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Objective: To assess 5-year oncologic outcomes of apparent early-stage high-intermediate and high-risk endometrial cancer undergoing sentinel node mapping versus systematic lymphadenectomy., Methods: This is a multi-institutional retrospective, propensity-matched study evaluating data of high-intermediate and high-risk endometrial cancer (according to ESGO/ESTRO/ESP guidelines) undergoing sentinel node mapping versus systematic pelvic lymphadenectomy (with and without para-aortic lymphadenectomy). Survival outcomes were assessed using Kaplan-Meier and Cox proportional hazard methods., Results: Overall, the charts of 242 patients with high-intermediate and high-risk endometrial cancer were retrieved. Data on 73 (30.1%) patients undergoing hysterectomy plus sentinel node mapping were analyzed. Forty-two (57.5%) and 31 (42.5%) patients were classified in the high-intermediate and high-risk groups, respectively. Unilateral sentinel node mapping was achieved in all patients. Bilateral mapping was achieved in 67 (91.7%) patients. Three (4.1%) patients had site-specific lymphadenectomy (two pelvic areas only and one pelvic plus para-aortic area), while adjunctive nodal dissection was omitted in the hemipelvis of the other three (4.1%) patients. Sentinel nodes were detected in the para-aortic area in eight (10.9%) patients. Twenty-four (32.8%) patients were diagnosed with nodal disease. A propensity-score matching was used to compare the aforementioned group of patients undergoing sentinel node mapping with a group of patients undergoing lymphadenectomy. Seventy patient pairs were selected (70 having sentinel node mapping vs. 70 having lymphadenectomy). Patients undergoing sentinel node mapping experienced similar 5-year disease-free survival (HR: 1.233; 95%CI: 0.6217 to 2.444; p = 0.547, log-rank test) and 5-year overall survival (HR: 1.505; 95%CI: 0.6752 to 3.355; p = 0.256, log-rank test) than patients undergoing lymphadenectomy., Conclusions: Sentinel node mapping does not negatively impact 5-year outcomes of high-intermediate and high-risk endometrial cancer. Further prospective studies are warranted., 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., (© 2024 Published by Elsevier Ltd.)

