PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy.

Objectives: To evaluate if vaginal metronidazole for 5 days before hysterectomy decreases postoperative infections and patient issues. Design: This randomized trial compared vaginal metronidazole for 5 days before a scheduled hysterectomy to no intervention. Sample size calculation was based on a 20% difference in issues and infection (30% incidence and 10% in the intervention arm) with 80% power and an alpha error of 0.05 and indicated 62 subjects needed in each arm. Setting: Outpatient gynecology clinics at a single academic institution. Participants: 154 subjects were screened for eligibility between July 2020 and September 2022. 133 underwent hysterectomy including 68 subjects (51.1%) randomized to the metronidazole and 65 (48.9%) controls. Overall, the population was racially and ethnically diverse. There was no significant difference in characteristics between the two groups. Interventions: Vaginal metronidazole for 5 days before hysterectomy. Main outcome measures: Postoperative patient issues and documented postoperative infections at 4-8 weeks after surgery. Results: There was no difference in the composite rate of patient-reported issues and/or documented postoperative infection (53/133 (39.8%) with no difference between groups (29/68 (42.6%) vs 24/65 (36.9%), p=0.50). There was no difference in patient-reported issues which was 51/133 (38.3%) with no difference between groups (28/68 (41.2%) vs 23/65 (33.8%), p=0.49) or in documented infections with a rate of 25/133 (18.8%) with no significant difference between groups (15/68 (22.0%) vs 10/65 (15.4%), p=0.33). In the intervention arm, the compliance rate was 73.5% for all 5 days of vaginal metronidazole, and a per-protocol analysis was performed which resulted in no significant difference between groups. Conclusions: There is insufficient evidence to suggest a significant benefit of preoperative vaginal metronidazole to prevent surgical site infections and postoperative patient issues in patients undergoing hysterectomy. Trial registration number: ClinicalTrials.gov, NCT04478617.

A Review of Cervical Cancer: Incidence and Disparities.

BACKGROUND: Cervical cancer is the fourth most common cancer amongst women worldwide. In the United States, its incidence and mortality have been declining due to the wide scale implementation of cytological screening programs. However, there have been geographic disparities in cervical cancer, particularly in the US. OBJECTIVE: This review will outline the overall incidence of cervical cancer and discuss the causes for disparities in its incidence and mortality rates. METHODS: A literature review was performed from 1999 to 2020 of English language manuscripts on the incidence and reasons for disparities in mortality rates of cervical cancer. RESULTS: Racial and ethnic minorities, socioeconomically disenfranchised, and those in rural areas have disparate rates of vaccination, screening and treatment of cervical cancer, leading to worse outcomes. CONCLUSIONS: By addressing these disparities via increased education, access to care, and the expansion of screening and vaccination programs, reductions in cervical cancer incidence and mortality may be achieved.

Regionalization of care for women with ovarian cancer.

OBJECTIVE: Long-term outcomes for women with ovarian cancer are improved when they are treated at high volume hospitals by high volume surgeons. We examined changes over time in surgeon and hospital procedural volume for ovarian cancer and explored the association between volume and perioperative outcomes. METHODS: The New York Statewide Planning and Research Cooperative System (SPARCS) database was used to examine women with ovarian cancer who underwent surgery from 2000 to 2014. Annualized surgeon and hospital procedural volume were estimated and each grouped into quartiles. Changes over time in the annual number of surgeons and hospitals rendering care were estimated. The association between surgeon and hospital volume and perioperative morbidity and mortality were analyzed. RESULTS: We identified 25,044 patients treated by 2728 surgeons at 213 hospitals. The number of surgeons decreased from 598 surgeons with 1737 patients (mean cases = 3) in 2000, to 278 surgeons who operated on 1503 patients (mean cases = 5) (P < 0.001) in 2014, while the mean hospital volume rose from 10 cases to 15 cases over the same time period (P < 0.001). There was no difference in morbidity based on surgeon volume (RR = 0.99 for high vs .low volume; 95% CI, 0.91-1.07) while perioperative mortality rates decreased with increasing surgeon volume quartile from 2.6% to 1.9%, 1.3% and 1.3%, respectively (P < 0.001). Similarly, there was no association between hospital volume and morbidity (RR = 1.00; 95% CI, 0.88-1.15). In contrast, the mortality rate declined with volume quartile from 2.5% in the lowest volume quartile to 0.9% in the highest volume quartile (P < 0.001). CONCLUSION: The surgical care of women with ovarian cancer has been concentrated to a smaller number of surgeons and hospitals over time. There was a modest association between increased surgeon and hospital volume and decreased perioperative mortality.

Prevalence of nonfounder BRCA1/2 mutations in Ashkenazi Jewish patients presenting for genetic testing at a hereditary breast and ovarian cancer center.

