Publications by authors named "Ritu Salani"

120 Publications

Implicit Biases in Healthcare: Implications and Future Directions for Gynecologic Oncology.

Am J Obstet Gynecol 2022 Jan 10. Epub 2022 Jan 10.

Department of Psychology, University of Arizona.

Health disparities have been found among patients with gynecologic cancers, with the greatest differences arising between groups based on racial, ethnic, and socioeconomic factors. While there may be multiple social barriers that can influence health disparities, another potential influence may stem from healthcare system factors that unconsciously perpetuate bias toward patients who are racially and socioeconomically disadvantaged. More recent research suggests that providers hold these implicit biases (automatic and unconscious attitudes) for stigmatized cancer populations, with emerging evidence for gynecologic cancer patients. These implicit biases may guide providers' communication and medical judgements, which in turn, may influence the patient's satisfaction with and trust in the provider. This narrative review consolidates the current research on implicit bias in healthcare, with a specific emphasis on oncology professionals, and identifies future areas of research for examining and changing implicit biases within gynecologic oncology.
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http://dx.doi.org/10.1016/j.ajog.2021.12.267DOI Listing
January 2022

Who will be readmitted? Evaluation of the laparoscopic hysterectomy readmission score in a gynecologic oncology population undergoing robotic-assisted hysterectomy.

Gynecol Oncol 2021 Dec 27. Epub 2021 Dec 27.

Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and James Cancer Hospital and Solove Research Institute, Columbus, OH, United States of America.

Objectives: The laparoscopic hysterectomy readmission score (LHRS) was created to identify patients for whom same day discharge (SDD) after minimally invasive hysterectomy (MIH) may not be advisable and includes diabetes, chronic obstructive pulmonary disease, disseminated cancer, chronic steroid use, bleeding disorder, length of surgery, and any postoperative complication prior to discharge. We evaluated the performance of the score at predicting readmission in a gynecologic oncology population, and additionally sought to determine if any factors known prior to surgery could replace those that are not known until the time of surgery (operative time and postoperative complication).

Methods: This was a single-institution retrospective cohort study of women undergoing robotic hysterectomy by a gynecologic oncologist in 2018. Associations between pre-operative, operative and post-operative factors and 30-day readmission, SDD and postoperative complications were assessed using logistic regression.

Results: The 30-day readmission rate among the 423 women in the cohort was 4.5% and 1.9% in those undergoing SDD. Readmission rates by LHRS were: score 1 (4.9%), score 2 (7.8%), score 3 (13.6%), score 4 (16.7%). Patients with a LHRS of ≥3 had higher odds of readmission compared to those with a lower score (OR 4.20, p = 0.02). Infectious morbidity accounted for the majority of postoperative complications, emergency room visits and readmissions. We did not identify preoperative factors to replace the intra- and post-operative factors used in the score.

Conclusions: The readmission rate following MIH is low, and a LHRS of ≥3 is associated with increased risk of readmission. Our findings support the applicability of the LHRS to a gynecologic oncology population; addressing risk factors for postoperative infection or closer follow up for patients with a LHRS ≥3 could reduce postoperative readmissions.
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http://dx.doi.org/10.1016/j.ygyno.2021.12.010DOI Listing
December 2021

Precision medicine for cervical cancer.

Curr Opin Obstet Gynecol 2022 Feb;34(1):1-5

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, USA.

Purpose Of Review: To summarize the data on precision medicine for cervical cancer including the use of potential biomarkers. We also review ongoing areas of research in cervical cancer therapeutics.

Recent Findings: In the current clinical practice, programmed death ligand 1 (PD-L1) expression is used to select patients with cervical cancer for treatment with checkpoint inhibitors. However, more recently presented data suggest that PD-L1 may not be a fully accurate biomarker for selection and further analysis is warranted. With the publication of the molecular landscape of cervical cancer, tumor profile-based therapy selection is of greater interest (i.e. targeting PI3K and HER2).

Summary: In this review, we discuss the role of potential biomarkers for cervical cancer that may assist with the selection of precision therapies. Enrolling patients on active clinical trials will help clarify the role of targeting specific mutations.
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http://dx.doi.org/10.1097/GCO.0000000000000755DOI Listing
February 2022

Patient-reported outcome changes at the end of life in recurrent platinum-resistant ovarian cancer: An NRG oncology/GOG study.

Gynecol Oncol 2021 11 20;163(2):392-397. Epub 2021 Sep 20.

Division of Gynecologic Oncology, Summa Health System, NEOMED, Akron, OH 44310, United States of America. Electronic address:

Objectives: In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS--P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months.

Methods: The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size.

Results: DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status.

Conclusion: The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.
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http://dx.doi.org/10.1016/j.ygyno.2021.08.028DOI Listing
November 2021

Changing paradigms in intermediate-risk cervical cancer: Sedlis revisited.

Gynecol Oncol 2021 09;162(3):527-528

Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of California Los Angeles, Los Angeles, CA, United States of America. Electronic address:

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http://dx.doi.org/10.1016/j.ygyno.2021.08.004DOI Listing
September 2021

NCCN Guidelines® Insights: Uterine Neoplasms, Version 3.2021.

J Natl Compr Canc Netw 2021 08 1;19(8):888-895. Epub 2021 Aug 1.

Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

The NCCN Guidelines for Uterine Neoplasms provide recommendations for diagnostic workup, clinical staging, and treatment options for patients with endometrial cancer or uterine sarcoma. These NCCN Guidelines Insights focus on the recent addition of molecular profiling information to aid in accurate diagnosis, classification, and treatment of uterine sarcomas.
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http://dx.doi.org/10.6004/jnccn.2021.0038DOI Listing
August 2021

Phase I evaluation of lenvatinib and weekly paclitaxel in patients with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal Cancer.

Gynecol Oncol 2021 09 14;162(3):619-625. Epub 2021 Jul 14.

Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center and James Cancer Hospital, Columbus, OH, United States.

Objectives: To estimate the maximally tolerated dose (MTD) and describe toxicities associated with lenvatinib and weekly paclitaxel in patients with recurrent endometrial and platinum resistant epithelial ovarian cancer.

Methods: Using a 3 + 3 design patients were given weekly paclitaxel 80 mg/m2 IV day 1, 8, 15 and oral levantinib daily on a 28-day cycle. Lenvatinib dose levels were 8 mg, 12 mg, 16 mg, 20 mg. Toxicities were recorded using CTCAE v4.03 and response was determined with imaging after cycle 2, then every 3rd cycle, using RECIST 1.1 criteria.

Results: 26 patients were enrolled; 19 with ovarian cancer (14 high grade serous, 1 low grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma), and 7 with endometrial cancer (3 serous, and 4 endometrioid). The MTD was established at lenvatinib 16 mg and weekly paclitaxel 80 mg/m2. Toxicities (all grades) occurring in ≥25% of patients included anemia, neutropenia, lymphopenia, mucositis, nausea, diarrhea, anorexia, hypertension, fatigue, proteinuria, epistaxis, hoarseness. Twenty-three patients were evaluable for response and PFS; 15 (65%) had a partial response, 7 (30%) stable, 1 (4%) progressive disease with an objective response rate of 65%; 71% in ovarian and 50% in endometrial cancer. Median progression free survival (PFS) is 12.4 months; 14.0 months in endometrial cancer, 7.2 months in ovarian cancer; 54% had a PFS > 6 months. The median duration of response for PR patients (n = 15) was 10.9 months.

Conclusions: The regimen was tolerable with manageable side effects. Encouraging activity was observed in endometrial and ovarian cancer, and warrants further development.
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http://dx.doi.org/10.1016/j.ygyno.2021.06.032DOI Listing
September 2021

The American Society of Clinical Oncology 2021 annual (virtual) meeting: A review and summary of selected abstracts.

Gynecol Oncol 2021 08 29;162(2):245-248. Epub 2021 Jun 29.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States of America.

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http://dx.doi.org/10.1016/j.ygyno.2021.06.021DOI Listing
August 2021

The long game: Evolution of clinical decision making throughout residency and fellowship.

Am J Surg 2021 Mar 18. Epub 2021 Mar 18.

Department of Surgery, The Ohio State University, 395 W 12th Ave Suite 670, Columbus, OH, 43201, USA.

Background: The purpose of this study was to explore the trajectory of autonomy in clinical decision making.

Methods: We conducted a qualitative secondary analysis of interviews with 45 residents and fellows from the General Surgery and Obstetrics & Gynecology departments across all clinical postgraduate years (PGY) using convenience sampling. Each interview was recorded, transcribed and iteratively analyzed using a framework method.

Results: A total of 16 junior residents, 22 senior residents and 7 fellows participated in 12 original interviews. Early in training residents take their abstract ideas about disease processes and make them concrete in their applications to patient care. A transitional stage follows in which residents apply concepts to concrete patient care. Chief residents re-abstract their concrete technical and clinical knowledge to prepare for future surgical practice.

Conclusions: Understanding where each learner is on this pathway will assist development of curriculum that fosters resident readiness for practice at each PGY level.
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http://dx.doi.org/10.1016/j.amjsurg.2021.03.023DOI Listing
March 2021

Unwittingly biased: A note to gynecologic cancer providers.

Gynecol Oncol 2021 03 20;160(3):646-648. Epub 2021 Jan 20.

Department of Psychology, University of Arizona, Tucson, AZ, United States of America.

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http://dx.doi.org/10.1016/j.ygyno.2021.01.009DOI Listing
March 2021

Double somatic mismatch repair gene pathogenic variants as common as Lynch syndrome among endometrial cancer patients.

Gynecol Oncol 2021 01 21;160(1):161-168. Epub 2020 Oct 21.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Comprehensive Cancer Center, OH, United States of America.

Objective: Lynch syndrome is the most common cause of inherited endometrial cancer, attributable to germline pathogenic variants (PV) in mismatch repair (MMR) genes. Tumor microsatellite instability (MSI-high) and MMR IHC abnormalities are characteristics of Lynch syndrome. Double somatic MMR gene PV also cause MSI-high endometrial cancers. The aim of this study was to determine the relative frequency of Lynch syndrome and double somatic MMR PV.

Methods: 341 endometrial cancer patients enrolled in the Ohio Colorectal Cancer Prevention Initiative at The Ohio State University Comprehensive Cancer Center from 1/1/13-12/31/16. All tumors underwent immunohistochemical (IHC) staining for the four MMR proteins, MSI testing, and MLH1 methylation testing if the tumor was MMR-deficient (dMMR). Germline genetic testing for Lynch syndrome was undertaken for all cases with dMMR tumors lacking MLH1 methylation. Tumor sequencing followed if a germline MMR gene PV was not identified.