Objective: To compare outcomes after hysterectomy and hysterectomy plus sentinel node mapping (SNM) in endometrial cancer (EC) patients., Materials and Methods: This is a retrospective study, collecting data of EC patients treated between 2006 and 2016 in nine referral centers., Results: The study population included 398 (69.5%) and 174 (30.5%) patients having hysterectomy and hysterectomy plus SNM. As the results of the adoption of a propensity-score matched analysis, we selected two homogeneous cohort of patients (150 having hysterectomy only vs. 150 having hysterectomy plus SNM). The SNM group had a longer operative time, but did not correlate with length of hospital stay and estimated blood loss. Overall severe complication rates were similar between groups (0.7% in the hysterectomy group vs. 1.3% in the hysterectomy plus SNM group; p = 0.561). No lymphatic-specific complication occurred. Overall, 12.6% of patients having SNM were diagnosed with disease harboring in their lymph nodes. Adjuvant therapy administration rate was similar between groups. Considering patients having SNM, 4% of patients received adjuvant therapy on the basis of nodal status alone; all the other patients received adjuvant therapy also on the basis of uterine risk factors. Five-year disease-free (p = 0.720) and overall (p = 0.632) survival was not influenced by surgical approach., Conclusions: Hysterectomy (with or without SNM) is a safe and effective method for managing EC patients. Potentially, these data support the omission of side specific lymphadenectomy in case of unsuccessful mapping. Further evidence is warranted in to confirm the role SNM in the era of molecular/genomic profiling., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Objective: Sentinel lymph node mapping (SNM) has gained popularity in managing apparent early-stage endometrial cancer (EC). Here, we evaluated the long-term survival of three different approaches of nodal assessment., Methods: This is a multi-institutional retrospective study evaluating long-term outcomes of EC patients having nodal assessment between 01/01/2006 and 12/31/2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm., Results: Overall, 940 patients meeting inclusion criteria were included in the study, of which 174 (18.5%), 187 (19.9%), and 579 (61.6%) underwent SNM, SNM followed by backup lymphadenectomy (LND) and LND alone, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients, including 125 SNM, 125 SNM/backup LND, and 250 LND. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM/backup LND and LND, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p = 0.750) and overall survival (p = 0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification based on uterine risk factors., Conclusion: Our study highlighted that SNM provides similar long-term oncologic outcomes than LND., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest. No funding sources supported this investigation., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: Coronavirus disease 2019 (COVID-19) outbreak has correlated with the disruption of screening activities and diagnostic assessments. Endometrial cancer (EC) is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms. Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of EC patients., Methods: This is a retrospective study involving 54 centers in Italy. We evaluated patterns of presentation and treatment of EC patients before (period 1: March 1, 2019 to February 29, 2020) and during (period 2: April 1, 2020 to March 31, 2021) the COVID-19 outbreak., Results: Medical records of 5,164 EC patients have been retrieved: 2,718 and 2,446 women treated in period 1 and period 2, respectively. Surgery was the mainstay of treatment in both periods (p=0.356). Nodal assessment was omitted in 689 (27.3%) and 484 (21.2%) patients treated in period 1 and 2, respectively (p<0.001). While, the prevalence of patients undergoing sentinel node mapping (with or without backup lymphadenectomy) has increased during the COVID-19 pandemic (46.7% in period 1 vs. 52.8% in period 2; p<0.001). Overall, 1,280 (50.4%) and 1,021 (44.7%) patients had no adjuvant therapy in period 1 and 2, respectively (p<0.001). Adjuvant therapy use has increased during COVID-19 pandemic (p<0.001)., Conclusion: Our data suggest that the COVID-19 pandemic had a significant impact on the characteristics and patterns of care of EC patients. These findings highlight the need to implement healthcare services during the pandemic., Competing Interests: The first author is a principal editor of the Journal of Gynecologic Oncology. No other potential conflict of interest relevant to this article was reported, (Copyright © 2022. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Objective: To investigate factors predicting the risk of developing 90-day postoperative complications and lymphatic-specific morbidity in patients undergoing surgical staging for high-risk endometrial cancer., Methods: This is a multi-institutional retrospective cohort study. Patients affected by apparent early-stage high-risk endometrial cancer (endometrioid FIGO grade 3 with deep myometrial invasion and non-endometrioid endometrial cancer) undergoing surgical staging between 2007 and 2019. Complications were graded according to the Clavien-Dindo classification system. Martin criteria were applied to improve quality of complications reporting., Results: Charts of 279 patients were evaluated. Lymphadenectomy, sentinel node mapping (SNM), and SNM followed by back-up lymphadenectomy were performed in 83 (29.7%), 50 (17.9%), and 146 (52.4%) patients, respectively. The former group of patients included 13 patients who had lymphadenectomy after the failure of the SNM technique. Thirteen (4.6%) patients developed severe postoperative events (grade 3 or worse). At multivariate analysis, body mass index (OR: 1.08 (95%CI: 1.01, 1.17)) and open abdominal surgery (OR: 2.27 (95%CI: 1.02, 5.32)) were the two independent factors predictive of surgery-related morbidity. Seven severe lymphatic complications occurred. The adoption of laparoscopic approach (p < 0.001, log-rank test) and SNM (p = 0.038, log-rank test) correlated with a lower risk of developing surgery-related events. Independently, open abdominal surgery was associated with an increased risk of developing lymphatic morbidity (OR: 37.4 (95%CI: 4.38, 319.5); p = 0.001)., Conclusion: The adoption of the laparoscopic approach and SNM technique were associated with lower 90-day complication rates than open surgery in high-risk endometrial cancer undergoing staging surgery., 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 © 2021 Elsevier B.V. All rights reserved.)

