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To assess, using a national surgical outcomes database, the association of various malnutrition definitions with post-operative morbidity in three gynecologic malignancies.Patients undergoing resection of ovarian, uterine, or cervical cancer between 2005 and 2019 were identified using the National Surgical Quality Improvement Program (NSQIP) database. Patients were classified based on specific, pre-defined malnutrition criteria: severe malnutrition (Body Mass Index (BMI)18.5 + 10% weight loss), European Society for Clinical Nutrition and Metabolism ((ESPEN1); BMI 18.5-22 + 10% weight loss), ESPEN2 (BMI18.5), American Cancer Society ((ACS); normal/overweight BMI + 10% weight loss), mild malnutrition (BMI 18.5-22), or albumin (3.5 g/dL). Outcomes included 30-day major complications, readmission, reoperation. Modified Poisson regression estimated associations between definitions and outcomes.Of 76,290 total patients undergoing surgery, those meeting malnutrition definitions were: severe-98 (0.1%), ESPEN1-148 (0.2%), ESPEN2-877 (1.1%), ACS-1028 (1.3%), mild-2853 (3.7%), and albumin (11.1%). Complication rates were: unplanned readmission-5.5%, reoperation-1.7%, major complications-13.5%. For ovarian cancer, ESPEN2 malnutrition was associated with higher readmissions (risk ratio 1.69; 95% confidence interval 1.29-2.20), reoperations (2.53; 1.70-3.77), and complications (1.36; 1.20-1.54). For uterine cancer, ACS malnutrition was associated with readmissions (2.74; 2.09-3.59), reoperations (3.61; 2.29-5.71) and complications (3.92; 3.40-4.53). For cervical cancer, albumin3.5 g/dL was associated with readmissions (1.48; 1.01-2.19), reoperations (2.25; 1.17-4.34), and complications (2.59; 2.11-3.17). Albumin3.5 was associated with adverse outcomes in ovarian and uterine cancer.Preoperative risk assessments might be tailored using cancer-specific malnutrition criteria. Major complications, readmissions, and reoperations are all associated with the ESPEN2 definition for ovarian cancer, the ACS definition for uterine cancer, and with albumin3.5 for all cancers.

Objective Accurate documentation is critical for patient care and hospital reimbursement. We sought to improve the accuracy of severity of illness (SOI) and risk of mortality (ROM) scores through implementation of documentation initiatives. Methods We performed a pre- versus post-implementation analysis to assess the impact of a documentation intervention bundle on calculated admission/discharge SOI/ROM scores on an inpatient gynecologic oncology service. Introduced in January 2017, the bundle included educational in-service, introduction of problem-based progress notes, a documentation tip ID badge and video, and weekly chart audits. Admission/discharge SOI/ROM scores (range 1–4) were obtained from hospital performance services. Demographics and 30-day mortality were collected from electronic medical records for all inpatients in historic (calendar year 2015) and intervention (2017) cohorts. Primary outcomes (discharge SOI/ROM) were modelled using ordinal and multinomial logistic regressions, controlling for confounders. 30-day observed/expected mortality ratios were reported for each cohort. Results 629 patients were included: 378 (60%) in 2015, 251 (40%) in 2017. Increased odds of having higher SOI score were observed in the intervention cohort for medical (OR = 2.22; 95% CI 1.38, 3.58) and surgical admissions (OR = 2.63; 95% CI 1.47, 4.40). Surgical (OR = 5.54; 95% CI 1.29, 23.96), but not medical (OR = 1.45; 95% CI 0.46, 4.57), admissions in the intervention cohort had higher odds of having the worst ROM score. Observed/expected mortality was 0.24 in the intervention compared to 0.37 in historic cohort (p = 0.58, NS). Conclusion An intervention bundle to improve physician documentation accuracy resulted in higher discharge SOI scores for medical and surgical admissions.