Results: Twenty-seven percent (91/341) of tumors were either MSI-high or had abnormal IHC indicating dMMR. As expected, most dMMR tumors had MLH1 methylation; (69, 75.8% of the dMMR cases; 20.2% of total). Among the 22 (6.5%) cases with dMMR not explained by methylation, 10 (2.9% of total) were found to have Lynch syndrome (6 MSH6, 3 MSH2, 1 PMS2). Double somatic MMR PV accounted for the remaining 12 dMMR cases (3.5% of total).

Conclusions: Since double somatic MMR gene PV are as common as Lynch syndrome among endometrial cancer patients, paired tumor and germline testing for patients with non-methylated dMMR tumor may be the most efficient approach for LS screening.
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http://dx.doi.org/10.1016/j.ygyno.2020.10.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7783191PMC
January 2021

Pilot study of fractional CO laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors.

Maturitas 2021 Feb 2;144:37-44. Epub 2020 Dec 2.

The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, United States.

Purpose: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO laser therapy in gynecologic cancer survivors.

Methods: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6).

Results: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events.

Conclusions: Fractional CO laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).
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http://dx.doi.org/10.1016/j.maturitas.2020.10.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7773136PMC
February 2021

An ecological evaluation of the increasing incidence of endometrial cancer and the obesity epidemic.

Am J Obstet Gynecol 2021 05 27;224(5):506.e1-506.e8. Epub 2020 Oct 27.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, CA.

Background: The prevalence of obesity has increased significantly in recent decades, particularly among younger women, and is a known risk factor for endometrial cancer.

Objective: This study aimed to evaluate the trend in the prevalence of obesity and the incidence of type I endometrial cancer over time in various age categories to determine whether an ecological relationship exists.

Study Design: Data from the Surveillance, Epidemiology, and End Results Program and the National Health and Nutrition Examination Survey were used. The overall trend in the incidence of type 1 endometrial cancer and prevalence of obesity were observed over time from 1988 to 2016 and further categorized by age group (<45, 45-54, and ≥55 years).

Results: The prevalence of obesity has increased for all women, but most significantly for women younger than 45 years with a 16.3% increase among women aged 20 to 34 years and a 17.9% increase for women aged 35 to 44 years. The incidence of endometrial cancer has also increased across all age categories, and although it has increased in patients younger than 45 years by more than 14-fold (from <0.1 per 100,000 in 1988 to 1.4 per 100,000 in 2016), a more pronounced increase of 63-fold and 50-fold was observed among women aged 45 to 54 years (0.2 per 100,000 in 1988 to 12.6 per 100,000 in 2016) and women aged 55 years and older (from 0.6 per 100,000 in 1988 to 30 per 100,000 in 2016), respectively. The mean age of women diagnosed as having endometrial cancer also decreased from 64.1 years from 1988 to 1990 to 61.0 years from 2014 to 2016.

Conclusion: The prevalence of obesity has increased significantly in women of all ages. This increase, particularly among women aged <45 years, occurred simultaneously with an increase in the incidence of endometrial cancer in young women, with an even more pronounced increase among women aged ≥45 years.
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http://dx.doi.org/10.1016/j.ajog.2020.10.042DOI Listing
May 2021

Feasibility of implementing a text-based symptom-monitoring program of endometrial, ovarian, and breast cancer patients during treatment.

Qual Life Res 2021 Nov 14;30(11):3241-3254. Epub 2020 Oct 14.

Division of Cancer Prevention and Control, College of Medicine, The Ohio State University, 1590 N. High St, Suite 525, Columbus, OH, 43201, USA.

Purpose: To evaluate the feasibility of implementing systematic patient symptom monitoring during treatment using a smartphone.

Methods: Endometrial [n = 50], ovarian [n = 70] and breast [n = 193] cancer patients participated in text-based symptom reporting for up to 12 months. In order to promote equity, patients without a smartphone were provided with a device, with the phone charges paid by program funds. Each month, patients completed the Patient Health Questionnaire (PHQ-9), and 4 single items assessing fatigue, sleep quality, pain, and global quality of life during the past 7 days rated on a 0 (low) -10 (high) scale. Patients' responses were captured using REDCap, with oncologists receiving monthly feedback. Lay navigators provided assistance to patients with non-medical needs.

Results: Patients utilizing this voluntary program had an overall mean age of 60.5 (range 26-87), and 85% were non-Hispanic white. iPhones were provided to 42 patients, and navigation services were used by 69 patients. Average adherence with monthly surveys ranged between 75-77%, with breast patients having lower adherence after 5 months. The most commonly reported symptoms across cancer types were moderate levels (scores of 4-7) of fatigue and sleep disturbance. At 6 months, 71-77% of all patients believed the surveys were useful to them and their health care team.

Conclusions: We established the feasibility of initiating and managing patients in a monthly text-based symptom-monitoring program. The provision of smartphones and patient navigation were unique and vital components of this program.
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http://dx.doi.org/10.1007/s11136-020-02660-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8528739PMC
November 2021

Pathologic chemotherapy response score in epithelial ovarian cancer: Surgical, genetic, and survival considerations.

Surg Oncol 2020 Sep 11;34:40-45. Epub 2020 Mar 11.

Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, United States. Electronic address:

Objective: A pathologic chemotherapy response score (CRS) is used to grade ovarian cancer response to neoadjuvant chemotherapy (NACT). We evaluated the prognostic significance of the CRS in a single institution cohort.

