5578 Background: Improvements in therapy have resulted in a growing population of ovarian cancer survivors, with both incidence and survivorship increasing among non-White racial and ethnic groups. Despite increasing survivors, supportive care for ovarian cancer survivors has been reported as insufficient. Existing instruments to address survivorship needs were developed in homogenous populations, predominantly consisting of White patients. The purpose of this study was to gain a deeper understanding of the needs and experiences in a diverse cohort of ovarian cancer survivors. Methods: Structured focus groups of ovarian cancer survivors were conducted at a single academic NCI-designated cancer center. During focus groups, participants were guided in discussion about their experience, perspective, and unmet needs as an ovarian cancer survivor. The topics were developed in consultation by providers involved in direct ovarian cancer research and patient care. Thematic analysis was used to systematically code and analyze focus group transcripts, allowing for identification of recurrent patterns and themes within the data. Results: Three focus groups of 20 patients were conducted. 12 (60%) patients identified as White, 4 (20%) as Asian, 3 (15%) as Black, and 1(5%) as Hispanic; additional patient characteristics are in Table 1. Participants generally reported their care during treatment was efficient and streamlined; however, gaps in survivorship care emerged. Key themes included poor care coordination with non-oncologic providers, feelings of abandonment after active treatment, limited communication about long-term expectations after surgery and/or chemotherapy, lack of individualized care plans, and uncertainty about where to find reliable resources. Suggested improvements included centralized access to survivorship resources, expanded peer support opportunities, and more tailored, patient-specific communication. Conclusions: The study highlights specific gaps in ovarian cancer survivorship among a diverse patient population. Deficits in care coordination, individualized communication, and access to tailored resources may contribute to feelings of abandonment and uncertainty following treatment. Targeted survivorship interventions addressing these areas may help to improve quality of life among an increasingly diverse population of ovarian cancer survivors. Focus group characteristics (N=20). Patient Characteristics # of Participants Age Range (Years) <50 4 50-59 7 60+ 9 Time Since Diagnosis (years) >10 2 5-10 4 3-5 2 <3 12
IntroductionOnly two-thirds of patients with ovarian cancer ever see a gynecologic oncologist. Our objective was to examine the feasibility of an electronic health record-based nudge to clinicians for referral to gynecologic oncology at suspected ovarian cancer by imaging.MethodsWe developed a nudge, a short behavioral economics informed best practice advisory with a pended referral order for gynecologic oncology, for primary care, emergency medicine, and obstetrician/gynecology clinicians for when a patient had a O-RADS 4 or 5 lesion on imaging and had not already seen gynecologic oncology. In 2024, clinicians were sent the nudge within 2 business days of a patient's abnormal imaging through the electronic health record. Our primary outcome was referral rate to gynecologic oncology compared to a historic cohort of patients with O-RADS 4 or 5 lesions from 2020-2023.ResultsIn this prospective cohort study, we sent 20 clinician nudges for gynecologic oncology referral; six clinicians (30%) responded that the nudge changed their referral behavior. The 90-day referral rate was 75% compared to historic baseline of 61%. In the pilot, 92% patients undergoing surgery for complex adnexal mases had surgery with gynecologic oncology compared to historic baseline of 82%. One in four patients in the pilot were diagnosed with cancer, all early-stage disease.ConclusionsA clinician nudge for gynecologic oncology referral at suspected ovarian cancer diagnosis was acceptable and associated with 75% referral rate. A clinician nudge standardizes gynecologic oncology referral and may improve early detection of ovarian cancer. A randomized controlled trial of the clinician nudge is warranted.
