"Having cancer is very expensive": A qualitative study of patients with ovarian cancer and PARP inhibitor treatment.

OBJECTIVE: To examine patient barriers and facilitators to PARP inhibitor (PARP-I) maintenance therapy in ovarian cancer. PARP-I improves survival in ovarian cancer, but these multi-year therapies cost around $100,000 annually and are under-prescribed. METHODS: We recruited patients with ovarian cancer treated with PARP-I maintenance therapy at an academic health system for a semi-structured interview. Patient demographics, including genetics and PARP-I cost, were self-reported. We assessed patient experiences with barriers and facilitators of PARP-I usage. Two team members used a thematic approach to analyze and identify key themes. RESULTS: In May 2022, we interviewed 10 patients (mean age = 65 years; 80% White; 60% with a germline genetic mutation). Patients paid on average $227.50 monthly for PARP-I, straining resources for some participants. While sampled patients were insured, all patients identified having no or inadequate insurance as a major barrier to PARP-I. At the same time, all participants prioritized clinical effectiveness over costs of care. Patients identified PARP-I delivery from specialty pharmacies, separate and different from other medications, as a potential barrier, but each had been able to navigate delivery. Patients expressed significant initial side effects of PARP-I as a potential barrier yet reported clinician communication and prompt dose reduction as facilitating continuation. CONCLUSIONS: Patients identified cost, restrictive pharmacy benefits, and initial side effects as barriers to PARP-I usage. Having insurance and a supportive care team were identified as facilitators. Enhancing communication about PARP-I cost and side effects could improve patient experience and receipt of evidence-based maintenance therapy in ovarian cancer.

Prior authorization for FDA-approved PARP inhibitors in ovarian cancer.

Objectives: PARP inhibitors (PARP-I) improve survival in ovarian cancer, especially in patients with germline or somatic BRCA mutations or other homologous recombination deficiency (HRD). With high efficacy and costs, insurers may enact barriers or facilitators to PARP-I. Our objective was to examine the prevalence of prior authorization for PARP-I in ovarian cancer. Methods: We performed a retrospective cross-sectional study of patients with ovarian cancer prescribed a PARP-I within the University of Pennsylvania practices from December 2018 through May 2021. We assessed prevalence of prior authorization for PARP-I overall, by frontline or recurrent maintenance, and by genetic status. We then assessed approval and appeal rates and time to PARP-I start. Results: Of 180 patients with a PARP-I prescription and information regarding prior authorization, 116 (64 %, 95 % CI 57-71) experienced prior authorization. Of patients in the frontline setting, 60 of 90 (67 %, 95 % CI 56-76) experienced prior authorization. Of patients prescribed PARP-I in recurrence, 55 of 85 (65 %, 95 % CI 54-74) experienced prior authorization. Having a germline or somatic genetic mutation was associated with higher risk of prior authorization (adjusted risk ratio 1.35, 95 %CI 1.09-1.67). 102 patients (89 %, 95 % CI 83-94) required one appeal, 8 required two appeals and 5 cases required 3 appeals. Five patients were denied. Mean time from PARP-I prescription to PARP-I start was 10 days longer for patients who experienced prior authorization. Conclusions: 64% of patients experienced prior authorization for PARP-I. Risk of prior authorization was increased for patients with BRCA, despite greater clinical benefit. Prior authorization contributes to delays in care, and reform is needed.

Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018).

PURPOSE: To evaluate the addition of ofranergene obadenovec (ofra-vec, VB-111), a novel gene-based anticancer targeted therapy, to once a week paclitaxel in patients with recurrent platinum-resistant ovarian cancer (PROC). METHODS: This placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT03398655) randomly assigned patients with PROC 1:1 to receive intravenous ofra-vec every 8 weeks with once a week IV paclitaxel or placebo with paclitaxel until disease progression. The dual primary end points were overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review. RESULTS: Between December 2017 and March 2022, 409 patients were randomly assigned. The median PFS was 5.29 months in the ofra-vec arm and 5.36 months in the control arm, hazard ratio (HR) 1.03 (CI, 0.83 to 1.29; P = .7823). The median OS with ofra-vec was 13.37 months versus 13.14 months, HR 0.97 (CI, 0.75 to 1.27; P = .8440). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 28.9% with ofra-vec versus 29.6% with control. In both treatment arms, response to CA-125 was a substantial prognostic factor for both PFS and OS. In the ofra-vec arm, the HR in CA-125 responders compared with that in nonresponders for PFS was 0.2428 (CI, 0.1642 to 0.3588), and for OS, the HR was 0.3343 (CI, 0.2134 to 0.5238). Safety profile was characterized by common transient flu-like symptoms such as fever and chills. CONCLUSION: The addition of ofra-vec to paclitaxel did not improve PFS or OS. The PFS and ORR in the control arm exceeded the results that were anticipated on the basis of the AURELIA chemotherapy control arm. CA-125 response was a substantial prognostic biomarker for PFS and OS in patients with PROC treated with paclitaxel.