Objective: Sentinel node mapping (SLN) has replaced lymphadenectomy for staging surgery in apparent early-stage low and intermediate risk endometrial cancer (EC). Only limited data about the adoption of SNM in high risk EC is still available. Here, we evaluate the outcomes of high-risk EC undergoing SNM (with or without back-up lymphadenectomy)., Methods: This is a multi-institutional international retrospective study, evaluating data of high-risk (FIGO grade 3 endometrioid EC with myometrial invasion >50% and non-endometrioid histology) EC patients undergoing SNM followed by back-up lymphadenectomy and SNM alone., Results: Chart of consecutive 196 patients were evaluated. The study population included 83 and 113 patients with endometrioid and non-endometrioid EC, respectively. SNM alone and SNM followed by back-up lymphadenectomy were performed in 50 and 146 patients, respectively. Among patients having SNM alone, 14 (28%) were diagnosed with nodal disease. In the group of patients undergoing SNM plus back-up lymphadenectomy 34 (23.2%) were diagnosed with nodal disease via SNM. Back-up lymphadenectomy identified 2 (1%) additional patients with nodal disease (in the para-aortic area). Back-up lymphadenectomy allowed to remove adjunctive positive nodes in 16 (11%) patients. After the adoption of propensity-matched algorithm, we observed that patients undergoing SNM plus back-up lymphadenectomy experienced similar disease-free survival (p = 0.416, log-rank test) and overall survival (p = 0.940, log-rank test) than patients undergoing SLN alone., Conclusions: Although the small sample size, and the retrospective study design this study highlighted that type of nodal assessment did not impact survival outcomes in high-risk EC. Theoretically, back-up lymphadenectomy would be useful in improving the removal of positive nodes, but its therapeutic value remains controversial. Further prospective evidence is needed., Competing Interests: Declaration of Competing Interest The Authors declare no conflicts of interest. No funding sources supported this investigation., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: The serum levels of glycoprotein human epididymis protein 4 (HE4) have been widely investigated in patients with ovarian cancer as a tumor marker to differentiate benign gynecological tumors from ovarian cancers (OC). A few studies demonstrated the promising role of HE4 in endometrial cancer (EC) too. The aim of this review is to provide an outline of published studies investigating HE4 in the diagnosis of gynecologic malignancies, focusing on its role in OC and EC., Evidence Acquisition: We conducted a systematic review of literature from January 1952 to June 2018 on the role of HE4 in OC and EC focusing on the diagnostic power in terms of sensitivity and specificity., Evidence Synthesis: We identified 49 articles with an overall sample size of 12,631 patients in OC group and five studies with an overall sample size of 1221 patients in EC group. We stated that HE4 had a pooled sensitivity of 78% and specificity of 86% in the detection of borderline or malignant OC and a pooled sensitivity of 78.8% and specificity of 100% in EC diagnosis., Conclusions: This systematic review confirms the importance of HE4 in the diagnosis of epithelial ovarian cancer and its promising role in endometrial cancer (endometrioid histology).

Objective: In 2013, our group assessed a risk stratification tool of endometrial cancer (EC), called REM (Risk of Endometrial Malignancy). A well known risk factor for EC is body mass index (BMI). In fact, (BMI > 30 and <35 kg/m2) and severe obesity (BMI > 35 kg/m2) were associated with a 2.6-fold and a 4.7-fold increase in EC risk, respectively. Therefore, in the present study we aim to improve the performance of REM, including BMI and developing a new scoring system, called REM-B (Risk of Endometrial Malignancy score associated to BMI), to classify patients into high risk or low risk groups for EC., Study Design: Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account., Results: A total of 675 patients (88 with EC and 587 with benign endometrial disease) were divided in training set (TS) and verification set (VS). Age, symptom, BMI, HE4 levels and ultrasound endometrial thickness were found statistically significant and included into multivariate logistic regression model in order to determine the probability to have EC. REM-B showed an overall sensitivity of 94.7% (versus 92% of REM) and a specificity of 97.4% (versus 96% of REM)., Conclusions: Our data support the use of REM-B to triage patients into low and high risk of EC, even if an external validation of model is needed., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The risk of endometrial malignancy (REM) score is a model formulated in a previous single-center validation study, which has been shown to predict endometrial cancer in women with ultrasound endometrial abnormalities based on multiple features (clinical, ultrasound and laboratorial). The purpose of this study was to validate the performance of REM score in an external validation setting. A population-based database with patients, who underwent elective hysteroscopy for ultrasound endometrial abnormalities between 2013 and 2016 at Department of Obstetrics and Gynecology of Campus Bio-medico of Rome, was used. Starting from January 2013 to June 2016, 330 patients were enrolled for hysteroscopy. Thirty-two patients were excluded due to Asherman syndrome or cervical stenosis. Therefore, a total of 298 patients were considered for the analysis. Based on pathologic examination, 102 patients were found to have endometrial cancer, and 196 had benign endometrial disease. Using the predefined cutoff of 0.3185, identified in the previous publication, in this independent cohort of patients we correctly classified 93/102 patients with endometrial cancer and 187/196 with benign disease, reporting an overall sensitivity and specificity of 93.9 and 95.4% (PPV = 0.91, NPV = 0.95), respectively. REM score showed a high positive predictive value for endometrial cancer prediction. However, before REM score can be applied in daily clinical practice, data from randomized controlled trials are needed.

