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Background Radiographic triage measures in patients with new advanced ovarian cancer have yielded inconsistent results. Objective To determine the correlation between surgeon radiology assessment and laparoscopic scoring by disease sites in patients with newly diagnosed advanced stage ovarian cancer. Methods Fourteen gynecologic oncology surgeons from a single institution performed a blinded review of preoperative contrast- enhanced CT imaging from patients with advanced stage ovarian cancer. Each of the patients had also undergone laparoscopic scoring assessment, between April 2013 and December 2017, to determine primary resectability using the validated Fagotti scoring method, and assigned a predictive index value score. Surgeons were asked to provide expected predictive index value scores based on their blinded review of the antecedent CT imaging. Linear mixed models were conducted to calculate the correlation between radiologic and laparoscopic score for surgeons individually, and as a group. Once the model was fit, the inter- class correlation and 95% CI were calculated. Results Radiology review was performed on 20 patients with advanced stage ovarian cancer who underwent laparoscopic scoring assessment. Surgeon faculty rank included assistant professor (n=5), associate professor (p=4), and professor (n=5). The kappa inter- rater agreement was -0.017 (95% CI -0.023 to -0.005), indicating low inter- rater agreement between radiology review and actual laparoscopic score. The inter- class correlation in this model was 0.06 (0.02-0.21), indicating that surgeons do not score the same across all the images. When using a clinical cut- off point for the predictive index value of 8, the probability of agreement between radiology and actual laparoscopic score was 0.56 (95% CI 0.49 to 0.73). Examination of disease site sub- scales showed that the probability of agreement was as follows: peritoneum 0.57 (95% CI 0.51 to 0.62), diaphragm 0.54 (95% CI 0.48 to 0.60), mesentery 0.51 (95% CI 0.45 to 0.57), omentum 0.61 (95% CI 0.55 to 0.67), bowel 0.54 (95% CI 0.44 to 0.64), stomach 0.71 (95% CI 0.65 to 0.76), and liver 0.36 (95% CI 0.31 to 0.42). The number of laparoscopic scoring cases, tumor reductive surgery cases, or faculty rank was not significantly associated with overall or sub- scale agreement. Conclusions Surgeon radiology review did not correlate highly with actual laparoscopic scoring assessment findings in patients with advanced stage ovarian cancer. Our study highlights the limited accuracy of surgeon radiographic assessment to determine resectability. [ABSTRACT FROM AUTHOR]

Background In the primary treatment of apparent uterine-confined endometrial carcinoma, pelvic ± paraaortic lymphadenectomy has been considered the standard of care. Although some retrospective data suggest that the sentinel lymph node algorithm without complete lymphadenectomy can be used without jeopardizing oncologic outcome, prospective data are lacking. Primary Objectives To assess the 36 month incidence of pelvic/non-vaginal recurrence in women with pathologically confirmed stage I intermediate-risk endometrioid endometrial carcinoma who have bilateral negative pelvic sentinel lymph nodes. Study Hypothesis We hypothesize that patients with stage I, intermediate-risk endometrioid endometrial carcinoma who have bilateral negative pelvic sentinel lymph nodes will demonstrate a pelvic/non-vaginal recurrence rate comparable to historical estimate of stage I, intermediate-risk endometrioid endometrial carcinoma patients (estimated 2.5%). Trial Design This prospective multicenter single-arm observational study will follow women with stage I, intermediate risk endometrioid endometrial adenocarcinoma who have undergone successful hysterectomy, bilateral salpingo-oophorectomy, and bilateral sentinel lymph node biopsies, for recurrence. All patients will undergo lymphatic mapping using indocynanine green and will either receive no adjuvant treatment or vaginal brachytherapy only. Patients will be followed for 36 months. Major Inclusion/Exclusion Criteria Patients will be enrolled in the study cohort if all the following criteria are met: (i) at time of surgery: hysterectomy with bilateral adnexectomy, and successful bilateral pelvic sentinel lymph node mapping; (ii) on final pathology: pathologic stage I, intermediate-risk endometrioid endometrial carcinoma (grade 1 or grade 2 with ≥50% myometrial invasion, or grade 3 with <50% myometrial invasion), negative pelvic peritoneal cytology, and bilateral sentinel lymph nodes negative for malignancy; (iii) recommended adjuvant treatment: vaginal brachytherapy or no adjuvant treatment. Primary Endpoint Incidence of pelvic/non-vaginal recurrence at 36 months. Sample Size 182 patients for study cohort Estimated Dates for Completing Accrual and Presenting Results Accrual will be completed in 2023 with results reported in 2026. [ABSTRACT FROM AUTHOR]