Extended Venous Thromboembolism Prophylaxis after Robotic Staging for Endometrial Cancer.

OBJECTIVES: Our objectives were to estimate the incidence of venous thromboembolism (VTE) after robotic staging for endometrial cancer and to compare the incidence of VTE in patients who received a single dose of preoperative prophylaxis of enoxaparin with those who received extended postoperative prophylaxis. METHODS: This study is a retrospective chart review of patients who underwent robot-assisted surgical staging for endometrial cancer. Patients were categorized into two groups: preoperative prophylaxis (PP), patients who received a single dose of enoxaparin preoperatively, and extended prophylaxis (EP), patients who received 28 days of enoxaparin postoperatively. RESULTS: In total, 148 patients were included, with 117 patients in the PP group and 31 patients in the EP group. The overall incidence of VTE within 30 days postoperatively was 0.67%. No significant difference was found between the PP and the EP groups (0.9% and 0%, respectively; P = 1.00). Most patients in the cohort had endometrioid adenocarcinoma (78%) with low-grade disease (70%), although there were a greater number of patients in the PP group with uterine serous carcinoma compared with the EP group (17% vs 10%; P = 0.034). The PP group had higher estimated blood loss (106 vs 81 mL; P = 0.009) and longer operative times (178 vs 151 min; P = 0.028) compared with the EP group. Significantly more patients in the PP group underwent lymph node dissection compared with the EP group (32% vs 7%; P = 0.008). CONCLUSIONS: The incidence of VTE following robot-assisted surgical staging for endometrial cancer in this study was 0.67%. No significant difference was found in VTE incidence between the PP group compared with the EP group. Mechanical prophylaxis plus a single dose of preoperative pharmacologic prophylaxis may suffice for low-risk patients following robotic surgical staging for endometrial cancer.

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue.

OBJECTIVE: Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed treatment for advanced ovarian cancer, but nearly half of patients experience significant fatigue. We conducted a two-site pilot randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a brief, acceptance-based telehealth intervention (REVITALIZE) designed to reduce fatigue interference in patients on PARPi. METHODS: From June 2021 to April 2022, 44 participants were randomized 1:1 to REVITALIZE (6 weekly one-on-one sessions+booster) or enhanced usual care. Feasibility was defined as: ≥50% approach-to-consent among potentially eligible patients and ≥70% completion of 12-week follow-up assessment; acceptance was <20% participants reporting burden and <20% study withdrawal. Fatigue, anxiety, depression, and quality of life were assessed at baseline, 4-, 8- and 12-weeks. RESULTS: Among 44 participants (mean age = 62.5 years, 81.8% stage III/IV disease), the study was feasible (56.4% approach-to-consent ratio, 86.3% completion of 12-week assessment) and acceptable (0% reporting burden, 11.3% study withdrawal). At 12-week follow-up, REVITALIZE significantly reduced fatigue interference (Cohen's d = 0.94, p = .008) and fatigue severity (d = 0.54, p = .049), and improved fatigue levels (d = 0.62, p = .04) relative to enhanced usual care. REVITALIZE also showed promise for improved fatigue self-efficacy, fatigue catastrophizing, anxiety, depression, and quality of life (ds = 0.60-0.86, p ≥ .05). Compared with enhanced usual care, REVITALIZE participants had fewer PARPi dose reductions (6.7% vs. 19.0%), and dose delays (6.7% vs. 23.8%). CONCLUSIONS: Among fatigued adults with ovarian cancer on PARPi, a brief, acceptance-based telehealth intervention was feasible, acceptable, and demonstrated preliminary efficacy in improving fatigue interference, severity, and levels. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation.

Insurance status and time to radiation care after pathologic diagnosis for cervical cancer patients.

