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PURPOSE: The uninsured rate began rising after 2016, which some have attributed to health policies undermining aspects of the Affordable Care Act. Our primary objectives were to assess the changes in insurance coverage and forgoing medical care because of cost in cancer survivors from pre-enactment (2016) through postenactment of those policies (2019) and determine whether there were subgroups that were disproportionately affected. METHODS: The 2016-2019 Behavioral Risk Factor Surveillance System surveys were queried for 18- to 64-year-old cancer survivors. Survey-weighted logistic regression was used to assess temporal changes in (1) insurance coverage and (2) forgoing medical appointments because of cost in the preceding 12 months. RESULTS: A total of 62,669 cancer survivors were identified. The percentage of insured cancer survivors decreased from 92.4% in 2016 to 90.4% in 2019 (odds ratio for change in insurance coverage or affordability per one-year increase [ORyear], 0.92; 95% CI, 0.86 to 0.98; P = .01), translating to 161,000 fewer cancer survivors in the United States with insurance coverage. There were decreases in employer-sponsored insurance coverage (ORyear, 0.89) but increases in Medicaid coverage (ORyear, 1.17) from 2016 to 2019. Forgoing medical appointments because of cost increased from 17.9% in 2016 to 20.0% in 2019 (ORyear, 1.05; 95% CI, 1.01 to 1.1; P = .025), affecting an estimated 169,000 cancer survivors. The greatest changes were observed among individuals with low income, particularly those residing in nonexpansion states. CONCLUSION: Between 2016 and 2019, there were 161,000 fewer cancer survivors in the United States with insurance coverage, and 169,000 forwent medical care because of cost.

PURPOSE Evidence-based guidelines recommend cascade genetic counseling and testing for hereditary cancer syndromes, providing relatives the opportunity for early detection and prevention of cancer. The current standard is for patients to contact and encourage relatives (patient-mediated contact) to undergo counseling and testing. Direct relative contact by the medical team or testing laboratory has shown promise but is complicated by privacy laws and lack of infrastructure. We sought to compare outcomes associated with patient-mediated and direct relative contact for hereditary cancer cascade genetic counseling and testing in the first meta-analysis on this topic. MATERIALS AND METHODS We conducted a systematic review and meta-analysis in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO No.: CRD42020134276). We searched key electronic databases to identify studies evaluating hereditary cancer cascade testing. Eligible trials were subjected to meta-analysis. RESULTS Eighty-seven studies met inclusion criteria. Among relatives included in the meta-analysis, 48% (95% CI, 38 to 58) underwent cascade genetic counseling and 41% (95% CI, 34 to 48) cascade genetic testing. Compared with the patient-mediated approach, direct relative contact resulted in significantly higher uptake of genetic counseling for all relatives (63% [95% CI, 49 to 75] v 35% [95% CI, 24 to 48]) and genetic testing for first-degree relatives (62% [95% CI, 49 to 73] v 40% [95% CI, 32 to 48]). Methods of direct contact included telephone calls, letters, and e-mails; respective rates of genetic testing completion were 61% (95% CI, 51 to 70), 48% (95% CI, 37 to 59), and 48% (95% CI, 45 to 50). CONCLUSION Most relatives at risk for hereditary cancer do not undergo cascade genetic counseling and testing, forgoing potentially life-saving medical interventions. Compared with patient-mediated contact, direct relative contact increased rates of cascade genetic counseling and testing, arguing for a shift in the care delivery paradigm, to be confirmed by randomized controlled trials.

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.

Genetic testing offers providers a potentially life saving tool for identifying and intervening in high-risk individuals. However, disparities in receipt of genetic testing have been consistently demonstrated and undoubtedly have significant implications for the populations not receiving the standard of care. If correctly used, there is the potential for genetic testing to play a role in decreasing health disparities among individuals of different races and ethnicities. However, if genetic testing continues to revolutionize cancer care while being disproportionately distributed, it also has the potential to widen the existing mortality gap between various racial and ethnic populations.

Salt marshes are increasingly valued for their role in coastal defense. In particular, marsh plants slow the progression of waves, thereby decreasing wave heights, orbital velocities and associated energy. Practical application of these effects has driven substantial research estimating the effects of plants on waves. However, the effects of waves on plants remain understudied, especially regarding plant responses along a wave climate gradient. To begin to understand these responses, we collected above- and belowground plant data and wave data from 60 sites across Mobile Bay, USA, and tributaries and evaluated plant responses along the range of assessed wave climate conditions. Plant responses among the dominant species, Juncus roemerianus and Spartina alterniflora, varied along the wave climate gradient. However, the basal diameter of shoots in both species declined linearly with increasing wave climate. While wave climate had no observable effect on other S. alterniflora parameters, the declining diameter of J. roemerianus shoots along the same gradient was commensurate with a decline in the percentage of live canopy shoots aboveground and an increase in root and rhizome biomass in the active rooting zone belowground. In contrast to previous studies, other responses including the height, biomass and density of aboveground shoots in both species were not related to wave climate. More broadly, these results demonstrate that plant features important for wave attenuation such as shoot diameter can change in response to varying wave conditions. These feedbacks should be incorporated to improve coastal modeling and successes of coastal conservation, restoration and enhancement projects.