The objective of this study was to evaluate medical adherence for patients with ovarian cancer who initiated treatment with a PARP inhibitor therapy, and to identify factors associated with nonadherence.We used the MarketScan Database to identify ovarian cancer patients who initiated PARP inhibitor therapy between January 1, 2008 and December 31, 2017. The primary outcome was adherence defined as ≥ 80% proportion of days covered (PDC). A secondary outcome included adherence assessed using the medication possession ratio (MPR). Multivariable logistic regression analysis was performed to assess relation between PDC and explanatory variables. Sensitivity analysis was performed to evaluate impact of dose-adjustments and toxicity-related delays on adherence.Among 170,976 patients diagnosed with ovarian cancer, 151 patients met inclusion criteria. The median time from diagnosis to initiating therapy was 33 months. Overall, 40 (26.5%) were non-adherent based on a PDC less than 80%. Non-adherent patients were more likely to receive niraparib and have a longer duration of therapy (p 0.05). We found no significant impact of age, comorbidities, insurance plan, or year of PARP inhibitor initiation on non-adherence. In a sensitivity analysis to assess different definition of adherence, non-adherence ranged from 11.3% to 41.1%. When accounting for possible dose-adjustments, 21.2% of patients were non-adherent.This population based study of ovarian cancer patients found that a quarter of patients may be sub-optimally adherent to PARP inhibitor therapy. Future research should focus on identification of patients at risk for nonadherence and interventions to lower nonadherence among these patients.

Objectives The clinical utility of maintenance therapy (MT) for patients with platinum-sensitive recurrent ovarian cancer has been validated in several clinical trials. We assessed “real-world” treatment patterns using an electronic health record (EHR) database. Methods A retrospective study of patients diagnosed with ovarian cancer between January 1, 2011 and July 31, 2019 was conducted using the US nationwide Flatiron Health (EHR)-derived de-identified database. Patients were included if they received second- or third-line (2 L or 3 L) platinum-based chemotherapy (PBCT). Information regarding biomarker status was obtained. Results 2292 patients with ovarian cancer received at least two lines of therapy. 222 patients completed PBCT on or after March 1, 2017 and had ≥2 months of active surveillance or received MT with poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) or bevacizumab. 46 (20%) had BRCA mutations (BRCAm), 132 (59%) had a wildtype BRCA (BRCAwt) gene, and 47 (21%) were unknown. Of patients with BRCAm, 63% received a PARPi, 17% received bevacizumab, and 20% underwent active surveillance. Of patients with BRCAwt, 40% received a PARPi, 23% received bevacizumab, and 36% underwent active surveillance. MT was more common in those with younger age and a BRCA mutation. PARPi use increased on average by 1.3% every 3 months (p = .02) with no statistically significant change in use of bevacizumab. Conclusions In this real-world population, MT is becoming progressively more common following 2 L or 3 L PBCT regardless of biomarker status. The results provide insight into the shifting treatment patterns for patients with recurrent ovarian cancer.

Objectives: With rapidly rising health care costs, affordability is a major concern of cancer treatment and survivorship. We sought to determine the role oncologists believe they should play in decreasing costs and improving cancer care affordability. Methods: A survey was developed to assess oncologists’ attitudes toward affordability and assess whether a range of provider-based solutions to reduce financial toxicity for patients would be practical or acceptable to practicing clinicians. Attending physicians practicing clinical cancer care at an urban, academic, tertiary referral center, were emailed a voluntarily, anonymous survey. Surveys were administered via REDCap between February and March 2020. Four reminder emails were sent to encourage participation. Results: Of 851 eligible physicians, 346 completed the survey (41% response rate); 342 answered all questions (99% completion rate). A total of 118 (34%) were medical oncologists, 52 (15%) were surgical oncologists, 46 (13%) were radiation oncologists, 7 (2%) were neuro-oncologists, and 123 (36%) were other specialty oncologists. One hundred twelve (32%) were within 5 years of their terminal year of training, 165 (48%) were 6-25 years out, and 69 (20%) were more than 25 years out. One hundred eighty-eight (54%) were male. Of all participants, 308 (89%) indicated they believed that at least 20% of patients on active treatment have significant financial issues related to paying for their cancer treatment; 57 participants (16%) indicated they thought that at least 60% of patients may have this concern; 286 (83%) felt there was at least some way of either preventing or mitigating patient financial toxicity; 285 (82%) indicated they thought they should play an active role in minimizing financial toxicity; and 270 (78%) indicated they thought they should be aware of a patient's risk for financial toxicity prior to making treatment recommendations. Two hundred thirty-nine participants (70%) believed they could modify test or treatment plans to reduce costs for patients at high risk for financial burden if they knew, and 232 (67%) said they would modify their plans; this included 55 (24%) who would modify treatment dosing/frequency, 152 (66%) would change testing/imaging frequency, and 154 (67%) who would change follow-up interval. A total of 223 (65%) felt that national guidelines should incorporate patient affordability concerns when being developed. Only 76 (22%) had received any training on costs, affordability, or value-based care, and only 18 (5%) had received any training on cost conversations. Conclusions: Academic oncologists overwhelmingly believe they should play an active role in addressing affordability issues for patients, and the majority believe it is possible to reduce financial toxicity through various means. Provider-facing interventions to improve patient affordability may include proactively identifying patients at high risk for financial burden in order to create tailored plans to reduce their risk of high costs and resultant financial toxicity.

