilead Science, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, Exact Sciences, and Agendia; and minority share holder: Westdeutsche Studiengruppe (WSG)mmc1. Prof. Dr. Med. Nadia Harbeck, honoraria for lectures and/or consulting: Amgen, AstraZeneca, Daiichi Sankyo, Gilead, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sandoz, Sanofi, Seagen, Viatris, and Zuellig Pharma; minority share holder: Westdeutsche Studiengruppe (WSG). Prof. Dr. Med. Andreas Hartkopf, honoraria for consulting and speaking engagements from AstraZeneca, Agendia, Amgen, Clovis, Daiichi Sankyo, Eisai, Exact Science, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Onkowissen, Pfizer, Roche, Pierre Fabre, Seagen, Stemline, and Verazyte. Prof. Dr. Med. Jörg Heil, none. Prof. Dr. Med. Jens Huober, trial funding: Novartis and Lilly; honoraria for lectures: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene; AbbVie, Seagen, Gilead, and Daiichi; honoraria for consulting/advisory board: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, AbbVie, Daiichi, and Gilead; and travel grants: Roche, Pfizer, Daiichi, and Gilead. Prof. Dr. Med. Christian Jackisch, advisory board: AstraZeneca, Novartis, Lilly, Gilead, Exact Sciences, Pfizer, Roche, GSK, Pierre Fabre, Roche, and Seagen; lecture: Art tempi, AstraZeneca, Lilly, Novartis, Roche, Amgen, Pierre Fabre, Exact Sciences, MSD, Gyn Update, and STREAMED UP. Prof. Dr. Med. Cornelia Kolberg-Liedtke, advisory board: SeaGen, Exact Sciences, Pfizer, Novartis, AstraZeneca, Lilly, SeaGen, Daiichi Sankyo, Agendia, Gilead, and Onkowissen; and lecture: Novartis Ireland, NOGGO, CECOG, PINK, Pfizer, Roche, AstraZeneca, Carl Zeiss Meditec, Lilly, SeaGen, and Daiichi Sankyo; other: Gilead Science and POMME; stockholding: Phaon Scientific and Theraclion SA; and trial Funding: Gilead Science. Prof. Dr. Med. Hans-Heinrich Kreipe, advisory board: Lilly; lecture: AstraZeneca, Roche, Daiichi Sankyo, and Pfizer. PD Dr. David Krug, lecture: Merck Sharp and Dohme, Onkowissen, and Pfizer; research funding: Merck KGaA; and advisory board: Gilead. Prof. Dr. med. Thorsten Kühn, advisory board: Sysmex and NeoDynamics; trial funding: Merit Medical, Endomag, and Mammotome; and lecture: Pfizer. Prof. Dr. Med. Sherko Kümmel, lecture: Roche, Lilly, Exact Sciences, Novartis, Amgen, Daiichi Sankyo, AstraZeneca, Somatex, MSD, Pfizer, pfm medical, Seagen, Gilead Science, and Agendia; other honoraria: Roche, Daiichi Sankyo, and Sonoscape; and advisory board: Lilly, MSD, and Roche. Prof. Dr. Med. Sibylle Loibl, board, advisory board, institutional: AbbVie, Amgen, AstraZeneca, BMS, Celgene, DSI, EirGenix, GSK, Gilead Science, Lilly, Merck, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeutics, Puma, Roche, Samsung, Sanofi, and Seagen; invited speaker, institutional: AstraZeneca, DSI, Gilead, Novartis, Pfizer, Pierre Fabre, Roche, and Seagen; invited speaker, personal: Medscape and Stemline-Menarini; trial funding/others: AstraZeneca, AbbVie, Celgene, Daiichi Sankyo, Greenwich Life Sciences, Immunomedics/Gilead, Molecular Health, Novartis, Pfizer, Roche, Seagen, VM Scope Gmbp. Prof. Dr. Med. Diana Lüftner, lecture: Lilly, Roche, MSD, Onkowissen, Novartis, Pfizer, Daiichi Sankyo, Gilead, AstraZeneca, Loreal, and high4md; advisory board: Lilly, Advisory board: Lilly, Roche, MSD, Novartis, Pfizer, Daiichi Sankyo, Gilead, and AstraZeneca; and other: Novartis. Prof. Dr. Med. Michael Patrick Lux: M.P.L. has participated on advisory boards for AstraZeneca, Lilly, MSD, Novartis, Pfizer, Eisai, Gilead, Exact Sciences, Pierre Fabre, Grünenthal, Daiichi Sankyo, PharmaMar, Roche, SamanTree, Sysmex, and Hexal; and has received honoraria for lectures from MSD, Lilly, Roche, Novartis, Pfizer, Exact Sciences, Daiichi Sankyo, Grünenthal, pfm, Gilead, AstraZeneca, and Eisai. Prof. Dr. Med. Nicolai Maass, advisory board: Amgen, AstraZeneca, Clovis, Daiichi Sankyo, GSK, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, and Seagen; and lecture: AstraZeneca, Daiichi Sankyo, GSK, Lilly, Novartis, Pfizer, and Roche. Prof. Dr. Med. Christoph Mundhenke, advisory board: AstraZeneca, Pfizer, Daiichi Sankyo, Seagen, and Novartis; and lecture: Pfizer and Novartis. Prof. Dr. Med. Toralf Reimer; trial funding: German Cancer Aid and Else