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Background: The impact of adjuvant radiotherapy (RT) to the vulva with regard to prognosis and local recurrence in patients with vulvar squamous cell cancer (VSCC) is poorly described.Patients and methods: In the AGO-CaRE-1 study 1618 patients with primary VSCC FIGO stage ≥ IB, treated between 1998-2008, were documented. In this retrospective subanalysis, 360 patients were included based on the following criteria: nodal involvement (pN+), known RT treatment and known radiation fields.Results: The majority had pT1b/pT2 tumors (n=299; 83.1%). In 76.7%, R0 resection was achieved. 57/360 (15.8%) N+ patients were treated with adjuvant RT to the groins/pelvis and 146/360 (40.5%) received adjuvant RT to the vulva and groins/pelvis. 157/360 (43.6%) patients did not receive any adjuvant RT. HPV status was available in 162/360 patients (45.0%), 75/162 tumors were HPV+(46.3%), 87/162 (53.7%) HPV-. During a median follow-up of 17.2 months, recurrence at the vulva only occurred in 25.5% of patients without adjuvant RT, in 22.8% of patients with adjuvant RT to groins/pelvis and in 15.8% of patients with adjuvant RT to the vulva and groins/pelvis respectively. The risk reducing effect of local RT was independent of the resection margin status. 50% disease free survival time (50% DFST) indicated a stronger impact of adjuvant RT to the vulva in HPV+ compared to HPV- patients (50% DFST 20.7 months vs. 17.8 months).Conclusion: Adjuvant RT to the vulva was associated with a lower risk for local recurrence in N+ VSCC independent of the resection margin status. This observation was more pronounced in patients with HPV+ tumors in comparison to HPV– tumors.

Signifikante Fortschritte in der Diagnostik und Therapie des primaren und rezidivierenden Ovarial‑, Tuben- und Peritonealkarzinoms stellen neue Herausforderungen an die Nachsorge. Patientinnen befinden sich in unterschiedlichen Therapiemustern mit individuell unterschiedlichen Nebenwirkungsprofilen und Anforderungen. Daher sollten Aufgaben und Ziele der Nachsorge fruhzeitig und individuell definiert und auch der zeitliche Ablauf sowie Inhalte der Untersuchungen erlautert werden, eingebettet in ein interprofessionelles und multimodales Netzwerk. Herausfordernd ist hier vor allem auch die Kommunikation mit den Patientinnen und Angehorigen. In Zukunft werden auch digitale Plattformen und spezifische Materialien in die Nachsorge implementiert werden.

Purpose The pandemic SARS-CoV-2 poses new and unprecedented challenges for health care systems on a national and global level. Although the current situation has been going on for more than 1 year, there is limited data on the impact of the pandemic on general hospital and medical practice care. This survey captures the perspective of patients with gynaecological diseases of this impact. Methods Using a paper-based questionnaire, 327 patients were asked about medical care and their experiences during the pandemic at the University Hospital Bonn and the University Hospital Charité Berlin. The study was performed from the 1st June to 30th September 2020. Results A total of 327 patients participated in the study: 156 stated to have been tested for coronavirus, and 1 patient reported a positive test. 41.3% of the patients felt insecure about the current situation, 30.4% were concerned about the risk of infection during the hospital stay. The pandemic-specific measures in hospitals and medical practices unsettled 6.8% of patients. 18.1% of patients feared that their gynaecological disease would not be treated adequately due to the pandemic. 55.7% of patients reported that their confidence in their physicians has increased during the pandemic. Conclusion The results show that patients’ confidence in the healthcare system and the physicians acting significantly increased during the COVID-19 crisis. Transparent and comprehensive information policy regarding actions and restrictions within the COVID-19 crisis eases patients concerns and improves patients’ confidence in their physicians, which is crucial for a successful treatment’s outcome.

Eine gute Kommunikation ist die Grundlage des Arzt-Patient-Verhaltnisses. Trotz der unstrittigen Bedeutung fur die Einleitung und Durchfuhrung aller medizinischen Interventionen ist die Aus- und Weiterbildung zum Thema Kommunikation noch unzureichend. Der vorliegende Beitrag beschreibt die verschiedenen Herausforderungen der Kommunikation im medizinischen Alltag und betrachtet dabei die verschiedenen Perspektiven, sowohl der Patienten als auch im interprofessionellen und interdisziplinaren Dialog. Praktische Tipps fur die klinische Routine werden ebenfalls formuliert.

Die COVID-19-Pandemie halt weiter an und stellt alle Beteiligten im Gesundheitssystem vor neue und bisher so nie dagewesene Herausforderungen, die sowohl die Strukturen innerhalb von Kliniken sowie des Gesundheitssystems als auch die Kommunikation inter-sowie intradisziplinar betreffen. Die Pandemie macht deutlich, wie wichtig die intersektorale (also zwischen der ambulanten und der stationaren Versorgung), -professionelle und -interdisziplinare Abstimmung ist, um die Versorgung der Patientinnen aufrechtzuerhalten. Dabei gilt es, wiederholt Bestandsaufnahmen vorzunehmen, um zum einen notwendige Anpassungen, zum anderen aber auch Konsequenzen fur zukunftige Entwicklungen zu diskutieren.

Introduction The aim of this study was to record the perinatal data of refugee women at Charité Hospital, Berlin, and to evaluate possible differences in pre-, peri- and postnatal outcomes compared with indigenous women. Material and Methods All pregnant women who gave birth in the period from 1 January 2014 to 30 September 2017 and were registered at least once in the hospital as “refugee” were included in the analysis. The data recorded from the refugee women were compared with the perinatal data of the German Federal obstetric analysis for the year 2016, which was published by the IQTIG (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen [Institute for Quality Assurance and Transparency in Healthcare]). Results The analysis comprised 907 refugee women and 928 infants (21 twin pregnancies). Pregnant refugee women were significantly younger than the pregnant women from the Federal analysis (birth before the age of 30: 66 vs. 41%, p 2 miscarriages: 9.7 vs. 5.9%, p Conclusion Both refugee women and their infants showed significant differences. Despite the average younger age of the pregnant refugee women, the rates of premature birth and stillbirth and congenital malformations were significantly more frequent. More intensive antenatal screening with differentiated foetal organ diagnostics including psychosomatic care could contribute to early identification and prompt diagnosis. As regards the postpartum anaemia and puerperal endometritis, which occur more often in refugee women, midwife engagement and an improvement in the living situation in homes and accommodation facilities could be of great importance.