Objectives: During the COVID-19 pandemic, the Society of Gynecologic Oncology and other medical societies provided guidelines about acceptable delays in oncologic treatments for patients with a suspected malignancy. The objective of this study was to characterize the association between timing of treatment and survival and to evaluate how extended delays to guideline-concordant treatment for suspected stage I high grade serous ovarian cancer might impact survival. Methods: Using the National Cancer Data Base (2004-2015), patients surgically treated for clinical stage I high grade serous ovarian cancer were identified. Patients receiving surgery within 14 days of diagnosis were compared to those receiving surgery 2-4 months after diagnosis. The groups were propensity matched with 2:1 matching to balance baseline characteristics. Survival outcomes of the two cohorts were assessed using Kaplan-Meier analysis, the log-rank test, and multivariable Cox proportional hazards analysis. Results: During the study period, 10,957 patients underwent guideline-concordant surgery for stage I high-grade serous ovarian cancer within 14 days of diagnosis (early) and 171 patients underwent surgery 2-4 months following diagnosis (delayed). Between patients in the early versus delayed treatment groups, the delayed group was more likely to be Black (5.3% vs 11.8%, p=0.003) and have a smaller tumor size (8.0 vs. 6.2 cm, p Download : Download high-res image (81KB) Download : Download full-size image Conclusions: In this national analysis, extended delay of treatment for stage I high grade serous ovarian cancer was associated with similar survival outcomes when compared to timely treatment in pre-match and post-match cohorts. In the setting of the COVID-19 pandemic, where hospital resources may be limited, delays in surgery are concerning and prompt oncologic treatment is preferred; however, at least based on these retrospective data, delays in surgery for presumed stage I ovarian cancer may not be associated with significantly worse survival.

Objectives Clinical trials evaluating universal PARP inhibitor (PARPi) frontline maintenance therapy for advanced stage ovarian cancer have reported progression-free survival (PFS) benefit. It is unclear whether PARPi maintenance therapy will universally enhance value (clinical benefits relative to cost of delivery). We compared a “PARPi-for-all” to a biomarker-directed frontline maintenance therapy approach as a value-based care strategy. Methods The cost of two frontline PARPi maintenance strategies, PARPi-for-all and biomarker-directed maintenance, was compared using modified Markov decision models simulating the study designs of the PRIMA, VELIA, and, PAOLA-1 trials. Outcomes of interest included overall costs and incremental cost-effectiveness ratios (ICERs) reported in US dollars per quality adjusted progression-free life-year (QA-PFY) gained. Results PARPi-for-all was more costly and provided greater PFS benefit than a biomarker-directed strategy for each trial. The mean cost per patient for the PARPi-for-all strategy was $166,269, $286,715, and $366,506 for the PRIMA, VELIA, and PAOLA-1 models, respectively. For the biomarker-directed strategy, the mean cost per patient was $98,188, $167,334, and $260,671 for the PRIMA, VELIA, and PAOLA-1 models. ICERs of PARPi-for-all compared to biomarker-directed maintenance were: $593,250/QA-PFY (PRIMA), $1,512,495/QA-PFY (VELIA), and $3,347,915/QA-PFY (PAOLA-1). At current drug pricing, there is no PFS improvement in a biomarker negative cohort that would make PARPi-for-all cost-effective compared to biomarker-directed maintenance. Conclusions This study highlights the high costs of universal PARPi maintenance treatment, compared with a biomarker-directed PARPi strategy. Maintenance therapy in the front-line setting should be reserved for those with germline or somatic HRD mutations until the cost of therapy is significantly reduced.

Patient-reported outcomes (PRO) are defined as a report of a patient's symptoms, function and general well-being that comes directly from the patient, without interpretation of the response by a medical provider. As greater emphasis is placed on high-quality, patient-centered care, the importance of PROs has become widely accepted by policymakers, third party payers, medical societies, health care systems and clinical researchers. Despite increased recognition of the importance of PROs, they have not become a widely-implemented part of clinical care and their use in clinical research has been limited by methodological concerns. Health service researchers and providers are working to standardize and develop new methods to improve implementation of PROs in clinical and research settings. This article reviews the development of PRO measurement tools, implementation in the healthcare setting and relevance in clinical trials, with a focus on clinical care and research in gynecologic oncology.