Kroener-Fresenius-Stiftung; advisory board: MSD, Novartis, and Myriad; and lecture: Pfizer, Novartis, Roche, and AstraZeneca. Prof. Dr. Med. Kerstin Rhiem, lecture: AstraZeneca, Amgen, and Roche. Prof. Dr. Med. Achim Rody, advisory board: AstraZeneca, Novartis, Roche, Exact Sciences, Pierre Fabre, Lilly, Seagen, Amgen, and MSD; lecture: Pfizer, Celgene, and Eisai; and trial funding: Eisai. Prof. Dr. Med. Marcus Schmidt: MS reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche, and SeaGen; his institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre, and SeaGen. In addition, he has a patent for EP 2390370 B1 and a patent for EP 2951317 B1 issued. Prof. Dr. Med. Andreas Schneeweiss, lecture: Amgen, AstraZeneca, Aurikamed, Clinsol, ConnectMedica, Gilead Science, GSK, I-Med, Lilly, MSD, NanoString, Novartis, Onkowissen, Promedicis, Pfizer, Pierre Fabre, Roche, Seagen, and STREAMED UP; and other: Thieme. Prof. Dr. Med. Florian Schütz, lecture: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Pfizer, MSD, Novartis, Onkowissen, and Roche Pharma; and advisory board: Lilly, MSD, and Atheneum Partners; and travel expenses: Lilly, Daiichi Sankyo, and Amgen. Prof. Dr. Med. Hans-Peter Sinn, advisory board: Exact Sciences and Daiichi Sankyo; lecture: AstraZeneca; and trial Funding: AstraZeneca. Prof. Dr. Med. Christine Solbach, lecture: DiaLog Service GmbH, Jörg Eickeler, Pfizer, MedConcept, Medicultus, GBG, Dt. Röntgengesellschaft, BVF Akademie, LÄK Hessen Akademie, Meet the Expert Academy; advisory board: MSD and Roche. Prof. Dr. Med. Erich-Franz Solomayer, Roche, Amgen, Celgen, Tesaro, AstraZeneca, Pfizer, Storz, Erbe, Gedeon Richter, Eisai, Medac, MSD, Vifor, Teva, Ethikon, Johnson & Johnson, Daiichi Sankyo, Gilead, Exact Sciences, GSK, and Pierre Fabre. Prof. Dr. Med. Elmar Stickeler, advisory boards: Gilead, Iomedico, Lilly, MSD, and Seagen; and lecture: Pfizer, Bsh Düsseldorf, Gilead, Iomedico, PharmaMar, Onkowissen, and Roche. Prof. Dr. Med. Christoph Thomssen, compensation for advisory boards, lectures or publications: Amgen, AstraZeneca, Aurikamed, Daiichi Sankyo, Forum Sanitas, Gilead, Jörg Eickeler, Hexal, Lilly, Medupdate, MSD, NanoString, Novartis, Onkowissen, Pfizer, Roche, Seagen, and Vifor. Prof. Dr. Med. Michael Untch: M. U. has received honoraria for lectures and consulting or advisory role from AstraZeneca, Art tempi, Amgen, Daiichi Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Pierre Fabre, Sanofi-Aventis, Myriad, Seagen, Novartis, Gilead, Stemline, Genzyme, Agendia, Onkowissen, Eisai; all honoraria and fees to the employer/institution. Prof. Dr. Isabell Witzel, lecture: Daiichi Sankyo, Pfizer, Roche, MSD, Lilly, Seagen, AstraZeneca, and Gilead; other: Onkowissen. Prof. Dr. Med. Achim Wöckel; advisory board: Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD, Genomic Health, Pierre Fabre, Clovis, and Organon. PD. Dr. Rachel Würstlein, Agendia, Amgen, Aristo, AstraZeneca, Aurikamed, Celgene, Clinsol, Clovis Oncology, Daiichi Sankyo, Eisai, Exact Sciences, FOMF, Gilead, Glaxo Smith Kline, Hexal, Lilly, MCI, medconcept, Medstrom Medical, MSD, Mundipharma, Mylan, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PINK, Pomme-med, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Sanofi Genzyme, Seattle Genetics/Seagen, Stemline, Tesaro Bio, Teva, Veracyte, and Viatris. Prof. Dr. Med. Volkmar Müller: VM received speaker honoraria from Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, Seattle Genetics, Genomic Health, Hexal, Roche, Pierre Fabre, Clinsol, Daiichi Sankyo, Eisai, Lilly, Tesaro, Seattle Genetics, and Nektar; institutional research support from Novartis, Roche, Seattle Genetics, and Genentech; and travel grants: Roche, Pfizer, and Daiichi Sankyo. Prof. Dr. Med. Wolfgang Janni, lecture: Amgen, AstraZeneca, Daiichi Sankyo, Lilly, MSD, Novartis, Pfizer, Roche, Seagen, and Gilead Science; trial Funding: Amgen, AstraZeneca, Lilly, Novartis, and Roche. Prof. Dr. Tjoung-Won Park-Simon, honoraria for lectures and/or consulting: Roche, AstraZeneca, GSK, Pfizer, Lilly, MSD, Exact Sciences, Daiichi Sankyo, Seagen, Novartis, Gilead Science, NCO, Onkowissen, Exact Sciences, and Seagen; and travel compensation: Roche, AstraZeneca, and Pfizer., (© 2023 S. Karger AG, Basel.)