Delays in starting potentially curative treatment for locally-advanced cervical cancer (LACC) decrease survival. Reasons for these delays are poorly understood. We conducted a retrospective chart review examining disparities in time from diagnosis of LACC to first clinic visit and to initiation of treatment based on insurance status within a single health system. We analyzed time to treatment using multivariate regression, adjusted for race, age, and insurance status. 25% of patients had Medicaid and 53% had private insurance. Having Medicaid was associated with delayed time from diagnosis to seeing a radiation oncologist (Mean 76.9 v. 31.3 days, p = 0.03). However, time from first radiation oncology visit to starting radiation was not delayed (Mean 22.6 v. 22.2 days, p = 0.67). Patients with locally-advanced cervical cancer and Medicaid had over double the time from pathologic diagnosis of cervical cancer to seeing radiation oncology; insurance disparities were not observed in treatment start after seeing radiation oncology. Improved referral and navigation processes for patients with Medicaid are needed to improve timely receipt of radiation and potentially improve survival.

Electronic medical record documentation of germline genetic evaluations in patients with ovarian cancer.

Germline genetic evaluation is indicated for all patients with epithelial ovarian cancer (EOC). For testing to have clinical utility, results must be documented within the electronic medical record (EMR) and accessible to providers at the point of care, which can be challenging in the context of current EMR limitations and genetic testing processes. We examined the receipt of genetics services and EMR capture of genetic testing results in patients with EOC. We conducted a retrospective chart review to examine germline genetic evaluations among patients with EOC seen by a gynecologic or medical oncologist at the University of Pennsylvania in 2016. EMRs were reviewed to determine: (1) if patients were referred for genetic evaluation; (2) if genetic testing was performed; (3) if results were documented in office notes, scanned third-party test reports, and/or the EMR problem list; (4) if provider notes correctly listed the variant classification. Overall, 413 (62%) of patients had documented genetic testing. Genetic testing was documented in almost all provider notes (96%) and the majority of scanned EMR reports (64%). Pathogenic variants were found in 119 (29%) individuals; the majority (70%) had genetic testing documented within EMR problem lists. Provider notes were highly accurate in describing variant classification. In this study, genetic testing was performed and documented in the EMR for most EOC patients. Approximately one-third of those tested did not have scanned test reports specifying variant found, limiting the utility of test results for cascade testing and therapeutic decisions.

Insurance and racial disparities in prior authorization in gynecologic oncology.

While prior authorization aims to reduce unnecessary care, it may limit or delay medically necessary care. Delays in cancer care can impact survival and are more common in historically-marginalized populations. Our objective was to examine to what extent disparities occurred in prior authorizations for gynecologic oncology. Using electronic medical records, we performed a retrospective review of prior authorization occurrence during gynecologic oncology care and analyzed the association with patient race and insurance in a multivariate regression model. In this cohort of 1,406 patients treated at an academic gynecologic oncology practice, patients with Medicare Advantage and patients of Asian descent were more likely to experience prior authorization. Addressing insurance-mediate disparities, such as in the occurrence of prior authorization, may help reduce disparities in gynecologic cancer care.

Prior authorization in gynecologic oncology: An analysis of clinical impact.

BACKGROUND: Prior authorization was designed to minimize unnecessary care and reduce spending but has been associated with delays in necessary care. Our objective was to estimate the occurrence of prior authorization, and impact on cancer care, in gynecologic oncology. METHODS: We performed a retrospective cross-sectional study of patients seen in University of Pennsylvania gynecologic oncology practices (January-March 2021). Using electronic medical records, we measured the incidence of prior authorization during the 3-month period and prior experience of prior authorization for cancer care overall and by type of order (chemotherapy, imaging, surgery, prescription drugs). We assessed the impact of prior authorization occurrence on clinical outcomes (time to service, changes in care). RESULTS: Of the 2112 clinic visits of 1406 unique patients, 5% experienced prior authorization during the 3-month study period. An additional 20% faced prior authorization requests earlier in cancer care. Of the 83 prior authorization requests, imaging accounted for the majority (54%) followed by supportive medications (29%) and chemotherapy (17%). After appeal, 79% of cases were approved. For patients whose prior authorizations were approved, there was a mean of 16 days from order placement to care delivery (95% CI 11-20, range 0-98 days). Of the 17 denials, 3 (18%) led to a substantial change in care (i.e., not receiving planned treatment). CONCLUSION: 25% of gynecologic oncology patients experienced prior authorization during their cancer care. While 80% of claims were ultimately approved, patients experienced over a 2-week delay in care when prior authorization occurred. Reform is needed to reduce the burden of prior authorization in oncology.