Objectives: Employment disruption in the gynecologic cancer population may be substantial, particularly during a recession. Our objective was to evaluate factors associated with unemployment among gynecologic cancer patients in a nationally representative survey. Methods: A retrospective cohort of women ages 18-64 reporting employment currently or in the past, denying retirement, and endorsing care related to a gynecologic malignancy was identified in the 2007-2017 Medical Expenditure Panel Survey (MEPS). Survey weights were applied to generate national estimates of unemployment and job disruption (job change or loss) among the study cohort compared to the overall US population. We considered patient characteristics and healthcare utilization. Adjusted Wald statistics were used to compare employment outcomes between groups. Weighted multivariable logistic regression was utilized to assess factors independently associated with unemployment. Results: Of the 839 respondents with a gynecologic malignancy, 516 reporting current or past employment were identified. This cohort represents an estimated yearly average population of 434,000 (95% CI 370,000-498,000) that is mostly Caucasian (87%) with a mean age of 44.6 years. Compared to the overall US population, gynecologic cancer patients reported more non-cancer comorbidities (1.3 vs. 0.72, P Download : Download high-res image (146KB) Download : Download full-size image Conclusions: Gynecologic cancer patients experienced higher rates of unemployment, and loss of productivity compared to the overall US population. Disrupted employment was associated with at least one month of no health insurance coverage, and lack of a high school degree and increased healthcare utilization were independently associated with unemployment. While there was no association between the 2008 financial crisis era and unemployment, these data may help identify patients vulnerable to employment loss and health insurance loss during the current recession.

Objectives: Oral presentations of phase 3 randomized controlled trials (RCTs) at oncology meetings often do not undergo peer review; this may lead to conclusions that do not reflect the primary results of the study. For example, the presentation may include a positive conclusion despite a negative trial result. Presentations at medical society meetings may have significant impact on the oncology community. The purpose of this study is to quantify and categorize not-negative conclusions made in oral plenary presentations of phase 3 RCTs for gynecologic malignancies. Methods: Abstracts related to oral presentations of phase 3 RCTs at the Society of Gynecologic Oncology's Annual Meetings on Women's Cancer between 2005-2020 were reviewed. Studies with a primary endpoint of overall survival (OS) or progression free survival (PFS) and with a formally negative primary endpoint were included. Abstract conclusion sentences were classified as negative or not-negative. Trials with formally negative results were categorized based on the type of not-negative conclusions: 1) positive subgroup emphasis, 2) positive secondary endpoint emphasis, 3) emphasis on better numerical outcome despite nonsignificant p-value, 4) noninferiority interpretation of negative superiority trial. Studies with negative results and not-negative conclusions were compared to respective published manuscripts if available. The results and conclusion from the manuscript were compared to quantify and categorize not-negative conclusions. Results: Oral presentations of 61 phase 3 RCTs met inclusion criteria. Of these, 22 had a formally negative primary PFS or OS endpoint, of which 6/22 (27%) presented a not-negative conclusion. There was a higher proportion of not-negative conclusions among negative trials in more recent years, with 50% (5/10) of abstracts from 2015-2020 including not-negative conclusions, vs just 8.3% (1/12) in studies from the preceding decade 2005-2014 (p=0.03; Figure 1). Authors emphasized a positive subgroup in 4/6 studies and a positive secondary endpoint in 1/6 studies. A numerically better outcome in the experimental arm was highlighted in 2/6 studies despite a nonsignificant p-value, and 1/6 studies made a non-inferiority interpretation of a negative superiority trial. Of 21 studies with formally negative results, 56% (5/9) for-profit studies had not-negative conclusions, whereas 8.3% (1/12) non-profit studies had not negative conclusions (p=0.02). Published manuscripts were available for 3/6 not-negative studies, all similarly incorporating not-negative conclusions despite negative results. Download : Download high-res image (76KB) Download : Download full-size image Conclusions: Since 2005, 27% of RCTs presented at SGO made not-negative conclusions despite formally negative results, with a majority emphasizing a positive subgroup and funded by for-profit organizations. These results further emphasize the importance of presenters’ accurate portrayal of results and attendees’ attention to bias during presentations.