Treatment approaches for relapsed ovarian cancer have evolved over the past decade from a calendar-based decision tree to a patient-oriented biologically driven algorithm. Nowadays, platinum-based chemotherapy should be offered to all patients with a reasonable chance of responding to this therapy. The treatment-free interval for platinum is only one of many factors affecting patients' eligibility for platinum re-treatment. Bevacizumab increases the response to chemotherapy irrespective of the cytotoxic regimen and can be valuable in patients with an urgent need for symptom relief (e.g. pleural effusion, ascites). For patients with recurrent high-grade ovarian cancer, which responds to platinum-based treatment, maintenance therapy with a poly(ADP-ribose) polymerase inhibitor can be offered, regardless of the BRCA mutation status. Here we review contemporary decision-making processes in the systemic treatment of relapsed ovarian cancer.

Purpose Despite the establishment of radical surgery for therapy of cervical cancer, data on quality of life and patient-reported outcomes are scarce. The aim of this retrospective cohort study was to evaluate bladder, bowel and sexual function in women who underwent minimally invasive surgery for early-stage cervical cancer. Methods From 2007–2013, 261 women underwent laparoscopically assisted radical vaginal hysterectomy (LARVH = 45), vaginally assisted laparoscopic or robotic radical hysterectomy (VALRRH = 61) or laparoscopic total mesometrial resection (TMMR = 25) and 131 of them completed the validated German version of the Australian Pelvic Floor Questionnaire (PFQ). Results were compared with controls recruited from gynecological clinics (n = 24) and with urogynecological patients (n = 63). Results Groups were similar regarding age, BMI and parity. The TMMR group had significantly shorter median follow-up (16 months versus 70 and 36 months). Postoperatively, deterioration of bladder function was reported by 70%, 57% and 44% in the LARVH, VARRVH and TMMR groups, respectively (p = 0.734). Bowel function was significantly worse after TMMR with a higher deterioration rate in 72 versus 43% (LARVH) and 47% (VARRVH) with a correspondingly higher bowel dysfunction score of 2.9 versus 1.5 and 1.8, respectively and 1.8 in urogynaecological patients. Sexual dysfunction was common in all surgical groups. 38% considered their vagina too short which was significantly associated with deep dyspareunia. Compared with controls, surgical groups had significantly increased PFQ scores. Conclusion Pelvic floor dysfunction commonly deteriorates and negatively impacts on quality of life after minimally invasive radical hysterectomy, especially bowel function after TMMR. Pelvic floor symptoms should routinely be addressed pre- and postoperatively.

Background: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16 & ndash;26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27 & ndash;45 versus 16 & ndash;26 years of age. Methods: This international, open-label study (NCT03158220) was conducted in women 16 & ndash;45 years of age. Participants (16 & ndash;26 years, n = 570 and 27 & ndash;45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study. Results: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27 & ndash;45 years were compared to those in women 16 & ndash;26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27 & ndash;45 years to 16 & ndash;26 years) was 0.60 & ndash;0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27 & ndash; 45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16 & ndash;26 years, and 85.2% and 24.1% of women 27 & ndash; 45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study. Conclusions: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27 & ndash;45 years compared with women 16 & ndash;26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16 & ndash;26 years to women 27 & ndash;45 years of age. Clinical trial registration NCT03158220. (c) 2021 Elsevier Ltd. All rights reserved.

ObjectiveTo evaluate the rate of secondary malignancies in long-term survivors with ovarian cancer.MethodsLong-term survivors with ovarian cancer (survival ≥8 years after initial diagnosis) with multiple malignancies were identified within the Tumorbank Ovarian Cancer and our study ‘Carolin meets HANNA – Holistic Analyses of Long-term Survivors with Ovarian Cancer’.ResultsOf a total of 225 long-term survivors with ovarian cancer, 36 patients (16%) had at least one more cancer diagnosis before, concomitant with, or after, ovarian cancer. Median age was 52.5 years (range 37–79). A total of 60% were diagnosed with stage III/IV and most tumors were high-grade (88.6%), as well as of serous histology (63.9%). Median overall survival was 10 years (range 8–19). Secondary cancer after ovarian cancer was found in 17 long-term survivors (7.6%). Breast cancer was the most frequent secondary malignancy. Median duration between diagnosis of primary ovarian cancer and secondary cancer diagnosis was 78.5 months (range 12–220). BRCA was tested in 11 patients with seven patients being BRCA1 and one patient BRCA2 positive. Secondary cancers were detected by screening in 35.3% and self-detected in 29.4% of patients (breast self-examination).ConclusionA secondary malignancy was diagnosed in 7.6% of long-term survivors. Routine follow-up and cancer screening should be performed in long-term ovarian cancer survivors.

Zusammenfassung Fragestellung Welche prädiktiven Faktoren lassen sich für die Gruppe der sog. Mehrfachnutzer (MFN; 4 und mehr Inanspruchnahmen einer Notaufnahme [NA] in den letzten 12 Monaten) finden? Sind Personen mit Migrationshintergrund häufiger in die Gruppe der MFN einzuordnen? Methodik Konsekutive Patienten, die von Juli 2017 bis Juli 2018 drei Klinik-NA in Berlin aufsuchten. Mittels Fragebogen Erfassung von Erkrankungen, Gründen für den NA-Besuch und sozioökonomischen Faktoren. Die Unterschiede zwischen Migranten (1. Generation), ihren Nachkommen (2. Generation) und Nichtmigranten wurden mithilfe der logistischen Regression bewertet. Ergebnisse 2339 Patienten konnten in die Auswertung einbezogen werden (Rücklaufrate 56 %), davon hatten 901 einen Migrationshintergrund. Bei jungen Frauen ( Schlussfolgerung MFN belasten das ohnehin zunehmende Patientenvolumen von NA. Sie stellen jedoch eine heterogene Patientengruppe dar, unter der Menschen mit Migrationshintergrund nicht häufiger vertreten sind. Weitere Untersuchungen sind erforderlich, um die Faktoren, die zu einer häufigen Inanspruchnahme führen, besser zu verstehen und wirksame Strategien zu entwickeln, um den komplexen Gesundheitsbedürfnissen von MFN gerecht zu werden.

