Are ethnic and racial minority women less likely to participate in clinical trials?

OBJECTIVES: Given the disparity that exists in enrollment of minorities to oncology clinical trials, the objective of our study was to assess whether race is associated with willingness to participate in gynecologic oncology clinical trials in a rural Southern academic medicine setting. Our secondary aim was to determine whether willingness to participate is impacted by an educational intervention. METHODS: A single institution prospective survey study was performed at an academic medical center. Women presenting to the gynecologic oncology clinic with a current or prior diagnosis of gynecologic malignancy were approached to participate. The validated Attitudes to Randomized Trials Questionnaire (ARTQ) assessed willingness to participate in clinical trials. Relevant demographic and clinical data were abstracted. Characteristics were compared between those willing and unwilling to participate in clinical trials with a chi-square test for categorical variables and Wilcoxon rank sum tests for continuous data. RESULTS: We enrolled 156 participants (50% White, 50% non-White) from May 2017 to January 2018. The minority group included 35% non-Hispanic Black, 9% Hispanic, 4% Asian, and 2% other. Median age was 63 years with endometrial cancer being the most common diagnosis (48%). On initial screen, only 35% were willing to participate in a clinical trial. Willingness to participate did not differ between race, age, marital status, education level, cancer type, stage, or mode of treatment. Rates improved to 82% after being provided additional educational information. Following education, White women and those with more education were significantly more willing to participate in clinical trials than their minority and less educated counterparts. CONCLUSIONS: Willingness to participate improved among all sub-categories following an educational intervention. The increase in willingness was less robust among racial and ethnic minorities, suggesting that different tools are needed for recruitment of minorities to gynecologic oncology clinical trials.

Cardiometabolic comorbidities and epithelial ovarian cancer risk among African-American women in the African-American Cancer Epidemiology Study (AACES).

BACKGROUND: Studies that have examined the association between cardiovascular comorbidities and epithelial ovarian cancer (EOC) have yielded inconsistent results. It remains unknown whether cardiometabolic disease is associated with EOC in African American (AA) women, who have a higher prevalence of cardiovascular disease and lower risk of EOC than White women. Here, we estimate the effect of cardiovascular comorbid conditions and EOC risk among AA women. METHODS: Data were available from 593 ovarian carcinoma patients and 752 controls enrolled in the African American Cancer Epidemiology Study (AACES). Participants were asked to self-report a history of hypertension, hyperlipidemia, and diabetes and any current medication use. The relationship between hypertension, hyperlipidemia, diabetes, and medications taken for these conditions was determined using multivariate logistic regression. RESULTS: Hypertension was associated with an increased risk (adjusted odds ratio (aOR) = 1.32, 95% confidence interval (CI) = 1.01, 1.73), whereas diabetes and hyperlipidemia were associated with a decreased risk (aOR = 0.67, 95% CI = 0.49, 0.91 and aOR = 0.61, 95% CI = 0.47, 0.80, respectively) of EOC. Use of anti-diabetic medication was inversely associated with EOC risk, as was use of lipid lowering medications (in the overall study population), which were predominantly statins. Among women with hypertension, use of anti-hypertensive medications was inversely associated with EOC risk, with associations that were most pronounced for diuretics, ARBs and ACE inhibitors. CONCLUSION: Hypertension was associated with an increased EOC risk in this patient population, whereas an inverse association was observed for diabetes and hyperlipidemia. The decreased risk of EOC identified with use of anti-hypertensive, anti-diabetes or lipid-lowering medications could have implications for risk reduction strategies.

Prognostic role of pathologic response and cytoreductive status at interval debulking surgery after neoadjuvant chemotherapy for advanced epithelial ovarian cancer.

BACKGROUND: We sought to determine if complete pathologic response (cPR) and cytoreductive status at interval debulking surgery (IDS) after neoadjuvant chemotherapy (NACT) are associated with improved clinical outcomes in ovarian cancer. METHODS: We evaluated 91 patients with advanced ovarian cancer who underwent NACT and IDS. Pathologic response, cytoreductive status, and outcomes were determined. Descriptive statistics, bivariate analysis, and Kaplan-Meier survival probabilities were calculated. RESULTS: cPR occurred in 9 (10%), microscopic pathologic response (microPR) in 18 (20%), and macroscopic pathologic response (macroPR) in 64 (70%) patients. Median progression-free survival (PFS) for patients with cPR was significantly improved compared with patients with any pathologic residual disease (microPR/macroPR; undefined vs 10.9 months, P = .01); whereas, microPR was not associated with significantly improved PFS compared with macroPR (16.3 months vs 10 months, P = .08). Cytoreduction to no gross residual disease was associated with improved PFS (undefined vs 7.5 months vs 5.5 months, P < .01) and overall survival (undefined vs 38.7 months vs 12 months, P < .01) compared with visible residual disease less than or equal to 1 cm or suboptimal. CONCLUSIONS: cPR is uncommon (10%) after NACT for advanced ovarian cancer. Better pathologic response and cytoreductive status are associated with improved PFS, emphasizing the importance of both chemotherapy response and surgical effort.