An important function of health insurance is protecting enrollees from excessively burdensome charges for unanticipated medical events. Unexpected surgery can be financially catastrophic for uninsu...

PURPOSE: In December 2019, the American Society for Reproductive Medicine designated ovarian tissue cryopreservation (OTC) as no longer experimental and an alternative to oocyte cryopreservation (OC) for women receiving gonadotoxic therapy. Anticipating increased use of OTC, we compare the cost-effectiveness of OC versus OTC for fertility preservation in oncofertility patients. METHODS: A cost-effectiveness model to compare OC versus OTC was built from a payer perspective. Costs and probabilities were derived from the literature. The primary outcome for effectiveness was the percentage of patients who achieved live birth. Strategies were compared using incremental cost-effectiveness ratios (ICER). All inputs were varied widely in sensitivity analyses. RESULTS: In the base case, the estimated cost for OC was $16,588 and for OTC $10,032, with 1.56% achieving live birth after OC, and 1.0% after OTC. OC was more costly but more effective than OTC, with an ICER of $1,163,954 per live birth. In sensitivity analyses, OC was less expensive than OTC if utilization was greater than 63%, cost of OC prior to chemotherapy was less than $8100, cost of laparoscopy was greater than $13,700, or standardized discounted costs were used. CONCLUSIONS: With current published prices and utilization, OC is more costly but more effective than OTC. OC becomes cost-saving with increased utilization, when cost of OC prior to chemotherapy is markedly low, cost of laparoscopy is high, or standardized discounted oncofertility pricing is assumed. We identify the critical thresholds of OC and OTC that should be met to deliver more cost-effective care for oncofertility patients.

BackgroundIdentifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing.Primary objectiveOur primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed BRCA1/2 mutation randomized to a facilitated cascade testing strategy versus standard of care, proband-mediated, information sharing.Study hypothesisWe hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care.Trial designThe FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known BRCA1/2 mutation (probands) cared for at participating sites will be randomized. Probands randomized to the standard of care group will be instructed to share a family letter with their first-degree relatives and encourage them to complete genetic testing. First-degree relatives of probands randomized to the intervention arm will receive engagement strategies with a patient navigator, an educational video, and accessible genetic testing services.Major inclusion/exclusion criteriaAdult participants who are first-degree relatives of a patient with a BRCA1/2 mutation and have not had prior genetic testing will be included.Primary endpointAnalyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm.Sample sizeOne hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants.Estimated dates for completing accrual and presenting resultsJanuary 2024.Trial registrationNCT04613440

OBJECTIVE To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine. METHODS In a single-site randomized trial, patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine-prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N=106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019. RESULTS From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine-prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine-prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine-prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [-45.1 to -6.3]; P

ImportancePoor health care access (HCA) is associated with racial and ethnic disparities in ovarian cancer (OC) survival.ObjectiveTo generate composite scores representing health care affordability, availability, and accessibility via factor analysis and to evaluate the association between each score and key indicators of guideline-adherent care.Design, Setting, and ParticipantsThis retrospective cohort study used data from patients with OC diagnosed between 2008 and 2015 in the Surveillance, Epidemiology, and End Results (SEER) Medicare database. The SEER Medicare database uses cancer registry data and linked Medicare claims from 12 US states. Included patients were Hispanic, non-Hispanic Black, and non-Hispanic White individuals aged 65 years or older diagnosed from 2008 to 2015 with first or second primary OC of any histologic type (International Classification of Diseases for Oncology, 3rd Edition [ICD-O-3] code C569). Data were analyzed from June 2020 to June 2022.ExposuresThe SEER-Medicare data set was linked with publicly available data sets to obtain 35 variables representing health care affordability, availability, and accessibility. A composite score was created for each dimension using confirmatory factor analysis followed by a promax (oblique) rotation on multiple component variables.Main Outcomes and MeasuresThe main outcomes were consultation with a gynecologic oncologist for OC and receipt of OC-related surgery in the 2 months prior to or 6 months after diagnosis.ResultsThe cohort included 8987 patients, with a mean (SD) age of 76.8 (7.3) years and 612 Black patients (6.8%), 553 Hispanic patients (6.2%), and 7822 White patients (87.0%). Black patients (adjusted odds ratio [aOR], 0.75; 95% CI, 0.62-0.91) and Hispanic patients (aOR, 0.81; 95% CI, 0.67-0.99) were less likely to consult a gynecologic oncologist compared with White patients, and Black patients were less likely to receive surgery after adjusting for demographic and clinical characteristics (aOR, 0.76; 95% CI, 0.62-0.94). HCA availability and affordability were each associated with gynecologic oncologist consultation (availability: aOR, 1.16; 95% CI, 1.09-1.24; affordability: aOR, 1.13; 95% CI, 1.07-1.20), while affordability was associated with receipt of OC surgery (aOR, 1.08; 95% CI, 1.01-1.15). In models mutually adjusted for availability, affordability, and accessibility, Black patients remained less likely to consult a gynecologic oncologist (aOR, 0.80; 95% CI, 0.66-0.97) and receive surgery (aOR, 0.80; 95% CI, 0.65-0.99).Conclusions and RelevanceIn this cohort study of Hispanic, non-Hispanic Black, and non-Hispanic White patients with OC, HCA affordability and availability were significantly associated with receiving surgery and consulting a gynecologic oncologist. However, these dimensions did not fully explain racial and ethnic disparities.