Variant-specific loss of heterozygosity (LOH) analyses may be useful to classify BRCA1/2 germline variants of unknown significance (VUS). The sensitivity and specificity of this approach, however, remains unknown. We performed comparative next-generation sequencing analyses of the BRCA1/2 genes using blood-derived and tumour-derived DNA of 488 patients with ovarian cancer enrolled in the observational AGO-TR1 trial (NCT02222883). Overall, 94 pathogenic, 90 benign and 24 VUS were identified in the germline. A significantly increased variant fraction (VF) of a germline variant in the tumour indicates loss of the wild-type allele; a decreased VF indicates loss of the variant allele. We demonstrate that significantly increased VFs predict pathogenicity with high sensitivity (0.84, 95% CI 0.77 to 0.91), poor specificity (0.63, 95% CI 0.53 to 0.73) and poor positive predictive value (PPV; 0.71, 95% CI 0.62 to 0.79). Significantly decreased VFs predict benignity with low sensitivity (0.26, 95% CI 0.17 to 0.35), high specificity (1.0, 95% CI 0.96 to 1.00) and PPV (1.0, 95% CI 0.85 to 1.00). Variant classification based on significantly increased VFs results in an unacceptable proportion of false-positive results. A significantly decreased VF in the tumour may be exploited as a reliable predictor for benignity, with no false-negative result observed. When applying the latter approach, VUS identified in four patients can now be considered benign. Trial registration number NCT02222883., publishedVersion

Objectives Ovarian cancer (OC) is the leading cause of death in gynecological oncology, primarily caused by limited prognostic and therapeutic options. The heat shock protein 27 (HSP27) is recognized as a prominent factor in OC, playing a pivotal role in cancer progression machinery such as treatment resistance. Thus, HSP27 may represent an appropriate biomarker for OC diagnosis, prognosis, and therapy response. Materials & methods Extracellular HSP27 levels were measured by enzyme-linked immunosorbent assay (ELISA) in serum samples of OC patients (n = 242) and compared to a non-malignant control group without any history of cancer (n = 200). Correlations between serum levels of HSP27 and clinical pathological parameters were analyzed by bivariate analysis. Survival analyses were carried out by Kaplan-Meier test. Results This study demonstrated that protein levels of HSP27 are comparable in the blood serum of healthy women and OC patients. However, HSP27 levels are significantly correlated with the volume of ascites, residual tumor mass, and age at first diagnosis in OC patients. Notably, elevated levels of HSP27 demonstrate significantly higher overall survival. Conclusion Taken together, our findings demonstrate that high levels of circulating HSP27 in serum are associated with improved overall survival of OC patients. Even though functionality of secreted HSP27 is still unclear, serum levels of HSP27 represent a putative non-invasive prognostic biomarker candidate for OC progression.

Since the publication of the updated German guideline in 2015, the recommendations for performing pelvic lymphadenectomy (LAE) in patients with vulvar cancer (VSCC) have changed considerably. The guideline recommends surgical lymph node staging in all patients with a higher risk of pelvic lymph node involvement. However, the current data do not allow the population at risk to be clearly defined, therefore, the indication for pelvic lymphadenectomy is still not clear. There are currently two published German patient populations who had pelvic LAE which can be used to investigate both the prognostic effect of histologically verified pelvic lymph node metastasis and the relation between inguinal and pelvic lymph node involvement. A total of 1618 patients with primary FIGO stage ≥ IB VSCC were included in the multicenter AGO CaRE-1 study (1998 – 2008), 70 of whom underwent pelvic LAE. During a retrospective single-center evaluation carried out at the University Medical Center Hamburg-Eppendorf (UKE), a total of 514 patients with primary VSCC treated between 1996 – 2018 were evaluated, 21 of whom underwent pelvic LAE. In both cohorts, around 80% of the patients who underwent pelvic LAE were inguinally node-positive, with a median number of three affected groin lymph nodes. There were no cases of pelvic lymph node metastasis without inguinal lymph node metastasis in either of the two cohorts. Between 33 – 35% of the inguinal node-positive patients also had pelvic lymph node metastasis; the median number of affected groin lymph nodes in these patients was high (> 4), and the maximum median diameter of the largest inguinal metastasis was > 40 mm in both cohorts. Pelvic lymph node staging and pelvic radiotherapy is therefore probably not necessary for the majority of node-positive patients with VSCC, as the relevant risk of pelvic lymph node involvement was primarily found in node-positive patients with high-grade disease. More, ideally prospective data collections are necessary to validate the relation between inguinal and pelvic lymph node involvement.

© 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.Aim: This multicenter investigation was performed to evaluate the adjuvant treatment options, prognostic factors, and patterns of recurrence in patients with grade 3 endometrioid endometrial cancer (G3-EEC). Materials and methods: The medical reports of patients undergoing at least total hysterectomy and salpingo-oophorectomy for G3-EEC between 1996 and 2018 at 11 gynecological oncology centers were analyzed. Optimal surgery was defined as removal of all disease except for residual nodules with a maximum diameter ≤ 1 cm, as determined at completion of the primary operation. Adequate systematic lymphadenectomy was defined as the removal of at least 15 pelvic and at least 5 paraaortic LNs. Results: The study population consists of 465 women with G3-EEC. The 5-year disease-free survival (DFS) and overall survival (OS) rates of the entire cohort are 50.3% and 57.6%, respectively. Adequate systematic lymphadenectomy was achieved in 429 (92.2%) patients. Optimal surgery was achieved in 135 (75.0%) patients in advanced stage. Inadequate lymphadenectomy (DFS; HR 3.4, 95% CI 3.0–5.6; P = 0.016—OS; HR 3.2, 95% CI 1.6–6.5; P = 0.019) was independent prognostic factors for 5-year DFS and OS. Conclusion: Inadequate lymphadenectomy and LVSI were independent prognostic factors for worse DFS and OS in women with stage I–II G3-EEC. Adequate lymphadenectomy and optimal surgery were independent prognostic factors for better DFS and OS in women with stage III–IV G3-EEC.

The prognosis for ovarian cancer patients remains poor. A key to maximizing survival rates is early detection and treatment. This requires an accurate prediction of malignancy. Our study seeks to improve the accuracy of prediction by focusing on early subjective assessment of malignancy. We therefore investigated the assessment of patients themselves in comparison to the assessment of physicians.One thousand three hundred and thirty patients participated in a prospective and multicenter study in six hospitals in Berlin. Using univariate analysis and multivariate logistic regression models, we measured the accuracy of the early subjective assessment in comparison to the final histological outcome. Moreover, we investigated factors related to the assessment of patients and physicians.The patients' assessment of malignancy is remarkably accurate. With a positive predictive value of 58%, the majority of patients correctly assessed a pelvic mass as malignant. With more information available, physicians achieved only a slightly more accurate prediction of 63%.For the first time, our study considered subjective factors in the diagnostic process of pelvic masses. This paper demonstrates that the patients' personal assessment should be taken seriously as it can provide a significant contribution to earlier diagnosis and thus improved therapy and overall prognosis.

