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Competing Interests: Competing interests: None declared.

Purpose: Endometrial cancer is associated with the highest comorbid disease burden of any cancer. The aim of this trial was to assess the feasibility and safety of an allied health intervention during adjuvant treatment., Methods: A mixed-methods pilot randomized (2:1) controlled trial with concealed allocation and assessor-blinding. Eligibility criteria: adjuvant endometrial cancer treatment scheduled, disease stage I-IIIC1, ECOG 0-2 and able to perform unsupervised physical activity (PA). Participants received usual care and 8 sessions of weekly, individualized, lifestyle education (diet and PA) with behavior change and social support (intervention group), delivered predominantly by telehealth, or usual care alone. Feasibility outcomes: recruitment and consent rates, decline reasons, program acceptability, intervention adherence and retention., Results: 22/44 eligible patients (50%, 95%CI: 36%, 64%) were recruited over 10 months (14 intervention, 8 usual care). The recruitment rate was 2.2 patients/month (95%CI: 1.4, 3.3). Patients who declined had too much going on (7/22, 32%) or were not interested (6/22, 27%). Mean (SD) age and BMI were 63.2 years (6.8) and 31.9 kg/m 2 (6.7). A majority were FIGO stage I (15/22, 68%) and received vaginal brachytherapy (14/22, 64%). Adherence was high, 11/14 (79%, 95%CI: 52%, 92%) participants attended >70% of scheduled sessions. Retention was 100% (95%CI: 85%, 100%) at 9 weeks, however completion of objective measures was impacted by COVID-19 restrictions. Telehealth and online questionnaires enabled participation. No serious adverse events occurred., Conclusion: The intervention was acceptable to participants with high levels of adherence and retention. Trial findings will be used to design a future RCT., Trial Registration: The trial was registered on www.anzctr.org.au (ACTRN12619000631101) 29/04/2019.

Introduction: Sentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance., Methods: A Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability., Results: Seventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88)., Conclusion: Specific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care., Competing Interests: Competing interests: AO reports grants and personal fees from Surgical Performance PTY LTD, grants from Medtronic, outside the submitted work; NRA-R reports grants from Stryker/Novadaq, outside the submitted work; MF reports grants from Astra Zeneca, grants from Tesaro/GSK, grants and personal fees from Stryker, grants from Biom’Up, outside the submitted work; ML reports Ad hoc consulting from Intuitive Surgical, serves on advisory board for Ethicon, partial grant support from NIH/NCI Memorial Sloan Kettering Cancer Center Support, outside the submitted work; TEI reports personal fees from Medtronic, personal fees from Intuitive Surgical, outside the submitted work; RK reports personal fees from Intuitive Surgical Inc., personal fees from Medtronic, personal fees from Medicaroid, outside the submitted work, and President of SERGS and Council Member of IGCS; HF reports personal fees from Intuitive Surgical Inc, outside the submitted work; JP reports personal fees from Intuitive Surgical Inc., outside the submitted work; AA reports grants and a site PI, speaker fees and serves on advisory board for Astrazeneca, serves on the advisory board for GSK, grants and grats and site Co-PI and speaker fees from Merck, speaker fees from Sanofi, grants from Pfizer, grants from Clovis, grants from CancerCare Manitoba Foundation, grants from Canadian Clinical Trials group, outside the submitted work., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Intrauterine levonorgestrel (LNG-IUD) is used to treat patients with endometrial adenocarcinoma (EAC) and endometrial hyperplasia with atypia (EHA) but limited evidence is available on its effectiveness. The study determined the extent to which LNG-IUD with or without metformin (M) or weight loss (WL) achieves a pathological complete response (pCR) in patients with EAC or EHA., Patients and Methods: This phase II randomized controlled clinical trial enrolled patients with histologically confirmed, clinically stage 1 FIGO grade 1 EAC or EHA; a body mass index > 30 kg/m2; a depth of myometrial invasion of less than 50% on MRI; a serum CA125 ≤ 30 U/mL. All patients received LNG-IUD and were randomized to observation (OBS), M (500 mg orally twice daily), or WL (pooled analysis). The primary outcome measure was the proportion of patients developing a pCR (defined as absence of any evidence of EAC or EHA) after 6 months., Results: From December 2012 to October 2019, 165 patients were enrolled and 154 completed the 6-months follow up. Women had a mean age of 53 years, and a mean BMI of 48 kg/m 2 . Ninety-six patients were diagnosed with EAC (58%) and 69 patients with EHA (42%). Thirty-five participants were randomized to OBS, 36 to WL and 47 to M (10 patients were withdrawn). After 6 months the rate of pCR was 61% (95% CI 42% to 77%) for OBS, 67% (95% CI 48% to 82%) for WL and 57% (95% CI 41% to 72%) for M. Across the three treatment groups, the pCR was 82% and 43% for EHA and EAC, respectively., Conclusion: Complete response rates at 6 months were encouraging for patients with EAC and EHA across the three groups., Trial Registration: U.S. National Library of Medicine, NCT01686126., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Human epididymis protein 4 (HE4) has shown promising utility as a prognostic biomarker in endometrial cancer. Increased serum HE4 levels may be associated with deeper myometrial invasion, extrauterine disease and poorer prognosis., Aim: To evaluate the use of serum HE4 level, compared to and alongside other investigations, to accurately guide management in apparent early-stage endometrial cancer., Materials and Methods: This is a single-site prospective study of 100 patients with histologically confirmed endometrial cancer. All patients underwent preoperative measurements of HE4 and CA125 levels and a preoperative magnetic resonance imaging (MRI) to assess the depth of invasion, nodal status and tumour