Addition of External Beam Radiation Therapy to Adjuvant Chemotherapy for Patients With Stage IIIC Uterine Endometrioid Carcinoma: Utilization and Outcomes.

OBJECTIVES: Evaluate whether the addition of external beam radiation (EBRT) to adjuvant chemotherapy with or without vaginal brachytherapy is associated with better survival for patients with stage IIIC endometrioid endometrial carcinoma. MATERIALS AND METHODS: Patients diagnosed between 2010 and 2015 with apparent early-stage endometrioid adenocarcinoma, without a history of another tumor, who underwent hysterectomy with lymphadenectomy and had positive lymph nodes were identified in the National Cancer Database. Those who received adjuvant chemotherapy (defined as receipt of treatment within 6 mo from surgery) and had at least 1 month of follow-up were selected for further analysis. Overall survival was compared between patients who did and did not receive EBRT within 6 months from surgery with the log-rank test. A Cox model was also constructed to control for confounders. RESULTS: A total of 3116 patients were identified; 1458 (46.8%) received chemotherapy without and 1658 (53.2%) with EBRT. Pathologic characteristics (tumor grade, size, endocervical, and lymph-vascular invasion) were comparable between the two groups. Patients who received external beam radiation had better survival compared with those who did not, P =0.001; 5-year overall survival rates were 83.1% and 77.9%, respectively. After controlling for patient age, race, presence of comorbidities, insurance status, tumor size, grade and endocervical invasion, and the presence of lymph-vascular invasion, the addition of EBRT was associated with a survival benefit (HR: 0.75, 95% CI: 0.62, 0.91). CONCLUSIONS: For patients with endometrioid adenocarcinoma metastatic to the lymph nodes, addition of external beam radiation to adjuvant chemotherapy may be associated with a survival benefit.

Oncologic outcomes of surgical para-aortic lymph node staging in patients with advanced cervical carcinoma undergoing chemoradiation.

OBJECTIVES: We aimed to evaluate the utilization and impact of surgical para-aortic lymph node staging on the survival of patients with locally advanced stage cervical carcinoma receiving definitive chemoradiation. METHODS: We identified patients in the National Cancer Database diagnosed between January 2010 and December 2015 with locally advanced (FIGO 2009 stage IB2-IVA) cervical carcinoma who did not undergo hysterectomy, received primary chemoradiation and had at least 1 month of follow-up. Two groups of patients were formed based on the assessment method of para-aortic lymph node status - radiologic assessment only versus surgical lymphadenectomy. Overall survival was compared with the log-rank test after Kaplan-Meier curves were generated. A Cox model was constructed to control for a priori selected confounders. RESULTS: We identified a total of 3540 patients who met the inclusion criteria. Para-aortic staging was performed in 333 (9.4%) patients. These patients were younger (median age 46 vs 52 years, p<0.001), less likely to have co-morbidities (8.7% vs 15.6%, p<0.001), more likely to have private insurance (48.9% vs 37.8%, p<0.001) and receive brachytherapy (76.9% vs 70.9%, p=0.022). The rate of para-aortic lymphadenectomy was comparable between patients with stage IB2-II and III-IVA disease (9.4% for both groups, p=0.98). Patients who underwent para-aortic lymphadenectomy were also more likely to have lymph nodes categorized as positive compared with those who had imaging only (27.3% vs 13.2%, p<0.001). There was no difference in overall survival between patients who underwent radiologic only or surgical para-aortic lymph node assessment (p=0.80 from log-rank test); 4 year overall survival rates were 62.9% and 63%. After controlling for confounders, performance of para-aortic lymphadenectomy was not associated with a survival benefit (HR 1.07, 95% CIs: 0.88 to 1.31). CONCLUSIONS: In a large cohort of patients with locally advanced stage cervical carcinoma, para-aortic lymphadenectomy was rarely performed and not associated with a survival benefit.

A prospective cross-sectional survey comparing patient and provider expectations regarding ovarian cancer prognosis.