ObjectiveLow grade serous ovarian cancers characterize a unique clinical pattern and likely less frequent incidence of lymphatic metastasis. The expression level of Ki67 is associated with differences in prognosis and therapy outcome. However, its expression in combination with lymphovascular space invasion has not been evaluated in the prediction of lymphatic metastasis.MethodsPatients with low grade serous ovarian cancer were identified in an institutional database. Patients with primary low grade serous ovarian cancer diagnosed and/or treated at our center between September 2000 and December 2018 were identified. Receiver operator characteristics curve analysis was performed to find the cut-off values of per cent Ki67 to discriminate patients with lymph node metastasis. The association between the presence of lymphovascular space invasion and lymph node involvement was analyzed.ResultsA total of 109 patients with primary low grade serous ovarian cancer were identified in our institution's database. Of these, 72 (66.1%) patients underwent primary surgery with pelvic and para-aortic lymph node dissection. Complete data for Ki67 expression and lymphovascular space invasion were obtained for 61 (84.7%) of these patients. Among them, 37 (60.7%) patients had lymph node metastasis. The presence of lymphovascular space invasion was associated with an increased risk of lymph node metastases (odds ratio (OR)=12.78, 95% confidence interval (CI) 3.15 to 51.81; p65 years, peritoneal carcinomatosis, and ascites>500 mL, lymphovascular space invasion remained a significant risk factor for lymphatic metastases (OR=35.11, 95% CI 2.38 to 517.69; p=0.010). Ki67 ≥6% was associated with a higher risk of lymphovascular space invasion (OR=3.67, 95% CI 1.26 to 10.64; p=0.017). No significant correlation between Ki67 expression level and nodal metastases was found (OR=2.19, 95% CI 0.76 to 6.26; p=0.14). Neither presence of lymphovascular space invasion or nodal metastases was associated with a statistically poorer prognosis.ConclusionsWe showed an association between lymphovascular space invasion, Ki67 expression, and risk of lymph node metastasis in primary low grade ovarian cancer. Further prospective trials evaluating lymphovascular space invasion and Ki-67 as predictors of lymph node metastasis are needed.

Purpose The aim of this study was to investigate preoperative quality of life (QoL) as a predictive tool for severe postoperative complications (POC) in gynecological cancer surgery. Methods This is a prospective study of patients undergoing gynecologic cancer surgery at an academic center in Germany. QoL was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) and the NCCN Distress Thermometer (DT). Several geriatric assessment tools have been applied. POC were graded using Clavien–Dindo criteria. Using multivariable logistic regression models, we identified predictive clinical characteristics for postoperative complications. Results Within 30 days of surgery, 40 patients (18%) experienced grade ≥ 3b complications including 9 patients (4%) who died. The dominant complication was anastomosis insufficiency with 13 patients (5.8%). In the multivariable stepwise logistic regression through all univariate significant variables, we found that impaired physical functioning was predictive of POC, defined by an EORTC score p 20 (OR 3.08, 95% CI 1.15–8.26, p = 0.025) indicated a significant predictive value. Being overweight or obese (BMI > 25) were also identified as predictive factors (OR 5.44, 95% CI 2.04–14.49, p = 0.001) as were reduced Mini Mental State Examination (MMSE) results p = 0.02). Conclusion Preoperative QoL measurements could help to predict postoperative complications in patients with gynecological cancer. Patients with limitations of mobility, debilitating symptoms and cognitive impairment have an increased risk for developing severe POC.

Although unilateral oophorectomies are performed more often than bilateral ones in women of reproductive age, their clinical consequences have been less intensively investigated. Experimental models in animals have shown that compensatory mechanisms occur after a unilateral oophorectomy (UO). This review aims to summarize the available evidence on the biological effects of unilateral oophorectomy on women. Evaluated outcomes include age at onset of menopause, risk of cardiovascular and neurological disease, risk of mortality and fertility outcome after spontaneous conception or in vitro fertilization (IVF). Results were compared with findings reported after bilateral oophorectomy and/or ovarian excision and/or women with intact ovaries. An electronic database search was performed using PubMed and Scopus, followed by a manual search to identify controlled studies that compared women after UO with women with two intact ovaries. In particular, a systematic review of fertility outcomes after IVF was performed, and the data were summarized in a table. Women who underwent UO had a similar age at menopause and similar clinical pregnancy rate compared to women with two ovaries. However, decreased ovarian reserve affecting the quantity but not the quality of the ovarian pool after IVF was observed in the UO group. Furthermore, an increased risk of neurological disease and even an increased risk of mortality was observed in women with single ovary. These data need to be confirmed by further studies, and a plausible mechanism of action must be identified. At present, patients who undergo UO can be reassured with regard to their reproductive potential and their age at onset of menopause.Obwohl einseitige Ovarektomien häufiger als bilaterale Eierstockentfernungen bei Frauen im reproduktionsfähigen Alter durchgeführt werden, hat man den klinischen Folgen von einseitigen Ovarektomien weniger Aufmerksamkeit gewidmet. Experimentelle Tiermodelle zeigen, dass Kompensationsmechanismen nach einseitigen Ovarektomien stattfinden. Ziel dieser Übersichtsarbeit war es, die existierenden Forschungsergebnisse zu den biologischen Auswirkungen von einseitigen Ovarektomien zusammenzufassen. Zu den untersuchten Aspekten zählten Alter bei Eintritt der Wechseljahre, Risiko für Herz-Kreislauf-Erkrankungen und neurologische Erkrankungen, Mortalitätsrisiko und Fertilitätsergebnis nach spontaner Empfängnis oder In-vitro-Fertilisation (IVF). Diese Ergebnisse wurden mit den Ergebnissen nach bilateraler Ovarektomie und/oder ovarieller Exzision bzw. von Frauen mit intakten Eierstöcken verglichen. Es wurde zunächst eine elektronische Datenbanksuche mithilfe von PubMed und Scopus durchgeführt. Danach wurde eine manuelle Suche durchgeführt, um kontrollierte Studien auszumachen, die Frauen nach einseitiger Ovarektomie mit Frauen mit 2 intakten Eierstöcken verglichen. Es wurde eine systematische Überprüfung der Fertilitätsergebnisse nach IVF durchgeführt, und die Daten wurden in einer Tabelle zusammengefasst. Bei Frauen, die sich einer einseitigen Ovarektomie unterzogen hatten, waren das Alter bei Eintritt der Wechseljahre sowie die klinischen Schwangerschaftsraten ähnlich wie bei Frauen mit 2 Eierstöcken. Es wurde zwar eine verminderte ovarielle Reserve bei Frauen nach einer einseitigen Ovarektomie festgestellt; diese wirkte sich aber auf die Quantität, nicht auf die Qualität des ovariellen Pools nach IVF aus. Es wurde ferner ein erhöhtes Risiko für neurologische Erkrankungen und sogar ein erhöhtes Mortalitätsrisiko bei Frauen mit nur einem Eierstock beobachtet. Diese Daten müssen in weiteren Studien bestätigt werden, und ein plausibler Wirkungsmechanismus dafür muss noch identifiziert werden. Nach aktuellem Wissensstand können Patientinnen, die sich einer einseitigen Ovarektomie unterziehen, hinsichtlich ihres reproduktiven Potenzials und ihres Alters bei Eintritt der Wechseljahre beruhigt sein.