Introduction The purpose of this study was to compare operative times, surgical outcomes, resource utilization, and hospital charges before and after the implementation of a sentinel lymph node (SLN) mapping algorithm in endometrial cancer. Methods All patients with clinical stage I endometrial cancer were identified pre- (2012) and post- (2017) implementation of the SLN algorithm. Clinical data were summarized and compared between groups. Total hospital charges incurred on the day of surgery were extracted from the hospital financial system for each patient and all charges were adjusted to 2017 US dollars. Results A total of 203 patients were included: 71 patients in 2012 and 130 patients in 2017. There was no difference in median age, body mass index, or stage. In 2012, 35/71 patients (49.3%) underwent a lymphadenectomy. In 2017, SLN mapping was attempted in 120/130 patients (92.3%) and at least one SLN was identified in 110/120 (91.7%). Median estimated blood loss was similar between groups (100 mL vs 75 mL, p=0.081). There was a significant decrease in both median operative time (210 vs 171 min, p=0.007) and utilization of intraoperative frozen section (63.4% vs 14.6%, p<0.0001). No significant differences were noted in intraoperative (p=1.00) or 30 day postoperative complication rates (p=0.30). The median total hospital charges decreased by 2.73% in 2017 as compared with 2012 (p=0.96). Discussion Implementation of an SLN mapping algorithm for high- and low-risk endometrial cancer resulted in a decrease in both operative time and intraoperative frozen section utilization with no change in surgical morbidity. While hospital charges did not significantly change, further studies are warranted to assess the true cost of SLN mapping. [ABSTRACT FROM AUTHOR]

Sentinel lymph node biopsy has proven safe and feasible in a number of gynecologic cancers such as vulvar cancer, cervical cancer, and endometrial cancer. The proposed aim of lymphatic mapping and sentinel node identification is to decrease the associated morbidity of a complete lymphadenectomy, particularly the rate of lymphedema, while also increasing the detection of small tumor deposits in the node. Different tracers have been shown to be useful, including technetium-99 and blue dye, with a detection reported in 66% to 86%. Recently, there has been increasing interest in the use of fluorescent dies such as indocyanine green (ICG). In this report we provide a review of the existing literature regarding the use of ICG in cervical or endometrial cancer with the goal to provide details on its utility and compare it with other tracers. [ABSTRACT FROM AUTHOR]

To describe the rate of port-site metastasis in patients who underwent robotic surgery for suspected gynecological malignancy.Using a prospective database, we identified all patients who underwent robotic surgery performed by the Gynecologic Oncology service at 1 institution between December 2006 and March 2010. Records of patients with confirmed malignancy were reviewed for clinicopathological data and information about port-site metastasis.One hundred eighty-one patients met the inclusion criteria. The median age was 55.4 years (range, 19-82 years), and the median body mass index was 29.6 kg/m2 (range, 17.9-70.7 kg/m2). Port-site metastases were detected in 2 patients (1.1%) at 3 weeks (patient 1) and 11 months (patient 2) after surgery. Patient 1 underwent surgery for an adnexal mass, and pathological examination revealed gallbladder adenocarcinoma metastatic to the ovary. She had a recurrence in the right lateral abdominal wall robotic trocar site with concurrent metastases in the gallbladder fossa and liver. Patient 2 was diagnosed with adenocarcinoma of unclear (cervical vs endometrial) origin. Imaging showed metastases in pelvic and para-aortic lymph nodes. She underwent laparoscopy and was found intraoperatively to have gross disease on the right ovary. The patient underwent right salpingo-oophorectomy and chemoradiation. She had residual disease in the cervix and subsequently underwent robotic hysterectomy and left salpingo-oophorectomy. Pathological examination revealed endometrial cancer. She had a recurrence at the transumbilical trocar site concurrent with retroperitoneal lymphadenopathy and carcinomatosis. There were no cases of isolated port-site metastasis.The rate of port-site metastasis after robotic surgery in women with gynecological cancer is low and similar to the rate for laparoscopic procedures. [ABSTRACT FROM AUTHOR]