Background In recent years, the issue of out-of-network billing for privately insured patients has been highlighted as a source of unexpected out-of-pocket charges for patients, even in the setting of an in-network primary surgeon. Congress recently passed the No Surprises Act to curtail these practices, but the new law contains exceptions, and its regulatory system has yet to be established. As one of the most frequently performed major surgical procedures, hysterectomy represents a significant exposure to out-of-network bills among non-elderly females in the United States. Objective To describe the extent and nature of out-of-network bills at the time of hysterectomy among privately insured patients in the context of the recently passed No Surprises Act. Study Design We performed a retrospective cohort study of women ages 18-64 who underwent simple hysterectomy from 2008 to 2018 with in-network primary surgeon in the IBM Watson Marketscan claims database, which includes data from over 350 different payers. We identified out-of-network claims for facility or professional services, and analyzed the frequency, size, and source of the payments. We used multivariable logistic regression to assess for patient, procedure, and facility characteristics associated with risk of out-of-network claims. Results We identified 585,223 hysterectomy cases meeting all inclusion criteria, evenly split between inpatient (49.6%) and outpatient (50.4%) procedures. Overall, 8.8% of cases included at least 1 out-of-network claim, with median out-of-network expenditures of $553 for inpatient procedures and $438 for outpatient procedures. Compared to professional out-of-network claims, facility out-of-network claims were less common (2.3% vs. 7.4%) but far greater in amount billed (median $8,307 vs. $400 inpatient, $3,281 vs. $407 outpatient). Among professional claims, those from midlevel surgical assistants were most frequently out-of-network when present (13.8% inpatient; 20.0% outpatient), while out-of-network claims from anesthesia were most common overall, and largest (median $890 inpatient, $1,021 outpatient) when present. In a multivariable model, older age, increasing comorbidity, and complications during the stay were associated with higher odds of any out-of-network claim. In contrast, risk of facility out-of-network claims was more strongly associated with facility region and surgical approach, with highest odds for cases in the North Central region and those using robotic approach. Conclusion Out-of-network bills for privately insured patients at the time of hysterectomy occurred in 8.8% of cases. Approximately one-quarter of these included out-of-network facility claims, which tended to have higher payments than out-of-network professional claims, and may not be prevented by the No Surprises Act. Gynecologic surgeons should be aware of potential out-of-network charges for ancillary services at the time of surgery, and particularly the network status of the facility, in order to provide maximal transparency and financial protection to our patients.

Background:Differential access to quality care is associated with racial disparities in ovarian cancer survival. Few studies have examined the association of multiple healthcare access (HCA) dimensions with racial disparities in quality treatment metrics, that is, primary debulking surgery performed by a gynecologic oncologist and initiation of guideline-recommended systemic therapy.Methods:We analyzed data for patients with ovarian cancer diagnosed from 2008 to 2015 in the Surveillance, Epidemiology, and End Results–Medicare database. We defined HCA dimensions as affordability, availability, and accessibility. Modified Poisson regressions with sandwich error estimation were used to estimate the relative risk (RR) for quality treatment.Results:The study cohort was 7% NH-Black, 6% Hispanic, and 87% NH-White. Overall, 29% of patients received surgery and 68% initiated systemic therapy. After adjusting for clinical variables, NH-Black patients were less likely to receive surgery [RR, 0.83; 95% confidence interval (CI), 0.70–0.98]; the observed association was attenuated after adjusting for healthcare affordability, accessibility, and availability (RR, 0.91; 95% CI, 0.77–1.08). Dual enrollment in Medicaid and Medicare compared with Medicare only was associated with lower likelihood of receiving surgery (RR, 0.86; 95% CI, 0.76–0.97) and systemic therapy (RR, 0.94; 95% CI, 0.92–0.97). Receiving treatment at a facility in the highest quartile of ovarian cancer surgical volume was associated with higher likelihood of surgery (RR, 1.12; 95% CI, 1.04–1.21).Conclusions:Racial differences were observed in ovarian cancer treatment quality and were partly explained by multiple HCA dimensions.Impact:Strategies to mitigate racial disparities in ovarian cancer treatment quality must focus on multiple HCA dimensions. Additional dimensions, acceptability and accommodation, may also be key to addressing disparities.