This is the first collaborative Enhanced Recovery After Surgery Society guideline for optimal perioperative care for vulvar and vaginal surgeries. An Embase and PubMed database search of publications was performed. Studies on each topic within the Enhanced Recovery After Surgery vulvar and vaginal outline were selected, with emphasis on meta-analyses, randomized controlled trials, and prospective cohort studies. All studies were reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation system. All recommendations on the Enhanced Recovery After Surgery topics are based on the best available evidence. The level of evidence for each item is presented.

Background/aim Angiosarcoma of primary gynecologic origin is an extremely rare and highly malignant tumor of endothelial origin with a 5-year survival rate of less than 35%. To date, only 61 cases have been described in the literature. The aim of this study was to present more cases and discuss potential therapy options. Case report The following case series presents three cases of gynecologic angiosarcomas that were under therapy at the Charite - University medicine of Berlin from June 2014 to February 2018. Results Two of the cases deal with primary angiosarcomas of the uterus whereas the third case was diagnosed after the suspicion of a recurrence of a poorly differentiated squamous cell carcinoma of the cervix uteri. In case one a 75-year old patient with initial postmenopausal bleeding and a tumor mass of the uterus is described. After surgery a hemangiosarcoma of the uterus was confirmed. After two months the patient presented with a presacral peritoneal sarcomatosis. Chemotherapy of weekly paclitaxel was administered. Case two deals with a patient presenting with abdominal pain. A uterine sarcoma with infiltration of the parametry and angiosarcomatosis peritonei was diagnosed during an emergency laparotomy because of spontaneous peritoneal bleeding. Moreover, osseous metastasis was found. The patient underwent weekly paclitaxel. Due to tumor progression, chemotherapy was changed to doxorubicin and olaratumab and radiotherapy was induced. The patient died 33 months after initial diagnosis. Case three describes a 34-year old patient with suspected local recurrence of cervical cancer with infiltration of the bladder. During TURB an angiosarcoma was found. Following laparoscopy revealed peritoneal metastasis. The patient underwent weekly paclitaxel followed by a paclitaxel and pazopanib maintainance therapy which showed a regression. Due to progression afterwards, chemotherapy was changed to gemcitabine and docetaxel and gemcitabine monotherapy. The patient died 33 months after initial diagnosis. Conclusion Even though there is no evidence on standard treatment of this extremely rare and aggressive tumor entity of the female genital tract the patients showed the longest stability of disease during chemotherapy with weekly paclitaxel.

Background Consolidation brachytherapy is a critical treatment component for cervical cancer patients undergoing primary chemoradiation. Some patients are unsuitable for brachytherapy for a variety of reasons. The use of alternatives (LINAC-based stereotactic radiosurgery or external beam boosts) compromise oncologic results in cervical cancer patients. Thus, we evaluated the value of brachytherapy-like doses prescriptions using robotic radiosurgery (CyberKnife®, CR, Acuuray, Sunnyvale, CA, USA). Methods From 06/2011 to 06/2015, 31 patients (median age 53 years; range 30–77 years) with histologically proven FIGO stages IB-IVB cervical cancer underwent primary chemoradiation. All patients were either not suitable for intracervical brachytherapy for a variety of reasons or refused the brachytherapy. To achieve an adequate dose within the tumor, a CK boost was applied after fiducial implantation. In 29 patients, a dose of either five times 6 Gy or five times 5 Gy was prescribed to the target volume. Two patients received three times 5 Gy. The target dose was prescribed to the 70% isodose. Treatment toxicity was documented once weekly regarding vaginal mucositis, bladder, and bowel irritation according to CTCAE v. 4.03. If possible 3 months after completion of treatment intracervical curettage was performed to exclude residual tumor and the patients were followed up clinically. Sparing of organs at risk (OAR) and outcome in terms of local control (LC), overall survival (OS), and progression-free survival (PFS) were assessed. Results Of the 31 patients, 30 have completed CK boost therapy. The median follow-up time was 40 months (range 5–84 months). General treatment tolerability was good. Except for 1 patient, who had diarrhea grade 3, no treatment related side effects above grade 2 were reported. Sparing of OAR was excellent. The 1‑, 3‑, and 5‑year OS rates were 89, 60, and 57% respectively across all stages. Seven patients showed progression (28%), only two of them with local relapse (8%), resulting in an LC rate of 92% after 3 and 5 years. Mean PFS was 41 months (range 2–84 months). Patients with local recurrence had PFS of 5 and 8 months. Five patients developed distant metastases. Fifteen patients (48%) underwent intracervical curettage 3 months after completion of treatment of which 14 (93%) had complete pathologic response. Conclusion Brachytherapy remains the standard of care for patients diagnosed with cervical cancer and indication for primary chemoradiation. In terms of local control, CyberKnife®-based boost concepts provide excellent local control. It can be an alternative for patients who cannot receive adequate brachytherapy. Distant relapse still remains a challenge in this context.

BackgroundThere is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer.ObjectiveTo evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial.MethodsThe Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function.ResultsOverall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4–75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (pConclusionThe majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.