Introduction: Endometrial cancer (EC) is one of the most common gynecological cancer worldwide. To date, no good markers are routinely used in clinical practice for prognosis and monitoring. Areas covered: During the last years, an increasing interest in literature has been growing on HE4 (Human epididimis 4). Therefore, we aimed to gather all the evidence reported in literature analysing the potential prognostic value of HE4, compared to the well know tumor's features (histological type and grade, stage of disease, depth of myometrial invasion, lymphovascular space involvement and cervical involvement). Expert commentary: The analysis of data suggests that HE4 seems to have a good performance in prognosis and monitoring of the disease, helping to schedule the appropriste timing of imaging and surgery in a more individualized fashion. However, these findings surely require a validation in a larger cohorts of patients. Probably, in the next five years, prospective randomized trials will be performed to confirm the prognostic role of HE4 in EC and to find a tailored EC management strategy.

Objective: The aim of this study is to prospectively evaluate and compare the accuracy of high-frequency TVS and of two type of MRI (dynamic contrast-enhanced MRI or diffusion-weighted MRI), in association with HE4 in preoperative endometrial cancer (EC) staging., Study Design: Starting from January 2012 to February 2015, all patients with EC at prior endometrial biopsy, referred to the Division of Gynaecologic Oncology of the University Campus Bio-Medico of Rome, were prospectively included in the study. All of them underwent complete surgical staging hysterectomy and bilateral oophorectomy, pelvic and lumboaortic lymphadenectomy, according to 2011 NCCN guidelines. The day before surgery, patients underwent to transvaginal ultrasonography (TVS), HE4 serum dosage, and using a computer-based random procedure, to dynamic contrast-enhanced MRI (Group A) or to diffusion-weighted MRI (Group B), to assess myometrial invasion and cervical involvement., Results: Starting from January 2012 to February 2015, a total of 79 patients were considered for the analysis and randomly divided into Group A (n = 38) and Group B (n = 41). Regarding myometrial invasion, MRI and TVS resulted comparable in terms of preoperative detection. Concerning the cervical infiltration, the association between TVS and HE4 is characterized by a better preoperative diagnostic validity (TVS + HE4 96.3 vs. 91 % for MRI and 85 % for the TVS)., Conclusion: Our results, even the low number of enrolled patients, are promising and may lead to a greater efficiency and lower health care costs in identifying those women who require radical surgery and pelvic lymphadenectomy and should be addressed, in specialized centers.

The aim of this study was to evaluate for the first time in the literature the role of HE4, at primary diagnosis, compared to CA125 as an indicator of endometrial cancer (EC) recurrence. Our study is a retrospective analysis of 252 EC patients treated, between January 2009 and July 2013, at the Division of Gynaecologic Oncology of Campus Bio-Medico University of Rome. Thirty-seven patients experienced recurrence. Median follow-up was 38 months. HE4 and CA125 levels were analyzed at primary diagnosis, during follow-up and either after histological or radiological confirmation of recurrent disease or at last registered visit, when patients returned to our Department with no evidence of recurrent disease. A statistically significant difference was observed between HE4 values at primary diagnosis and at recurrence, respectively, comparing recurrent and non-recurrent patients (p < 0.05), while CA125 values resulted not statistically significant (p = 0.08) at each time point. Considering the poor specificity of HE4 at threshold of 70 pmol/L at primary diagnosis, in our cohort of patients, we found out that HE4 cut-off of 201.3 pmol/L is able to correctly classify patients at high or low risk of EC recurrence, with a sensitivity of 80 % and a specificity of 91 % (PPV = 90.3 % and NPV = 90.8 %). In particular, HE4 performance improves in cases of endometrioid histotype. HE4 levels at primary diagnosis correlate with an increased risk of EC recurrence, particularly in cases of endometrioid histotype, and they may help to recognize patients who may need a more intensive follow-up.

