Cervical neoplasia–related factors and decreased prevalence of uterine fibroids among a cohort of African American women

To investigate whether the previously reported inverse association between cervical neoplasia and uterine fibroids is corroborated

Developing a Machine Learning-Based Clinical Decision Support Tool for Uterine Tumor Imaging

Uterine leiomyosarcoma (LMS) is a rare but aggressive malignancy. On imaging, it is difficult to differentiate LMS from, for example, degenerated leiomyoma (LM), a prevalent but benign condition. We curated a data set of 115 axial T2-weighted MRI images from 110 patients (mean [range] age=45 [17-81] years) with UTs that included five different tumor types. These data were randomly split stratifying on tumor volume into training (n=85) and test sets (n=30). An independent second reader (reader 2) provided manual segmentations for all test set images. To automate segmentation, we applied nnU-Net and explored the effect of training set size on performance by randomly generating subsets with 25, 45, 65 and 85 training set images. We evaluated the ability of radiomic features to distinguish between types of UT individually and when combined through feature selection and machine learning. Using the entire training set the mean [95% CI] fibroid DSC was measured as 0.87 [0.59-1.00] and the agreement between the two readers was 0.89 [0.77-1.0] on the test set. When classifying degenerated LM from LMS we achieve a test set F1-score of 0.80. Classifying UTs based on radiomic features we identify classifiers achieving F1-scores of 0.53 [0.45, 0.61] and 0.80 [0.80, 0.80] on the test set for the benign versus malignant, and degenerated LM versus LMS tasks. We show that it is possible to develop an automated method for 3D segmentation of the uterus and UT that is close to human-level performance with fewer than 150 annotated images. For distinguishing UT types, while we train models that merit further investigation with additional data, reliable automatic differentiation of UTs remains a challenge

Practice patterns and complications of benign hysterectomy following the FDA statement warning against the use of power morcellation

IMPORTANCE In November 2014, the US Food and Drug Administration (FDA) issued a black box warning against the use of power morcellation for excision of uterine fibroids to decrease the risk of disseminating malignant cells and worsening survival outcomes of patients with unexpected malignant neoplasms. After the FDA statement was issued, studies showed decreased rates of minimally invasive surgery and increased rates of open abdominal hysterectomy. However, there are limited and controversial data on the association of these changed rates with 30-day hysterectomy complications. OBJECTIVE To assess changes in the rates of 30-day major and minor complications of hysterectomy for benign gynecologic indications following the FDA-issued statement. DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program database and included 603 hospitals participating between January 1, 2013, and December 31, 2015. Thirty-day posthysterectomy complications were compared before and after the FDA-issued warning. Women who underwent hysterectomy for benign gynecologic indications (n = 75 487), including hysterectomies with indication of uterine fibroids (n = 25 571), were included. Complication rates and procedure distributions between the periods were compared with ?2 tests and multivariable logistic regression controlling for patient and operative factors. MAIN OUTCOMES AND MEASURES Major and minor 30-day complication rates before (from 2013 through the first quarter of 2014) and after (from the fourth quarter of 2014 through 2015) the FDA-issued warning. RESULTS Of 75 487 women (mean [SD] age, 47.8 [10.7] years) who underwent hysterectomy for benign gynecologic indications, 32 186 (42.6%) were treated before and 43 301 (57.4%) after the FDA-issued warning. Non-Hispanic white women comprised most (59.4%) of the total population, followed by African American women (15.1%). Overall, major and minor complications remained stable before and after the FDA-issued warning. By contrast, among a subset of 25 571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01). In this subgroup, the rate of open abdominal surgery increased from 37.2% to 43.0%, and the rate of minimally invasive surgery (total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, and laparoscopic-assisted vaginal hysterectomy) decreased from 56.1% to 49.7% (P < .001). CONCLUSIONS AND RELEVANCE Major and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement. This increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation during a shared decision-making process between clinician and patient. Regulatory bodies and medical societies should consider these findings when issuing relevant communications

Incidence of sarcoma in patients undergoing hysterectomy for benign indications: a population-based study

Background: Minimally invasive hysterectomy may require the use of morcellation to remove the uterus. In the presence of unexpected sarcoma, morcellation risks disseminating malignant cells and worsening survival outcomes. As a consequence, in 2014 the US Food and Drug Administration issued a black box warning against the use of power morcellator for the treatment of uterine fibroids. However, the proportion of unexpected sarcoma at the time of hysterectomy for presumed benign indication remains unclear. Objective: The objective of the study was to estimate the incidence of sarcoma among women undergoing hysterectomy for benign indication in Olmsted County, MN, between 1999 and 2013. Study Design: We conducted a population-based study including all hysterectomies performed for benign indication in Olmsted County women between Jan. 1, 1999, and Dec. 31, 2013. Cases were identified using the medical records\u2013linkage system of the Rochester Epidemiology Project, and data were abstracted by a gynecologist who reviewed the complete medical records of each woman who underwent hysterectomy. An expert pathologist reviewed the pathologic slides of each sarcoma to ensure the accuracy of the diagnosis. Incidences of sarcoma (overall and by type of sarcoma) were estimated both overall and stratified by menopausal status, indication for surgery, and uterine weight as a rate per 100 persons. Results: A total of 4232 hysterectomies were performed during the study period. Among them, we identified 16 sarcomas, of which 11 (69%) were suspected preoperatively and 5 (31%) were unexpected. Of the total number of hysterectomies, 3759 (88.8%) were performed for benign indication. Among those, the incidence of unexpected sarcoma was 0.13% (5 per 3759 [95% confidence interval, 0.04\u20130.31%]). Uterine fibroids comprised 27.3% of all hysterectomies for benign indication (n = 1025) and was the indication most commonly associated with diagnosis of unexpected sarcoma. The incidence of unexpected sarcoma among surgeries for uterine fibroids was 0.35% (3 of 851) for premenopausal women and 0.57% (1 of 174) for peri/postmenopausal, and all 4 unexpected sarcomas were leiomyosarcoma. The incidence of unexpected sarcoma progressively increased with higher uterine weight with an incidence of 0.03% (1 of 2993) among women with a uterine weight <250 g vs 15.4% (2 of 13) with a uterine weight 652000 g. Conclusion: Unexpected uterine sarcoma was low in all women undergoing hysterectomy for benign indication (0.13% or 1 in 752 surgeries) while it was increased in women with uterine fibroids (0.39% or 1 in 256 surgeries). Peri/postmenopausal women, women with large uteri, and age 6545 years were risk factors for sarcoma