To assess 30-day outcomes for hysterectomy by body mass index (BMI) classification and estimate trends in 30-day outcomes by BMI over time.This is a retrospective cohort study of patients older than age 18 years undergoing hysterectomy with data in the National Surgical Quality Improvement Program database from 2005 to 2018. Exclusions were made for ambiguous indication or route of surgery and missing values in covariates or outcomes of interest. Patient characteristics and outcomes were compared across BMI classifications. Outcomes included operative time, length of stay, and major and minor complications. Multivariable linear regression models were used for continuous outcomes, and modified Poisson regression models were used for binary outcomes. Patients with benign and malignant indications for hysterectomy were analyzed separately. Models were adjusted for age, race, hysterectomy route, hypertension, diabetes, smoking, selected preoperative laboratory values, and cancer type, if applicable.Obesity rate increased from 41.2% in 2005-2007 to 51.8% in 2018. Among 319,462 patients, minimally invasive surgery was the most common approach (58.8% vs 24.5% laparotomy vs 16.7% vaginal). Higher BMI classifications were associated with longer operative times (benign indication: average 25.0 minutes longer, 95% CI 22.1-27.9; malignant indication: average 25.1 minutes longer, 95% CI 20.8-29.4) and higher risk of complications compared with normal-weight BMIs, though operative time declined over time for patients with malignant surgical indications. Relative to normal-weight patients, rates of major complications did not increase until a BMI of 40 for hysterectomy for benign indications and 50 for hysterectomy for malignant indications.Operative times and complications both increase with obesity when performing hysterectomy. Knowledge of evolving risk level at various weight subclassifications can improve shared decision making preoperatively.

In recent years, there has been growing recognition of the financial burden of severe illness, including associations with higher rates of nonemployment, uninsurance, and catastrophic out-of-pocket health spending. Patients with gynecologic cancer often require expensive and prolonged treatments, potentially disrupting employment and insurance coverage access, and putting patients and their families at risk for catastrophic health expenditures.This study aimed to describe the prevalence of insurance churn, nonemployment, and catastrophic health expenditures among nonelderly patients with gynecologic cancer in the United States, to compare within subgroups and to other populations and assess for changes associated with the Affordable Care Act.We identified respondents aged 18 to 64 years from the Medical Expenditure Panel Survey, 2006 to 2017, who reported care related to gynecologic cancer in a given year, and a propensity-matched cohort of patients without cancer and patients with cancers of other sites, as comparison groups. We applied survey weights to extrapolate to the US population, and we described patterns of insurance churn (any uninsurance or insurance loss or change), catastrophic health expenditures (10% annual family income), and nonemployment. Characteristics and outcomes between groups were compared with the adjusted Wald test.We identified 683 respondents reporting care related to a gynecologic cancer diagnosis from 2006 to 2017, representing an estimated annual population of 532,400 patients (95% confidence interval, 462,000-502,700). More than 64% of patients reported at least 1 of 3 primary negative outcomes of any uninsurance, part-year nonemployment, and catastrophic health expenditures, with 22.4% reporting at least 2 of 3 outcomes. Catastrophic health spending was uncommon without nonemployment or uninsurance reported during that year (1.2% of the population). Compared with patients with other cancers, patients with gynecologic cancer were younger and more likely with low education and low family income (≤250% federal poverty level). They reported higher annual risks of insurance loss (8.8% vs 4.8%; P=.03), any uninsurance (22.6% vs 14.0%; P=.002), and part-year nonemployment (55.3% vs 44.6%; P=.005) but similar risks of catastrophic spending (12.6% vs 12.2%; P=.84). Patients with gynecologic cancer from low-income families faced a higher risk of catastrophic expenditures than those of higher icomes (24.4% vs 2.9%; P.001). Among the patients from low-income families, Medicaid coverage was associated with a lower risk of catastrophic spending than private insurance. After the Affordable Care Act implementation, we observed reductions in the risk of uninsurance, but there was no significant change in the risk of catastrophic spending among patients with gynecologic cancer.Patients with gynecologic cancer faced high risks of uninsurance, nonemployment, and catastrophic health expenditures, particularly among patients from low-income families. Catastrophic spending was uncommon in the absence of either nonemployment or uninsurance in a given year.