Objectives: To determine safety, efficacy, and biomarkers of response to neoadjuvant therapy (NACT) with atezolizumab (atezo), weekly paclitaxel and carboplatin (wPC) followed by maintenance (maint) atezo±bevacizumab (bev) in women with advanced epithelial ovarian, tubal, and peritoneal cancer (EOC). Methods: Patients (pts) with high-grade EOC were eligible. Pts underwent pretreatment biopsy, received paclitaxel 80 mg/m2 IV D1/8/15 + carboplatin AUC6 IV D1 + atezo 1200 mg D1 every 3 weeks x 3 cycles followed by interval cytoreductive surgery (ICS). Post-surgery, pts received adjuvant atezo, wPC±bev followed by maint atezo±bev. Primary objective was to assess safety of the combination when given prior to ICS. Early stopping rules were built around the primary safety endpoint if patients were unable to proceed to planned ICS within the specified timeframe (≤6 weeks from last dose of NACT) due to atezo-related toxicities. Safety was assessed in all treated pts using frequency and severity of adverse events (AE). Objective response rate (ORR), pathologic complete response rate (pCR) at ICS, and progression free survival (PFS) were determined. Planned exploratory objectives included quantitation of changes in PD-L1 expression, tumor-infiltrating lymphocyte subpopulations, immune checkpoint receptor profile, and immune blood-based markers. Results: A total of 18 pts enrolled and received therapy between 05/15/2018 - 07/14/2020. Median age was 69 years (range 46-87). Key disease characteristics: 18 (100%) pts had high-grade serous EOC; 13 (72%) pts had Stage III and 5 (28%) had stage IV disease; BRCA status: 5 (28%) mutations, 13 (72%) wildtype. Grade (G) 3/4 atezo-related AEs included 1 (6%) G3 anemia, 2 (11%) G3 thrombocytopenia, 2 (11%) G4 hypokalemia, 2 (11%) G3 rash, 1 (6%) thrombotic event. Other AEs of special interest included pneumonitis (n=3, 2 G2, 1 G1), blurred vision (n=1, G1), and myositis (n=1, G1). A total of 3 pts withdrew prior to ICS; 1 to change to every 3 weeks therapy locally, 1 due to non-atezo related AEs, and 1 due to negative results of IMAGYN050. These 3 pts are not included in the response-evaluable population (n=15). Nine (60%) pts had a partial response (PR) after 3 cycles and 6 (40%) had stable disease. All 15 pts underwent ICS; 1 had delayed cytoreduction due to pulmonary embolism, possibly atezo-related. Cytoreduction status was optimal in 86% pts [R0 8 (53%), R1 (33%)], and suboptimal in 2 (13%) pts; no pCRs were observed. All response-evaluable pts completed chemotherapy. Pts opted for maint therapy as follows: 6 (40%) adjuvant/maint atezo+bev; 4 (27%) atezo alone; and 5 (33%) withdrew for PARP inhibitor maint. A total of 2 (20%) of 10 receiving atezo maint discontinued due to recurrence. Blood-based and tumor biomarker results will be presented. Download : Download high-res image (90KB) Download : Download full-size image Conclusions: NACT with atezo + wPC followed by maint atezo±bev was feasible with no new safety signals. Biomarker analysis is ongoing to identify potential candidates who may benefit from atezo front-line therapy.

Objectives: Although often considered a static characteristic in oncology research, insurance coverage is dynamic in reality, potentially changing month-to-month. The Affordable Care Act (ACA) was passed in 2010 with aims of stabilizing and expanding insurance markets, and reducing financial burden, particularly for the poor and sick. We sought to assess insurance churn and catastrophic health expenditures (CHE) among patients with gynecologic cancer in the era of the ACA. Methods: Retrospective study of 2006-2017 Medical Expenditure Panel Survey (MEPS) respondents under age 65 reporting care in the given year related to a gynecologic cancer diagnosis. MEPS is an annual survey representative of the civilian, non-institutionalized US population. Weights were applied to estimate national rates of insurance churn (loss/change of coverage) and CHE (family out-of-pocket health spending >10% family income), and differences between subgroups and over time were assessed by the adjusted Wald test. Results: A total of 684 MEPS respondents under age 65 reported care related to a gynecologic cancer diagnosis in 2006-2017, representing an estimated average annual population of 533,000 persons (95% CI 462,000-603,000), which was majority White (87.0%) and non-Hispanic (85.5%). Relative to the overall under 65 US population, patients with gynecologic cancer reported higher rates of low-income (family income ≤250% federal poverty level; 45.1% vs 32.2%; p Download : Download high-res image (157KB) Download : Download full-size image Conclusions: Gynecologic cancer patients face high rates of insurance churn, with over one in five reporting uninsurance for least one month every year, and catastrophic health spending, with over one in four reporting CHE annually. Low-income patients face the highest risks of CHE, and are better protected with Medicaid coverage as compared to private insurance. There was no significant impact of the ACA, but small sample size limited estimate precision and power to detect small changes.