Cervical neoplasia–related factors and decreased prevalence of uterine fibroids among a cohort of African American women

OBJECTIVE: To investigate whether the previously reported inverse association between cervical neoplasia and uterine fibroids is corroborated. DESIGN: Cross-sectional analysis of enrollment data from an ongoing prospective study of fibroid development. SETTING: Detroit, Michigan area. PATIENTS(S): Self-reported data on abnormal Pap smear, colposcopy and cervical treatment were obtained from 1,008 African-American women ages 23-34 with no previous fibroid diagnosis and no reported history of HPV vaccination. Presence of fibroids was assessed at a standardized ultrasound examination. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The association between the 3 cervical neoplasia-related variables and presence of fibroids was evaluated with logistic regression to estimate age-adjusted and multivariable-adjusted odds ratios (ORs). RESULT(S): Of the analysis sample, 46%, 29% and 14% reported a prior abnormal Pap smear, colposcopy and cervical treatment, respectively. Twenty-five percent had fibroids at ultrasound. Those reporting cervical treatment had a 39% [aOR: 0.61, 95%CI (0.38-0.96)] reduction in fibroid risk. Weak non-significant associations were found for abnormal Pap smear and colposcopy. CONCLUSION(S): Although a protective-type association of cervical neoplasia with uterine fibroids seems counter intuitive, a causal pathway is possible, and the findings are consistent with two prior studies. Further investigation is needed on the relationship between fibroids and cervical neoplasia and HPV-related mechanisms

Risk assessment of endometrial cancer and endometrial intraepithelial neoplasia in women with abnormal bleeding and implications for clinical management algorithms

© 2020 Background: Most endometrial cancer cases are preceded by abnormal uterine bleeding, offering a potential opportunity for early detection and cure of endometrial cancer. Although clinical guidelines exist for diagnostic workup of abnormal uterine bleeding, consensus is lacking regarding optimal management for women with abnormal bleeding to diagnose endometrial cancer. Objective: We report the baseline data from a prospective clinical cohort study of women referred for endometrial evaluation at the Mayo Clinic, designed to evaluate risk stratification in women at increased risk for endometrial cancer. Here, we introduce a risk-based approach to evaluate diagnostic tests and clinical management algorithms in a population of women with abnormal bleeding undergoing endometrial evaluation at the Mayo Clinic. Study Design: A total of 1163 women aged ≥45 years were enrolled from February 2013 to May 2019. We evaluated baseline absolute risks and 95% confidence intervals of endometrial cancer and endometrial intraepithelial neoplasia according to clinical algorithms for diagnostic workup of women with postmenopausal bleeding (assessment of initial vs recurrent bleeding episode and endometrial thickness measured through transvaginal ultrasound). We also evaluated risks among women with postmenopausal bleeding according to baseline age (\u3c60 vs 60+ years) as an alternative example. For this approach, biopsy would be conducted for all women aged 60+ years and those aged \u3c60 years with an endometrial thickness of \u3e4 mm. We assessed the clinical efficiency of each strategy by estimating the percentage of women who would be referred for endometrial biopsy, the percentage of cases detected and missed, and the ratio of biopsies per case detected. Results: Among the 593 women with postmenopausal bleeding, 18 (3.0%) had endometrial intraepithelial neoplasia, and 47 (7.9%) had endometrial cancer, and among the 570 premenopausal women with abnormal bleeding, 8 (1.4%) had endometrial intraepithelial neoplasia, and 7 (1.2%) had endometrial cancer. Maximum risk was noted in women aged 60+ years (17.7%; 13.0%–22.3%), followed by those with recurrent bleeding (14.7%; 11.0%–18.3%). Among women with an initial bleeding episode for whom transvaginal ultrasound was recommended, endometrial thickness did not provide meaningful risk stratification: risks of endometrial cancer and endometrial intraepithelial neoplasia were nearly identical in women with an endometrial thickness of \u3e4 mm (5.8%; 1.3%–10.3%) and ≤4 mm (3.6%; 0.9%–8.6%). In contrast, among those aged \u3c60 years with an endometrial thickness of \u3e4 mm, the risk of endometrial cancer and endometrial intraepithelial neoplasia was 8.4% (4.3%–12.5%), and in those with an endometrial thickness of ≤4 mm, the risk was 0% (0.0%–3.0%; P=.01). The most efficient strategy was to perform biopsy in all women aged 60+ years and among those aged \u3c60 years with an endometrial thickness of \u3e4 mm, with the lowest percentage referred to biopsy while still detecting all cases. Conclusion: Existing clinical recommendations for endometrial cancer detection in women with abnormal bleeding are not consistent with the underlying risk. Endometrial cancer risk factors such as age can provide important risk stratification compared with the assessment of recurrent bleeding. Future research will include a formal assessment of clinical and epidemiologic risk prediction models in our study population as well as validation of our findings in other populations