Methods: A retrospective review of all consecutive epithelial ovarian cancer patients undergoing interval debulking surgery (IDS) after NACT from 2016 to 2017 were included. Clinical, pathologic, surgical, outcomes, and genetic data were abstracted from medical records. CRS was assigned by pathology based on a section of omentum as follows: 1 = minimal response, 2 = moderate response, and 3 = near complete response.

Results: Among the 50 subjects, 14 (28%) were classified as CRS1, 29 (58%) as CRS2, and 7 (14%) as CRS3. The majority of patients were diagnosed with high grade serous histology (94%). Most women in this cohort underwent either an optimal or complete cytoreduction to no gross residual disease (96%). Women in the CRS2 group were most likely to have a pathogenic variant (51.7%) while those in the CRS1 were least likely (7.1%). Most women recurred regardless of CRS. CRS was not associated with progression-free survival (log-rank p = 0.82) or overall survival (log-rank p = 0.30).

Conclusions: Though previous data support the use of CRS as a prognostic indicator, we failed to show a correlation between CRS and survival in our continuous single institution cohort. The high rate of optimal debulking across all CRS groups in this study may mitigate the prognostic significance of the scoring system. Nevertheless, tumors that respond poorly to traditional chemotherapy should remain of avid interest for potential novel therapies.
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http://dx.doi.org/10.1016/j.suronc.2020.03.001DOI Listing
September 2020

Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology-Gynecologic Oncology Group Study 240 (NCT 00803062).

Mol Cancer Ther 2020 11 26;19(11):2363-2370. Epub 2020 Aug 26.

Massachusetts General Hospital, Boston, Massachusetts.

To isolate circulating tumor cells (CTC) from women with advanced cervical cancer and estimate the impact of CTCs and treatment on overall survival and progression-free survival (PFS). A total of 7.5 mL of whole blood was drawn pre-cycle 1 and 36 days post-cycle 1 from patients enrolled on Gynecologic Oncology Group 0240, the phase III randomized trial that led directly to regulatory approval of the antiangiogenesis drug, bevacizumab, in women with recurrent/metastatic cervical cancer. CTCs (defined as anti-cytokeratin/anti-CD45 cells) were isolated from the buffy coat layer using an anti-EpCAM antibody-conjugated ferrofluid and rare earth magnet, and counted using a semiautomated fluorescence microscope. The median pre-cycle 1 CTC count was 7 CTCs/7.5 mL whole blood (range, 0-18) and, at 36 days posttreatment, was 4 (range, 0-17). The greater the declination in CTCs between time points studied, the lower the risk of death [HR, 0.87; 95% confidence interval (CI), 0.79-0.95)]. Among patients with high (≥ median) pretreatment CTCs, bevacizumab treatment was associated with a reduction in the hazard of death (HR, 0.57; 95% CI, 0.32-1.03) and PFS (HR, 0.59; 95% CI, 0.36-0.96). This effect was not observed with low (< median) CTCs. CTCs can be isolated from women with advanced cervical cancer and may have prognostic significance. A survival benefit conferred by bevacizumab among patients with high pretreatment CTCs may reflect increased tumor neovascularization and concomitant vulnerability to VEGF inhibition. These data support studying CTC capture as a potential predictive biomarker.
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http://dx.doi.org/10.1158/1535-7163.MCT-20-0276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907274PMC
November 2020

Meeting report from the 2020 Annual (virtual) Meeting of the American Society of Clinical Oncology.

Gynecol Oncol 2020 10 5;159(1):13-16. Epub 2020 Aug 5.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States of America.

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http://dx.doi.org/10.1016/j.ygyno.2020.06.502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405821PMC
October 2020

Practice patterns in post-treatment surveillance in patients with primary epithelial ovarian cancer.

Int J Gynecol Cancer 2021 06 5;31(6):888-892. Epub 2020 Aug 5.

Department of Obstetrics and Gynecology, The Ohio State University Medical Center, Columbus, Ohio, USA.

Background: The Society of Gynecologic Oncology created guidelines to standardize cost-effective clinical surveillance for detection of recurrence of gynecologic cancers.

Objective: To determine practice patterns for surveillance of primary ovarian cancer after complete response to therapy and to identify the percentage of clinicians who follow the surveillance guidelines endorsed by the Society of Gynecologic Oncology.

Methods: A single-institution retrospective cohort study was conducted including patients with epithelial ovarian cancer with a complete response to primary therapy between January 2012 and December 2016. Patients were excluded if they were participating in clinical trials that required routine imaging. Data on surveillance and recurrence were collected. Descriptive statistics as well as Fisher's exact test and chi-square test were performed due to the exploratory nature of the study.

Results: A total of 184 patients met the inclusion criteria. Median follow-up for the cohort was 37 months (range 6-80). Surveillance was completed in compliance with Society of Gynecologic Oncology guidelines in 78% of patients. Of 39 visits that were non-compliant, 44% (17) were patient initiated (scheduling conflict, missed appointment), 15% (6) were due to the provider intentionally scheduling alternative follow-up, while 41% (16) were off schedule due to problem visits (patient complaint of symptoms). Patients with early-stage cancers were more likely than advanced-stage patients to be non-compliant (33% vs 15%, p=0.006). Patients with non-serous histologies had a higher frequency of non-compliance (31% vs 16%, p=0.035). When stratified by early versus advanced stage, there was no difference in progression-free survival or overall survival based on compliance.