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38. Physical Activity and the Impact of Continued Exercise on Health-Related Quality of Life Prior to and during Pregnancy: A German Cohort Study.
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Kasoha M, Hamza A, Leube A, Solomayer EF, Frenzel J, Schwab R, Sima RM, and Haj Hamoud B
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The goal of this study was to examine how regular physical activity before and during pregnancy affected life quality throughout pregnancy. Between July 2020 and May 2021, 218 pregnant women were recruited from 11 outpatient clinics for this survey. Data were collected prospectively in a panel format beginning with the 10th gestational week over a 20-week period. Prior to pregnancy, a previous time point was also defined. The International Physical Activity Questionnaire, the EQ-5D-3L questionnaire, and the EQ-VAS questionnaire were used to collect data on the duration and intensity of daily physical exercises, as well as to assess health-related quality of life and self-estimated health status. The final survey included data from 113 women. During pregnancy, physical activity decreased dramatically. The duration of strenuous activities, but not moderate activities, was significantly reduced. Continuous physical activity independently predicted higher life quality scores at all points of assessment. Cases who participated in moderate and strenuous activities on a regular basis had higher self-estimated health status scores than cases who only participated in moderate activity. Instead of focusing solely on specific types of physical activity, we believe that strategies for motivating all pregnant women to be constantly active should be developed.
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- 2023
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39. Sex Differences in the Frequencies of B and T Cell Subpopulations of Human Cord Blood.
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Bous M, Schmitt C, Hans MC, Weber R, Nourkami-Tutdibi N, Tenbruck S, Haj Hamoud B, Wagenpfeil G, Kaiser E, Solomayer EF, Zemlin M, and Goedicke-Fritz S
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- Humans, Male, Infant, Newborn, Female, Lymphocyte Subsets, B-Lymphocytes, Flow Cytometry, T-Lymphocyte Subsets, Fetal Blood, Sex Characteristics
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Cord blood represents a link between intrauterine and early extrauterine development. Cord blood cells map an important time frame in human immune imprinting processes. It is unknown whether the sex of the newborn affects the lymphocyte subpopulations in the cord blood. Nine B and twenty-one T cell subpopulations were characterized using flow cytometry in human cord blood from sixteen male and twenty-one female newborns, respectively. Except for transitional B cells and naïve B cells, frequencies of B cell counts across all subsets was higher in the cord blood of male newborns than in female newborns. The frequency of naïve thymus-negative Th cells was significantly higher in male cord blood, whereas the remaining T cell subpopulations showed a higher count in the cord blood of female newborns. Our study is the first revealing sex differences in the B and T cell subpopulations of human cord blood. These results indicate that sex might have a higher impact for the developing immune system, urging the need to expand research in this area.
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- 2023
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40. Sonographic features of adenomyosis correlated with clinical symptoms and intraoperative findings: a case-control study.
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Haj Hamoud B, Kasoha M, Sillem M, Solomayer EF, Sima RM, Ples L, Schwab R, and Olmes GL
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- Female, Humans, Adolescent, Young Adult, Adult, Middle Aged, Case-Control Studies, Uterus diagnostic imaging, Uterus surgery, Uterus pathology, Ultrasonography, Hysterectomy, Adenomyosis diagnostic imaging, Adenomyosis surgery
- Abstract
Purpose: Adenomyosis is a common disease of females during their reproductive age. As of today, histologic examination of the uterus after hysterectomy constitutes the gold standard for diagnosis. The aim of this study was to determine the validity of sonographic, hysteroscopic, and laparoscopic criteria for the diagnosis of the disease., Methods: This study included data collected from 50 women in the reproductive age of 18-45 years, who underwent a laparoscopic hysterectomy in the gynecology department of the Saarland University Hospital in Homburg between 2017 and 2018. The patients with adenomyosis were compared with a healthy control group., Results: We collected data of anamnesis, sonographic criteria, hysteroscopic criteria and laparoscopic criteria and compared it with the postoperative histological results. A total 25 patients were diagnosed with adenomyosis postoperatively. For each of these; at least three sonographic diagnostical criteria for adenomyosis were found compared with a maximum of two for the control group., Conclusion: This study demonstrated an association between pre- and intraoperative signs of adenomyosis. In this way, it shows a high diagnostic accuracy of the sonographic examination as a pre-operative diagnostic method of the adenomyosis., (© 2023. The Author(s).)
