An Intervention-Based Approach to Achieve Racial Equity in Gynecologic Oncology.

Racial inequities within gynecologic oncology exist at every step of the cancer continuum. Although the disparities have been well described, there is a significant gap in the literature focused on eliminating inequities in gynecologic cancer outcomes. The goal of this narrative review is to highlight successful, evidence-based interventions from within and outside of gynecologic oncology that alleviate disparity, providing a call to action for further research and implementation efforts within the field. These solutions are organized in the socioecologic framework, where multiple levels of influence-societal, community, organizational, interpersonal, and individual-affect health outcomes.

Understanding Perceived Barriers to Colposcopy Follow-Up Among Underserved Women at an Urban Teaching Hospital: A Qualitative Study.

OBJECTIVE: Loss to follow-up after abnormal cervical cancer screening disproportionately impacts underserved populations. Our objective was to identify perceived barriers to follow-up after abnormal Pap smear among underserved women. METHODS: Women with abnormal Pap smear presenting for colposcopy at an urban teaching hospital were asked to participate in qualitative interviews. A topic guide was developed to assess knowledge about cervical cancer screening and perceived barriers to follow-up. A demographic survey was completed and interviews were recorded and transcribed. Responses were coded and placed into a framework: intrapersonal, interpersonal, and community barriers. Major themes and subthemes were identified. Demographic data were reported descriptively. RESULTS: Of 24 women enrolled, 18 (75%) completed full interviews. Median age was 38 years (range = 21-64). Participants were racially diverse: 10 (56%) Hispanic, 7 (39%) non-Hispanic White, 1 (5.5%) non-Hispanic Black, and 1 (5.5%) Asian, and all had public insurance. Seven (39%) presented for their 1st colposcopy visit and 11 (61%) had previous visits. Seventeen (94%) had a positive human papillomavirus test and 7 (39%) had atypical squamous cells of undetermined significance. The most common themes identified were related to knowledge gaps, including lack of understanding of Pap smears/human papillomavirus and cervical cancer risk factors. Most participants were satisfied with provider communication but dissatisfied with communication with the office, like scheduling appointments. CONCLUSIONS: Despite positive patient perception of physician communication, knowledge was most commonly identified as a barrier to colposcopy follow-up. Implementing a web-based intervention addressing knowledge gaps may improve abnormal cervical cancer screening follow-up among this population.

Relative importance of individual insurance status and hospital payer mix on survival for women with cervical cancer.

OBJECTIVE: To assess the relative contributions of individual insurance status and hospital payer mix (safety net status) to quality of care and survival for patients with cervical cancer. METHODS: We used the National Cancer Database to identify patients with cervical cancer diagnosed from 2004 to 2017. Patients were classified by insurance (uninsured/Medicaid/private/Medicare/other) and hospitals were grouped into quartiles based on the proportion of uninsured/Medicaid patients (payer mix) (top quartile defined as safety-net hospital (SNHs) and lowest as Q1 hospitals). Quality-of-care was assessed by adherence to evidence-based metrics. Individual contributions of insurance status and payer mix to survival was assessed with a proportional hazards Cox model. RESULTS: A total of 124,339 patients including 11,338 uninsured (9.1%) and 27,281 Medicaid (21.9%) recipients treated at 1156 hospitals were identified. Quality-of-care was not significantly different across hospital quartiles. Adjusting for patients' clinical/demographic characteristics, treatment at a SNH was associated with a 14% higher mortality (HR = 1.14; 95% CL, 1.08-1.20) than at Q1 hospitals. Testing for individual insurance, uninsured patients had 32% increased mortality (HR = 1.32; 95% CI,1.26-1.38) and Medicaid recipients 40% increased (HR = 1.40; 95%CI,1.35-1.44) compared to privately insured patients. Examining both payer mix and insurance, only individual insurance retained a significant impact on mortality. CONCLUSIONS: Individual insurance may be a more important predictor of survival than site-of-care and hospital payer mix for women with cervical cancer. There is substantial variation in outcomes within hospitals based on individual insurance, regardless of hospital payer mix.