Objectives: Niraparib has been FDA approved as frontline maintenance therapy (FMT) for advanced-stage ovarian cancer regardless of biomarker status. A recently published preferences study demonstrated that, on average, ovarian cancer patients are willing to pay (WTP) $424 per month for an additional 6 months of progression-free survival (PFS) and $6 per month if the PFS benefit is only 2 months. The objective of this study is to determine whether a niraparib-for-all FMT approach is cost-effective compared to a biomarker-based strategy (BBS) from a patient out-of-pocket (OOP) cost perspective. Methods: A Markov-based decision model simulating the publicly available PRIMA trial results was used to evaluate the cost-effectiveness of two FMT strategies from a patient perspective: (1) niraparib for all (niraparib-for-all) and (2) BBS, defined as niraparib only for deleterious germline/somatic BRCA mutations and homologous recombination deficient (HRD)+ tumors. Monthly OOP drug costs were estimated for commercially insured beneficiaries with ovarian cancer using MarketScan (2014 - 2017) and for Medicare beneficiaries using Surveillance, Epidemiology, and End Results (SEER)-Medicare (2014-2016). The median OOP cost for any PARP inhibitor given during the time period were aggregated. OOP costs fortoxicities were incorporated into the model as emergency department copay costs. For comparison to previously reported patient WTP data, cost-effectiveness was reported as the incremental cost-effectiveness ratio (ICER) in U.S. dollars per quality-adjusted progression-free month (QA-PFM) gained between strategies. Results: The median monthly OOP cost of PARP maintenance was $43 for commercially insured beneficiaries and $694 for Medicare beneficiaries. In the model, niraparib-for-all was more costly ($638 versus $362 for commercial insurance; $5841 vs $1029 for Medicare) and more effective (11-month PFS vs 9.6-month PFS) than BBS. For patients with commercial insurance, niraparib-for-all had an ICER of $200/QA-PFM compared to BBS, and could be considered potentially cost-effective compared to a previously published patient WTP of $424/QA-PFM. For patients with Medicare, niraparib-for-all had an ICER of $3,213/QA-PFM compared to BBS and is not cost-effective. A monthly OOP cost of $90 or less wound render niraparib-for-all cost-effective based on the published WTP threshold. Conclusions: For patients with private insurance, accounting for only OOP costs and assuming a PFS benefit of approximately 6 months, niraparib-for-all could be considered cost-effective, falling within patients’ WTP, with an ICER of $200/QA-PFM compared to BBS. However, for patients with Medicare, both strategies incur considerably higher OOP expenses, and niraparib-for-all cannot be considered cost-effective. These results highlight the stark differences in financial burden on patients depending on their insurance coverage. Future cost-effectiveness studies should incorporate patient OOP costs and willingness to pay so that relative financial burden can be used to facilitate treatment conversations.

Objectives: Clinical trials are critical for guiding evidence-based cancer treatment that maximizes survival in balance with toxicities of therapy, yet only 2-4% of patients participate, more often in the setting of recurrence rather than upfront therapy. Access to trials depends on patient, disease, and treating facility characteristics and is not equitable. Our objective was to assess for disparities in upfront clinical trial participation and associations with overall survival. Methods: Retrospective study of patients with cancers of the uterus, cervix, ovary/fallopian tube, vulva, and vagina from the National Cancer Database (NCDB). NCDB samples approximately 70% of new diagnoses in the US and includes information on upfront treatment, including participation in a clinical trial. Patients with unknown trial participation status, or receiving unknown or no treatment were excluded. Disparities in upfront trial participation were assessed through comparison of characteristics using t-tests, chi2 tests, and multivariable logistic regression. Impact on overall survival was assessed with cox proportional hazards models. Download : Download high-res image (333KB) Download : Download full-size image Results: From the NCDB, we identified 877,534 patients diagnosed 2004-16, of which 461 (0.05%) were enrolled in a clinical trial of upfront therapy. Participants in upfront clinical trials were on average younger, had fewer comorbidities, and were less likely to be Hispanic. Participation was focused on ovarian (70.1%) and advanced stage disease (77.9%), with over 60% of those in trials having stage III-IV ovarian cancer. Trial participants had similar rate of surgery (85.5% vs. 86.9%), but more frequently received chemotherapy (87.8% vs 39.4%; p Conclusions: Participation in upfront clinical trials is rare across gynecologic cancers. Upfront trials disproportionately study treatment of advanced stage ovarian cancer with chemo- or immunotherapies. Access is not equitable, with greater participation among younger, better-educated, privately insured patients. Future clinical trial development should consider these disparities in disease targets, and strategies for outreach and recruitment.