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- 2023
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41. The 3q Oncogene SEC62 Predicts Response to Neoadjuvant Chemotherapy and Regulates Tumor Cell Migration in Triple Negative Breast Cancer.
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Radosa JC, Kasoha M, Doerk M, Cullmann A, Kaya AC, Linxweiler M, Radosa MP, Takacs Z, Tirincsi A, Lang S, Jung M, Puppe J, Linxweiler B, Wagner M, Bohle RM, Solomayer EF, and Zimmermann JSM
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- Humans, Neoadjuvant Therapy, Oncogenes, Cell Movement genetics, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Membrane Transport Proteins metabolism, Triple Negative Breast Neoplasms drug therapy, Triple Negative Breast Neoplasms genetics, Triple Negative Breast Neoplasms pathology
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In the absence of targeted treatment options, neoadjuvant chemotherapy (NACT) is applied widely for triple-negative breast cancer (TNBC). Response to NACT is an important parameter predictive of oncological outcomes (progression-free and overall survival). An approach to the evaluation of predictive markers enabling therapy individualization is the identification of tumor driver genetic mutations. This study was conducted to investigate the role of SEC62 , harbored at 3q26 and identified as a driver of breast cancer pathogenesis, in TNBC. We analyzed SEC62 expression in The Cancer Genome Atlas database, and immunohistologically investigated SEC62 expression in pre- and post-NACT tissue samples from 64 patients with TNBC treated at the Department of Gynecology and Obstetrics/Saarland University Hospital/Homburg between January 2010 and December 2018 and compared the effect of SEC62 on tumor cell migration and proliferation in functional assays. SEC62 expression dynamics correlated positively with the response to NACT ( p ≤ 0.01) and oncological outcomes ( p ≤ 0.01). SEC62 expression stimulated tumor cell migration ( p ≤ 0.01). The study findings indicate that SEC62 is overexpressed in TNBC and serves as a predictive marker for the response to NACT, a prognostic marker for oncological outcomes, and a migration-stimulating oncogene in TNBC.
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- 2023
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42. The Impact of the Microbiological Vaginal Swab on the Reproductive Outcome in Infertile Women.
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Findeklee S, Urban L, Sima RM, Baus SL, Halfmann A, Wagenpfeil G, Solomayer EF, and Haj Hamoud B
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Background: The thesis on which this paper is based intended to investigate whether the result of the microbiological vaginal swab has an influence on the outcome of the fertility treatment., Methods: The microbiological vaginal swabs of patients who received fertility treatment at Saarland University Hospital were evaluated. Depending on the microorganisms detected, the swab result was classified as inconspicuous, intermediate, or conspicuous. The SPSS software was used to determine the correlation between the swab result and the outcome of the fertility treatment., Results: Dysbiosis was associated with a worse outcome of fertility treatment. The pregnancy rate with a conspicuous swab was 8.6%, whereas it was 13.4% with an inconspicuous swab. However, this association was not statistically significant. Furthermore, an association of endometriosis with dysbiosis was found. Endometriosis was more frequent with a conspicuous swab result than with an inconspicuous result (21.1% vs. 17.7%), yet the correlation was not statistically significant. However, the absence of lactobacilli was significantly associated with endometriosis ( p = 0.021). The association between endometriosis and a lower pregnancy rate was also statistically significant ( p = 0.006)., Conclusion: The microbiological vaginal and cervical swabs can be used as predictors for the success of fertility treatments. Further studies are needed to assess the impact of transforming a dysbiotic flora into a eubiotic environment on the success of fertility treatments.
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- 2023
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43. Liver phenotypes in PCOS: Analysis of exogenous and inherited risk factors for liver injury in two European cohorts.