Room for improvement in capturing cancer family history in a gynecologic oncology outpatient setting.

The literature demonstrates that the quality of cancer family history (CFH) as currently collected in the outpatient setting is inadequate to assess disease risk. Prior to implementation of a web-based application for cancer family history collection, we aimed to review the quality of collected CFH in a gynecologic oncology outpatient clinic and determine contributing patient factors. Medical records were reviewed for 200 new patients presenting between 4/2019-7/2019. CFH was collected during the patient interview and evaluated for inclusion of eight elements based on standards set by the genetics community. Univariate and multivariable linear regression analyses were utilized to evaluate the effect of patient characteristics on the number of relatives included in the CFH. Among our cohort of 200 patients, CFH was documented for 185 patients (92.5%). On univariate analysis, patients with a family history of cancer and prior genetic testing had significantly greater median number of relatives included in the CFH. On multivariable analysis, patients with family members with cancer had significantly more relatives included. Our data are consistent with the literature, suggesting that the current collection methods may not adequately capture all measures of a high quality CFH. Patients reporting no family history of cancer and those without prior genetic testing were least likely to have CFH that included key quality elements and these patients might benefit from health information technology CFH collection tools.

Patterns of use and outcomes of adjuvant bevacizumab therapy prior to regulatory approval in women with newly diagnosed ovarian cancer.

PURPOSE: We used real-world claims data to assess the utility of the relatively novel therapeutic bevacizumab in patients with newly diagnosed ovarian cancer in the United States after release of clinical data but prior to FDA approval. METHODS: We used the IQVIA Pharmetrics Plus commercial claims database to identify women with a new diagnosis of ovarian cancer who underwent primary surgery or neoadjuvant chemotherapy followed by interval surgery from 2006 to 2018. We calculated the rate of use of bevacizumab, and the relative frequency of hospital and emergency department (ED) admissions. Treatment-related toxicities, and time to second line chemotherapy were calculated. RESULTS: Among 8923 women who met study parameters, 533 (6.0%) received bevacizumab. The rate of use increased over time from 1.5% in 2006 to 7.0% in 2017 (P < 0.001), with a peak of 8.6% in 2011. The use was lowest in those ≥ 70 years old (2.8%), and in the West (4.5%), and was unaffected by number of comorbidities. Over one third (35.1%) received bevacizumab for less than 3 months, and 15.9% remained on it for greater than 13 months. Bevacizumab use was not associated with hospitalization or ED admission. Toxicities included hypertension (15.0%), kidney damage (6.8%), bleeding (3.8%), venous thrombo-embolism (2.3%) and fistula (1.1%). Time from initiation of first line chemotherapy to initiation of second line therapy was 19.9 months without bevacizumab and 22.6 months with bevacizumab use. CONCLUSIONS: Real-world patterns of upfront bevacizumab use prior to FDA approval in 2018 differed significantly from trial data.

Precision medicine testing in ovarian cancer: The growing inequity between patients with commercial vs medicaid insurance.

INTRODUCTION: Precision medicine technologies have significant impact in the care of patients with ovarian cancer. Compared to affluent patients, socioeconomically vulnerable patients are less likely to have access to this testing. There is little data that demonstrate this inequity over time. METHODS: We used the IBM Truven Health MarketScan Research Database to identify patients in the United States who underwent surgery for ovarian cancer between 2011 and 2017. The presence of claims for precision medicine testing within six months of surgery was assessed for each patient. Precision medicine testing included both molecular genetic testing (BRCA limited or full sequencing, somatic and germline testing) as well as ancillary pathology tests (immunohistochemistry, microsatellite instability). Demographic data was extracted. RESULTS: We identified 27,181 patients who met eligibility. Of these, 88.6% had commercial insurance, and 11.4% had Medicaid. While the proportion of patients who underwent precision medicine testing increased over time for both cohorts (47.0% to 66.6% for commercially insured, 41.4% to 57.6% for Medicaid insured, p < 0.0001), the inequity in testing rates widened (5.6% disparity to 9.0%, p < 0.0001). This was driven by growing inequity in germline and somatic genetic testing (7.6% disparity to 21.3%, p < 0.0001). CONCLUSIONS: There is widening inequity in precision medicine testing rates between commercially insured and Medicaid insured poate patients with ovarian cancer.