Objectives: Minority participation in clinical trials is important for expanding opportunities in access to cancer therapies and may aid in understanding racial disparities in oncology care. Prior studies have identified underrepresentation in gynecologic oncology phase I recruitment and large group trials in the United States, but minority participation specific to trials that drive current treatment recommendations remains unclear. We sought to evaluate minority participation as described in publications of curated, high quality clinical evidence for ovarian cancer therapies as identified by the National Comprehensive Cancer Network (NCCN). Methods: NCCN Clinical Practice Guidelines for Ovarian Cancer, Version 1.2020, was accessed in order to identify evidence provided for ‘preferred’ primary and recurrent systemic therapies and dosing regimens in advanced epithelial ovarian cancer using explicitly listed citations. Race and ethnicity data of trial enrollment provided in publications listed as references was manually abstracted. Results: We identified 26 prospective trials including 13,887 participants, published across 5 journals: New England Journal of Medicine, Lancet, Lancet Oncology, Gynecologic Oncology, and Journal of the National Cancer Institute. All were phase II or III trials and 96% of trials were published in or more recently than 2003. Of these trials, race or ethnicity was reported in only 9 publications (35%). Of these 9 publications, there was marked language variation between trials in reporting race and ethnicity. There were 7 trials that included a description of participants as Black or African American. Of the 4,701 women who participated in these trials, 206 were Black or African American, representing approximately 4% of trial participants. There were 4 trials that included a description of participants as Hispanic. Of the 3,436 women who participated in these trials, 152 were Hispanic, representing approximately 4% of trial participants. Conclusions: Of the clinical trial evidence for preferred systemic therapies identified in the NCCN clinical practice guidelines for advanced ovarian cancer, minority participation was reported in less than half of publications and description of race and ethnicity varied between trials. Of trials that reported minority participation, Black and hispanic women represented

Objective To estimate the survival benefit and cost-effectiveness of performing hysterectomy during risk-reducing salpingo-oophorectomy (RRSO) for BRCA1 mutation carriers. Methods Based on a recent prospective cohort study indicating an elevated incidence of serous/serous-like uterine cancers among BRCA1 mutation carriers, we constructed a modified Markov decision model from a payer perspective to inform decisions about performance of hysterectomy during RRSO at age 40. We assumed patients had previously undergone a risk-reducing mastectomy and had a residual risk of death from breast or ovarian cancer. Disease-specific survival, age-adjusted competing hysterectomy rates, and deaths from other causes were incorporated. Costs of risk-reducing surgery, competing hysterectomy, and care for serous/serous-like uterine cancer were included. Results A 40year old woman who undergoes RRSO+Hysterectomy gains 4.9 additional months of overall survival (40.38 versus 39.97 undiscounted years) compared to RRSO alone. The lifetime probabilities of developing or dying from serous/serous-like uterine cancer in the RRSO group are 3.5% and 2%, respectively. The RRSO alone strategy has an average cost of $9013 compared to $8803 for RRSO+Hysterectomy, and is dominated (less effective and more costly) when compared to RRSO+Hysterectomy. In an alternative analysis, delayed hysterectomy remains a cost-effective prevention strategy with an ICER of less than $100,000/year for up to 25years following RRSO at age 40. Conclusions The addition of hysterectomy to RRSO in a 40year old BRCA1 mutation carrier results in a mean gain of 4.9 additional months of life and is cost-effective.