BACKGROUND: Genetic assessment in Ashkenazi Jewish (AJ) patients often is limited to BRCA1/2 founder mutation testing. With access to time-efficient and cost-efficient multigene panel testing, some advocate expanding genetic testing in this population. However, to the best of the authors' knowledge, rates of nonfounder BRCA1/2 mutations and mutations in cancer-associated genes other than BRCA1/2 among AJ are not known. In the current study, the authors sought to assess the prevalence of mutations other than BRCA1/2 founder mutations among AJ patients undergoing genetic assessment. METHODS: The authors reviewed the medical records for all AJ patients who underwent genetic assessment at a single institution between June 2013 and December 2016. Mutations were categorized as 1) BRCA1/2 AJ founder mutations (BRCA1 185delAG, BRCA1 5382insC, or BRCA2 6174delT); 2) nonfounder BRCA1/2 mutations; or 3) mutations in non-BRCA1/2 cancer-associated genes. RESULTS: A total of 732 AJ patients underwent genetic assessment. Of these, 371 patients (51%) had a personal history of breast or ovarian cancer, 540 patients (73.8%) had a family history of breast cancer, and 132 patients (18%) had a family history of ovarian cancer. In the study population, 101 patients (13.8%) were found to have a pathogenic mutation, 78 patients (10.7%) had a BRCA1/2 founder mutation, 3 patients (0.4%) had a nonfounder BRCA1/2 mutation, and 20 patients (2.7%) had a mutation in a non-BRCA1/2 cancer-associated gene. Non-BRCA1/2 cancer-associated genes harboring mutations included RAD51D, TP53, mutS homolog 6 (MSH6), checkpoint kinase 2 (CHEK2), adenomatous polyposis coli (APC), and Fanconi anemia group C protein (FANCC). CONCLUSIONS: Among AJ patients found to have a pathogenic mutation on genetic assessment, approximately 22.8% had a mutation that would be missed with BRCA1/2 AJ founder mutation testing. Comprehensive multigene panel sequencing can provide clinically relevant genetic information for AJ patients and should be considered for genetic assessment in this population.

Impact of hospital volume on racial disparities and outcomes for endometrial cancer.

OBJECTIVE: Little is known about the influence of hospital procedural volume on racial disparities for uterine cancer. We examined whether the magnitude of the survival differential between black and white women varied based on hospital procedural volume for endometrial cancer. METHODS: We utilized the National Cancer Data Base to examine women with endometrial cancer from 1998 to 2012. Annualized hospital procedural volume was calculated and hospitals grouped into volume-based quartiles. Multivariable models were developed to examine differences in two and five-year survival between black and white women across the hospital volume categories. Patients were classified as early or advanced stage and as type I (low grade, endometrioid) or type II (high grade endometrioid, other histologies) cancers. RESULTS: We identified 243,422 (75.0%) white and 27,764 (8.6%) black women treated at 1059 hospitals. Regardless of hospital volume, black women had decreased survival. For each tumor class, the absolute difference in adjusted two-year survival between black and white women decreased with increasing hospital volume. For example, for women with early-stage, type I tumors, the adjusted two-year survival differential between blacks and whites was -1.4% (95%CI, -2.4 to -0.5%) at low volume centers and decreased to -0.5% (95%CI, -0.9 to 0%) at high-volume hospitals (P<0.0001). For advanced stage, type I tumors, the adjusted survival differential decreased from -12.4% (95%CI, -24.0 to -0.9%) to 1.2% (95%CI, -2.9 to 5.3%) at high volume hospitals (P<0.0001). CONCLUSION: Black race is an independent predictor of mortality. The impact of race on mortality is mitigated, albeit not eliminated, by increasing hospital volume.

Racial disparities in treatment of high-grade endometrial cancer in the Medicare population.

OBJECTIVE: To examine the patterns of care and survival for African American and white women with high-grade endometrial cancer. METHODS: The linked Surveillance, Epidemiology, and End Results and Medicare databases were queried to identify patients diagnosed with grade 3 endometrioid endometrial adenocarcinoma, uterine carcinosarcoma, uterine clear cell carcinoma, and uterine serous carcinoma between 1992 and 2009. The effect of treatment modality on survival was analyzed using the Kaplan-Meier method. Factors predictive of outcome were compared using the Cox proportional hazards model. RESULTS: A total of 9,042 patients met study eligibility criteria. African Americans had definitive surgery (76.8% compared with 88.7%; P<.001) less frequently. There was no difference in the rate of adjuvant treatment between the groups. In the crude models for both all-cause mortality and cancer-specific mortality, African American women had an increased overall and disease-specific hazard of death compared with white women. The overall hazard ratio for African American women was 1.6 (95% confidence interval [CI] 1.5-1.7), and the disease-specific hazard ratio was 1.5 (95% CI 1.3-1.6). Over the entire study period, after adjusting for stage, age, period of diagnosis, registry region, urban compared with rural setting, marital status, treatment, surgery, socioeconomic status, and comorbidities, there was no association between race and lower disease-specific survival (hazard ratio 1.1, 95% CI 1-1.2; P=.06). CONCLUSION: African American women had lower cancer-specific and all-cause survival compared with white women. Controlling for treatment, sociodemographics, comorbidities, and histopathologic variables eliminated the difference between African American and white women in the disease-specific analysis.

Adnexal mass in the postmenopausal patient.

The adnexal mass in a postmenopausal patient poses an important diagnostic and management dilemma for primary care providers and gynecologists. Postmenopausal women are at a significantly increased risk of gynecologic malignancy; yet even in this population the majority of adnexal masses are benign. Evaluation and management of these lesions centers on the identification of malignancy, especially ovarian cancer, while avoiding unnecessary intervention in patients with benign lesions. Tumor markers and imaging can help in the evaluation of adnexal mass in postmenopausal women. Transvaginal ultrasound has long been considered the imaging modality of choice for the evaluation of adnexal masses. Particularly in the setting of high frequency utilization of transvaginal probes, which project high quality images allowing for detailed descriptions of the macroscopic appearance of the mass, and remains the least expensive of all imaging modalities currently available. For adnexal masses that are highly suspicious for cancer, women should be referred a gynecologic oncologist and facility for optimal care.