Conclusions: Overall, there was a relatively high rate of compliance with Society of Gynecologic Oncology surveillance guidelines for patients with epithelial ovarian cancer. Patients with non-serous histologies and patients with early-stage disease had a higher rate of non-compliance, and these patients may represent special groups that would benefit from additional survivorship education.
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http://dx.doi.org/10.1136/ijgc-2020-001522DOI Listing
June 2021

Resident Self-Entrustment and Expectations of Autonomy: OB > GYN?

J Surg Educ 2021 Jan-Feb;78(1):275-281. Epub 2020 Aug 2.

Department of General Surgery, The Ohio State University Wexner Medical Center, The Ohio State University Wexner Medical Center, Columbus, Ohio.

Introduction: Entrustment is a key component connecting to resident preparedness for surgical practice in the operating room (OR). Residents' self-entrustment of their surgical competencies closely associates with their OR training experience and granted autonomy. Some recent studies have investigated how attending surgeons entrusted residents in the OR. There is little to no data, however, in examining these issues from the resident perspective. The goal of this study was to identify the perception and expectations of autonomy from residents' perspective, as well as the self-entrustment of their surgical competencies in obstetrics (OB) and gynecologic (GYN) procedures.

Methods: Focus group interviews of OB/GYN residents were performed. Residents were selected by convenience sampling. Audio recordings of each interview were transcribed, iteratively analyzed, and emergent themes identified, using a framework method.

Results: A total of 123 minutes of interviews were recorded. Eight junior residents (PGY1-2) and 12 senior residents (PGY3-4) participated. Our data illustrated that (1) the perception of autonomy shifted significantly throughout residency training; (2) residents demonstrated higher expectations and self-entrustment for OB surgical procedures than for GYN surgical procedures upon graduation; and (3) case volume, modalities of OR teaching and mutual communication are 3 factors influencing resident self-entrustment of their surgical competencies.

Conclusions: Residents showed disparities in their self-entrustment and expectations of autonomy between OB and GYN surgical procedures. Better understanding these differences and the 3 influencing factors could help programs develop a potential solution for improvement in resident entrustment and autonomy upon graduation.
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http://dx.doi.org/10.1016/j.jsurg.2020.07.019DOI Listing
June 2021

Polygenic risk scores and breast and epithelial ovarian cancer risks for carriers of BRCA1 and BRCA2 pathogenic variants.

Genet Med 2020 10 15;22(10):1653-1666. Epub 2020 Jul 15.

Royal Devon & Exeter Hospital, Department of Clinical Genetics, Exeter, UK.

Purpose: We assessed the associations between population-based polygenic risk scores (PRS) for breast (BC) or epithelial ovarian cancer (EOC) with cancer risks for BRCA1 and BRCA2 pathogenic variant carriers.

Methods: Retrospective cohort data on 18,935 BRCA1 and 12,339 BRCA2 female pathogenic variant carriers of European ancestry were available. Three versions of a 313 single-nucleotide polymorphism (SNP) BC PRS were evaluated based on whether they predict overall, estrogen receptor (ER)-negative, or ER-positive BC, and two PRS for overall or high-grade serous EOC. Associations were validated in a prospective cohort.

Results: The ER-negative PRS showed the strongest association with BC risk for BRCA1 carriers (hazard ratio [HR] per standard deviation = 1.29 [95% CI 1.25-1.33], P = 3×10). For BRCA2, the strongest association was with overall BC PRS (HR = 1.31 [95% CI 1.27-1.36], P = 7×10). HR estimates decreased significantly with age and there was evidence for differences in associations by predicted variant effects on protein expression. The HR estimates were smaller than general population estimates. The high-grade serous PRS yielded the strongest associations with EOC risk for BRCA1 (HR = 1.32 [95% CI 1.25-1.40], P = 3×10) and BRCA2 (HR = 1.44 [95% CI 1.30-1.60], P = 4×10) carriers. The associations in the prospective cohort were similar.

Conclusion: Population-based PRS are strongly associated with BC and EOC risks for BRCA1/2 carriers and predict substantial absolute risk differences for women at PRS distribution extremes.
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http://dx.doi.org/10.1038/s41436-020-0862-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521995PMC
October 2020

Residents' method for gaining operative autonomy.

Am J Surg 2020 10 29;220(4):893-898. Epub 2020 Mar 29.

Department of Surgery, USA.

Introduction: The goal of this study was to explore the resident construct for their perceived successful method of actions that lead to OR autonomy during residency and the strategies they employed.

Methods: We conducted focus group interviews with residents from the General Surgery (GS) and Obstetrics & Gynecology (OBGYN) departments at a single academic institution across all clinical postgraduate years (PGY) using convenience sampling. Audio recordings of each interview were transcribed, analyzed and emergent themes were identified using a framework method.

Results: A total of 38 residents participated. A 3-stage resident method to gain operative autonomy emerged. This progresses from building rapport, developing mutual entrustment, and finally to obtaining autonomy. We identified 4 common strategies used by residents to construct this method: smart communication, attention to attending preferences, helpful allies and visible attributes.