Key Points Question Was the Patient Protection and Affordable Care Act (ACA) associated with reductions in risks of insurance churn (ie, gain, loss, or change in coverage) and catastrophic health expenditures for nonelderly patients with cancer in the United States? Findings In this cross-sectional study, patients with cancer had a lower risk of insurance churn but a higher risk of catastrophic spending vs those without cancer. Implementation of the ACA was associated with small reductions in annual risks of uninsurance and catastrophic spending, although only when excluding premiums. Meaning The ACA was associated with small improvements in insurance continuity and out-of-pocket cost burden, but further action is still needed to lessen financial burdens on US patients with cancer and their families., Importance Health insurance coverage is dynamic in the United States, potentially changing from month to month. The Patient Protection and Affordable Care Act (ACA) aimed to stabilize markets and reduce financial burden, particularly among those with preexisting conditions. Objective To describe the risks of insurance churn (ie, gain, loss, or change in coverage) and catastrophic health expenditures among nonelderly patients with cancer in the United States, assessing for changes associated with ACA implementation. Design, Setting, and Participants This retrospective, cross-sectional study uses data from the Medical Expenditure Panel Survey, a representative sample of the US population from 2005 to 2018. Respondents included were younger than 65 years, identified by health care use associated with a cancer diagnosis code in the given year. Statistical analysis was conducted from July 30, 2020, to January 5, 2021. Exposures The Patient Protection and Affordable Care Act. Main Outcomes and Measures Survey weights were applied to generate estimates for the US population. Annual risks of insurance churn (ie, any uninsurance or insurance change or loss) and catastrophic health expenditures (spending >10% income) were calculated, comparing subgroups with the adjusted Wald test. Weighted multivariable linear regression was used to assess for changes associated with ACA implementation. Results From 6069 respondents, we estimated a weighted mean of 4.78 million nonelderly patients (95% CI, 4.55-5.01 million; female patients: weighted mean, 63.9% [95% CI, 62.2%-65.7%]; mean age, 50.3 years [95% CI, 49.7-50.8 years]) with cancer annually in the United States. Patients with cancer experienced lower annual risks of insurance loss (5.3% [95% CI, 4.5%-6.1%] vs 7.6% [95% CI, 7.4%-7.8%]) and any uninsurance (14.6% [95% CI, 13.3%-16.0%] vs 24.1% [95% CI, 23.5%-24.7%]) but increased risk of catastrophic health expenditures (expenses alone: 12.4% [95% CI, 11.2%-13.6%] vs 6.3% [95% CI, 6.2%-6.5%]; including premiums: 26.6% [95% CI, 25.0%-28.1%] vs 16.5% [95% CI, 16.1%-16.8%]; P, This cross-sectional study describes the risks of insurance churn (ie, gain, loss, or change in coverage) and catastrophic health expenditures among nonelderly patients with cancer in the US, assessing for changes associated with implementation of the Patient Protection and Affordable Care Act.

Highlights • Use of neoadjuvant chemotherapy is increasingly common among women with advanced stage endometrial cancer. • Compared to primary cytoreduction, neoadjuvant chemotherapy is associated with improved rates of optimal cytoreduction. • Neoadjuvant chemotherapy is associated with decreased perioperative morbidity and decreased operative times. • Neoadjuvant chemotherapy followed by surgery is associated with similar overall survival compared to primary surgery., Objective While primary cytoreductive surgery (PCS) is considered the standard of care for women who present with stage IV endometrial cancer, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery (ICS) has emerged as an alternative treatment strategy. We summarized the literature and compared outcomes of PCS compared to NACT and ICS. Methods We conducted a systematic search on PubMed, Embase, Web of Science, and Scopus for articles published from January 1, 1990 to December 31, 2020. Key search terms included multiple descriptors of advanced disease status in combination with “endometrial cancer” and “neoadjuvant chemotherapy”. Our review included studies that examined survival and surgical outcomes of patients with stage III or IV endometrial cancer treated with neoadjuvant chemotherapy followed by interval cytoreductive surgery versus those who received primary cytoreductive surgery. We excluded studies examining only patients with leiomyosarcomas, carcinosarcomas, and stromal sarcomas due to the biologic heterogeneity of these malignancies. Results The nine included studies encompassed 5,844 patients, of which 1,317 (22.5%) received NACT and 4,527 received PCS (77.5%). With the exception of a single study, all were retrospective observational studies or case series. Use of NACT in patients with stage IV EC increased from 16.0% in 2010 to 23.9% in 2015. Five studies analyzed median overall survival and all but one reported no significant difference between NACT + ICS vs. PCS. Optimal cytoreduction (