Clinical research in gynecologic oncology has seen a proliferation of studies that investigate the effectiveness of treatments using existing data sources such as cancer registries, electronic health records, and insurance claims. These observational studies are often feasible when randomized trial may not be, and may be more generalizable than randomized trials, because of greater diversity in the study populations. While statistical methods such as multivariable regression, matching, stratification, and weighting can adjust for the confounding in observational studies, statistical adjustment cannot control for confounders that are unmeasured in the data. Observational studies comparing the effectiveness of treatments for gynecologic malignancies are susceptible to bias from unmeasured confounding because factors like functional status, frailty and disease burden, which influence treatment selection and outcome, are often not reported in existing data sources. Like randomized trials, quasi-experimental designs attempt to account for both measured and unmeasured confounding by exploiting natural experiments arising in the real world. These methods are underutilized in gynecologic oncology research and are particularly relevant to studies that use large datasets to study the effectiveness of treatments. In this review, we consider methodological challenges that arise in the analysis of non-randomized studies, and describe how application of quasi-experimental methodology can estimate unbiased treatment effects even in the presence of unmeasured confounders.

Objectives Sentinel lymph node biopsy (SLNB) may be considered in the setting of a pre-operative diagnosis of endometrial intraepithelial neoplasia (EIN) due to high rates of concurrent invasive cancer. The aim of this study is to compare the cost-effectiveness of different surgical management strategies for a pre-operative diagnosis of EIN. Methods A decision model was developed from a third party payer perspective to compare four surgical strategies for the management of EIN: (1) hysterectomy; (2) hysterectomy with frozen section (hysterectomy + frozen); (3) hysterectomy with SLNB (hysterectomy + SLNB); (4) hysterectomy with frozen section and SLNB (hysterectomy + frozen + SLNB). The probability that frozen section identifies high- or low-risk cancer, final pathology distribution, adjuvant treatments, and surgery/imaging costs were abstracted from the literature, Medicare reimbursement data, and the financial department of a private academic hospital. Adjuvant treatments were determined through NCCN guidelines and published studies. Effectiveness was quantified as percentage of patients who received the guideline-based treatment that aligned with their true stage. Results The base case cost and effectiveness of each strategy was: hysterectomy-$4383/89%, hysterectomy + frozen-$5220/99.2%, hysterectomy + SLNB-$5354/94.7% and hysterectomy + frozen + SLNB-$5938/99.6%. Hysterectomy + frozen had an incremental cost effectiveness ratio of $8111 per patient who received adjuvant treatment that aligned with true stage compared to hysterectomy. Hysterectomy + frozen + SLNB had an ICER of $168,171 per additional patient who received adjuvant treatment that aligned with their true stage compared to hysterectomy + frozen. Conclusion Hysterectomy + frozen + SLNB is a costly strategy for pre-operative EIN when compared to hysterectomy + frozen, with limited clinical benefit. Hysterectomy with frozen section and subsequent intraoperative staging decisions should continue to be standard of care.

Objective The Patient Protection and Affordable Care Act (ACA) included provisions to expand insurance coverage by expanding Medicaid eligibility, providing subsidies of private coverage and enforcing an individual mandate. The objective of this study is to examine the impact of the ACA on insurance rates among women diagnosed with a gynecologic malignancy. Methods Using Surveillance, Epidemiology, and End Results 18 registries database, women newly diagnosed with cervical, uterine or ovarian cancer between 2008 and 2014 were identified. Insurance rates were examined before and after the passage of the ACA (2011) as well as before (January 2011–December 2013) versus after (January 2014–December 2014) Medicaid expansion to examine the impact of specific provisions. Rates of insurance were then compared between states that elected for expansion of Medicaid in 2014 vs. those states that had not. Results Among 181,866 diagnosed with cervical, uterine or ovarian cancer, there was a significant increase in patients enrolled in Medicaid after 2011. Between 2011 and 2014, there was a significant decrease in the rates of uninsured for all cancer types (p=0.001). Uninsured rates decreased by 50% for those diagnosed with uterine and ovarian cancer (6% to 3% and 8% to 4% respectively, p≤0.001), and by 25% in cervical cancer (8.9% to 6.7%, p=0.001) after January 2014. Decreases in the rate of the uninsured and associated increases in insurance coverage were only observed in states which expanded Medicaid coverage (p≤0.001). Conclusions The Affordable Care Act resulted in expanded insurance coverage for women diagnosed with a gynecologic cancer, however, the impact was significantly increased in states which increased their Medicaid eligibility in 2014.