The Role of Minimally Invasive Surgery in the Care of Women with Ovarian Cancer: A Systematic Review and Meta-analysis.

OBJECTIVE: To synthesize evidence from studies investigating survival outcomes for patients with ovarian cancer undergoing minimally invasive surgery (traditional or robotic laparoscopy) compared with those for patients with ovarian cancer undergoing laparotomy. DATA SOURCES: We searched Ovid MEDLINE and Embase (from inception to December 2019). METHODS OF STUDY SELECTION: Observational cohort studies and randomized controlled trials that compared risk of recurrence or death between women undergoing minimally invasive and open procedures for staging (10), interval cytoreduction (4), secondary cytoreduction (2), and evaluation of resectability (1) were included. TABULATION, INTEGRATION, AND RESULTS: Data on the number of participants, number of deaths and recurrences, and results of analyses of overall or progression-free survival were abstracted for all studies. A random-effects meta-analysis was used to pool the results of studies comparing minimally invasive staging and open staging. The surgical approach (minimally invasive versus open) was not significantly associated with hazard of death or recurrence (pooled hazard ratio 0.92; 95% confidence interval, 0.61-1.38) or all-cause mortality (pooled hazard ratio 0.96; 95% confidence interval, 0.49-1.89). One randomized trial demonstrated that diagnostic laparoscopy could triage patients to neoadjuvant chemotherapy and avoid suboptimal primary surgery, without affecting recurrence-free or overall survival. Most studies included in this review were observational and at high risk for bias, and few studies accounted for potential confounding. CONCLUSION: Although existing studies do not demonstrate deleterious survival effects associated with minimally invasive surgery for ovarian cancer, these data must be viewed with caution given the significant methodologic shortcomings in the existing literature.

Gynecologic oncology care during the COVID-19 pandemic at three affiliated New York City hospitals.

BACKGROUND: New York City was among the epicenters during the COVID-19 pandemic. Oncologists must balance plausible risks of COVID-19 infection with the recognized consequences of delaying cancer treatment, keeping in mind the capacity of the health care system. We sought to investigate treatment patterns in gynecologic cancer care during the first two months of the COVID-19 pandemic at three affiliated New York City hospitals located in Brooklyn, Manhattan and Queens. METHODS: A prospective registry of patients with active or presumed gynecologic cancers receiving inpatient and/or outpatient care at three affiliated New York City hospitals was maintained between March 1 and April 30, 2020. Clinical and demographic data were abstracted from the electronic medical record with a focus on oncologic treatment. Multivariable logistic regression analysis was explored to evaluate the independent effect of hospital location, race, age, medical comorbidities, cancer status and COVID-19 status on treatment modifications. RESULTS: Among 302 patients with gynecologic cancer, 117 (38.7%) experienced a COVID-19-related treatment modification (delay, change or cancellation) during the first two months of the pandemic in New York. Sixty-four patients (67.4% of those scheduled for surgery) had a COVID-19-related modification in their surgical plan, 45 (21.5% of those scheduled for systemic treatment) a modification in systemic treatment and 12 (18.8% of those scheduled for radiation) a modification in radiation. Nineteen patients (6.3%) had positive COVID-19 testing. On univariate analysis, hospital location in Queens or Brooklyn, age ≤65 years, treatment for a new cancer diagnosis versus recurrence and COVID-19 positivity were associated with treatment modifications. On multivariable logistic regression analysis, hospital location in Queens and COVID-19 positive testing were independently associated with treatment modifications. CONCLUSIONS: More than one third of patients with gynecologic cancer at three affiliated New York City hospitals experienced a treatment delay, change or cancellation during the first two months of the COVID-19 pandemic. Among the three New York City boroughs represented in this study, likelihood of gynecologic oncology treatment modifications correlated with the case burden of COVID-19.