Introduction: There is limited data comparing patient and physician expectations regarding ovarian cancer prognosis. Our primary objective was to compare physician and patient estimates of survival to 6 months, 1 year, and 5 years; secondary objectives included comparing provider and patient responses on the likelihood of requiring future treatments and categorizing patient and provider preferences regarding communication about prognosis. Methods: A prospective cross-sectional survey was delivered to 10 gynecologic oncology providers and 50 adult ovarian cancer patients from November 2015-April 2016 at one institution. Descriptive statistics were used to categorize survey answers and compare survey answers between patients and providers; multivariable logistic regression evaluated patient survey responses. Results: All providers (100%) believed treating providers should discuss prognosis and 90% reported having prognostic conversations with patients, compared to 63%, 37%, and 4% of patients who reported discussing prognosis, living wills/advance directives, and palliative care/hospice services, respectively, with their provider. Compared to their provider, patients gave significantly lower estimations of requiring any future therapy (mean score 84.6 vs 74, p <.001) and future chemotherapy (mean score 84.1 vs 69.8, p <.001) and significantly higher estimations of requiring future surgery (mean score 23.3 vs 40, p <.001), achieving remission (mean score 33.5 vs 47.5, p =.009), survival to 1 year (mean score 77.1 vs 86.4, p =.002), and survival to 5 years (mean score 40.5 vs 61.3, p <.001). Conclusions: Although gynecologic oncology providers believe it is important to discuss prognosis and end-of-life care, there are gaps in communication, knowledge, and expectations between providers and ovarian cancer patients.

Safety of ovarian preservation for premenopausal patients with FIGO stage I grade 2 and 3 endometrioid endometrial adenocarcinoma.

OBJECTIVE: To investigate the utilization and outcomes of ovarian preservation for premenopausal patients with International Federation of Gynecology and Obstetrics (FIGO) stage I grade 2 and 3 endometrioid endometrial carcinoma undergoing hysterectomy. METHODS: The National Cancer Database was accessed; patients aged ≤45 years diagnosed between January 2004 and December 2015 with FIGO stage I grade 2 or 3 endometrioid endometrial carcinoma, who underwent hysterectomy with or without bilateral salpingo-oophorectomy and had at least 1 month of follow-up, were identified. Overall survival was assessed following generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for a priori selected variables. RESULTS: A total of 2941 patients who met the inclusion criteria were identified; 200 (6.8%) patients did not undergo bilateral salpingo-oophorectomy. Rate of ovarian preservation was comparable between patients with grade 2 (n=163, 6.6%) and grade 3 (n=37, 7.7%) tumors (p=0.38). Patients who did not undergo bilateral salpingo-oophorectomy were younger (median 39 vs 41 years, p<0.001) and less likely to undergo surgical lymph node assessment (52% vs 76.2%, p<0.001). There was no difference in overall survival between patients who did and did not undergo bilateral salpingo-oophorectomy (p=0.94); 5 year overall survival rates were 96.6% and 97%, respectively. After controlling for confounders, including tumor grade, ovarian preservation was not associated with worse overall survival (HR 0.92, 95% CI 0.47 to 1.84). CONCLUSIONS: For patients with grade 2 and 3 FIGO stage I endometrioid carcinoma undergoing hysterectomy, ovarian preservation is rarely performed while no clear detrimental effect on overall survival was found.

Adjuvant chemotherapy for stage I high-intermediate risk endometrial carcinoma with lymph-vascular invasion.

OBJECTIVE: The goal of this study was to evaluate if addition of adjuvant chemotherapy to radiation therapy improves overall survival in patients with high-intermediate risk stage I endometrial carcinoma with lymphovascular invasion. METHODS: Patients diagnosed between January 2010 and December 2015 with FIGO (International Federation of Gynecology and Obstetrics) stage I endometrioid endometrial carcinoma with lymphovascular invasion who underwent hysterectomy with lymphadenectomy and met the GOG-99 criteria for high-intermediate risk were identified in the National Cancer Database. Patients who received adjuvant radiotherapy with or without adjuvant chemotherapy (administered within 6 months of surgery) and had at least 1 month of follow-up were selected for further analysis. Overall survival was compared with the log-rank test following stratification by type of radiation treatment. A Cox model was constructed to control for a priori selected confounders. RESULTS: A total of 2881 patients who met the inclusion criteria were identified; 2417 (83.9%) patients received radiation therapy alone while 464 (16.1%) received chemoradiation. Rate of adjuvant chemotherapy administration was comparable between patients who received vaginal brachytherapy alone (16.2%), and external beam radiation therapy (with or without vaginal brachytherapy) (15.8%), p=0.78. Rate of chemoradiation was higher for patients with grade 3 (28.8%) tumors compared with those with grade 2 (9.9%) and grade 1 (8.3%) tumors, p<0.001. After controlling for confounders for patients receiving external beam radiation, addition of chemotherapy was not associated with improved overall survival (HR 0.90, 95% CI 0.56 to 1.46). For patients receiving vaginal brachytherapy addition of chemotherapy was associated with better overall survival (HR 0.644, 95% CI 0.45 to 0.92). Benefit was limited to patients with grade 3 tumors, p=0.026; 4-year overall survival rate was 81.1% versus 74.9%. CONCLUSIONS: In patients with high-intermediate risk FIGO stage I endometrioid endometrial carcinoma and lymphovascular invasion, addition of chemotherapy to radiation therapy was associated with a survival benefit for patients with grade 3 tumors receiving vaginal brachytherapy.