Abstract: Study Objective: The purpose of our study was to report on our case series of 7 patients with gynecologic cancer who underwent laparoscopic colostomy for elective fecal diversion. Our aim was to retrospectively estimate feasibility, safety, and efficacy of the laparoscopic approach in the setting of gynecologic malignancy, given the high incidence of earlier abdominal surgery and pelvic radiation treatment in this select population. Design: Retrospective chart review (Canadian Task Force classification I). Setting: University of Texas, M.D. Anderson Cancer Center. Patients: All patients with a history of gynecologic cancers who underwent laparoscopic colostomy during the study period. Interventions: We retrospectively reviewed all patients who underwent elective laparoscopic diverting colostomy in our department of gynecologic oncology. Surgical indications, medical history, operative and stomal complications, estimated blood loss, return of bowel function, and length of hospital stay were collected. Measurements and Main Results: Seven patients underwent laparoscopic colostomy during the study period. Six of these patients underwent an end descending colostomy, and 1 patient underwent a loop colostomy. Indications included rectovaginal fistula (n = 5), colonic/pelvic fistula (n = 1), or large bowel obstruction (n = 1). No intraoperative or postoperative complications occurred, nor did any conversions to laparotomy. The median blood loss was 50 mL (range 10–75). Median operative time was 102 minutes (range 69–159). Six (86%) patients had a history of pelvic radiation. In addition, 3 (43%) patients had a history of laparotomy. The median patient weight was 59.8 kg (range 47.1–82.2). The median time to tolerance of a regular diet was 2 days (range 1–3) and the median length of hospital stay was 3 days (range 2–4). No immediate or delayed stomal complications were noted with a median follow-up of 6 months (range 1–15). Conclusion: Laparoscopic colostomy in advanced gynecologic cancer may be a safe and feasible technique with minimal morbidity, rapid return of bowel function, and short hospital stay. [Copyright &y& Elsevier]

Abstract: Study Objective: Cervical cancer is a significant health problem in countries of the developing world. Although case series suggest advantages of total laparoscopic radical hysterectomy (TLRH) compared with total abdominal radical hysterectomy (TARH), no randomized controlled trial is currently available to establish TLRH as the new standard treatment. In this study, TLRH or total robotic radical hysterectomy (TRRH) will be performed without a vaginally assisted portion of the procedure. Design: A biphasic randomized controlled trial was designed to test feasibility of recruitment and equivalence in regard to disease-free survival (Canadian Task Force classification I). Setting: Tertiary referral hospital. Patients: Patients with histologically confirmed invasive squamous cell carcinoma or adenocarcinoma of the cervix, stage IA1 (with lymphovascular space invasion), IA2, and IB1 are eligible. Interventions: During the first phase, 100 patients will be randomized (1:1) to receive either TLRH/TRRH or TARH, with the primary end point being the rate of enrollment. During the second phase, recruitment will be extended by another 640 patients in a 1:1 TLRH/TRRH:TARH allocation, to determine equivalence with respect to disease-free survival with 80% power and α=0.05. Measurements and Main Results: Equivalence will be assumed if the difference in disease-free survival does not exceed 7% at 4 years. Secondary outcomes include treatment-related morbidity, costs and cost effectiveness, patterns of recurrence, quality of life, pelvic floor function, feasibility of intraoperative sentinel node sampling, and overall survival. All data from this multicenter study will be entered using online electronic case report forms, allowing real-time assessment of data completeness and patient follow-up. Conclusion: This prospective trial aims to show the equivalence of a TLRH/TRRH versus TARH approach for patients with early stage cervical cancer following a 2-phase protocol. This trial was developed and designed with the input and approval of the members of the Gynecologic Oncology Committee from the American Association of Gynecologic Laparoscopists. [Copyright &y& Elsevier]

Cervical cancer continues to be a major worldwide health concern, particularly in developing countries. In the past few decades, great strides have been made in understanding the molecular basis of the development of this disease. Human papillomavirus (HPV) has become recognized as the major factor in the genetic abnormalities associated with both pre-invasive and invasive cervical cancer. As a result, multiple therapies for the prevention and treatment of cervical cancer have been developed to target HPV. [Copyright &y& Elsevier]