OBJECTIVE:We evaluated the implementation of a pilot patient-ambassador program designed to facilitate peer-to-peer discussion and education about gynecologic oncology (GYO) clinical trials among trial-naïve patients. METHODS:We conducted a mixed-methods interventional behavioral study at an NCI designated comprehensive cancer center to assess a program initiating peer conversations about GYO clinical trials. From Feb-Oct 2024, patients who had previously participated in GYO clinical trials were recruited as ambassadors. Ambassadors completed a structured educational curriculum and were paired with 5-8 trial-naïve mentees with high-risk or advanced gynecologic cancers. Implementation outcomes included acceptability, feasibility, net promotor score, clinical trials knowledge, confidence discussing trials, and perception of trials. Qualitative analyses of recorded chats, and ambassador feedback were also performed. RESULTS:Three ambassadors and 20 mentees completed the program, generating 20 "chats" from 266 eligible mentees. At baseline, 90% of mentees had heard of clinical trials and 75% reported somewhat or very positive perceptions. Post chat, 90% reported somewhat or very positive perceptions, 85% felt the chat changed their view of trials, and 95% felt confident to ask their oncology provider about trials. Although overall survey-based knowledge did not improve, 95% reported the chats were educational and addressed concerns. Acceptability, feasibility, and program promotion were high. Implementation challenges included emotional strain on ambassadors, mismatched expectations, and variability in discussing recruitment of diverse populations. CONCLUSIONS:This pilot patient-ambassador program is a feasible and acceptable intervention that improved patient confidence in discussing clinical trials with providers.
Objective Women are the fastest growing demographic within the military-Veteran population in the United States. Our objective was to characterize gynecologic cancer occurrence, and trends over time, in Veterans and service members compared to non-veterans. Methods We performed a retrospective cohort study using National Cancer database comparing cancer occurrence, age at diagnosis, histology, and survival among veterans and service members compared to non-veterans from 2004 to 2021. Results Annual new gynecologic cancer diagnoses increased among Veterans from 301 in 2004 to 883 in 2021. Veterans now account for 1% of gynecologic cancer diagnoses nationwide. Veterans were diagnosed with gynecologic cancers at younger ages and earlier stages than non-veterans. Cancer histologies differed from non-veterans with endometrioid uterine cancer, germ cell ovarian cancer, and cervical adenocarcinoma being more common in Veterans. Overall survival was similar among Veterans and non-Veterans. Conclusions As the proportion of women in the military has grown, gynecologic cancer diagnoses and survivorship among service members and Veterans are increasing. Further work is needed to understand the epidemiology of gynecologic cancer and optimize gynecologic cancer prevention and care delivery for service members and Veterans.
e17557 Background: Women with ovarian cancer may have subtle symptoms, delaying diagnosis to late stage. Guidelines recommend use of cancer antigen 125 (CA-125) in the work up of suspected ovarian cancer, especially for which patients need referral to gynecologic oncology. Yet “normal” CA-125 thresholds of 35 units/mL in practice were developed in 1980s in a homogenous group of women with different distribution of ovarian cancer histologies than current. Our objective was to compare the sensitivity of different CA-125 thresholds across ovarian cancer histologies. Methods: We identified patients with newly-diagnosed ovarian cancer from the Penn Medicine Cancer Registry, 2009-2023 (n=2,785) supplemented with patients identified by ICD codes, 2020-2023 (n=1,342). CA-125 values obtained within 60 days of diagnosis were abstracted from the electronic health record. We examined the sensitivity of current CA-125 thresholds by histology. Results: Among 1670 patients with ovarian cancer and CA-125 at diagnosis, the median CA-125 at diagnosis was 255.0 (interquartile range 49.0-955.0) in epithelial tumors compared to 41.0 (IQR 26.0-264.8) for germ cell and 23.2 (IQR 16.0-53.5) for sex cord stromal tumors. Within epithelial tumor types, CA-125 ranged from 31.2 (IQR 21.0,92.0) in mucinous tumors, 34.0 (IQR 21.0,104.0) in borderline tumors, 193.0 (IQR 35.0,807.6) in low-grade serous to 466.0 (IQR 112.0,1328.0) in high-grade serous tumors. At diagnosis, 50% of patients with ovarian cancer had CA-125 <35 units/mL, including 20% of epithelial tumors. Lowering CA-125 threshold to 15 units/mL improved sensitivity to 92%. Conclusions: Current thresholds of abnormal CA-125, used for gynecologic oncology referral, miss up to half of individuals with ovarian cancer. Sensitivity is lowest for mucinous and borderline tumors that are increasingly common. Updated thresholds are needed to avoid delays in diagnosis, and strengthen the potential for cure, in ovarian cancer.