Delay in adjuvant chemotherapy administration for patients with FIGO stage I epithelial ovarian carcinoma is associated with worse survival; an analysis of the National Cancer Database.

OBJECTIVE: The administration of adjuvant chemotherapy within 42 days from surgery is one of the proposed quality measures for patients with epithelial ovarian cancer (EOC). The aim of the present study was to evaluate the impact of chemotherapy delay in the survival of patients with stage I EOC. METHODS: The National Cancer Database was accessed, and patients diagnosed between 2004 and 2015 with FIGO stage I EOC who received multi-agent chemotherapy were identified. Overall survival (OS) was compared between patients who received chemotherapy <6 weeks and 6-12 weeks from surgery with the log-rank test following generation of Kaplan-Meier curves. Cox model was constructed to control for a priori selected confounders. RESULTS: A total of 8549 patients who received adjuvant chemotherapy at a median 35 days from surgery (interquartile range 19) were identified; 67.7% received adjuvant chemotherapy <6 weeks from surgery while 32.3% experienced a delay. Patients who experienced a delay were more likely to have comorbidities (18.4% vs 14.9%, p < 0.001), and be managed in non-academic facilities (57.1% vs 53.2%, p = 0.001). Patients who experienced a delay had worse OS compared to those who did not, p < 0.001; 5-year OS rates 85.7% and 89.7%, respectively. For patients with high-grade serous tumors, those who experienced a delay had a 5-yr OS of 81.9% compared to 88.6% for those who did not, p < 0.001. After controlling for age, race, presence of comorbidities, insurance status, tumor histology and grade, performance of lymphadenectomy and substage, chemotherapy delay was associated with worse survival (HR: 1.25, 95% CI: 1.10, 1.42). CONCLUSIONS: For patients with early stage EOC administration of adjuvant chemotherapy within 6 weeks from surgery was associated with better overall survival, especially for those with stage IC disease.

The frequency and persistence of lymphedema diagnosis and self-reported symptoms over 5 years in patients with endometrial carcinoma.

A potentially debilitating sequela of diagnosis or treatment for endometrial cancer islower limb lymphedema (LLL), which can have significant impacts on quality of life. Theobjective of this study was to determine the frequency of LLL symptoms in uterinecancer survivors over a 5-year study period. An IRB-approved prospective study of quality of life of endometrial cancer patients whounderwent surgical intervention was undertaken. The Gynecologic CancerLymphedema Questionnaire (GCLQ) was used to survey patients in 2011 and again in2016 to evaluate for symptoms of LLL.205 patients initially answered the survey, and 75 patients completed the follow upsurvey as well, with no differences in demographics between the cohorts. 90.7% ofpatients underwent lymph node dissection. Patients commonly reported symptoms ofnumbness (66.83%), aching (54.2%), and poor physical function (47.8%). On initialsurvey, 14.7% (n = 11) of patients met criteria for LLL by GCLQ criteria, with 8 patientsreporting improvement in symptoms and 3 reporting persistent diagnosis at follow up. At follow up survey, 12.0% (n = 9) patients meeting criteria five years later, with 6patients newly meeting criteria. The most persistent symptoms were poor physicalfunction (70.6%), numbness (72.5%), general swelling (55.6%), aching (64.1%), andlimb-related swelling (60%).While the rate of LLL was similar to previous reports, there were a number of newdiagnoses of LLL at interval follow up distant from surgery, up to 7 years later.Symptoms of LLL also persisted for many years after diagnosis.

Disparities in cancer-specific and overall survival in black women with endometrial cancer: A Medicare-SEER study.