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Smyk W, Papapostoli I, Żorniak M, Sklavounos P, Blukacz Ł, Madej P, Koutsou A, Weber SN, Friesenhahn-Ochs B, Cebula M, Bosowska J, Solomayer EF, Hartleb M, Milkiewicz P, Lammert F, Stokes CS, and Krawczyk M
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- Humans, Female, Risk Factors, Phenotype, Polycystic Ovary Syndrome genetics, Polycystic Ovary Syndrome complications, Non-alcoholic Fatty Liver Disease complications
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Background & Aims: Fatty liver disease (FLD) is common in women with polycystic ovary syndrome (PCOS). Here, we use non-invasive tests to quantify liver injury in women with PCOS and analyse whether FLD-associated genetic variants contribute to liver phenotypes in PCOS., Methods: Prospectively, we recruited women with PCOS and controls at two university centres in Germany and Poland. Alcohol abuse was regarded as an exclusion criterion. Genotyping of variants associated with FLD was performed using TaqMan assays. Liver stiffness measurements (LSM), controlled attenuation parameters (CAP) and non-invasive HSI, FLI, FIB-4 scores were determined to assess hepatic steatosis and fibrosis., Results: A total of 42 German (age range 18-53 years) and 143 Polish (age range 18-40 years) women with PCOS, as well as 245 German and 289 Polish controls were recruited. In contrast to Polish patients, Germans were older, presented with more severe metabolic profiles and had significantly higher LSM (median 5.9 kPa vs. 3.8 kPa). In the German cohort, carriers of the PNPLA3 p.I148M risk variant had an increased LSM (p = .01). In the Polish cohort, the minor MTARC1 allele was linked with significantly lower serum aminotransferases activities, whereas the HSD17B13 polymorphism was associated with lower concentrations of 17-OH progesterone, total testosterone, and androstenedione (all p < .05)., Conclusions: FLD is common in women with PCOS. Its extent is modulated by both genetic and metabolic risk factors. Genotyping of variants associated with FLD might help to stratify the risk of liver disease progression in women suffering from PCOS., (© 2023 The Authors. Liver International published by John Wiley & Sons Ltd.)
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- 2023
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44. Differential nasal swab cytology represents a valuable tool for therapy monitoring but not prediction of therapy response in chronic rhinosinusitis with nasal polyps treated with Dupilumab.
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Danisman Z, Linxweiler M, Kühn JP, Linxweiler B, Solomayer EF, Wagner M, Wagenpfeil G, Schick B, and Berndt S
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- Humans, Quality of Life, Prospective Studies, Nasal Mucosa, Immunoglobulin E, Chronic Disease, Nasal Polyps diagnosis, Nasal Polyps drug therapy, Rhinitis diagnosis, Rhinitis drug therapy, Sinusitis diagnosis, Sinusitis drug therapy
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Introduction: Chronic Rhinosinusitis with nasal polyps (CRSwNP) is a common chronic disease with a high impact on patients' quality of life. If conservative and surgical guideline treatment cannot sufficiently control disease burden, biologicals can be considered as a comparably new treatment option that has revolutionized CRSwNP therapy since the first approval of Dupilumab in 2019. With the aim to select patients who benefit from this new treatment and to find a marker for therapy monitoring, we investigated the cellular composition of nasal mucous membranes and inflammatory cells of patients suffering from CRSwNP and undergoing Dupilumab therapy using non-invasive nasal swab cytology., Methods: Twenty CRSwNP patients with the indication for Dupilumab therapy have been included in this prospective clinical study. In total, five study visits were conducted with ambulatory nasal differential cytology using nasal swabs starting with the beginning of therapy and followed by visits every 3 months for 12 months. First, these cytology samples were stained with the May-Grunwald-Giemsa method (MGG) and the percentage of ciliated cells, mucinous cells, eosinophil cells, neutrophil cells, and lymphocytes was analyzed. Secondly, an immunocytochemical (ICC) ECP-staining was performed to detect eosinophil granulocytes. Additionally, during each study visit the nasal polyp score, SNOT20 questionnaire, olfactometry, the total IgE concentration in peripheral blood as well as the eosinophil cell count in peripheral blood were recorded. The change of parameters was evaluated over one year and the correlation between clinical effectiveness and nasal differential cytology was analyzed., Results: In both MGG (p<0.0001) and ICC analysis (p<0.001) a significant decrease of eosinophils was seen under Dupilumab treatment. When patients were divided into a Eo-low- (<21%) and Eo-high- (≥21%) group according to the percentage eosinophils in nasal swab catology in the first study visit, the Eo-high-group showed a greater change of eosinophils over time (Δ17.82) compared to the Eo-low-group (Δ10.67) but, however, no better response to therapy. The polyp score, SNOT20 questionnaire, and total IgE concentration in peripheral blood showed a significant decrease during the observation period (p<0.0001)., Discussion: Nasal swab cytology as an easy-to-apply diagnostic method allows detection and quantification of the different cell populations within the nasal mucosa at a given time. The nasal differential cytology showed a significant decrease of eosinophils during Dupilumab therapy and can therefore be used as non-invasvive method for monitoring therapy success of this cost intensive therapy and potentially can allow an optimized individual therapy planning and management for CRSwNP patients. Since the validity of initial nasal swab eosinophil cell count as a predictive biomarker for therapy response was limited in our study, additional studies including larger number of participants will be necessary to further evaluate the potential benefits for clinical practice of this new diagnostic method., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Danisman, Linxweiler, Kühn, Linxweiler, Solomayer, Wagner, Wagenpfeil, Schick and Berndt.)