Objective: This study aimed to assess primarily the role of chemotherapy as adjuvant treatment for International Federation of Gynecology and Obstetrics (FIGO) stage IA G3, IB G2-G3, and II endometrial cancer (EC) in terms of disease-free interval and overall survival, and secondarily, the rate of local and distant recurrence., Methods: The present prospective pilot study includes 68 patients with surgical staged EC who referred between 2007 and 2011 to the Division of Gynecologic Oncology at the University Campus Bio-Medico of Rome. All enrolled patients received adjuvant chemotherapy every 3 weeks according to the scheme carboplatin, dosed at an area under the curve of 6, and paclitaxel 175 mg/mq given every 3 weeks for at least 3 cycles., Results: The median number of chemotherapy cycles was 6 (range, 3-6 cycles). Chemotherapy was well tolerated. The 3-year overall survival was 92.8% and 91.6% for stages I and II, respectively. The 3-year disease-free interval was 91.8% and 83.3% for stages I and II, respectively. Of 68 patients, 7 (10.3%) relapsed: 5 patients with a FIGO stage I and 2 patients with FIGO stage II EC., Conclusions: Platinum-based chemotherapy is feasible and safe and it could be used in adjuvant setting for early-stage ECs. Although its effectiveness is comparable to radiotherapy, chemotherapy represents an excellent treatment option due to its systemic action. Further randomized studies will be needed to confirm our promising data.

This study aims to investigate the correlation between preoperative human epididymis protein 4 (HE4) levels, endometrial cancer (EC) staging, and ideal cutoff for stage prediction. All EC patients, treated within January 2009 and February 2014 at the Division of Gynaecologic Oncology of the University Campus Bio-Medico of Rome, were considered for the study. For the first part of the study, we consider an HE4 cutoff of 70 pmol/L. Histotypes (endometrioid versus non-endometrioid), grading (G1, G2, G3), and stage were correlated with HE4 levels. In the second part of the study, the logistic regression was performed in stepwise mood to identify the ideal HE4 cutoff for stage prediction. Two hundred thirty-two patients with surgically staged EC and preoperative HE4 dosage were included in the study. We found that higher HE4 levels correlate with undifferentiated grading (p < 0.05). Moreover, we found that 42, 77, 90, 93 and 100 % of patients classified as International Federation of Gynecology and Obstetrics (FIGO) stage IA, IB, II, III, and IV, respectively, presented HE4 levels above the standard cutoff of 70 pmol/L. Based on receiver operating characteristic (ROC) curves, we found the ideal HE4 cutoff as follows: 61.3 pmol/L for FIGO stage IA (sensitivity = 82.3 % and specificity = 96 %), 89.2 pmol/L for FIGO stage IB (sensitivity = 83.3 % and specificity = 96 %), 104.3 pmol/L for FIGO stage II (sensitivity = 80.9 % and specificity = 98.6 %), 152.6 pmol/L for FIGO stage III (sensitivity = 92.5 % and specificity = 98.6 %), and 203.8 pmol/L for FIGO stage IV (sensitivity = 81.8 % and specificity = 99.3 %). Our results suggest a potential role of HE4 in EC stage prediction.

Background: Ovarian cancers have been recently categorized into types I and II according to a dualistic model of tumorigenesis. Data on the correlation between this classification and clinical outcome are still scarce and controversial., Methods: A retrospective analysis of patients with ovarian cancer treated from 1998 to 2013 and operated by the same surgeon was conducted. Patients were classified into two groups: type I (125 patients), including low-grade serous, mucinous, endometrioid, and clear cell tumors; and type II (286 patients), including high-grade serous tumors, unspecified adenocarcinomas, and undifferentiated carcinomas., Results: Type II patients had a significantly higher incidence of advanced disease than type I (88.4 vs. 65.6 %, P = 0.0001) and required more aggressive surgical procedures. Rates of optimal tumor debulking were almost similar between groups (92.6 vs. 91.7 %, type I vs. II, P = NS). After a median follow-up of 41 months, 207 patients (50.4 %) were alive and 204 (49.6 %) were dead; 79 type I patients (63.8 %) and 237 type II patients (82.7 %) experienced relapse (P = 0.02). Progression-free survival was significantly different between groups: 25 months for type I vs. 17 months for type II (P = 0.023). Overall survival was not significantly different between groups, with a median overall survival of 75 months for type I vs. 62 months for type II (P = 0.116)., Conclusions: The dualistic histotype-based classification into types I and II of ovarian cancer does not seem to correlate with prognosis. Different molecular characteristics of type I and II tumors may have therapeutic implications and should be deeply investigated.