Tumor molecular profiles have contributed to our understanding of the development and behavior of uterine cancer with varying mutational patterns across differing patient populations. Age is an important factor that may influence the microenvironment and molecular landscape of EC. Our objective was to explore the relationships of the endometrial cancer (EC) biomarkers TP53, Her2, PTEN, PIK3CA, POle, CCNE1, and KRAS and their relationship with patient age <50 vs age ≥ 50 years old. The University Institutional Review Board reviewed and exempted this study. We identified patients diagnosed with EC between January 2014 – 2023 within the University of Pennsylvania Health System’s cancer registry and electronic medical record with tumor histology and molecular profile with institutional personalized diagnostics and CARIS Life Sciences©. Only those with confirmation of presence or absence of all mutations were included in this analysis. Analyses were stratified by patient age <50 and ≥50 years old threshold. 3,418 patients were identified, and 211 patients were included in this analysis. 17(8%) were <50 years old and 194 (92%) patients were ≥50 years old. 51(24%) patients were identified as Black/Afr. Amer., 7(3%) Asian, 4 (2%) Other, and 149(71%) as White in their medical records. 102 (48%) were diagnosed at Stage I/II, 88(42%) at Stage III/IV and 21(10%) with an unknown stage. Patients with age ≥50 years old had a greater risk of TP53 mutation (OR 1.54; 95% CI: 1.21, 1.96; p=0.0005). There was no difference with regards to Her2 mutation status (OR=0.99; 95%CI: 0.89, 1.11; p=0.898). However, for PTEN, those ≥50 years old had a lower risk of PTEN mutations (OR=0.69, 95% CI: 0.54, 0.88; p=0.003). There was no difference in age risk for PIK3CA mutation (OR=1.12; 95%CI: 0.87, 1.43; p=0.38), POLe mutation (OR=1.13, 95%CI: 0.97, 1.32; p=0.13) and KRAS mutation (OR=1.04; 95%CI: 0.87, 1.24; p=0.69). No CCNE1 mutations were identified in this patient sample. Patients under <50 years were more likely to have PTEN mutation than patients ≥50 years old. Camille McCallister, Caroline Shermoen, Sneha Kadiyala, Anna Liu, Nathanael Koelper, Ronny Drapkin, Mary Boland, Emily Ko1, Kimberly Lee, Anna Jo Bodurtha Smith. Endometrial cancer mutation patterns by age with possible increased TP53 and decreased PTEN mutations in patients 50+ years old [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: The Rise in Early-Onset Cancers—Knowledge Gaps and Research Opportunities; 2025 Dec 10-13; Montreal, QC, Canada. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(23_Suppl):Abstract nr C025.
Transportation barriers can lead to delays in care and suboptimal treatment. Our objective was to assess the utilization of a novel transportation pilot intervention in gynecologic oncology. Since May 2022, we have provided donor-funded transportation to patients receiving gynecologic cancer treatment at 5 University of Pennsylvania practices. Patients are screened for transportation barriers at first visit and re-screened during care. Patients who screen positive are referred to the intervention, a HIPAA-compliant ride-sharing service. There are no income or insurance restrictions; distance was limited to 25 miles. We report descriptive statistics on ride completion, distance traveled, and cost. In the 15-month pilot, 133 of 4,376 patients (3
11082 Background: Financial toxicity, transportation needs, and emotional strain are known barriers to receipt of cancer care and cause for disparities in cancer outcomes. We sought to evaluate the implementation of a supportive care program (SCP) on the delivery of cancer care, its associated health care utilization outcomes and cost. Methods: From May 2022-Nov 2024, SCP included a standardized social determinant of health (SDOH) screening tool, financial navigation, transportation ridesharing, and peer-support program in the 5 gynecologic oncology practices within a NCI Comprehensive Cancer Center. Patients were referred through the SDOH screener or usual clinical care referrals. We report descriptive statistics on the mechanism for referral for SCP, associated health care utilization, and costs. We assessed differences in SCP financial and transportation sub-groups with bivariable non-parametric testing (p-value< .05 considered statistically significant). Results: Of 7159 patients encompassing 22041 encounters, 259 received SCP (41 financial navigation, 177 transportation, 3 transportation + financial navigation, 18 peer-support program). Only 73 (28.7%) were referred through the SDOH screening tool, and the rest through usual clinical care. Most SCP recipients (60.6%) were Black/Asian/Other, in