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- 2023
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45. Prevalence and Relevance of Vitamin D Deficiency in Newly Diagnosed Breast Cancer Patients: A Pilot Study.
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Zemlin C, Altmayer L, Stuhlert C, Schleicher JT, Wörmann C, Lang M, Scherer LS, Thul IC, Spenner LS, Simon JA, Wind A, Kaiser E, Weber R, Goedicke-Fritz S, Wagenpfeil G, Zemlin M, Solomayer EF, Reichrath J, and Müller C
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- Humans, Female, Pilot Projects, Prevalence, Vitamin D, Breast Neoplasms complications, Breast Neoplasms epidemiology, Vitamin D Deficiency
- Abstract
(1) Background: Vitamin D plays an important role in many types of cancer. It was the aim of this study to analyze serum 25-hydroxyvitamin D (25(OH)D) levels in newly diagnosed breast cancer patients, and the association with prognostic and lifestyle factors. (2) Methods: 110 non-metastatic breast cancer patients were included in the prospective observational "BEGYN" study at Saarland University Medical Center between September 2019 and January 2021. At the initiation visit, serum 25(OH)D levels were measured. Clinicopathological data on prognosis, nutrition, and lifestyle were extracted from data files and obtained using a questionnaire. (3) Results: Median serum 25(OH)D in breast cancer patients was 24 ng/mL (range 5-65 ng/mL), with 64.8% of patients being vitamin D deficient. 25(OH)D was higher among patients that reported the use of vitamin D supplements (43 ng/mL versus 22 ng/mL; p < 0.001), and in summer compared to other seasons ( p = 0.03). Patients with moderate vitamin D deficiency were less likely to have triple negative breast cancer ( p = 0.047). (4) Conclusions: Routinely measured vitamin D deficiency is common in breast cancer patients and needs to be detected and treated. However, our results do not support the hypothesis that vitamin D deficiency may be a main prognostic factor for breast cancer.
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- 2023
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46. Neurologic Consultations and Headache during Pregnancy and in Puerperium: A Retrospective Chart Review.
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Zimmermann JSM, Fousse M, Juhasz-Böss I, Radosa JC, Solomayer EF, and Mühl-Benninghaus R
- Abstract
Headache is a common symptom during pregnancy and in puerperium that requires careful consideration, as it may be caused by a life-threatening condition. Headaches in pregnant women and women in puerperium are classified as primary or secondary; acute, severe and newly diagnosed headaches should prompt further investigation. We aimed to further characterise the demographic features, symptoms, examination findings, and neuroimaging results of cases of headache during pregnancy and in puerperium. All pregnant women or women in postpartum conditions who attended neurological consultations at the emergency department of the clinic for Gynaecology, Obstetrics and Reproductive Medicine of Saarland University/Germany between 2001/2015 and 2012/2019 were enrolled in this retrospective chart review. Data collected from the charts included demographic/pregnancy characteristics, clinical features and imaging findings. Descriptive statistics as well as binary logistic regression were performed. More than 50% of 97 patients had abnormal findings in their neurological examination. Magnetic resonance imaging findings were pathological for almost 20% of patients-indicating conditions such as cerebral venous thrombosis, reversible posterior leukoencephalopathy, brain tumour and intracranial bleeding. The odds of abnormal neuroimaging results were 2.2-times greater among women with abnormal neurological examination findings than among those with normal examination results. In cases of headache during pregnancy and in puerperium, neuroimaging should be indicated early on. Further research is needed to determine which conditions indicate a need for immediate neuroimaging.
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- 2023
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47. Quality of life and sexual function in patients aged 35 years or younger undergoing hysterectomy for benign gynecologic conditions: A prospective cohort study.