Clinicopathologic features of endometrial cancer with mismatch repair deficiency.

The inclusion of DNA mismatch repair (MMR) evaluation as a standard of care for endometrial cancer management will result in a growing population of patients with MMR deficiency and negative germline Lynch syndrome testing (MMR-deficient). In this systematic review and study, the clinicopathologic features of endometrial cancer in patients with MMR-intact, MLH1 methylation positive, MMR-deficient or Lynch syndrome are evaluated. A systematic search of online databases between 1990 and 2018 identified studies of endometrial cancer patients with tumour testing (MMR protein immunohistochemistry or microsatellite instability) and germline assessment for Lynch syndrome. Extracted data included tumour testing, germline genetic testing, age, body mass index (BMI), family history, tumour stage, grade and histologic type. Associations between MMR-intact, MLH1 methylation positive, MMR-deficient and Lynch syndrome groups were analysed using descriptive statistics. The comprehensive search produced 4,400 publications, 29 met inclusion criteria. A total of 7,057 endometrial cancer cases were identified, 1,612 with abnormal immunohistochemistry, 977 with microsatellite instability. Nine-hundred patients underwent germline genetic testing, identifying 212 patients with Lynch syndrome. Patients in the Lynch syndrome and MMR-deficient groups were significantly younger than patients in the MMR-intact and MLH1 methylation positive groups. Patients with MMR-intact tumours had the highest BMI, followed by MMR-deficient, then Lynch syndrome. MMR-intact tumours were more likely to be grade I at diagnosis than other groups. Patients with Lynch syndrome and MMR-deficient tumours were less likely to have stage I disease as compared to patients with MMR-intact tumours. Endometrial cancer patients with MMR-deficient tumours have similar features to those with germline Lynch syndrome mutations, including age, grade, histology and stage. Even in the absence of a germline mutation, tumour evaluation for MMR status may have important clinical implications.

Is hysterectomy necessary for the treatment of preinvasive stratified mucin producing intraepithelial lesions of the cervix?

OBJECTIVES: Stratified mucin producing intraepithelial lesion (SMILE) is an uncommon premalignant cervical intraepithelial lesion, characterized by histopathologic features resembling those observed in high grade squamous intraepithelial lesions and adenocarcinoma in situ of the cervix. Its hybrid morphology poses a pathologic challenge with no specific management guidelines. The goal of this study was to review the natural history of SMILE and treatment based outcomes. METHODS: A retrospective pathology review of all cases of cervical intraepithelial lesions, with confirmation of all SMILE lesions, at one institution between 2007 and 2019, was performed. Clinical and pathologic characteristics, management options, and patient outcomes were reviewed and analyzed. Inclusion criteria included all patients diagnosed initially with SMILE on biopsy, excisional procedure, or simple hysterectomy. Patients diagnosed with SMILE had to fulfill the following pathologic features: stratified columnar epithelium with nuclear atypia and mucin production throughout the epithelial thickness with increased mitotic activity, and/or apoptotic bodies. Pathologic slides were re-evaluated by a pathologist to confirm the diagnosis and review margin status. RESULTS: 24 patients with SMILE were identified. Mean age at diagnosis was 36.2 years (range 25-53) with 67% (16/24) diagnosed before the age of 40. The majority (54%, 13/24) were nulliparous and 63% (15/24) had a past history of abnormal Pap smears. 92% (22/24) of patients were positive for high risk human papillomavirus, with 13% (n=3) presenting with a normal Pap smear. Diagnosis was made primarily on colposcopy (n=16), cold knife cone/loop electrosurgical excision procedure (n=7), or hysterectomy (n=1). Most patients (71%, 17/24) had a co-existing precancerous lesion at the time of diagnosis and the most common was high grade squamous intraepithelial lesion (53%). Five invasive lesions were also identified at the time of diagnosis of SMILE (2 adenocarcinoma, 3 adenosquamous), 1 of which underwent chemoradiation. Among all patients, 25% (6/24) underwent hysterectomy (4 simple, 2 radical), while 63% (17/24) of patients underwent a fertility sparing excisional procedure; 4% (1/24) were incidentally diagnosed on hysterectomy. 18 patients had negative margins and 2 patients had positive margins. Over a median follow-up of 29 months (range 3-105), all of the fertility sparing patients with negative margins had no recurrence. Among the two patients with positive margins, one had no recurrence on repeat excision and the other underwent repeat excision with persistent SMILE identified, subsequent negative margin, and no recurrence since. DISCUSSION: Our data showed that most patients with SMILE were young, positive for high risk human papillomavirus, nulliparous, and presented with coexisting lesions. Excisional procedures with negative margins may be sufficient fertility sparing treatment in patients with preinvasive SMILE with a low risk of recurrence. There should be consideration of hysterectomy at the completion of childbearing.