contrast to our general clinical population (63% White). Only 65 (25.6%) of SCP patients were employed, and 72.8% had Medicare or Medicaid. Nearly all SCP patients resided in the MidAtlantic tristate area. Patients receiving financial navigation were younger (p<0.001), more likely to be privately insured (p<0.001), and less likely to reside in the metropolitan area (43.9% v. 63.8%, p=0.05) compared to those receiving transportation. A total of 1770 rides were completed, costing $51885.20 which included the ride and administrative scheduling fee. A total of 14 SCP participants were clinical trial participants; of these, 78.6% utilized transportation assistance. Following receipt of SCP, the total scheduled visits for SCP patients included 7768 visits. Patients receiving transportation assistance had higher rates of unplanned admission (43.5% v. 22.0%, p=0.011), and no-show rates (4.6% vs 1.2%, p<0.001) compared to those receiving financial navigation. Conclusions: Our SCP served primarily racial-minority and publicly insured patients. Only 25% were employed during active cancer treatment. Transportation was the most frequently used SCP service, including by our clinical trial participants. Patients with transportation needs had higher rates of unplanned admissions and no-shows than those receiving financial navigation. Financial toxicity affected younger patients including those privately insured. SCP facilitates cancer care delivery, but requires infrastructural development, substantial investment in resources, and further analyses of health care utilization, outcomes and cost.
Importance International guidelines use cancer antigen (CA) 125 thresholds to recommend which patients with pelvic masses should undergo evaluation by gynecologic oncologists for ovarian cancer. However, CA-125 thresholds were developed from White populations. If CA-125 levels differ among patient populations, current guidelines may contribute to delayed ovarian cancer diagnoses among women of other races and ethnicities than White. Objective To examine CA-125 levels at ovarian cancer diagnosis by patient race and ethnicity and associations of elevated CA-125 levels with timely treatment. Design, Setting, and Participants This retrospective cohort study included all patients with ovarian cancer diagnosed between January 1, 2004, and December 31, 2020, using the US National Cancer Database. The data analysis was performed between November 1, 2023, and July 10, 2024. Exposure Patient race and ethnicity as identified in the National Cancer Database. Main Outcome and Measures Cancer antigen 125 level was defined as elevated or borderline and negative or normal. Multivariable logistic regression models were used to examine the association of patient race and ethnicity with CA-125 level overall and for epithelial and high-grade serous cancers. Generalized linear models were used to examine the association of CA-125 level with days from diagnosis to chemotherapy start for patients with stage II to IV ovarian cancer. Results Of the 250 749 patients with ovarian cancer diagnosed between 2004 and 2020 (median [IQR] age, 62.0 [52.0-73.0] years; 0.4% American Indian, 3.7% Asian, 8.6% Black, 85.2% White, and 2.0% other or unknown race and 6.7% Hispanic, 88.8% non-Hispanic, and 4.6% of unknown ethnicity), 212 477 had measured CA-125 levels, and 88.2% had an elevated CA-125 level at diagnosis. Patients with American Indian, Asian, or Black race were less likely to have an elevated CA-125 level at ovarian cancer diagnosis than White patients. In multivariable analyses adjusted for stage, comorbidities, and menopausal status, Black patients had lower odds of elevated CA-125 levels (adjusted odds ratio [AOR], 0.77; 95% CI, 0.74-0.81) compared with White patients, as did American Indian patients (AOR, 0.77; 95% CI, 0.62-0.94). Among patients with high-grade serous ovarian cancer only, Black patients had a lower odds of having an elevated CA-125 level at diagnosis (AOR, 0.81; 95% CI, 0.73-0.91). Patients with stage II to IV ovarian cancer with false-negative CA-125 findings at diagnosis had 9.38 days longer (95% CI, 8.43-10.34 days) to chemotherapy start compared with patients with an elevated CA-125 level. Conclusions and Relevance In this cohort study of patients with ovarian cancer, American Indian and Black patients were 23% less likely to have an elevated CA-125 level at diagnosis. Current CA-125 thresholds may miss racially and ethnically diverse patients with ovarian cancer. Work is needed to develop inclusive CA-125 thresholds and diagnostic guidelines and not compound disparities in ovarian cancer diagnosis and treatment.