Conclusion: Our findings provide insight into resident strategies to achieve progressive autonomy in the OR helping programs improve resident's learning efficiency.
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http://dx.doi.org/10.1016/j.amjsurg.2020.03.022DOI Listing
October 2020

Moving Forward in Cervical Cancer: Enhancing Susceptibility to DNA Repair Inhibition and Damage, an NCI Clinical Trials Planning Meeting Report.

J Natl Cancer Inst 2020 11;112(11):1081-1088

Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA.

Cervical cancer is the fourth most common cancer in women worldwide, and prognosis is poor for those who experience recurrence or develop metastatic disease, in part due to the lack of active therapeutic directions. The National Cancer Institute convened a Cervical Cancer Clinical Trials Planning Meeting in October 2018 to facilitate the design of hypothesis-driven clinical trials focusing on locally advanced, metastatic, and recurrent cervical cancer around the theme of enhancing susceptibility to DNA repair inhibition and DNA damage. Before the meeting, a group of experts in the field summarized available preclinical and clinical data to identify potentially active inducers and inhibitors of DNA. The goals of the Clinical Trials Planning Meeting focused on identification of novel experimental strategies capitalizing on DNA damage and repair (DDR) regulators and cell cycle aberrations, optimization of radiotherapy as a DDR agent, and design of clinical trials incorporating DDR regulation into the primary and recurrent or metastatic therapies for cervical carcinoma. Meeting deliverables were novel clinical trial concepts to move into the National Clinical Trials Network. This report provides an overview for the rationale of this meeting and the state of the science related to DDR regulation in cervical cancer.
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http://dx.doi.org/10.1093/jnci/djaa041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669233PMC
November 2020

Guideline-concordant treatment is associated with improved survival among women with non-endometrioid endometrial cancer.

Gynecol Oncol 2020 06 23;157(3):716-722. Epub 2020 Mar 23.

Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, United States of America. Electronic address:

Background: Among women diagnosed with non-endometrioid endometrial carcinoma (EC), we investigated associations between race/ethnicity and receipt of guideline-concordant treatment (GCT), as well as relationships between GCT and survival.

Methods: We used the National Cancer Database and identified 21,177 non-Hispanic White (NHW), 6657 non-Hispanic Black (NHB), 1689 Hispanic, and 903 Asian/Pacific Islander (AS/PI) women diagnosed with non-endometrioid EC between 2004 and 2014. Year-specific National Comprehensive Cancer Network (NCCN) guidelines were used to classify GCT. We used multivariable logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between race/ethnicity and GCT receipt. Multivariable-adjusted Cox proportional hazards models were used to estimate hazards ratios (HRs) and 95% CIs for relationships between GCT and overall survival in the total study population and stratified by race/ethnicity.

Results: Overall, 43.8% of women with non-endometrioid EC received GCT. Compared to NHW women, NHB (OR = 1.01, 95% CI = 0.95-1.07), Hispanic (OR = 1.01, 95% CI = 0.91-1.12) and AS/PI women (OR = 1.10, 95% CI = 0.96-1.26) did not have significantly different odds of receiving GCT. GCT was significantly associated with improved survival among NHW (HR = 0.84, 95% CI = 0.80-0.87), NHB (HR = 0.85, 95% CI = 0.80-0.91), and Hispanic women (HR = 0.84, 95% CI = 0.72-0.98) but not among AS/PI women (HR = 0.97, 95% CI = 0.78-1.19).

Conclusions: While more than half of women with non-endometrioid EC did not receive GCT, no difference in GCT receipt by race/ethnicity was observed. When received, GCT was associated with improved survival in almost all racial groups. Interventions to improve GCT adherence may improve survival for most women with non-endometrioid EC.
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http://dx.doi.org/10.1016/j.ygyno.2020.03.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293554PMC
June 2020

The Construction of Case-Specific Resident Learning Goals.

J Surg Educ 2020 Jul - Aug;77(4):859-865. Epub 2020 Mar 19.

Department of Surgery, The Ohio State University, Columbus, Ohio.

Objective: Developing resident autonomy in the operating room is a complex process and resident established case specific learning goals may increase resident operating room training efficiency. However, little is understood about residents' experience identifying learning goals for a given case. The aim of this study was to explore the essential components contributing to surgery residents' identification of specific learning goals for surgical cases.

Design: We conducted focus group interviews with general surgery residents across all post-graduate years (PGY) through convenience sampling. Audio recordings of each interview were transcribed and iteratively analyzed. Emerging themes were identified using a framework method.

Setting: The study was conducted within the Department of General Surgery at the Ohio State University Medical Center, a tertiary academic medical center.

Participants: Eight junior (PGY 1-2) and 10 senior (PGY 3-5) residents participated, of whom 10 were female and 8 were male.

Results: On average, each focus group interview lasted 57.00 (SD ± 12.99) minutes. Three essential components of residents' creation of case-specific learning goals emerged from the focus group interviews: medical knowledge, surgical experience and entrustment. Residents require baseline knowledge and surgical experience with an operation to identify the learning goal they would aim to execute. They also require entrustment of themselves and support of the attending to accomplish the case specific learning goal. Differences in the possession of these three components would likely influence differences in the ability to create learning goals between junior and senior residents.

Conclusions: Medical knowledge, surgical experience and entrustment are 3 factors that are imperative to the creation of a resident's case specific learning goal. The complex combination of these three components contributes to the building of the learning goal prior to the start of the operation. Elucidating these aspects provides additional information for targeted interventions in the future.
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http://dx.doi.org/10.1016/j.jsurg.2020.02.021DOI Listing
June 2021

Diagnosis and Management of Adenocarcinoma in Situ: A Society of Gynecologic Oncology Evidence-Based Review and Recommendations.