An educational intervention to improve human papilloma virus (HPV) and cervical cancer knowledge among African American college students.

OBJECTIVES: Misinformation and lack of formal education about cervical cancer may contribute to disparities. The objective of this study was to assess the role of an educational intervention in improving knowledge about Human papilloma virus (HPV) and cervical cancer among African American female college students. METHODS: We completed a total of 5 lectures at 4 different historically Black Colleges in North Carolina, Virginia, and West Virginia. Each 60min lecture reviewed basic female anatomy, HPV pathogenesis, cervical dysplasia, cervical cancer, HPV vaccination and cervical cancer screening. Participants completed pre- and post-lecture surveys assessing knowledge, attitudes and beliefs related to cervical cancer screening, HPV, and the HPV vaccine. RESULTS: A total of 72 students attended the lectures and 57 students completed the surveys. 96% of students reported knowledge of the HPV vaccine, however only 52% reported receiving the vaccine, and 42% completed the 3-shot series. About 77% of students over 21years of age reported having a Pap smear. Of the 16 knowledge-based questions, correct response rates significantly increased (74% v. 91%, p=0.005) with the intervention. At the completion of the intervention, 94% affirmed plans to get regular Pap smears and 87% affirmed plans to get the HPV vaccine. CONCLUSIONS: Primary prevention and early detection are key interventions for reducing disparities in cervical cancer incidence and treatment. Community outreach efforts play an important role in reducing inequities in cancer among high-risk groups. The educational intervention utilized in this study was successful in improving knowledge about HPV and cervical cancer.

Evaluating the risk of post-operative abscess formation following use of hemostatic agents at time of hysterectomy.

Objective: At an academic institution in rural Virginia, we noticed a trend of increased re-admissions for postoperative pelvic abscesses. The primary study objective was to determine if intraoperative use of hemostatic agents (HA) was associated with postoperative abscess formation in patients undergoing hysterectomy. Methods: Retrospective chart review identified women who underwent hysterectomy by a Gynecologic Oncologist for any indication at a single institution from January 1, 2019 through December 31, 2019. Patient and surgical characteristics were abstracted and comparisons were made among those who received any HA and those that did not. The relationship between intraoperative HA use and postoperative pelvic abscess formation was determined using multivariate logistic regression. Secondary outcomes evaluated included the presence of other major post-operative adverse events. Results: 428 hysterectomies were identified with a postoperative pelvic abscess rate of 3.7 %. Abscesses were identified in 4 (2.2 %) of cases without vs 12 (4.9 %) of cases with HA use with a logistic regression model demonstrating no significant difference in the groups (OR = 2.10, p = 0.22). Data showed an increase in presentation to the Emergency Department (ED) (OR = 3.43, p = 0.002 adjusted) and higher odds of readmission within 30 days of surgery (OR = 3.19, p = 0.03) with HA use. Conclusions: No association was found between HA use and abscess formation; however, data showed HA use was associated with increased odds of presentation to the ED and readmission to the hospital within 30 days of surgery. Given the potential negative impact on patient outcomes, use of these products at time of hysterectomy should be made with careful consideration.

Exploring socio-demographic and geospatial variation in human papillomavirus vaccination uptake in Virginia.

Significant variation in human papillomavirus (HPV) vaccine coverage exists across the United States. A closer look at state and region-specific coverage is necessary to identify potentially modifiable disparities. Using ArcGIS software, we identify geospatial variation in HPV vaccine coverage in the state of Virginia and examine the relationship between various socio-demographic indicators and HPV vaccination uptake. HPV vaccination rates among adolescents 11 to 17 years as of 07/01/2018 were retrieved at the zip-code level from the Virginia Immunization Information System and chloropleth maps produced. The ArcGIS Hot Spot Analysis tool identified spatial clusters of zip codes with high and low vaccination rates. Population characteristics and socioeconomic indicators were retrieved from the 2010 United States Census and compared between statistically significant clusters of higher or lower than expected vaccination rates. Regions with significantly lower initiation rates were less populated, less educated, and had a lower median household income (MHI) with higher rates of poverty and unemployment. Among male adolescents, these areas had a significantly lower density of primary care providers and smaller African American and Hispanic populations. In contrast, regions with significantly lower series completion were more populated and had a higher MHI, but there was no difference in provider density or minority population. Ultimately, regional socioeconomic indicators are significant predictors of HPV vaccination, but have contrasting implications for series initiation and completion. Targeted interventions and safety net programs have traditionally focused on the socioeconomically disadvantaged, however it is the more affluent communities that may be struggling with series completion.

Chemotherapy alone may have equivalent survival as compared to suboptimal surgery in advanced endometrial cancer patients.