Objective: A sentinel lymph node biopsy is widely accepted as the standard of care for surgical staging in low-grade endometrial cancer, but its value in high-grade endometrial cancer remains controversial. The aim of this systematic review and meta-analysis was to evaluate the performance characteristics of sentinel lymph node biopsy in patients with endometrial cancer with high-grade histology (registered in the International Prospective Register of Systematic Reviews with identifying number CRD42020160280).Data Sources: We systematically searched the MEDLINE, Epub Ahead of Print, MEDLINE In-Process & Other Non-Indexed Citations, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Embase databases all through the OvidSP platform. The search was performed between January 1, 2000, and January 26, 2021. ClinicalTrials.gov was searched to identify ongoing registered clinical trials.Study Eligibility Criteria: We included prospective cohort studies in which sentinel lymph node biopsy were evaluated in clinical stage I patients with high-grade endometrial cancer (grade 3 endometrioid, serous, clear cell, carcinosarcoma, mixed, undifferentiated or dedifferentiated, and high-grade not otherwise specified) with a cervical injection of indocyanine green for sentinel lymph node detection and at least a bilateral pelvic lymphadenectomy as a reference standard. If the data were not reported specifically for patients with high-grade histology, the authors were contacted for aggregate data.Methods: We pooled the detection rates and measures of diagnostic accuracy using a generalized linear mixed-effects model with a logit and assessed the risk of bias using the Quality Assessment of Diagnostic Accuracy Studies 2 tool.Results: We identified 16 eligible studies of which the authors for 9 of the studies provided data on 429 patients with high-grade endometrial cancer specifically. The study-level median age was 66 years (range, 44-82.5 years) and the study-level median body mass index was 28.6 kg/m2 (range, 19.4-43.7 kg/m2). The pooled detection rates were 91% per patient (95% confidence interval, 85%-95%; I2=59%) and 64% bilaterally (95% confidence interval, 53%-73%; I2=69%). The overall node positivity rate was 26% (95% confidence interval, 19%-34%; I2=44%). Of the 87 patients with positive node results, a sentinel lymph node biopsy correctly identified 80, yielding a pooled sensitivity of 92% per patient (95% confidence interval, 84%-96%; I2=0%), a false negative rate of 8% (95% confidence interval, 4%-16%; I2=0%), and a negative predictive value of 97% (95% confidence interval, 95%-99%; I2=0%).Conclusion: Sentinel lymph node biopsy accurately detect lymph node metastases in patients with high-grade endometrial cancer with a false negative rate comparable with that observed in low-grade endometrial cancer, melanoma, vulvar cancer, and breast cancer. These findings suggest that sentinel lymph node biopsy can replace complete lymphadenectomies as the standard of care for surgical staging in patients with high-grade endometrial cancer. [ABSTRACT FROM AUTHOR]