ObjectiveThe role and type of adjuvant therapy for patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIA grade 1 endometrioid endometrial adenocarcinoma are controversial. This retrospective cohort study aimed to determine associations between adjuvant therapy use and survival among patients with stage IIIA grade 1 endometrial cancer.MethodsPatients who underwent primary surgery for stage IIIA (FIGO 2009 staging) grade 1 endometrial cancer between January 2004 and December 2016 were identified in the National Cancer Database. Demographics and receipt of adjuvant therapy were compared. Overall survival was analyzed using Kaplan–Meier curves, log-rank test, and multivariable Cox proportional hazard models.ResultsOf 1120 patients, 248 (22.1%) received no adjuvant treatment, 286 (25.5%) received chemotherapy alone, 201 (18.0%) radiation alone, and 385 (34.4%) chemotherapy and radiation. Five-year overall survival rate was 83.0% (95% CI 80.1% to 85.6%). Older age, increasing comorbidity count, and lymphovascular space invasion status were significant negative predictors of survival. Over time, there was an increasing rate of chemotherapy (45.4% in 2004–2009 vs 69.2% in 2010–2016; pConclusionsThe use of adjuvant chemotherapy for the treatment of stage IIIA grade 1 endometrial cancer increased over time and was associated with improved overall survival compared with radiation alone or chemoradiation. Patients with lymphovascular space invasion may benefit from combination therapy.

BACKGROUND: Cancer diagnosis and treatment can lead to disruptions in employment for patients, which can, in turn, lead to financial problems and uninsurance. We used a nationally representative survey to describe predictors of non-employment among cancer patients compared to a matched cohort of individuals without cancer. METHODS: This was a retrospective study of the 2005–2018 nationally representative Medical Expenditure Panel Survey. We included respondents aged 18–64 and identified the cohort with current cancer by healthcare utilization related to a cancer diagnosis in the given year. We propensity-score matched controls to cancer cases in a 2:1 ratio. Survey weights were applied to generate national estimates of non-employment among the study cohort compared to the overall U.S. population. The Adjusted Wald test was used to compare employment outcomes between groups. Weighted multivariable linear regression was utilized to assess factors independently associated with non-employment. RESULTS: An estimated annual mean of 3.9 million cancer patients in the U.S. were included. Relative to controls, cancer patients had higher rates of part-year (36.0% vs 28.3%, P

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 Patient Protection and Affordable Care Act called for expansion of Medicaid in 2014. As some states elected to expand Medicaid and others did not, the goal of this study was to determine the effect of Medicaid expansion on the insurance status at cancer diagnosis of brachytherapy patients.Patients aged 19-64 years with breast, cervical, uterine, or prostate cancer treated with brachytherapy from 2011 to 2014 with known insurance status were identified within the Surveillance, Epidemiology, and End Results registry. Fisher's exact test was used to test for associations of insurance status with expanded versus nonexpanded states. For multivariate analysis, a binomial logistic regression was performed, dichotomized to uninsured versus any insurance.Fifteen thousand four hundred ninety-seven subjects met entry criteria. In the entire cohort, rates of uninsurance were higher in nonexpanded states at baseline (4.5% vs. 2.9%, p0.00001). With selective Medicaid expansion in 2014, expanded states had a reduction in uninsurance rates (2.9-1.8%, p = 0.026), whereas nonexpanded states had a nonsignificant increase in uninsurance (4.5-5.0%, p = 0.371). There was a reduction in uninsurance in expanded states in areas of highest poverty (2.9-1.1%, p = 0.0004) not seen in nonexpanded states. These associations remained significant on multivariate analysis (OR 2.2, 95% CI 1.8-2.8, p0.00001).Patients who received brachytherapy were less likely to be uninsured in states where Medicaid was expanded, particularly evident in regions with highest poverty levels. These results should help inform policy decisions and efforts to ensure that all patients have access to high quality treatments, such as brachytherapy.

Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare.We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy.A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold.Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783).Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.

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.

Persons with HIV (PWH) represent a socially and medically vulnerable population who often depend on public resources. We examined voter registration among PWH in North Carolina. Sixty-four percent were registered to vote. Registration was lower among PWH who were young, Hispanic, publicly insured or uninsured, and who had poor HIV health status.

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.