Caring for Patients With Uterine Cancer in Rural and Public Hospitals in New York State.

OBJECTIVE: To evaluate perioperative outcomes for women with uterine cancer undergoing hysterectomy at rural and public hospitals in New York State. METHODS: The New York Statewide Planning And Research Cooperative System database was used to identify women with uterine cancer who underwent hysterectomy from 2000 to 2015. Perioperative complications, inpatient mortality, and resource utilization were compared at rural, public and private hospitals. Multilevel mixed effect log-linear models were developed to evaluate the association between hospital type and outcomes of interest. Patient characteristics, hospital and surgeon clustering were accounted for within the model. RESULTS: Over the years studied, there were 193 hospitals that cared for 46,298 women with uterine cancer. Of these, 9.8% were public, 15.0% were rural, and 75.1% were private metropolitan. They cared for 11.0%, 2.2% and 86.8% of patients, respectively. The proportion of patients cared for at rural hospitals decreased significantly from 5.2% in 2000 to 0.6% in 2014 (P<.001). There was no change in the volume of patients cared for at public hospitals (11.3 to 10.3%, P>.05). In a multivariable model adjusting for patient risk, there were no significant differences in perioperative morbidity, transfusion and length of stay across the three hospital types (P>.05). Compared with private hospitals, treatment at a rural hospital was associated with increased inpatient mortality (adjusted risk ratio 4.03, 95% CI 1.02-15.97). CONCLUSION: In New York State, operative uterine cancer care is shifting away from rural hospitals. Public hospitals have similar risk-adjusted outcomes compared with private metropolitan facilities.

Quality of Care and Outcomes of Patients With Gynecologic Malignancies Treated at Safety-Net Hospitals.

BACKGROUND: Although safety-net hospitals (SNH) provide a valuable role serving vulnerable patients, the quality of gynecologic oncology care at these hospitals remains inadequately documented. We examined the quality of care at SNH for women with gynecologic cancers. METHODS: We used the National Cancer Database to identify hospitals that treated patients with uterine, ovarian, or cervical cancer from 2004 to 2015. Hospitals with the greatest proportion of uninsured patients or Medicaid beneficiaries were defined as SNH. Quality metrics were derived from evidence-based recommendations. Thirty-day mortality, readmission rates, and 5-year survival were calculated. Multivariable models were developed to determine the association between treatment at SNH and outcomes. RESULTS: Overall, 594 750 patients diagnosed with gynecologic cancer were treated at 1340 hospitals. Compared with non-SNH, patients at SNH were younger, more frequently racial minorities, low income, and had more aggressive histologies and advanced-stage tumors. SNH had lower rates of minimally invasive surgery for uterine cancer (62.3% vs 75.9%, P < .0001), debulking for ovarian cancer (83.6% vs 86.9%, P < .05), and lymph node assessment for all three cancer types (P < .05). Rates of chemotherapy for uterine and ovarian cancer was greater whereas concurrent chemoradiation for cervical cancer was lower (P < .05 for all). Thirty-day mortality and readmission rates were equivalent. Mortality was moderately worse for patients with stage IV ovarian cancer and stage II-III cervical cancer (P < .05) but were otherwise equivalent. CONCLUSIONS: After adjusting for patient and tumor characteristics, women with gynecologic cancers treated at SNH receive lower-quality surgical care and equivalent medical care and a subset of these patients has modest decreases in survival.