BACKGROUND:Racial disparities in clinical trial participation for uterine cancer have been reported. OBJECTIVE:We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States. STUDY DESIGN:We conducted a retrospective cohort study of patients with advanced or recurrent patients with endometrial cancer diagnosed from 2013 to 2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors. RESULTS:Of 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (CI) 1.12-4.62 and RR 2.59, 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95% CI 0.30-0.83). CONCLUSION:Black patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.
The Ovarian-Adnexal Reporting and Data System (O-RADS) 4 and 5 lesions correspond with a 10–50% and greater than 50% chance of malignancy, respectively. We examined the accuracy of these classifications across imaging type and patient demographic factors in predicting malignancy. The university IRB reviewed and exempted this retrospective cohort study of patients with O-RADS 4 or 5 lesions on ultrasound (US) or magnetic resonance imaging (MRI) from July 1, 2020, to December 31, 2023 (n=425). We examined the positive predictive value (PPV) of O-RADS classifications in predicting malignancy in patients with diagnostic resolution, ie, who received surgery (n=266) or whose lesions resolved on follow-up imaging (n=44). Across all subgroups, the classifications corresponded with the percent chance of malignancy consistent with previously published studies: O-RADS 4 ranged from 0.13 to 1.0; O-RADS 5 ranged from 0.50 to 1.0. Both classifications were more accurate in MRI (0.91 and 0.28) than US (0.57 and 0.18). The PPVs of O-RADS 4 and 5 on US were similar across postmenopausal status: 17% and 56% PPV for premenopausal, 20% and 52% for postmenopausal for O-RADS 4 and 5, respectively. Stratifying by race, PPVs were within published estimates by imaging modality and O-RADS score. Rates of incomplete follow-up were higher for Black than White patients. We found that O-RADS scores remained highly predictive of malignancy in a clinical population diverse in age and race. There were modifiable disparities in follow-up by race. Validating diagnostic classification systems in diverse populations is essential for diagnostic and treatment equity.
5544 Background: Ovarian-Adnexal Reporting Data System (O-RADS) is an international lexicon and risk stratification tool. O-RADS 4 or 5 lesions are complex adnexal masses that a 10-90% risk of malignancy, and national guidelines recommend gynecologic oncology referral. Our objective was to examine patient, clinician, and imaging factors associated with referral to gynecologic oncology for complex adnexal masses. Methods: This retrospective cohort study was exempt from IRB review. We identified all patients with O-RADS 4 or 5 lesions on ultrasound (US) or MRI from July 1, 2020 to December 31, 2023. Our primary outcome was referral to gynecologic oncology. We gathered patient demographic data and ordering clinician characteristics from electronic health records. We performed descriptive statistics and multivariate logistic regression of patient demographics and ordering clinician characteristics associated with gynecologic oncology referral. Results: Our cohort included 373 patients with O-RADS 4 or 5 lesions and no prior gynecologic oncology care. The referral rate to gynecologic oncology was 68%, and referral within 30 days of abnormal imaging was 43%. Time from abnormal imaging to referral ranged from 0 to 407 days (mean 15.3, median 4 days). In multivariate analyses, the likelihood of referral to