Objectives: To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease, in terms of satisfaction about preoperative received informations, hospitalization days, postoperative pain experienced using visual analogue scale (VAS) and number of pain drugs used daily., Study Design: From January 2008 to December 2012, consecutive patients with diagnosis of endometrial cancer, referred to the Division of Gynecology of University Campus Bio-Medico of Rome, were enrolled. Eligible subjects were randomized into two groups: Group V (Verbal information ward) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W (Written Information ward) consisted of patients who had written preoperative information. All preoperative and postoperative data were recorded. Concerning satisfaction about preoperative received informations, patients were asked to complete the QLQ-C30 and the EORTC INFO25., Results: 190 patients were considered in this study. Group W (n=92) has a better info satisfaction (p=0.0008, statistically significant), a mean VAS value lower (p=0.02, statistically significant) and also a lower number of hospitalization days (p=0.0265, statistically significant) and pain medications used daily, (p=0.0120, statistically significant), comparing with group V (n=98)., Conclusions: We support the use of preoperative information leaflet to better prepare patients for a surgical procedure, showing a faster recovery, low medications use and a better quality of life outcome., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

To date, no good marker for endometrial cancer (EC) that may be routinely used in clinical practice for diagnosis, prognosis and monitoring is available; besides the use of tumour markers is not recommended by international guidelines. However, during the last years, an increasing interest in literature has been growing on human epididymis protein 4 (HE4) that demonstrated to be a useful clinical marker with high sensitivity and specificity even at early stage. However, published studies differ for some variables such as HE4 cut-off and sample size. Therefore, we assess this comprehensive review to gather all the evidence reported in literature on HE4 potential value in diagnosis, prognosis, and recurrence of EC. A systematic literature search was performed using PubMed/PubMed Central/MEDLINE predefined keywords from January 1952 to June 2013. We divided all the relevant studies into three different clinical issues: "Diagnosis", "Prognosis" and "Disease monitoring". The analysis of published data suggests that HE4 is the most accurate and sensitive EC marker identified to date. In particular, this new marker seems to have a good performance in diagnosis. The best cut-off of HE4 in diagnosis ranges between 50 and 70 pmol/L, resulting at least in 78.8 % of sensitivity and 100 % of specificity in all stages. Another important aspect to consider is HE4 capacity in predicting the stage of disease and myometrial involvement, which can help scheduling the appropriate timing of imaging and surgery in a more individualised fashion and as indicator of patients prognosis.

Purpose: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help the physician are needed to triage patients into high and low risk of endometrial cancer. The purpose of this study was to obtain a predictive model to assess the risk of endometrial malignancy (REM) in women with ultrasound endometrial abnormalities., Experimental Design: Women, between ages 45 to 80 years, diagnosed through ultrasound with endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at the Department of Gynaecologic Oncology of Campus Bio-Medico, University of Rome. Preoperative clinical, ultrasound and laboratory characteristics were taken into account. Logistic regression algorithm was used to categorize patients into low- and high-risk groups for endometrial cancer., Results: A total of 675 patients were considered for the analysis: 88 with endometrial cancer and 587 with benign endometrial disease. We divided the patients into two groups: training set (TS) and verification set (VS). Preoperative age, symptom, HE4 levels, and ultrasound endometrial thickness were found statistically significant, and were included into a multivariate logistic regression model to determine the probability to have endometrial cancer. In the TS, REM reported 93.3% sensitivity and 97.1% specificity [positive predictive value (PPV), 0.83; negative predictive value (NPV), 0.98; AUC, 0.957; 95% confidence interval (CI), 0.908-0.984]. In the VS, REM reported 89.3% sensitivity and 95.4% specificity (PPV, 0.73; NPV, 0.98; AUC, 0.919; 95% CI, 0.829-0.970)., Conclusions: Our data support the use of REM to triage patients into low- and high-risk groups for endometrial cancer, even if an external validation of the model is needed., (©2013 AACR.)

Objective: To compare the quality of life (QoL) of women affected by endometrial cancer treated with surgery with or without systematic lymphadenectomy., Study Design: Consecutive patients affected by stages I and II endometrial cancer and treated with surgery between 2008 and 2011 were selected. Eligible subjects were divided into two groups: Group A consisted of 36 patients who had hysterectomy plus bilateral salpingo-oophorectomy without lymphadenectomy; Group B consisted of 40 patients who had hysterectomy plus salpingo-oophorectomy plus pelvic and aortic lymphadenectomy. The EORTC Quality of Life Questionnaire-Cancer Module (QLQ-C30) and Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24) were administered to selected patients. All data were recorded and then analyzed using the scoring manual of the EORTC Quality of Life Group., Results: Among symptom scales, only lymphedema gave a statistically significant difference among two groups, with a score of 10.64 ± 17.43 in Group A and 21.66 ± 24.51 in Group B (p=0.0285). The p value obtained comparing the "Global Health Status" (items 29 and 30) in Group A and in Group B was not statistically significant., Conclusion: Lymphadenectomy did not influence negatively global health status, but lymphadenectomy maintained its importance in determining a patient's prognosis and in tailoring adjuvant therapies. We therefore support its practice as part of the surgical procedure in patients affected by high risk endometrial cancer., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