Endometrial cancer uncommonly presents at an advanced stage and little prospective evidence exists to guide the management thereof. We aimed to summarize the evidence about primary cytoreductive surgery in the treatment of advanced stage endometrial cancer.MEDLINE, Embase, and Scopus databases were searched from inception to September 11, 2020, using search terms representing the themes "endometrial cancer," "advanced stage," and "primary cytoreductive surgery."We included full-text, English reports that included ≥10 patients undergoing primary cytoreductive surgery for advanced stage endometrial cancer and that reported on the outcomes of primary cytoreductive surgery and survival rates based on the residual disease burden.Two reviewers independently screened the studies and with disagreements between the reviewers resolved by a third reviewer. Data were extracted using a standardized form. The percentage of cases reaching maximal (no gross residual disease) and optimal (1 cm or2 cm residual disease) cytoreduction were assessed by summing binomials proportions, and the association with survival was assessed using an inverse variance-weighted meta-analysis of logarithmic hazard ratios.From 1219 unique records identified, 34 studies were selected for inclusion. Studies consisted of single or multi-institutional cohorts of patients collected over a period of 6 to 24 years and included various mixes of histologies (endometrioid, serous, clear cell, and carcinosarcoma) and disease stages (III or IV). In a meta-analysis of the extent of residual disease after primary cytoreductive surgery, we found that 52.1% of cases reached no gross residual disease status (n=18 studies; 1329 patients) and 75% reached1 cm residual disease status (n=27 studies; 2343 patients). The proportion of cytoreduction for both thresholds was lower for studies of stage IV vs stage III to IV disease (41.4% vs 69.8% for no gross residual disease; 63.2% vs 82.2% for1 cm residual disease) but did not vary notably by histology. In a meta-analysis of the reported hazard ratios, submaximal (any gross residual disease vs no gross residual disease) and suboptimal (≥1 cm vs1 cm) cytoreduction thresholds were associated with worse progression-free survival (submaximal hazard ratio, 2.16; 95% confidence interval, 1.45-3.21; IAmong cases of advanced stage endometrial cancer undergoing primary cytoreductive surgery, a significant proportion of patients are left with residual disease, which is associated with worse survival outcomes. Further investigations about the roles of neoadjuvant chemotherapy and primary cytoreductive surgery in prospective trials is warranted in this population.

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.

Women with gynecologic cancer face socioeconomic disparities in care that affect survival outcomes. The Affordable Care Act offered states the option to expand Medicaid enrollment eligibility criteria as a means of improving timely and affordable access to care for the most vulnerable. The variable uptake of expansion by states created a natural experiment, allowing for quasi-experimental methods that offer more unbiased estimates of treatment effects from retrospective data than the traditional regression adjustment.To use a quasi-experimental, difference-in-difference framework to create unbiased estimates of impact of Medicaid expansion on women with gynecologic cancer.We performed a quasi-experimental retrospective cohort study from the National Cancer Database files for women with invasive cancers of the uterus, ovary and fallopian tube, cervix, vagina, and vulva diagnosed from 2008 to 2016. Using a marker for state Medicaid expansion status, we created difference-in-difference models to assess the impact of Medicaid expansion on the outcomes of access to and timeliness of care. We excluded women aged40 years owing to the suppression of the state Medicaid expansions status in the data and women aged ≥65 years owing to the universal Medicare coverage availability. Our primary outcome was the rate of uninsurance at diagnosis. Secondary outcomes included Medicaid coverage, early-stage diagnosis, treatment at an academic facility, and any treatment or surgery within 30 days of diagnosis. Models were run within multiple subgroups and on a propensity-matched cohort to assess the robustness of the treatment estimates. The assumption of parallel trends was assessed with event study time plots.Our sample included 335,063 women. Among this cohort, 121,449 were from nonexpansion states and 213,614 were from expansion states, with 79,886 posttreatment cases diagnosed after the expansion took full effect in expansion states. The groups had minor differences in demographics, and we found occasional preperiod event study coefficients diverging from the mean, but the outcome trends were generally similar between the expansion and nonexpansion states in the preperiod, satisfying the necessary assumption for the difference-in-difference analysis. In a basic difference-in-difference model, the Medicaid expansion in January 2014 was associated with significant increases in insurance at diagnosis, treatment at an academic facility, and treatment within 30 days of diagnosis (P.001 for all). In an adjusted model including all states and accounting for variable expansion implementation time, there was a significant treatment effect of Medicaid expansion on the reduction in uninsurance at diagnosis (-2.00%; 95% confidence interval, -2.3 to -1.7; P.001), increases in early-stage diagnosis (0.80%; 95% confidence interval, 0.2-1.4; P=.02), treatment at an academic facility (0.83%; 95% confidence interval, 0.1-1.5; P=.02), treatment within 30 days (1.62%; 95% confidence interval, 1.0-2.3; P.001), and surgery within 30 days (1.54%; 95% confidence interval, 0.8-2.3; P.001). In particular, large gains were estimated for women living in low-income zip codes, Hispanic women, and women with cervical cancer. Estimates from the subgroup and propensity-matched cohorts were generally consistent for all outcomes besides early-stage diagnosis and treatment within 30 days.Medicaid expansion was significantly associated with gains in the access and timeliness of treatment for nonelderly women with gynecologic cancer. The implementation of Medicaid expansion could greatly benefit women in nonexpansion states. Gynecologists and gynecologic oncologists should advocate for Medicaid expansion as a means of improving outcomes and reducing socioeconomic and racial disparities.