gynecologic oncology was higher among patients with repeat abnormal imaging compared to those with single instance of abnormal imaging (aOR 20.61, 95%CI 2.63-161.6), O-RADS 5 lesions compared to O-RADS 4 lesions (aOR 9.15, 95%CI 3.47-24.85) and detection on MRI compared to US (aOR 7.79, 95%CI 1.57-38.65). The likelihood of referral to gynecologic oncology was lower among non-white patients (aOR 0.24, 95%CI 0.08-0.76). There were no differences by Hispanic ethnicity, rurality, insurance, or language. Referral was higher among patients whose imaging was ordered by an internal medicine clinician (aOR 3.89, 95%CI 1.48-10.20) compared to ob/gyn. Conclusions: One-third of patients with complex adnexal masses were not referred to gynecologic oncology. Disparities in referral to gynecologic oncology for complex adnexal masses rates based on patient race and ordering clinician specialty highlight the need for system-based approaches including clinician education or automated referrals. Gynecologic oncology referral after O-RADS 4/5. Multivariate OR (95%CI) Postmenopausal (≥55 years) 1.89 (0.95-3.74) Race - White Reference - Black 0.57 (0.27-1.21) - Asian 1.03 (0.30-3.58) - Some other race 0.24 (0.08-0.76) Ordering specialty - Obstetrics/Gynecology Reference - Emergency Medicine 0.93 (0.33-2.62) - Internal Medicine 3.89 (1.48-10.20) - Family Medicine 1.62 (0.66-3.98) - Other specialty 0.87 (0.27-2.76) Has PCP 1.66 (0.81-3.42) O-RADS - 4 Reference - 5 9.15 (3.27-24.85) Imaging - MRI 7.79 (1.57-38.65) - US Reference Repeat abnormal imaging 20.61 (2.63-161.79)
International guidelines recommend follow-up imaging and gynecologic oncology referral for patients with Ovarian-Adnexal Reporting and Data System (O-RADS) 4/5 lesions. We examined factors associated with guideline-concordant follow-up of these lesions in our health system. The university IRB exempted this retrospective cohort study of patients with O-RADS 4/5 lesions on ultrasound (US) or magnetic resonance imaging (MRI) from July 1, 2020, to December 31, 2023. Patients with adnexal surgery within 120 days of detection were excluded (n=253). We performed descriptive statistics of our final cohort (n=172). 59.9% were not referred to gynecologic oncology (103/172, 59.9%). 65.7% had a documented pelvic examination after initial detection (113/172, 65.7%), 48.8% had generalist follow-up (84/172, 48.8%), and 15.7% had both generalist and gynecologic oncology follow-ups (27/172, 15.7%). 13.4% had ongoing lesion surveillance at data collection (23/172). 55.0% of the remaining (82/149, 55.0%) had benign follow-up imaging. 9.4% received surgery for persistent abnormalities (14/149, 9.4%) with three cancers diagnosed (3/149, 2.0%). Black compared to White patients had higher rates of incomplete or no follow-up imaging (14/40, 35.0% versus 18/91, 19.8%), follow-up pelvic examinations (30/40, 75.0% versus 62/91, 68.1%), and generalist visits (23/40, 57.5% versus 47/91, 51.6%), with lower rates of gynecologic oncology follow-up (13/40, 32.5% versus 43/91, 47.3%). Insured patients had higher rates of completed follow-up imaging (80/156, 51.3% versus 2/6, 33.3%). 22.7% (39/172) of patients with O-RADS 4/5 lesions had no or incomplete follow-up imaging. Higher rates of guideline discordant care among Black and uninsured patients suggest opportunities for care optimization.
This Viewpoint highlights the need for recognition that ovarian cancer affects women from racial and ethnic minority groups worldwide and that the rates of ovarian cancer are increasing in those populations while decreasing among White women.