The aim of the study was to explore the clinical value of serum human epididymis secretory protein E4 (HE4) and CA125 in endometrial carcinoma. From January 2010 to April 2012, serum specimens were collected from consecutive cases of endometrial carcinoma and from cases of uterus benign disease (control group). The CA125 normal value is considered less than 35 U/mL. Two HE4 cutoff are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the Mann-Whitney test for the CA125 and HE4 series. The level of statistical significance is set at p < 0.05. The sensitivity of CA125 in detecting endometrial cancer is 19.8 %, whereas the sensitivity of HE4 is 59.4 and 35.6 % for 70 and 150 pmol/L cutoff, respectively. Thus the specificity of HE4 is 100 % (positive predictive value = 100 %, negative predictive value = 71.52 and 61.31 % considering the two HE4 cutoff, respectively), whereas the CA125 specificity is 62.14 % (positive predictive value = 33.9 %, negative predictive value = 44.14 %) in detection of endometrial cancer. Combining CA125 and HE4, the sensitivity to detect endometrial cancer is 60.4 and 34.6 %, at HE4 cutoff of 70 and 150 pmol/L, respectively, with a specificity of 100 %. HE4 may be a new tool for preoperative evaluation and postoperative surveillance of endometrial cancer patients, with a positive predictive value = 100 %. HE4 at cutoff of 70 pmol/L yields the best sensitivity and specificity.

Human epididymis protein 4 (HE4) was recently approved by the Food and Drug Administration to monitor recurrence or progressive disease in epithelial ovarian cancer in conjunction with CA125. This is the first prospective controlled study in literature evaluating the sensitivity and specificity of HE4 and CA125 in detecting recurrent ovarian cancer. Serum samples were obtained 24 h before surgery from 34 patients with suspicious recurrent ovarian cancer and from 34 patients with benign adnexal pathology, operated from November 2010 to November 2011 at University Campus Bio-Medico of Rome. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric t test to compare the CA125 series and the Mann-Whitney test for the HE4 series. The level of statistical significance is set at p < 0.05. The CA125 sensitivity and specificity in detecting recurrent ovarian cancer is 35.29 and 58.82 %, respectively. The HE4 sensitivity is 73.53 and 26.47 %, for 70 pmol/L and 150 pmol/L cut-off, respectively. The HE4 specificity is 100 %. Combining CA125 and HE4 at cut-off of 70 pmol/L, the sensitivity to detect recurrent ovarian cancer is 76.47 % with a specificity of 100 %. The combination of CA125 and HE4 at cut-off of 70 pmol/L improves the overall sensitivity and specificity of CA125 alone, suggesting a useful application of HE4 in strategies for surveillance of ovarian cancer recurrence.

Background: This is the first case-control study on the use of a fibrin sealant (Tisseel) on uterine suture during laparoscopic myomectomy (LM), with the primary endpoint to evaluate the intraoperative bleeding and postoperative blood loss. In addition, we evaluated the time required to achieve hemostasis using Tisseel and how much it can influence operative time., Methods: From December 2009 to January 2011, consecutive patients older than 18 years with symptomatic isolate intramural myoma with maximal diameter B6 cm and ≥ 4 cm and with a sonographically diagnosed free myometrium margin ≥ 0.5 cm were included in the study. We selected from our institute's database a group of consecutive patients with homogeneous features of the study group, who underwent laparoscopic myomectomy without Tisseel application., Results: Fifteen women with symptomatic myoma were enrolled in the study (group A). Regarding the control group (group B), we selected a homogenous group of 15 patients with the same preoperative characteristics of the study group. Mean operative time was 47.7 min and 62.1 min, for groups A and B respectively (p < 0.05). Mean time required to achieve complete haemostasis was 195.5 s in group A and 361.8 in control group B (p < 0.0001). Mean estimated blood loss was 111.3 mL and 230 mL in groups A and B, respectively (p < 0.05). Mean hemoglobin decrease was 1.36 g/dL and 2.04 g/dL in groups A and B, respectively (p < 0.05)., Conclusions: The use of Tisseel during LM may represent a valid alternative solution for obtaining hemostasis, reducing intra- and postoperative bleeding. Furthermore, it may help the surgeon to obtain a rapid healing of the injured surfaces, probably reducing the use of electrocoagulationand traumatisms.