- Author
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Zimmermann JSM, Sima RM, Radosa MP, Radosa CG, Ples L, Wagenpfeil S, Solomayer EF, and Radosa JC
- Subjects
- Female, Humans, Prospective Studies, Quality of Life, Hysterectomy methods, Hysterectomy, Vaginal methods, Postoperative Complications epidemiology, Uterine Diseases surgery, Laparoscopy methods
- Abstract
Objective: To evaluate how hysterectomy performed for benign gynecologic pathologies affects the quality of life and sexual function of patients aged 35 years or younger, and if outcomes differ according to the surgical technique., Methods: Seventy-three patients who underwent total laparoscopic hysterectomy (TLH), supracervical laparoscopic hysterectomy (SLH), or vaginal hysterectomy (VH) for benign uterine disorders between April 2014 and June 2020 at the Department of Gynecology and Obstetrics, Saarland University Hospital, Homburg, Germany, were enrolled in this prospective observational cohort study. Quality of life and sexual function were assessed preoperatively and 6 months postoperatively using standardized validated questionnaires: the European Quality of Life Five-Dimension Scale (EQ-5D) and the Female Sexual Function Index (FSFI)., Results: Thirty-three (45%) patients underwent TLH, 25 (34%) underwent SLH, and 15 (21%) patients underwent VH. The median preoperative EQ-5D score, FSFI score, and EQ-5D visual analog scale were 0.9 (range 0.62-1), 19.25 (range 2.4-27.4), and 50 (range 0-100); postoperative scores were 1 (range 0.61-1), 24.15 (range 3.9-29.3), and 90 (range 30-100), respectively (P ≤ 0.001). Postoperative scores were significantly higher than preoperative scores, with no significant difference according to the surgical technique., Conclusion: Hysterectomy for benign indication in women aged 35 years or less significantly improved the patients' quality of life and sexual function with no differences regarding the surgical technique., Clinical Trial Registration: The study was registered in the German trial registry (no. DRKS00005622)., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)
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- 2023
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48. CDK4/6 Inhibitors in Advanced HR+/HER2 - Breast Cancer: A Multicenter Real-World Data Analysis.
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Müller C, Kiver V, Solomayer EF, Wagenpfeil G, Neeb C, Blohmer JU, Abramian AV, Maass N, Schütz F, Kolberg-Liedtke C, Ralser DJ, and Rambow AC
- Abstract
Purpose: CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy are considered standard-of-care for first-line therapy of patients with hormone receptor positive, HER2 negative, advanced breast cancer (HR+/HER2- ABC). Superiority of combination therapy over endocrine monotherapy has been demonstrated in a multitude of randomized controlled trials (RCTs) in phase III and IV. However, RCTs reflect clinical reality only to a limited extent, as narrow inclusion criteria lead to a selected patient collective. Here, we present real-world data (RWD) on CDK4/6i treatment in patients with HR+/HER2- ABC at four certified German university breast cancer centers., Methods: Patients diagnosed with HR+/HER2- ABC who were treated in clinical routine with CDK4/6i between November 2016 and December 2020 at four certified German university breast cancer centers (Saarland University Medical Center, University Medical Center Charité Berlin, University Medical Center Bonn, and University Medical Center Hospital Schleswig-Holstein, Campus Kiel) were identified and enrolled in this retrospective study. Clinicopathological characteristics and clinical outcomes were recorded with particular emphasis on CDK4/6i therapy course [progression-free survival (PFS) following treatment initiation, toxicity, dose reduction, therapy discontinuation, prior and subsequent therapy line]., Results: Data from n = 448 patients were evaluated. The mean patient age was 63 (±12) years. Of these patients, n = 165 (36.8%) were primarily metastasized, and n = 283 (63.2%) had secondary metastatic disease. N = 319 patients (71.3%) received palbociclib, n = 114 patients (25.4%) received ribociclib, and n = 15 patients (3.3%) received abemaciclib, respectively. Dose reduction was performed in n = 132 cases (29.5%). N = 57 patients (12.7%) discontinued the treatment with CDK4/6i due to side effects. N = 196 patients (43.8%) experienced disease progression under CDK4/6i treatment. The median PFS was 17 months. Presence of hepatic metastases and prior therapy lines were associated with shorter PFS, whereas estrogen positivity and dose reduction due to toxicity were positively associated with PFS. Presence of bone and lung metastases, progesterone positivity, Ki67 index, grading, BRCA1/2 and PIK3CA mutation status, adjuvant endocrine resistance, and age did not significantly impact on PFS., Conclusion: Our RWD analysis on CDK4/6i treatment in Germany supports data from RCTs regarding both treatment efficacy and safety of CDK4/6i for treatment of patients with HR+/HER2- ABC. In comparison to data from the pivotal RCTs, median PFS was lower but within the expected range for RWD, which could result from inclusion of patients with more advanced diseases (i.e., higher therapy lines) to our dataset., (Copyright © 2022 by The Author(s). Published by S. Karger AG, Basel.)
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- 2023
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49. Effect of the 3q26-coding oncogene SEC62 as a potential prognostic marker in patients with ovarian neoplasia.