Importance Disparities in minoritized racial and ethnic populations' participation in gynecologic cancer clinical trials are well documented despite the high rates of endometrial cancer in these populations. Geographic proximity to trials is a critical component to ensure equitable trial access. Objective To characterize the geographic distribution of gynecological cancer trials across the US and identify disparities. Design, Setting, and Participants This study is a cross-sectional analysis of trials first posted on ClinicalTrials.gov from January 1, 2013, through January 10, 2024. This study involved a state-level analysis of clinical trials located in the US. Enrollment criteria of clinical trials for ovarian, uterine, cervical, endometrial, vaginal and/or vulvar, and other gynecological cancers were reviewed to exclude nongynecological cancers (1643 trials) or noninvasive gynecological conditions (224 trials). Exposure The number of gynecological trials per 100 000 persons in each state. Main Outcomes and MeasuresA state-level analysis was performed to determine whether gynecologic cancer clinical trial availability in the US is associated with other state-level characteristics to identify areas of increased need. Census data, state-level total population size, percentage of non-Hispanic White persons, and the Federal Emergency Management Agency expected annual loss per state as a measure of social vulnerability were aggregated. The association between these variables and the number of gynecological trials per 100 000 persons was measured using Spearman rank correlation. Results Of the 1561 invasive gynecological cancer trials that met the inclusion criteria, most cancer trials were ovarian (911 trials [58.4%]), followed by cervical (438 trials [28.1%]), and endometrial (385 trials [24.7%]). Predominantly minoritized population-serving states (ie, those with <50% non-Hispanic White persons) had fewer than 4 trials per 100 000 persons, but this was not significant nationally (rho = 0.20; 95% CI, -0.08 to 0.45; P = .16). States with higher Federal Emergency Management Agency expected annual loss had lower numbers of gynecological trials per 100 000 persons, which was significant nationally (rho = -0.53; 95% CI, -0.70 to -0.29; P < .001). Conclusions and RelevanceIn this cross-sectional study of female gynecological cancer trials by state, states with particularly high economic vulnerability and minoritized populations had low clinical trial availability. Further efforts are needed to address disparities identified in this study to ensure equitable trial access.
In the United Sates, over 115,000 individuals are diagnosed with a gynecologic cancer annually with access to a gynecologic oncologist and evidence-based treatment remaining a persistent challenge. Coverage decisions by private and public insurance, including Medicaid and Medicare, play key roles in access to care, impacting oncologic outcomes. The expansion of Medicaid insurance under the Affordable Care Act improved early diagnosis, treatment, and survival in gynecologic cancers, but disparities remain for individuals in non-Medicaid expansion states. For individuals with Medicare or private insurance, coverage gaps and high out-of-pocket costs are barriers to cancer care, particularly for novel therapeutic treatments. Efforts to streamline care access, expand clinical trial participation, and reduce administrative burdens continue. Addressing these disparities require improving insurance literacy in patients and clinicians, coordination, and community partnerships to support equitable and comprehensive gynecologic cancer care.
5549 Background: PARP inhibitors improve survival in ovarian cancer, especially in patients with BRCA 1/2 mutations or homologous recombination deficiency (HRD). However, these FDA-approved drugs cost $100,000 annually on average, and concerns have been raised about insurance barriers like prior authorization to such medications. Our objective was to examine the prevalence of prior authorization for PARP inhibitors in ovarian cancer overall, by frontline or recurrent maintenance, and by genetic status. Methods: We performed a retrospective cross-sectional study of ovarian cancer patients prescribed a PARP inhibitor within the University of Pennsylvania oncology practices from May 2020-2021. Using electronic medical records, we assessed the prevalence of prior authorization for PARP inhibitors overall, by frontline or recurrent maintenance, and by BRCA or HRD status. We then assessed the associated approval and appeal rates. Results: We identified 110 patients with ovarian cancer who were prescribed a PARP inhibitor. Of these, 67% (95%CI 57-75) experienced prior authorization for their PARP inhibitor. In contrast, 31 (95%CI 23-40) experienced prior authorization for other components of their gynecologic oncology care. Of patients in the frontline setting, 74 (95%CI 58-86) experienced prior authorization for FDA-approved PARP maintenance. Of patients prescribed PARP maintenance after recurrence, 58 (95%CI 45-71) experienced prior authorization. Of patients with germline BRCA, 70% (95%CI 47-85) experienced prior authorization for PARP inhibitors. Of patients with germline or somatic BRCA or HRD+, 76% (95%CI 61-87) experienced prior authorization. 95% (95%CI 86-94) of prior authorizations for PARP inhibitors were approved on their 1st appeal, and 99% (95%CI 95-100) were approved by the 2nd appeal. Conclusions: Two-thirds of patients of ovarian cancer patients who were prescribed PARP inhibitor experienced prior authorization, including equally high rates among women with germline or somatic BRCA mutations, as well as with HRD-deficient tumors. Given the nearly 100% approval after prior authorization, improvements in insurance processes are needed to streamline PARP inhibitor access in ovarian cancer.