Obstet Gynecol 2020 04;135(4):869-878

Department of Obstetrics, Gynecology & Women's Health, University of Minnesota, Minneapolis, Minnesota; the Department of Gynecology, Pacific Gynecology Specialists, Seattle, Washington; and the Departments of Obstetrics & Gynecology, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, and NYU Winthrop Hospital, Mineola, New York.

This publication represents an extensive literature review with the goal of providing guidelines for the evaluation and management of cervical adenocarcinoma in situ (AIS). The authors drafted the guidelines on behalf of the Society of Gynecologic Oncology, and the guidelines have been reviewed and endorsed by the ASCCP. These guidelines harmonize with the ASCCP Risk-Based Management Consensus Guidelines and provide more specific guidance beyond that provided by the ASCCP guidelines. Examples of updates include recommendations to optimize the diagnostic excisional specimen, AIS management in the setting of positive compared with negative margins on the excisional specimen, surveillance and definitive management after fertility-sparing treatment, and management of AIS in pregnancy. The increasing incidence of AIS, its association with human papillomavirus-18 infection, challenges in diagnosis owing to frequent origin within the endocervical canal, and the possibility of skip lesions all make AIS a unique diagnosis whose management needs to be differentiated from the management of the more prevalent squamous cell dysplasia.
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http://dx.doi.org/10.1097/AOG.0000000000003761DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098444PMC
April 2020

Black and Hispanic women are less likely than white women to receive guideline-concordant endometrial cancer treatment.

Am J Obstet Gynecol 2020 09 3;223(3):398.e1-398.e18. Epub 2020 Mar 3.

Division of Epidemiology, College of Public Health, College of Medicine, Ohio State University, Columbus, OH. Electronic address:

Background: Differences in receipt of guideline-concordant treatment might underlie well-established racial disparities in endometrial cancer mortality.

Objective: Using the National Cancer Database, we assessed the hypothesis that among women with endometrioid endometrial cancer, racial/ethnic minority women would have lower odds of receiving guideline-concordant treatment than white women. In addition, we hypothesized that lack of guideline-concordant treatment was linked with worse survival.

Study Design: We defined receipt of guideline-concordant treatment using the National Comprehensive Cancer Network guidelines. Multivariable logistic regression models were used to compute odds ratios and 95% confidence intervals for associations between race and guideline-concordant treatment. We used multivariable Cox proportional hazards regression models to estimate hazards ratios and 95% confidence intervals for relationships between guideline-concordant treatment and overall survival in the overall study population and stratified by race/ethnicity.

Results: This analysis was restricted to the 89,319 women diagnosed with an invasive, endometrioid endometrial cancer between 2004 and 2014. Overall, 74.7% of the cohort received guideline-concordant treatment (n = 66,699). Analyses stratified by race showed that 75.3% of non-Hispanic white (n = 57,442), 70.1% of non-Hispanic black (n = 4334), 71.0% of Hispanic (n = 3263), and 72.5% of Asian/Pacific Islander patients (n = 1660) received treatment in concordance with guidelines. In multivariable-adjusted models, non-Hispanic black (odds ratio, 0.92, 95% confidence interval, 0.86-0.98) and Hispanic women (odds ratio, 0.90, 95% confidence internal, 0.83-0.97) had lower odds of receiving guideline-concordant treatment compared with non-Hispanic white women, while Asian/Pacific Islander women had a higher odds of receiving guideline-concordant treatment (odds ratio, 1.11, 95% confidence interval, 1.00-1.23). Lack of guideline-concordant treatment was associated with lower overall survival in the overall study population (hazard ratio, 1.12, 95% confidence interval, 1.08-1.15) but was not significantly associated with overall survival among non-Hispanic black (hazard ratio, 1.09, 95% confidence interval, 0.98-1.21), Hispanic (hazard ratio, 0.92, 95% confidence interval=0.78-1.09), or Asian/Pacific Islander (hazard ratio, 0.90, 95% confidence interval, 0.70-1.16) women.

Conclusion: Non-Hispanic black and Hispanic women were less likely than non-Hispanic white women to receive guideline-concordant treatment, while Asian/Pacific Islander women more commonly received treatment in line with guidelines. Furthermore, in the overall study population, overall survival was worse among those not receiving guideline-concordant treatment, although low power may have had an impact on the race-stratified models. Future studies should evaluate reasons underlying disparate endometrial cancer treatment.
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http://dx.doi.org/10.1016/j.ajog.2020.02.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483220PMC
September 2020

Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study.

Int J Gynecol Cancer 2020 05 28;30(5):596-601. Epub 2020 Feb 28.

University of California Irvine School of Medicine, Orange, California, USA.

Introduction: To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.

Methods: Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.

Results: Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.

Discussion: Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.
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http://dx.doi.org/10.1136/ijgc-2019-000869DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7780262PMC
May 2020

Meeting report from the 19th meeting of the International Gynecologic Cancer Society (IGCS) 2019: Summary of selected abstracts and meeting highlights.

Gynecol Oncol 2019 12 10;155(3):389-392. Epub 2019 Oct 10.

Division of Gynecologic Oncology, The Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address:

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http://dx.doi.org/10.1016/j.ygyno.2019.10.006DOI Listing
December 2019

Intentional weight loss, weight cycling, and endometrial cancer risk: a systematic review and meta-analysis.