Background Health reform and the merits of Medicaid expansion remain at the top of the legislative agenda, with growing evidence suggesting an impact on cancer care and outcomes. A systematic review was undertaken to assess the association between Medicaid expansion and the goals of the Patient Protection and Affordable Care Act in the context of cancer care. The purpose of this article is to summarize the currently published literature and to determine the effects of Medicaid expansion on outcomes during points along the cancer care continuum. Methods A systematic search for relevant studies was performed in the PubMed/MEDLINE, EMBASE, Scopus, and Cochrane databases. Three independent observers used an abstraction form to code outcomes and perform a quality and risk of bias assessment using predefined criteria. Results A total of 48 studies were identified. The most common outcomes assessed were the impact of Medicaid expansion on insurance coverage (23.4% of studies), followed by evaluation of racial and/or socioeconomic disparities (17.4%) and access to screening (14.5%). Medicaid expansion was associated with increases in coverage for cancer patients and survivors as well as reduced racial- and income-related disparities. Conclusions Medicaid expansion has led to improved access to insurance coverage among cancer patients and survivors, particularly among low-income and minority populations. This review highlights important gaps in the existing oncology literature, including a lack of studies evaluating changes in treatment and access to end-of-life care following implementation of expansion.

Purpose: The Affordable Care Act (ACA) aimed to increase insurance coverage through key provisions such as expansion of Medicaid eligibility and enforcement of an individual mandate. The objective of this study is to examine the impact of the ACA on insurance rates among patients newly diagnosed with colon, lung, or breast cancer. Methods: Using the SEER database, patients younger than age 65 years diagnosed with colon, lung, or breast cancer between 2008 and 2014 were identified. Insurance rates were examined before versus after passage of the ACA (2011) and before (2011 to 2013) versus after (2014) Medicaid expansion in nine expansion states and five nonexpansion states. Difference-in-differences models were used to estimate the differential impact of ACA in expansion compared with nonexpansion states. Results: A total of 414,085 patients with known insurance status were diagnosed with colon, lung, or breast cancer between 2008 and 2014. For all cancer types, there was a significant increase in patients enrolled in Medicaid after 2011 in expansion states. Between 2011 to 2013 and 2014, in patients living in states with Medicaid expansion, the uninsured rates decreased by ≥ 50% among patients with a new diagnosis of lung and colon cancer (6.5% in 2011 to 2013 to 3.1% in 2014 and 6.8% in 2011 to 2013 to 3.4% in 2014, respectively; P < .001); the uninsured rate decreased to a lesser degree for patients with breast cancer (2.7% in 2011 to 2013 to 1.6% in 2014; P < .001). This decrease in the rate of uninsured patients was absent in patients living in nonexpansion states. Conclusion: The ACA resulted in expanded insurance coverage for patients diagnosed with colon, lung, and breast cancer. However, the impact was only observed in states that increased their Medicaid eligibility.

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.

PURPOSE/OBJECTIVE(S) In 2010, the Affordable Care Act (ACA) was enacted, which allowed for increased access to health insurance in the US. Since then, there was a decrease in uninsured patients including those with cancer receiving radiation therapy. In 2017, federal policy was changed in regards to the ACA including a shortened enrollment period and significantly reduced funding. We aimed to determine trends in rates of uninsured patients receiving radiation therapy within this time period in order to identify correlations of these policy changes. MATERIALS/METHODS We obtained data from the National Cancer Database (NCDB) Public Benchmark Reports from 2008-2017 to investigate trends in uninsured cancer patients who received radiation therapy. This data was stratified by all patients who received radiation therapy, and calculated percentages of those without insurance from the years 2008 to 2017. We then identified trends of uninsured status by race including White, Black, Hispanic, Asian/Pacific, Native American, and unknown. RESULTS According to the data, the percentage of patients receiving any kind of radiotherapy without health insurance declined over the years of 2008 to 2016 (2.3% to 1.76%). In 2017, the trend reversed with 1.78% of patients without health insurance. The percentage of patients who were uninsured that identified as White was lower than the entire population, and also declined from 2008 to 2016 (1.73% to 1.12%). In 2017, the trend reversed to 1.18%. The percentage of patients who were uninsured that identified as Black was higher than the entire population, but also declined from 2008 to 2016 (4.2% to 2.92%). In 2017, this trend continued to decline to 2.69%. The percentage of patients who were uninsured that identified as Hispanic was the highest of any group at any year. This group had an initial increase in uninsured patients from 2008 to 2012 (7.35% to 10%), then decrease by 2016 (7.78%). By 2017, this trend reversed again with 8% of the Hispanic population to be reported as uninsured. CONCLUSION In the last decade, there has been an overall trend towards less uninsured patients receiving radiation therapy in the United States, with the exception of 2017, which saw a slight increase, disproportionately affecting the Hispanic population. While it is uncertain as to whether federal policy changes in the promotion and administration of ACA affected these trends, this data mirrors observations in other series looking at un-insurance in cancer survivors. Further work is indicated to determine if this trend continues throughout the remainder of the past federal administration. In the meantime, it is essential to acknowledge the continued racial health disparities increase efforts in making access to cancer care more equitable.

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.