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Radosa JC, Kasoha M, Schilz AC, Takacs ZF, Kaya A, Radosa MP, Linxweiler B, Linxweiler M, Bohle RM, Wagner M, Wagenpfeil G, Solomayer EF, and Zimmermann JSM
- Abstract
With approximately 220,000 newly diagnosed cases per year, ovarian cancer is among the most frequently occurring cancers among women and the second leading cause of death from gynecological malignancies worldwide. About 70% of these cancers are diagnosed in advanced stages (FIGO IIB-IV), with a 5-year survival rate of 20-30%. Due to the poor prognosis of this disease, research has focused on its pathogenesis and the identification of prognostic factors. One possible approach for the identification of biological markers is the identification of tumor entity-specific genetic "driver mutations". One such mutation is 3q26 amplification in the tumor driver SEC62 , which has been identified as relevant to the pathogenesis of ovarian cancer. This study was conducted to investigate the role of SEC62 in ovarian malignancies. Patients with ovarian neoplasias (borderline tumors of the ovary and ovarian cancer) who were treated between January 2007 and April 2019 at the Department of Gynecology and Obstetrics, Saarland University Hospital, were included in this retrospective study. SEC62 expression in tumor tissue samples taken during clinical treatment was assessed immunohistochemically, with the calculation of immunoreactivity scores according to Remmele and Stegner, Pathologe, 1987, 8, 138-140. Correlations of SEC62 expression with the TNM stage, histological subtype, tumor entity, and oncological outcomes (progression-free and overall survival) were examined. The sample comprised 167 patients (123 with ovarian cancer and 44 with borderline tumors of the ovary) with a median age of 60 (range, 15-87) years. At the time of diagnosis, 77 (46%) cases were FIGO stage III. All tissue slides showed SEC62 overexpression in tumor cells and no SEC62 expression in other cells. Median immunoreactivity scores were 8 (range, 2-12) for ovarian cancer and 9 (range, 4-12) for borderline tumors of the ovary. Patients with borderline tumors of the ovary as well as patients with ovarian cancer and an immunoreactive score (IRS) ≤ 9 showed an improved overall survival compared to those presenting with an IRS score >9 ( p = 0.03). SEC62 seems to be a prognostic biomarker for the overall survival of patients with ovarian malignancies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Radosa, Kasoha, Schilz, Takacs, Kaya, Radosa, Linxweiler, Linxweiler, Bohle, Wagner, Wagenpfeil, Solomayer and Zimmermann.)
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- 2023
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50. Immunohistochemical assessment of PD-L1 expression using three different monoclonal antibodies in triple negative breast cancer patients.
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Schmidt G, Guhl MM, Solomayer EF, Wagenpfeil G, Hammadeh ME, Juhasz-Boess I, Endrikat J, Kasoha M, and Bohle RM
- Subjects
- Antibodies, Monoclonal, Biomarkers, Tumor, Humans, Immunohistochemistry, Ki-67 Antigen, Middle Aged, Retrospective Studies, B7-H1 Antigen metabolism, Triple Negative Breast Neoplasms
- Abstract
Background: PD-L1 receptor expression in breast cancer tissue can be assessed with different anti-human PD-L1 monoclonal antibodies. The performance of three specific monoclonal antibodies in a head-to-head comparison is unknown. In addition, a potential correlation of PD-L1 expression and clinico-pathological parameters has not been investigated., Methods: This was a retrospective study on tissue samples of patients with histologically confirmed triple negative breast cancer (TNBC). PD-L1 receptors were immune histochemically stained with three anti-human PD-L1 monoclonal antibodies: 22C3 and 28-8 for staining of tumor cell membranes (TC) and cytoplasm (Cyt), SP142 for immune cell staining (IC). Three different tissue samples of each patient were evaluated separately by two observers in a blinded fashion. The percentage of PD-L1 positive tumor cells in relation to the total number of tumor cells was determined. For antibodies 22C3 and 28-8 PD-L1 staining of 0 to < 1% of tumor cells was rated "negative", 1-50% was rated "positive" and > 50% was rated "strong positive". Cyt staining was defined as "negative" when no signal was observed and as "positive", when any positive signal was observed. For IC staining with SP142 all samples with PD-L1 expression ≥ 1% were rated as "positive". Finally, the relationship between PD-L1 expression and clinico-pathological parameters was analyzed., Results: Tissue samples from 59 of 60 enrolled patients could be analyzed. Mean age was 55 years. Both the monoclonal antibodies 22C3 and 28-8 had similar properties, and were positive for both TC in 13 patients (22%) and for Cyt staining in 24 patients (40.7%). IC staining with antibody SP142 was positive in 24 patients (40.7%), who were also positive for Cyt staining. The differences between TC and Cyt staining and TC and IC staining were significant (p = 0.001). Cases with positive TC staining showed higher Ki67 expression compared to those with negative staining, 40 vs 30%, respectively (p = 0.05). None of the other clinico-pathological parameters showed any correlation with PDL1 expression., Conclusions: Antibodies 22C3 and 28-8 can be used interchangeably for PD-L1 determination in tumor cells of TNBC patients. Results for Cyt staining with 22C3 or 28-8 and IC staining with SP142 were identical. In our study PD-L1 expression correlates with Ki67 expression but not with OS or DFS., (© 2022. The Author(s).)
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- 2022
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