Cost Effectiveness of Risk-Reducing Mastectomy versus Surveillance in BRCA Mutation Carriers with a History of Ovarian Cancer.

BACKGROUND: The appropriate management of breast cancer risk in BRCA mutation carriers following ovarian cancer diagnosis remains unclear. We sought to determine the survival benefit and cost effectiveness of risk-reducing mastectomy (RRM) among women with BRCA1/2 mutations following stage II-IV ovarian cancer. DESIGN: We constructed a decision model from a third-party payer perspective to compare annual screening with magnetic resonance imaging (MRI) and mammography to annual screening followed by RRM with reconstruction following ovarian cancer diagnosis. Survival, overall costs, and cost effectiveness were determined by decade at diagnosis using 2015 US dollars. All inputs were obtained from the literature and public databases. Monte Carlo probabilistic sensitivity analysis was performed with a $100,000 willingness-to-pay threshold. RESULTS: The incremental cost-effectiveness ratio (ICER) per year of life saved (YLS) for RRM increased with age and BRCA2 mutation status, with greater survival benefit demonstrated in younger patients with BRCA1 mutations. RRM delayed 5 years in 40-year-old BRCA1 mutation carriers was associated with 5 months of life gained (ICER $72,739/YLS), and in 60-year-old BRCA2 mutation carriers was associated with 0.8 months of life gained (ICER $334,906/YLS). In all scenarios, $/YLS and mastectomies per breast cancer prevented were lowest with RRM performed 5-10 years after ovarian cancer diagnosis. CONCLUSION: For most BRCA1/2 mutation carriers following ovarian cancer diagnosis, RRM performed within 5 years is not cost effective when compared with breast cancer screening. Imaging surveillance should be advocated during the first several years after ovarian cancer diagnosis, after which point the benefits of RRM can be considered based on patient age and BRCA mutation status.

Low-hanging fruit: a clementine as a simulation model for advanced laparoscopy.

INTRODUCTION: Low-cost, high-fidelity models for training in advanced laparoscopic surgery techniques are not currently available. The objective of this study was to evaluate a model and assessment protocol for developing associated fine, precise laparoscopic dissection skills with accompanying surgical decision making. METHODS: Novice to expert laparoscopists (n = 41) were asked to remove the peel of a clementine in as few pieces as possible, separate and remove all albedo from and between all fruit segments, and return the clementine to as close to its natural state as possible with completely closed skin (sutured). Clinical decision making included deciding when unacceptable segment damage would result by removing difficult-to-extract albedo, analogous to treating lesions or metastases through other methods, rather than risking damage to vital anatomic structures. Faculty assessed deidentified video-recorded performances. Data analyses included analysis of variance with Bonferroni post hoc. RESULTS: A single-performance construct (operative ability) with 2 scoring dimensions (surgical skills and clinical judgment) was confirmed through factor analysis. There were significant performance differences between all experience levels (F2,41 = 59.175, P < 0.000). There were no statistical time differences between the groups. CONCLUSIONS: Validation of this low-cost, easily facilitated model for developing advanced laparoscopic surgical skills may support the preparation of residents and fellows and provide a platform for skill acquisition, assessment, and basic critical thinking for performing laparoscopic tasks.