Background: Obesity is a well-known risk factor for endometrial cancer, but the mechanisms of obesity-related carcinogenesis are not well defined, particularly for premenopausal women. With the continuing obesity epidemic, increases in the incidence of endometrial cancer and a younger age of diagnosis are often attributed to a hyperestrogenic state created by hormone production in adipose tissue, but significant knowledge gaps remain. The balance of estrogen-responsive signals has not been defined in the endometrium of premenopausal women with obesity, where obesity may not create hyperestrogenism in the context of ovaries being the primary source of estrogen production. Obesity is associated with a state of low-grade, chronic inflammation that can promote tumorigenesis, and it is also known that hormonal changes alter the immune microenvironment of the endometrium. However, limited research has been conducted on endometrial immune-response changes in women who have an increased risk for cancer due to obesity.Objective: Endometrial estrogen-regulated biomarkers, previously shown to be dysregulated in endometrial cancer, were evaluated in a cohort of premenopausal women to determine if obesity is associated with differences in the biomarker expression levels, which might reflect an altered risk of developing cancer. The expression of a multiplexed panel of immune-related genes was also evaluated for expression differences related to obesity.Study Design: Premenopausal women with a body mass index of ≥30 kg/m2 (n=97) or a body mass index of ≤25 kg/m2 (n=33) were prospectively enrolled in this cross-sectional study, which included the assessment of serum metabolic markers and a timed endometrial biopsy for pathologic evaluation, hormone-regulated biomarker analysis, and immune response gene expression analysis. Medical and gynecologic histories were obtained. Endometrial gene expression markers were also compared across the body mass index groups in a previous cohort of premenopausal women with an inherited cancer risk (Lynch syndrome).Results: In addition to known systemic metabolic differences, histologically normal endometria from women with obesity showed a decrease in gene expression of progesterone receptor (P=.0027) and the estrogen-induced genes retinaldehyde dehydrogenase 2 (P=.008), insulin-like growth factor 1 (P=.016), and survivin (P=.042) when compared with women without obesity. The endometrial biomarkers insulin-like growth factor 1, survivin, and progesterone receptor remained statistically significant in multivariate linear regression models. In contrast, women with obesity and Lynch syndrome had an increased expression of insulin-like growth factor 1 (P=.017). There were no differences in endometrial proliferation, and limited endometrial immune differences were observed.Conclusion: When comparing premenopausal women with and without obesity in the absence of endometrial pathology or an inherited cancer risk, the expression of the endometrial biomarkers does not reflect a local hyperestrogenic environment, but it instead reflects a decreased cancer risk profile that may be indicative of a compensated state. In describing premenopausal endometrial cancer risk, it may be insufficient to attribute a high-risk state to obesity alone; further studies are warranted to evaluate individualized biomarker profiles for differences in the hormone-responsive signals or immune response. In patients with Lynch syndrome, the endometrial biomarker profile suggests that obesity further increases the risk of developing cancer. [ABSTRACT FROM AUTHOR]

Background: The incidence of complex atypical hyperplasia and early-stage endometrioid endometrial cancer is increasing, in part owing to the epidemic of obesity, which is a risk factor tightly linked to the development of endometrial hyperplasia and cancer. The standard upfront treatment for complex atypical hyperplasia and early-stage endometrial cancer is hysterectomy. However, nonsurgical treatment of early-stage endometrial neoplasia may be necessary owing to medical comorbidities precluding surgery or desired future fertility.Objective: This study aimed to evaluate the efficacy of the levonorgestrel intrauterine device to treat complex atypical hyperplasia and grade 1 endometrioid endometrial carcinoma.Study Design: A single-institution, single-arm, phase II study of the levonorgestrel intrauterine device (52 mg levonorgestrel, Mirena) was conducted in patients with complex atypical hyperplasia or grade 1 endometrioid endometrial cancer. The primary endpoint was pathologic response rate at 12 months, including complete or partial response. Quality of life and toxicity were assessed. Molecular analyses for proliferation markers, hormone-regulated genes, and wingless-related integration site pathway activation were performed at baseline and 3 months.Results: A total of 57 patients were treated (21 endometrial cancer, 36 complex atypical hyperplasia). The median age was 48.0 years, and the median body mass index was 45.5 kg/m2. Of the 47 evaluable patients, 12-month response rate was 83% (90% credible interval, 72.7-90.3)-37 were complete responders (8 endometrial cancer; 29 complex atypical hyperplasia), 2 were partial responders (2 endometrial cancer), 3 had stable disease (2 endometrial cancer; 1 complex atypical hyperplasia), and 5 had progressive disease (3 endometrial cancer; 2 complex atypical hyperplasia). After stratification for histology, the response rate was 90.6% for complex atypical hyperplasia and 66.7% for grade 1 endometrioid endometrial cancer. Notably, 4 patients (9.5%) experienced relapse after the initial response. Adverse events were mild, primarily irregular bleeding and cramping. Quality of life was not negatively affected. At 3 months, exogenous progesterone effect was present in 96.9% of responders (31 of 32) vs 25% of nonresponders (2 of 8) (P=.001). Nonresponders had higher baseline proliferation (Ki67) and lower dickkopf homolog 3 gene expression than responders (P=.023 and P=.030). Nonresponders had significantly different changes in secreted frizzled-related protein 1, frizzled class receptor 8, and retinaldehyde dehydrogenase 2 compared with responders.Conclusion: The levonorgestrel intrauterine device has a substantial activity in complex atypical hyperplasia and grade 1 endometrioid endometrial cancer, with a modest proportion demonstrating upfront progesterone resistance. Potential biomarkers were identified that may correlate with resistance to therapy; further exploration is warranted. [ABSTRACT FROM AUTHOR]