Int J Gynecol Cancer 2019 11 26;29(9):1361-1371. Epub 2019 Aug 26.

Division of Epidemiology, The Ohio State University College of Public Health, Columbus, OH, USA

Purpose: Weight cycling, defined as intentional weight loss followed by unintentional weight regain, may attenuate the benefit of intentional weight loss on endometrial cancer risk. We summarized the literature on intentional weight loss, weight cycling after intentional weight loss, bariatric surgery, and endometrial cancer risk.

Methods: A systematic search was conducted using MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases published between January 2000 and November 2018. We followed Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) guidelines. We qualitatively summarized studies related to intentional weight loss and weight cycling due to the inconsistent definition, and quantitatively summarized studies when bariatric surgery was the mechanism of intentional weight loss.

Results: A total of 127 full-text articles were reviewed, and 13 were included (bariatric surgery n=7, self-reported intentional weight loss n=2, self-reported weight cycling n=4). Qualitative synthesis suggested that, compared with stable weight, self-reported intentional weight loss was associated with lower endometrial cancer risk (RR range 0.61-0.96), whereas self-reported weight cycling was associated with higher endometrial cancer risk (OR range 1.07-2.33). The meta-analysis yielded a 59% lower risk of endometrial cancer following bariatric surgery (OR 0.41, 95% CI 0.22 to 0.74).

Conclusions: Our findings support the notion that intentional weight loss and maintenance of a stable, healthy weight can lower endometrial cancer risk. Strategies to improve awareness and maintenance of weight loss among women with obesity are needed to reduce endometrial cancer risk.
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http://dx.doi.org/10.1136/ijgc-2019-000728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6832748PMC
November 2019

Preoperative predictors of endometrial cancer at time of hysterectomy for endometrial intraepithelial neoplasia or complex atypical hyperplasia.

Am J Obstet Gynecol 2020 01 8;222(1):60.e1-60.e7. Epub 2019 Aug 8.

Division of Gynecologic Oncology, Department of Obstetrics/Gynecology, The Ohio State University College of Medicine, Columbus, OH. Electronic address:

Background: Endometrial intraepithelial neoplasia, also known as complex atypical hyperplasia, is a precancerous lesion of the endometrium associated with a 40% risk of concurrent endometrial cancer at the time of hysterectomy. Although a majority of endometrial cancers diagnosed at the time of hysterectomy for endometrial intraepithelial neoplasia are low risk and low stage, approximately 10% of patients ultimately diagnosed with endometrial cancers will have high-risk disease that would warrant lymph node assessment to guide adjuvant therapy decisions. Given these risks, some physicians choose to refer patients to a gynecologic oncologist for definitive management. Currently, few data exist regarding preoperative factors that can predict the presence of concurrent endometrial cancer in patients with endometrial intraepithelial neoplasia. Identification of these factors may assist in the preoperative triaging of patients to general gynecology or gynecologic oncology.

Objective: To determine whether preoperative factors can predict the presence of concurrent endometrial cancer at the time of hysterectomy in patients with endometrial intraepithelial neoplasia; and to describe the ability of preoperative characteristics to predict which patients may be at a higher risk for lymph node involvement requiring lymph node assessment at the time of hysterectomy.

Materials And Methods: We conducted a retrospective cohort study of women undergoing hysterectomy for pathologically confirmed endometrial intraepithelial neoplasia from January 2004 to December 2015. Patient demographics, imaging, pathology, and outcomes were recorded. The "Mayo criteria" were used to determine patients requiring lymphadenectomy. Unadjusted associations between covariates and progression to endometrial cancer were estimated by 2-sample t-tests for continuous covariates and by logistic regression for categorical covariates. A multivariable model for endometrial cancer at the time of hysterectomy was developed using logistic regression with 5-fold cross-validation.

Results: Of the 1055 charts reviewed, 169 patients were eligible and included. Of these patients, 87 (51.5%) had a final diagnosis of endometrial intraepithelial neoplasia/other benign disease, whereas 82 (48.5%) were ultimately diagnosed with endometrial cancer. No medical comorbidities were found to be strongly associated with concurrent endometrial cancer. Patients with endometrial cancer had a thicker average endometrial stripe compared to the patients with no endometrial cancer at the time of hysterectomy (15.7 mm; standard deviation, 9.5) versus 12.5 mm; standard deviation, 6.4; P = .01). An endometrial stripe of ≥2 cm was associated with 4.0 times the odds of concurrent endometrial cancer (95% confidence interval, 1.5-10.0), controlling for age. In all, 87% of endometrial cancer cases were stage T1a (Nx or N0). Approximately 44% of patients diagnosed with endometrial cancer and an endometrial stripe of ≥2 cm met the "Mayo criteria" for indicated lymphadenectomy compared to 22% of endometrial cancer patients with an endometrial stripe of <2 cm.

Conclusion: Endometrial stripe thickness and age were the strongest predictors of concurrent endometrial cancer at time of hysterectomy for endometrial intraepithelial neoplasia. Referral to a gynecologic oncologist may be especially warranted in endometrial intraepithelial neoplasia patients with an endometrial stripe of ≥2 cm given the increased rate of concurrent cancer and potential need for lymph node assessment.
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http://dx.doi.org/10.1016/j.ajog.2019.08.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201377PMC
January 2020
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