IntroductionThe daily clinical routine in the operating room includes patient positioning. The number of perioperative positioning-related complications is growing, along with the legal proceedings concerning this topic, and only a few guidelines exist to provide specific recommendations. The aim of this survey was to assess perioperative positioning and associated adverse events during gynecological cancer surgery in Germany.MethodsA total of 633 gynecological departments of primary, secondary, and maximum healthcare hospitals in Germany were invited to participate in this multiple-choice online questionnaire. The survey was conducted anonymously for a period of six months. The survey was divided into five different sections: descriptive information about the respondent department, pre- and postoperative management, management of positioning in the operating room based on two fictional case examples, and quality management.ResultsThe response rate of our survey was 29.1 % (184/633). Nearly half of the departments (46.7 %) reported to have had one to five patients with positioning-related complications during the prior 12 months, and 29.1 % had experienced a legal dispute due to positioning-related complications. Departments with more than 50 gynecologic-oncological surgeries per year more often reported positioning-related complications (p=0.003). Standard operating procedures exist in almost every department for laparoscopic (97 %) and open surgery (95.1 %), respectively.DiscussionThe high number of positioning-related complications throughout all departments of different healthcare levels underlines the relevance of this issue and supports the need for a prospective European registry for further analysis. Training and education for all staff members should be routinely implemented to reduce and prevent positioning-related complications.

Zusammenfassung Fragestellung Unterscheiden sich stationär behandelte Hyperemesis gravidarum (H.g.)-Fälle in Abhängigkeit von einem Migrationshintergrund (MH)? Beeinflusst eine H.g den Geburtsausgang? Methodik Retrospektive monozentrische Datenanalyse zwischen 1997 und 2015 stationär behandelter Patientinnen mit H.g.; Erfassen von Schwangerschaftsparametern und Daten zum Klinikaufenthalt sowie zum Geburtsverlauf (Subgruppe). Ergebnisse Bei 434 von 1103 stationär behandelten Schwangeren konnte auch auf geburtshilfliche Daten zurückgegriffen werden. Der Anteil von Frauen mit MH im H.g.-Kollektiv war überproportional hoch, sie wurden früher in der Schwangerschaft wegen H.g. stationär aufgenommen, waren seltener psychosozialem Stress (laut anamnestischen Angaben) ausgesetzt. H.g.-Patientinnen insgesamt sind jünger und haben häufiger Mehrlingsschwangerschaften. Die Neugeborenen von H.g.-Patientinnen sind leichter (−70g), haben weniger kongenitale Fehlbildungen (aOR 0,32, 95%CI 0,11−0,96), müssen seltener post natum auf einer Neugeborenenstation behandelt werden (aOR 0,59, 95%CI 0,36−0,97). Schlussfolgerung Es zeigten sich keine relevanten negativen Auswirkungen einer H.g. auf den Geburtsausgang. Schwangere mit MH sind eine besondere Risikogruppe für H.g

Objective According to prevalence studies, at least 5–6 % of women in Europe experience rape in their lives. The initial treatment after a sexual assault can influence the individual healing process positively. In Germany, there are hardly any studies that investigate larger collection of cases of sexual assault treated in hospitals. However, knowledge about characteristics of cases of sexual assault is a prerequisite for the optimal processing of primary care. Study design For this study, the retrospective collection of data on cases of suspected sexual assault of patients presented for treatment at the Charite was carried out. Standardized findings sheets as part of a rape kit used in all cases were evaluated. Overall, 850 cases from the period between 01.01.2011 and 30.06.2016 were analyzed. The statistical evaluation was descriptive. Results The median age of patient was 26 years (range 16–92). Penetration (vaginal/anal/oral) occurred in 75 % of cases. The suspect was unknown to 48,4 % of those affected, 26 % came from a circle of friends or acquaintances. 15,5 % were partners or expartners. 2/3 of the sexual assaults took place in private rooms, especially in the apartments of the victims. More than 2/3 of the women had drunk alcohol in temporal proximity to the crime. Extragenital injuries were present in 61,4 % of those affected and anogenital injuries in 25,4 %. Extragenital injuries were predominantly classified as mild (92,9 % in general physical examination and 62,4 % in eyes-nose-throat-examination). 42,1 % of the assaults took place on the weekend. 74,8 % of the patients presented themselves within 24 h of the suspected offence. Conclusion To our knowledge, this is the largest analysis of cases of sexually assaulted women treated at a hospital in Germany. The results point to important components of primary care, e.g. standardized injury recording and alcohol measurement, as these can serve as evidence in subsequent court proceedings. The structures of the first care of victims after sexual assault should consider that the majority of those affected present themselves at the weekend.

BackgroundImprovement in clinical outcomes of patients with platinum-resistant disease is an unmet medical need and trials in this population are urgently needed. Checkpoint-inhibitors have already shown activity in multiple other tumor entities and ovarian cancer, especially in the combination with anti-angiogenic treatment.Primary objectiveTo test if the activity of non-platinum-based chemotherapy and bevacizumab could be improved by the addition of atezolizumab.Study hypothesisThe addition of atezolizumab to standard non-platinum combination of chemotherapy and bevacizumab improves median overall survival from 15 to 20 months.Trial designPatients are randomized to chemotherapy (paclitaxel weekly or pegylated liposomal doxorubicin) + bevacizumab + placebo vs chemotherapy + bevacizumab + atezolizumab. Stratification factors are: number of prior lines, planned type of chemotherapy, prior use of bevacizumab, and tumor programmed death-ligand 1 (PD-L1) status.Major inclusion/exclusion criteriaRecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with up to three prior therapies and a treatment-free interval after platinum of less than 6 months. Patients with three prior lines of chemotherapy are eligible irrespective of the platinum free-interval. A de novo tumor tissue sample biopsy for determination of PD-L1 status prior to randomization for stratification is mandatory. Major exclusion criteria consider bevacizumab-specific and immunotherapy-specific criteria.Primary endpointOverall survival and progression-free survival are co-primary endpoints.Sample sizeIt is planned to randomize 664 patients.Trial registrationNCT03353831.

The poly(ADP-ribose) polymerase inhibitor rucaparib is approved as monotherapy in the treatment and maintenance settings for women with relapsed ovarian cancer in the European Union and the United States. We review the safety profile of rucaparib in both settings and provide recommendations for the clinical management of the main adverse events (AEs) that may occur during rucaparib treatment. We searched PubMed and congress proceedings for safety data on oral rucaparib monotherapy (600 mg twice daily) from clinical trials involving patients with relapsed ovarian cancer. AE management guidance was developed from clinical trial protocols, rucaparib prescribing information, oncology association guidelines, and author experience. The most frequent any-grade treatment-emergent AEs (TEAEs) included gastrointestinal symptoms, asthenia/fatigue, dysgeusia, anemia/decreased hemoglobin, and increased alanine/aspartate aminotransferase. Across clinical trials, 61.8% of patients had one or more grade 3 or higher TEAEs. Clinicians should employ close follow-up for TEAEs, particularly early in treatment, and educate patients about expected TEAEs and methods for their monitoring and management (e.g., antiemetics for nausea/vomiting, transfusions for hematologic TEAEs, or dose interruptions/reductions for moderate/severe TEAEs). Overall, 16.2% of patients discontinued rucaparib due to TEAEs. Management of AEs that may occur during rucaparib treatment is crucial for patients to obtain optimal clinical benefit by remaining on therapy and to avoid their detrimental impact on quality of life.