OBJECTIVE: To describe outcomes in patients with advanced endometrial cancer treated with chemotherapy only and compare them to patients treated with a combination of chemotherapy and surgery. METHODS: Retrospective chart review for all patients diagnosed with stage III and IV endometrial cancer from January 1, 2000 to December 31, 2015. We abstracted relevant demographic and clinical data. Kaplan-Meier analysis was used to create survival curves; Cox proportional hazards regression model was used to identify prognostic factors. RESULTS: Ninety-six patients met inclusion criteria; the median age was 64.5. Seventy patients were treated with combination therapy and 26 with chemotherapy alone. For the entire group, median overall survival (OS) was significantly different between groups (22.3 months surgery versus 9.8 months chemotherapy only, p = 0.0002). After multivariable analysis, having carcinosarcoma (HR 3.84 95% CI 2.64-5.03, p = 0.03), having grade 3 disease (HR 4.95 95% CI 3.70-6.18, p = 0.01), and having chemotherapy only (HR 4.13 95% CI 3.23-5.02, p = 0.002) were associated with increased mortality. When analysis was restricted to just patients who had a suboptimal debulking or chemotherapy alone, median OS was equivalent similar at 9.4 and 9.8 months (p = 0.46). CONCLUSION: For advanced endometrial cancer patients, surgery in addition to chemotherapy confers a survival advantage except when optimal debulking cannot be achieved.

The role of pulmonary resection in the management of metastatic gestational trophoblastic neoplasia: Two cases of durable remission following surgery for chemo-resistant disease.

•GTN is typically a chemo-responsive and highly curative gynecologic malignancy.•Surgery may be beneficial in as many as 2/3 of patients with high-risk GTN.•In select patients, resection of drug-resistant pulmonary metastases is effective.

Cancer Screening and Prevention Highlights in Gynecologic Cancer.

This article provides an up-to-date summary of screening approaches and key strategies in prevention of gynecologic malignancies. The Pap smear is the only proven screening intervention in the field of gynecologic oncology. Women should receive treatment for precancerous conditions of the cervix, vulva, vagina, and endometrial lining. Women with inherited conditions should consider having a risk-reducing surgery once they have finished childbearing. The human papilloma virus vaccination should be offered to all girls and boys aged 11 to 12 years, and can also be given as early as age 9 and through 26 years of age.

Endometrial cancer in an increasingly obese population: Exploring alternative options when surgery may not cut it.

OBJECTIVES: The study objectives were to describe outcomes of obese patients with early endometrial cancer following primary non-surgical treatment, assess predictors of response, and estimate the increased surgical risk for these women. METHODS: Retrospective chart review identified women with early stage endometrial cancer at a single institution with BMI ≥ 30 kg/m2 who did not undergo surgery as primary treatment modality due to obesity and medical co-morbidities. Clinicopathologic factors were abstracted, characteristics of responders vs. non-responders compared and the National Surgical Quality Improvement Program (NSQIP) surgical risk calculator utilized to quantify surgical risks. RESULTS: Fifty-one patients were identified, with a mean BMI of 49.0 kg/m2. The NSQIP calculator predicted a significantly higher complication rate for our cohort compared to the expected average risk for hysterectomy (18.8% vs 7.2%, p < .0001). The majority of patients were treated with radiation alone (49%), followed by hormone therapy (45.1%). Response rates were 38.1% for women treated with hormones and 63.6% in the radiation group (p = .063). No significant differences were identified between responders and non-responders with regard to NSQIP scores, BMI, co-morbidities or age. Among those with persistent or progressive disease, 87.5% responded to secondary treatment. Only one death was from cancer progression. Two individuals died following treatment complications (one surgical, one chemotherapy); the remaining twelve deaths were due to pre-existing co-morbidities. CONCLUSIONS: Hormone and radiation therapy are both viable options for obese patients deemed to have too significant risk of surgical complications. Pursuing surgical intervention in this population may do more harm than good.

Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

Background: Low English fluency in large culturally diverse institutions may contribute to meager minority accrual. Our objective was to: 1) Assess knowledge of proper consenting procedures among the research team when consenting a low English fluency patient. 2) Assess the enrollment rate of participants in cancer therapeutic trials who identify a preferred language other than English. Methods: An anonymous web-based survey was distributed at a single institution to investigators, research staff and translator services to assess knowledge of consenting procedures. Patient enrollment data was retrieved from the clinical trials enrollment tracking system from January 2011 ­ October 2014 and matched to registration data indicating preferred language (N = 1521). The number and type of cancer cases from January 2011­October 2014 were retrieved from the institutional cancer registry and matched to registration data indicating preferred language. Results: Although there are many organizational in-person and web-based trainings focused on the requirements for consenting low English fluency patients, members of the research team responded correctly to only 64.8% (σ = 24.6%) of the knowledge-based portion of the survey. Of the 12,538 index cancer cases indentified, 10% preferred a language other than English. Trial enrollment rates for cancer clinical trials were similar for English (13%), Spanish (11%), and, Armenian (10%) speakers. Populations speaking Russian and Arabic had the lowest participation at 5% each. Conclusions: In order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages (AU)