We evaluated the effects of an oral mTOR inhibitor in reducing endometrial hyperplasia in an animal model. [ABSTRACT FROM PUBLISHER]

Abstract: Purpose: The paraortic nodes are a common site of recurrence of endometrial cancer, especially among patients previously treated with pelvic radiation. Intensity modulated radiation therapy (IMRT) can be used to deliver a tumoricidal dose to paraortic disease while minimizing dose to normal adjacent structures. In this study, we reviewed the outcomes of patients treated with IMRT for unresected or incompletely resected paraortic recurrences of primary uterine cancer. Methods and Materials: Between 2000 and 2009, 27 patients with unresected (19 patients) or incompletely resected (8 patients) paraortic relapse of endometrial cancer were treated with curative intent using IMRT. The paraortic basin was generally treated to a dose of 45-50 Gy, and gross disease was treated to a mean total dose of 61.7 Gy (range, 54-66 Gy). Seventeen patients (63%) received neoadjuvant or adjuvant chemotherapy. Fifteen (56%) received cisplatin concurrently with IMRT. Rates of overall survival and progression-free survival following salvage IMRT were determined using the Kaplan-Meier method, and differences between subgroups were assessed using the log-rank statistic. Results: Of the 27 patients, 19 (70%) had local control of paraortic disease after a median follow-up time of 25 months (range, 4-83 months). Two-year actuarial overall survival and progression-free survival rates were 63% and 53%, respectively. Five patients (19%) experienced severe late gastrointestinal toxic effects (grade 3-5). Conclusions: IMRT can serve as salvage therapy of paraortic recurrence of endometrial cancer. However, the risk of severe gastrointestinal toxic effects is high, and care should be taken during treatment planning to minimize the dose to the small bowel. [Copyright &y& Elsevier]

Objective: Obesity and estrogen are strong risk factors for endometrial cancer (EC). Whereas diabetes also increases the risk, little is known about related insulin resistance (IR). The purpose of this study was to determine the prevalence of IR in newly diagnosed EC patients. Study Design: EC patients from a large, metropolitan county were prospectively enrolled from 2005 to 2008. Fasting serum was analyzed for glucose and insulin. IR was defined as a history of diabetes or a quantitative insulin sensitivity check index (QUICKI) (1/[log fasting insulin + log fasting glucose]) value of less than 0.357. Results: Among 99 patients, diabetes was present in 30, and an abnormal QUICKI was found in 36 additional patients. Increased risk of IR was significantly associated with higher body mass index (P < .001), lower socioeconomic status (P = .007), and nulliparity (P = .029). Conclusion: IR was highly prevalent in endometrial cancer patients, including nonobese women. Better characterization of metabolic risks in addition to obesity may provide avenues for targeted cancer prevention in the future. [ABSTRACT FROM AUTHOR]

Objective: Adiponectin, a protein secreted by adipose cells, is inversely associated with endometrial cancer. Our objective was to assess prediagnostic adiponectin levels in relation to risk of endometrial cancer. Study Design: This was a prospective nested case-control study within the Nurses'' Health Study with 146 cases and 377 controls. Adiponectin was measured using enzyme-linked immunosorbent assay. Logistic regression analyses were performed adjusting for known endometrial cancer risk factors. Results: Mean age at diagnosis was 64.6 years. Mean interval between blood draw and diagnosis was 7.4 years (range, 2–13). There was no difference in median adiponectin (cases 12.9 vs controls 12.9 μg/mL; P = .97). Adiponectin >15 μg/mL was not associated with endometrial cancer risk (relative risk = 0.86; 95% confidence interval, 0.53–1.39; P = .48), even among postmenopausal women (odds ratio, 0.66; 95% confidence interval, 0.29–1.5). Results did not vary by time from blood draw to diagnosis (P for heterogeneity = .18). Conclusion: Prediagnostic adiponectin was not predictive of endometrial cancer risk. Further study will better define the relationship between adiponectin and endometrial cancer. [Copyright &y& Elsevier]