ObjectiveObesity is associated with worse survival and an increased risk of relapse in several malignancies. The influence of obesity on vulvar cancer recurrence has not been previously described. The primary objective of this study was to evaluate the association between obesity and tumor recurrence in patients with vulvar cancer.MethodsThis is an analysis of the AGO-CaRE-1 study. Patients diagnosed with squamous cell vulvar cancer (stage IB and higher), treated in 29 cancer centers between January 1998 and December 2008, were registered in a centralized database. The cohort was divided into two gropus depending on the body mass index (BMI) (ResultsIn 849 (52.4%) of 1618 patients in the database, the BMI was documented. Patients were grouped according to their BMI (ConclusionsIn this study a BMI ≥30 kg/m² was associated with a shorter time to recurrence in patients with vulvar cancer and this was mainly attributed to a higher risk of local recurrence.

Although thrombocytosis in patients with primary ovarian cancer has been widely investigated, there are only very few data about the role of thrombocytosis in recurrent ovarian cancer. The aim of our study was to investigate the impact of pretreatment thrombocytosis prior to chemotherapy on clinical outcome in patients with recurrent platinum eligible ovarian cancer. In our retrospective analysis we included 300 patients who were treated by AGO Study Group Centers within three prospective, randomized phase-III-trials. All patients included had been treatment-free for at least 6 months after platinum-based chemotherapy. We excluded patients who underwent secondary cytoreductive surgery before randomization to the trial. Thrombocytosis was defined as a platelet count of ≥ 400⋅109/L. Pretreatment thrombocytosis was present in 37 out of 300 (12.3%) patients. Patients with thrombocytosis responded statistically significantly less to chemotherapy (overall response rate 35.3% and 41.6%, P = 0.046). The median progression-free survival (PFS) for patients with thrombocytosis was 6.36 months compared to 9.00 months for patients without thrombocytosis (hazard ratio [HR] = 1.19, 95% confidence interval [CI] = 0.84–1.69, P = 0.336). Median overall survival (OS) of patients with thrombocytosis was 16.33 months compared to 23.92 months of patients with a normal platelet count (HR = 1.46, 95% CI = 1.00–2.14, P = 0.047). The present analysis suggests that pretreatment thrombocytosis is associated with unfavorable outcome with regard to response to chemotherapy and overall survival in recurrent ovarian cancer.

Mechanisms of intrinsic resistance of serous ovarian cancers to standard treatment with carboplatin and paclitaxel are poorly understood. Seventeen primary serous ovarian cancers classified as responders or nonresponders to standard treatment were screened with DigiWest protein array analysis for 279 analytes. Histone methyl transferase EZH2, an interaction partner of ataxia telangiectasia mutated (ATM), was found as one of the most significantly represented proteins in responsive tumors. Survival analysis of 616 patients confirmed a better outcome in patients with high EZH2 expression, but a worse outcome in patients with low EZH2 and high-ATM–expressing tumors compared with patients with low EZH2 and low-ATM–expressing tumors. A proximity ligation assay further confirmed an association between ATM and EZH2 in tumors of patients with an increased disease-free survival. Knockdown of EZH2 resulted in treatment-resistant cells, but suppression of both EZH2 and ATM, or ATM alone, had no effect. DigiWest protein analysis of EZH2-knockdown cells revealed a decrease in proteins involved in mitotic processes and checkpoint regulation, suggesting that deregulated ATM may induce treatment resistance. Implications: Ovarian cancer is a malignancy with high mortality rates, with to date, no successful molecular characterization strategies. Our study uncovers in a comprehensive approach the involvement of checkpoint regulation via ATM and EZH2, potentially providing a new therapeutic perspective for further investigations.

Purpose: Predicting surgical outcome could improve individualizing treatment strategies for patients with advanced ovarian cancer. It has been suggested earlier that gene expression signatures (GES) might harbor the potential to predict surgical outcome. Experimental Design: Data derived from high-grade serous tumor tissue of FIGO stage IIIC/IV patients of AGO-OVAR11 trial were used to generate a transcriptome profiling. Previously identified molecular signatures were tested. A theoretical model was implemented to evaluate the impact of medically associated factors for residual disease (RD) on the performance of GES that predicts RD status. Results: A total of 266 patients met inclusion criteria, of those, 39.1% underwent complete resection. Previously reported GES did not predict RD in this cohort. Similarly, The Cancer Genome Atlas molecular subtypes, an independent de novo signature and the total gene expression dataset using all 21,000 genes were not able to predict RD status. Medical reasons for RD were identified as potential limiting factors that impact the ability to use GES to predict RD. In a center with high complete resection rates, a GES which would perfectly predict tumor biological RD would have a performance of only AUC 0.83, due to reasons other than tumor biology. Conclusions: Previously identified GES cannot be generalized. Medically associated factors for RD may be the main obstacle to predict surgical outcome in an all-comer population of patients with advanced ovarian cancer. If biomarkers derived from tumor tissue are used to predict outcome of patients with cancer, selection bias should be focused on to prevent overestimation of the power of such a biomarker. See related commentary by Handley and Sood, p. 9

BackgroundQuality of surgical care as a crucial component of a comprehensive multi-disciplinary management improves outcomes in patients with endometrial carcinoma, notably helping to avoid suboptimal surgical treatment. Quality indicators (QIs) enable healthcare professionals to measure their clinical management with regard to ideal standards of care.ObjectiveIn order to complete its set of QIs for the surgical management of gynecological cancers, the European Society of Gynaecological Oncology (ESGO) initiated the development of QIs for the surgical treatment of endometrial carcinoma.MethodsQIs were based on scientific evidence and/or expert consensus. The development process included a systematic literature search for the identification of potential QIs and documentation of the scientific evidence, two consensus meetings of a group of international experts, an internal validation process, and external review by a large international panel of clinicians and patient representatives. QIs were defined using a structured format comprising metrics specifications, and targets. A scoring system was then developed to ensure applicability and feasibility of a future ESGO accreditation process based on these QIs for endometrial carcinoma surgery and support any institutional or governmental quality assurance programs.ResultsTwenty-nine structural, process and outcome indicators were defined. QIs 1–5 are general indicators related to center case load, training, experience of the surgeon, structured multi-disciplinarity of the team and active participation in clinical research. QIs 6 and 7 are related to the adequate pre-operative investigations. QIs 8-22 are related to peri-operative standards of care. QI 23 is related to molecular markers for endometrial carcinoma diagnosis and as determinants for treatment decisions. QI 24 addresses the compliance of management of patients after primary surgical treatment with the standards of care. QIs 25–29 highlight the need for a systematic assessment of surgical morbidity and oncologic outcome as well as standardized and comprehensive documentation of surgical and pathological elements. Each QI was associated with a score. An assessment form including a scoring system was built as basis for ESGO accreditation of centers for endometrial cancer surgery.