size. Correlation was sought between serum HE4 level, CA125 level, MRI findings and intra-operative frozen section with tumour type, grade and stage., Results: While both median HE4 and CA125 levels were higher with worsening clinicopathological features, serum HE4 level showed a more consistent association with high-risk features. Patients with a low-grade biopsy preoperatively and a low HE4 level (<70 pmol/L) demonstrated an 86.8% likelihood of having low-risk disease on final histopathology. In comparison, preoperative MRI or intraoperative frozen section alongside a low-grade biopsy demonstrated a similar likelihood of 86.2 and 87.7%, respectively., Conclusions: When used in conjunction with an initial low-grade endometrial biopsy, serum HE4 level demonstrated a similar likelihood to both preoperative MRI and intraoperative frozen section in identifying low-risk disease on final histopathology. As a triaging tool this may be significant given that a preoperative, serum-based assay would likely be the least invasive, least resource-intensive and most cost-effective approach., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Endometrial cancer is the most common gynecologic cancer in women today. It is surgically staged, and while surgery is the primary treatment modality, the identification of disease extent-in particular extrauterine spread-prior to surgery is important to optimize treatment decision making. Ultrasound and MRI are useful for evaluating the extent of local disease, while CT and PET are used for detecting lymph node or distant metastases. Diffusion-weighted MRI has also been used for detecting small metastatic deposits in lymph nodes and omentum. Extrauterine soft tissue involvement can be detected by ultrasound, CT, MRI, and PET. Recently, intraoperative visualization techniques, such as sentinel lymph node mapping, are increasingly used to avoid extensive surgical staging without compromising treatment. Imaging is also used for planning adjuvant treatment and detection of postoperative residual disease in high-risk patients, monitoring and detecting recurrent disease, and in post-treatment surveillance of asymptomatic patients with high risk of relapse., (© 2018 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Background: Endometrial cancer is the most common invasive gynaecological cancer in Australia. Despite the fact that review after treatment of early endometrial cancer has not been shown to detect recurrent disease, practice at several hospitals brings women back for specialist hospital review for 5 years after definitive cancer surgery., Aim: Implement an improved model of follow-up care following hospital treatment for early endometrial cancer., Evaluation Methods: Quantitative and qualitative., Results: Seventy-three of the eligible 81 women undertook the model of care. All general practitioners (GPs) agreed to follow-up care. Thirty-one women (42%) and 37 GPs (51%) returned surveys. All women found the nurse consultation very useful or useful with 77% reporting making lifestyle changes and 87% found the GP consultation very useful or useful with 72% reporting making lifestyle changes. Eighty-nine percent of GPs found the care plan useful, 94% set up patient recall systems, 79% used the care plan to develop their own care plan, 100% felt confident in providing follow-up care with 91% reporting the care plan and hospital processes improved their confidence. Comparison with the pre-cohort women showed: higher rates of communication at various care points to GPs (from P < 0.001); more referrals (P < 0.001); and a projected decrease of nine hospital doctor appointments per patient., Discussion: With an increasing number of people surviving cancer, in order to address holistic health needs and maintain tertiary service capacity, general practice will be required to provide more follow-up care. Our model demonstrates an acceptable and quality mechanism for this to occur., (© 2017 Commonwealth of Australia. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2017 Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Objective: Uterine papillary serous carcinoma (UPSC) is a rare variant of endometrial carcinoma responsible for up to 40% of endometrial cancer deaths. Controversy remains regarding optimal adjuvant therapy for UPSC, with lack of randomized trials to date. The objective of this retrospective study was to evaluate clinicopathological factors and determine event-free survival and overall survival (OS) in patients with UPSC managed within a single institution., Materials and Methods: Medical and pathological records between 1987 and 2004 were reviewed at the Royal Women's Hospital, Melbourne, Australia. Cox regression analysis was used to analyze effects of clinical and histopathological variables on patient survival and survival times following adjuvant therapy. Event-free survival and OS were analyzed using the Kaplan-Meier survival curve., Results: Sixty-two patients were included; 96.8% were managed surgically and 56.5% were completely surgically staged. Myoinvasion was present in 72.6% (n = 45) of the patients.In patients with stage I disease, recurrence rate was 41.4% with a 5-year OS of 46%. In stage II, recurrence rate was 20% with a 5-year OS of 67%. In stage III, recurrence rate was 58.8% with a 5-year OS of 34%. In stage IV, recurrence rate was 71.4% with a 5-year OS of 29%.There was no significant difference in survival based on the presence of positive peritoneal cytology, positive lymphovascular space invasion or positive lymph nodes at diagnosis, and no significant difference in survival based on the type of adjuvant therapy administered. Depth of myometrial invasion was a significant determinant of poor prognosis (P = 0.027)., Conclusions: Uterine papillary serous carcinoma is an aggressive variant of endometrial cancer associated with a high proportion of advanced-stage disease at diagnosis, high recurrence rates, and low OS. In our patients, prognosis was determined by myometrial invasion and International Federation of Gynecology and Obstetrics stage at diagnosis. Randomized trials in this area are required to clarify optimal adjuvant therapy for patients with UPSC.