OBJECTIVES: To examine overall survival (OS) and cancer-specific survival (CSS) for different racial groups of women with surgically staged endometrial cancer by histologic subtype. METHODS: This is a retrospective cohort study of women with stage I-III endometrioid, serous, clear cell, and carcinosarcoma who underwent hysterectomy as primary surgical staging in the 2000-2016 SEER-Medicare database. OS and CSS outcomes were stratified by race (defined as White, Black, Other), stage, and histology. Survival was assessed with descriptive analyses, log-rank tests and unadjusted and adjusted multivariable cox regression models. RESULTS: Of the 24,142 women identified, 85.5% were White, 8.5% Black, and 6% other races. Receipt of adjuvant therapy differed only for stage III endometrioid: Black women were less likely to receive adjuvant treatment after hysterectomy (61.2% vs. 70.1% White, p = 0.03). For stage I, Black women had worse CSS for all histologies other than clear cell in unadjusted and adjusted analyses. For stage II, Black women had worse CSS for endometrioid histology in unadjusted analyses and similar OS. For stage III, Black women with endometrioid carcinoma had worse CSS and OS in unadjusted analyses, but no significant difference in CSS in adjusted analyses. "Other" race showed improved OS for Stage I endometrioid adenocarcinoma without significant differences in outcomes when compared to White women. CONCLUSION: Across histologies other than clear cell, Black women diagnosed with stage I endometrial cancer had consistently worse CSS, despite similar receipt of adjuvant therapy. Differences in CSS and OS at higher stages disappeared once accounting for treatment disparities.

Keratin Granulomas in the Peritoneum on Frozen Section: A Case Report with Multiple Suspects and the Search for the Culprit.

Keratin granulomas in the peritoneum are a rare finding with multiple etiologies and can be especially challenging for both the pathologist and the surgeon when these lesions are grossly visible. We report a case of a unique frozen section diagnostic scenario of evaluation of keratin granulomas in the peritoneum of a 47-year-old woman in the setting of multiple potential culprits: endometrial endometrioid adenocarcinoma following fertility sparing treatment, and a concurrent dermoid cyst. We discuss the various etiologies of keratin granulomas in the peritoneum, mechanism of their formation, diagnostic significance, as well as implications of fertility sparing treatments. To the best of our knowledge, this is the only case of keratin granulomas in the peritoneum with multiple distinct potential pathologic culprits as well the only case following fertility sparing treatment.

Fertility-sparing surgery for patients with stage IC2 or IC3 epithelial ovarian carcinoma: any evidence of safety?

OBJECTIVE: Investigate the overall survival of patients with stage IC2/IC3 epithelial ovarian carcinoma undergoing fertility-sparing surgery. METHODS: Patients aged <45 years diagnosed between January 2004 and December 2015 with epithelial ovarian carcinoma, who underwent surgical staging and had tumor involving the ovarian surface (IC2), malignant ascites or positive cytology (IC3), were identified in the National Cancer Database. The fertility-sparing surgery group included patients who had preservation of the uterus and the contralateral ovary while the radical surgery group included patients who had hysterectomy with bilateral salpingo-oophorectomy. Overall survival was evaluated following generation of Kaplan-Meier curves while a Cox model was constructed to control for tumor grade and performance of lymphadenectomy. A systematic review of the literature was performed and cumulative relapse rate among patients with IC2/IC3 disease who underwent fertility-sparing surgery was calculated. RESULTS: A total of 235 cases were identified; 105 (44.7%) patients underwent fertility-sparing surgery. There was no difference in overall survival between the fertility-sparing and radical surgery groups (p=0.37; 5- year overall survival rates 90.2% and 85%, respectively). After controlling for tumor grade and performance of lymphadenectomy, fertility-sparing surgery was not associated with worse overall survival (HR 1.22, 95% CI 0.56, 2.62). A systematic review identified 151 patients with stage IC2/IC3 disease who underwent fertility-sparing surgery. Cumulative relapse rate was 19.3% (n=29) while 12 (6.7%) deaths were reported. Median time to recurrence was 19 (range 1-128.5) months. Tumor recurrence involved the ovary exclusively in 42% (11/26) of patients, while 15% (4/26) had a lymph node, 35% (9/26) a pelvic/abdominal, and 8% (2/26) a distant tumor relapse. CONCLUSIONS: In a large cohort of patients with stage IC2/IC3 epithelial ovarian carcinoma, fertility-sparing surgery was not associated with worse overall survival. However, based on a literature review, relapse rate is approximately 20%.