Introduction/Background* Endometrial cancer (EC) patients (Pts) with advanced and recurrent disease relapse despite treatment with combination chemotherapy and have a short progression-free survival (PFS). Nintedanib (N) is a potent, orally available triple receptor tyrosine kinase inhibitor targeting VEGFR 1–3, PDGFR α/β, and FGFR 1–3. This study explored the preliminary efficacy of nintedanib in EC. Methodology The primary objective of this placebo-controlled, randomized study was to evaluate efficacy defined by median PFS of concomitant and maintenance N against placebo (P) in combination with chemotherapy. Patients with histologically confirmed stage IIIC2 or IVA & B or relapsed after adjuvant therapy for stage I-III disease; prior surgery; adjuvant chemotherapy; radiation therapy; hormonal therapy in metastatic setting; with measurable/non-measurable disease were permitted. Pts were randomized 1:1 to receive N 200mg or P, twice daily days 2–21 during chemotherapy (six cycles of Carboplatin (AUC5) and paclitaxel (175mg/m2) every 21 days) and continuously in maintenance phase. N/P was continued until disease progression, unacceptable toxicity, or withdrawal of consent. Stratification by stage of disease, prior adjuvant chemotherapy and measurable/non-measurable disease. This is an ENGOT Model A study. Clinical trial information: NCT02730416. Result(s)* 146 of 148 pts were eligible for PFS: 72N/74P; mean age 66yrs; FIGO stage III 18%, IV 42%, recurrent 40%; follow-up 30 mo. N added to chemotherapy did not improve PFS (119 events) as compared to chemotherapy plus P: median for N 8.3 vs. for P 7.2 mo; hazard ratio (HR) adjusted for stratification factors 1.03; 95% confidence interval (CI),[0.71 to 1.48]; p0.879. Median overall survival (85 events) for N 20 vs. for P 22 mo; HR: 1.10; CI: 0.72–1.69; p0.665. Treatment-emerged grade 3–4 adverse events were higher in N vs P arm: liver function tests 13%/0%; diarrhea 12%/6%; neutropenia 21%/14%; asthenia 4%/1%. Patient-reported outcomes will be reported. Conclusion* Addition of nintedanib to chemotherapy did not improve PFS nor OS. This regimen cannot be recommended to undergo further testing in a phase III trial.

Introduction/Background* Delivering bad news to patients is one of the most challenging everyday tasks in medical practice. Despite its high relevance for patients, relatives, and medical staff, there is lacking data about training, experience, expectations and preferences of physicians and medical students on breaking bad news. Methodology We therefore conducted an international survey in Germany, Switzerland and Austria using an online questionnaire among physicians and medical students. Recorded data includes demographics, physician and medical student’s clinical experience and their training and educational preferences. Result(s)* A total of 831 physicians, including 25% gynecologists, 23.1% internal specialists and 315 medical students have participated in the survey. Physicians stated that 45,2% deliver bad news several times a week and 32.6% several times a month. Difficulties controlling their emotions was declared by 37% of the participants. The median score concerning fear was 3.5 on a scale of 0 to 10; for medical students the median score was 5.2. When delivering bad news, 70.4% of the physicians are generally alone with the patient; only 57.4% encouraging patients to be accompanied by their friends or relatives. Among the physicians, only 31.2% mentioned having learned adequate communication skills. Almost all physicians stated that communication with patients has a significant impact on their employee satisfaction. Therefore, a need for systematic training and education in breaking bad news exists. The most preferred educational tools were seminars with simulation patients (53.3%/79.3%), learning from supervisors (59.7%/64.1%) and systematic supervision (48.9%/40.4%) for physicians and medical students respectively. Digital tools may help in preparing individual sessions (54.6%) and for debriefing (38.8%) in the clinical day practice. Missing awareness (52.5%), costs (35.1%) and limited time (10.3%), were the largest barriers for communication education. Conclusion* We could demonstrate the high need for more education and training in breaking bad news communication skills among physicians and medical students. Hospitals, authorities, medical schools and post-graduate training programs are strongly encouraged to fill this gap.

Introduction/Background* This survey describes the German-wide impact of the COVID-19 pandemic on provision of clinical care and recruitment in clinical trials of patients with gynecologic malignancies from a physician’s perspective. Methodology We performed an online anonymous multicentric prospective survey across clinicians in Germany. The multiple-choice questionnaire was administered at 4-6 weekly intervals from April 2020 to October 2020 for a total of four series. Result(s)* 483 questionnaires were completed. The majority of participants were gynecological oncologists (83.3%) in certified gynecologic cancer centers (61%) and breast cancer (BC) centers (80.4%). The majority stated a 50% reduction in surgical interventions for gyne-oncological cases. Cases that were prioritized for surgery across all tumors were those with early stage disease, at primary situation and with a good ECOG status. For BC, patients following neoadjuvant chemotherapy treatment and those with high-risk or locally-advanced BC were prioritized. The majority (73%) continued to conduct clinical trials throughout the pandemic. In cases were trials were discontinued, this decision was made by sponsors, and hospital officers. Other reasons for discontinuation included lack of patient-participation (due to fear of attending appointments). Almost 100% of the responders refuted any increased tendency to treat with a neoadjuvant approach (cytotoxic, hormonal, radiation) patients that would qualify for surgery under normal circumstances . This comes in direct contrast to the increased attitude to treat with neoadjuvant anticancer therapy of advanced cancers in other European countries. Only 18% of the clinicians reported feeling adequately informed about established safety pathways for COVID-19 positive patients with gynecological cancers. More than 43% of the clinicians felt that the COVID-19 pandemic will continue to impact on clinical care for up to 2 years. Conclusion* Targeted emergency algorithms for patients with gynecological cancers need to be developed to protect and preserve care and treatment options for our patients in future pandemics.