Endometrial cancer is the most common neoplasia of the female reproductive system, with the highest incidence among uterine malignancies, and is rarely associated with pregnancy. Thirty-five cases of pregnancy-associated endometrial cancer have been reported in literature, of which ours represents the 20th case diagnosed during the first trimester. A 39-year-old woman, gravida 4, para 2, was diagnosed with a focal, well- to moderately differentiated endometrial adenocarcinoma (International Federation of Gynecology and Obstetrics stage IA and grades G1 and G2) after dilatation and curettage (D&C) for a spontaneous abortion. The patient underwent progestational therapy and follow-up hysteroscopies and D&C to preserve fertility; she is alive and well 18 months after diagnosis. Recurrence of endometrial cancer coexisting with early pregnancy has not been reported in the literature. Conservative therapy for early endometrial cancer, diagnosed at the time of pregnancy, may be an option. Routine histologic examination after D&C performed for spontaneous abortion seems advisable.

Background: Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival., Methods: From October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients' clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided., Results: The median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively)., Conclusion: Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.

Objective: To evaluate operative resectoscopy versus hysteroscopic bipolar electrode excision for the treatment of endometrial polyps., Design: Prospective, randomized study., Setting: Tertiary-care university hospital., Patient(s): One hundred consecutive patients with endometrial polyps., Intervention(s): Patients underwent diagnostic hysteroscopy, and after assignment on a random basis, they underwent polyp excision either by operative resectoscopy or by a bipolar electrode passed through the operating sheath of a small-caliber hysteroscope. MAIN OUTCOME MEASURE(S) AND RESULT(S): Operating times, difficulty of the operation, surgeon satisfaction with the procedure, intra- and postoperative complications, postoperative pain, and patient satisfaction were recorded. The two procedures did not differ in total surgery times. In subgroup analysis, the resectoscope was faster for large polyps (>2 cm) and for polyps with a fundal implant. The bipolar electric probe was faster for small polyps (<2 cm) and for polyps with a nonfundal implant., Conclusion(s): Operative resectoscopy appears to be the technique of choice for endometrial polyps >2 cm or with a fundal implant. Bipolar electrode excision appears to be preferable for smaller, nonfundal polyps.

Simple Summary: Endometrial cancer is the sixth most common cancer among women worldwide, with an increasing mortality rate. The standard treatment of patients with advanced or recurrent endometrial cancer has not changed significantly in recent decades. However, in recent years, immunotherapy has emerged as a promising strategy that harnesses the body's immune system against cancer, particularly in advanced or recurrent cases, offering patients the possibility of better results and longer survival. Our critical review analyses recent findings in the literature in this field, focusing on the role of immunotherapy in the treatment of this disease. In particular, it focuses on the importance of molecular biology and highlights how this can change the choice of treatment, providing insights for future therapeutic strategies. The Cancer Genome Atlas (TCGA) has radically changed the history of endometrial cancer by outlining a new classification, based on its molecular characteristics. In the field of oncology, we are approaching the new era of molecular biology, particularly regarding endometrial cancer, with the increasing importance of targeted therapy. This paper is a review of phase III randomized controlled trials published in English between January 2019 and December 2023, comparing drugs of interest with standard adjuvant treatment and molecular subtypes in endometrial cancer. The use of immunotherapy alone or in combination with chemotherapy as therapy in patients with recurrent or advanced primary or metastatic endometrial cancer significantly improves the prognosis of these patients. The results show greater efficacy of all proposed treatments for mismatch repair deficiency (dMMR/MSI-H) patients compared to mismatch repair proficiency (pMMR) patients. Progression-free survival (PFS) and overall survival (OS) are better in dMMR patients in all studies analysed. Immunotherapy has the potential to revolutionize the gynaecological cancer treatment landscape, offering a new pathway and new hope for endometrial cancer patients, improving their outcomes in the future. Given the exciting results obtained in dMMR/MSI-H patients, MMR status should be investigated in every patient with advanced endometrial cancer at the time of diagnosis. [ABSTRACT FROM AUTHOR]