Cost-Effectiveness of Gene-Specific Prevention Strategies for Ovarian and Breast Cancer.

Importance: Pathogenic variants (PVs) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, and BRIP1 cancer susceptibility genes (CSGs) confer an increased ovarian cancer (OC) risk, with BRCA1, BRCA2, PALB2, RAD51C, and RAD51D PVs also conferring an elevated breast cancer (BC) risk. Risk-reducing surgery, medical prevention, and BC surveillance offer the opportunity to prevent cancers and deaths, but their cost-effectiveness for individual CSGs remains poorly addressed. Objective: To estimate the cost-effectiveness of prevention strategies for OC and BC among individuals carrying PVs in the previously listed CSGs. Design, Setting, and Participants: In this economic evaluation, a decision-analytic Markov model evaluated the cost-effectiveness of risk-reducing salpingo-oophorectomy (RRSO) and, where relevant, risk-reducing mastectomy (RRM) compared with nonsurgical interventions (including BC surveillance and medical prevention for increased BC risk) from December 1, 2022, to August 31, 2023. The analysis took a UK payer perspective with a lifetime horizon. The simulated cohort consisted of women aged 30 years who carried BRCA1, BRCA2, PALB2, RAD51C, RAD51D, or BRIP1 PVs. Appropriate sensitivity and scenario analyses were performed. Exposures: CSG-specific interventions, including RRSO at age 35 to 50 years with or without BC surveillance and medical prevention (ie, tamoxifen or anastrozole) from age 30 or 40 years, RRM at age 30 to 40 years, both RRSO and RRM, BC surveillance and medical prevention, or no intervention. Main Outcomes and Measures: The incremental cost-effectiveness ratio (ICER) was calculated as incremental cost per quality-adjusted life-year (QALY) gained. OC and BC cases and deaths were estimated. Results: In the simulated cohort of women aged 30 years with no cancer, undergoing both RRSO and RRM was most cost-effective for individuals carrying BRCA1 (RRM at age 30 years; RRSO at age 35 years), BRCA2 (RRM at age 35 years; RRSO at age 40 years), and PALB2 (RRM at age 40 years; RRSO at age 45 years) PVs. The corresponding ICERs were -£1942/QALY (-$2680/QALY), -£89/QALY (-$123/QALY), and £2381/QALY ($3286/QALY), respectively. RRSO at age 45 years was cost-effective for RAD51C, RAD51D, and BRIP1 PV carriers compared with nonsurgical strategies. The corresponding ICERs were £962/QALY ($1328/QALY), £771/QALY ($1064/QALY), and £2355/QALY ($3250/QALY), respectively. The most cost-effective preventive strategy per 1000 PV carriers could prevent 923 OC and BC cases and 302 deaths among those carrying BRCA1; 686 OC and BC cases and 170 deaths for BRCA2; 464 OC and BC cases and 130 deaths for PALB2; 102 OC cases and 64 deaths for RAD51C; 118 OC cases and 76 deaths for RAD51D; and 55 OC cases and 37 deaths for BRIP1. Probabilistic sensitivity analysis indicated both RRSO and RRM were most cost-effective in 96.5%, 89.2%, and 84.8% of simulations for BRCA1, BRCA2, and PALB2 PVs, respectively, while RRSO was cost-effective in approximately 100% of simulations for RAD51C, RAD51D, and BRIP1 PVs. Conclusions and Relevance: In this cost-effectiveness study, RRSO with or without RRM at varying optimal ages was cost-effective compared with nonsurgical strategies for individuals who carried BRCA1, BRCA2, PALB2, RAD51C, RAD51D, or BRIP1 PVs. These findings support personalizing risk-reducing surgery and guideline recommendations for individual CSG-specific OC and BC risk management.

Regionalizing ovarian cancer cytoreduction to high-volume centers and the impact on patient travel in New York State.

OBJECTIVE: To evaluate the theoretical impact of regionalizing cytoreductive surgery for ovarian cancer (OC) to high-volume facilities on patient travel. METHODS: We retrospectively identified patients with OC who underwent cytoreduction between 1/1/2004-12/31/2018 from the New York State Cancer Registry and Statewide Planning and Research Cooperative System. Hospitals were stratified by low-volume (<21 cytoreductive surgical procedures for OC annually) and high-volume centers (≥21 procedures annually). A simulation was performed; outcomes of interest were driving distance and time between the centroid of the patient's residence zip code and the treating facility zip code. RESULTS: Overall, 60,493 patients met inclusion criteria. Between 2004 and 2018, 210 facilities were performing cytoreductive surgery for OC in New York; 159 facilities (75.7%) met low-volume and 51 (24.3%) met high-volume criteria. Overall, 10,514 patients (17.4%) were treated at low-volume and 49,979 (82.6%) at high-volume facilities. In 2004, 78.2% of patients were treated at high-volume facilities, which increased to 84.6% in 2018 (P < .0001). Median travel distance and time for patients treated at high-volume centers was 12.2 miles (IQR, 5.6-25.5) and 23.0 min (IQR, 15.2-37.0), and 8.2 miles (IQR, 3.7-15.9) and 16.8 min (IQR, 12.4-26.0) for patients treated at low-volume centers. If cytoreductive surgery was centralized to high-volume centers, median distance and time traveled for patients originally treated at low-volume centers would be 11.2 miles (IQR, 3.8-32.3; P < .001) and 20.2 min (IQR, 13.6-43.0; P < .001). CONCLUSIONS: Centralizing cytoreductive surgery for OC to high-volume centers in New York would increase patient travel burden by negligible amounts of distance and time for most patients.

Neo-adjuvant chemotherapy does not reduce surgical complexity nor the accuracy of intra-operative visual assessment of disease in advanced ovarian cancer.

AIM: Compare the surgical complexity and histological accuracy of visual inspection of disease in patients undergoing primary debulking (PDS) versus delayed debulking surgery (DDS) following neo-adjuvant chemotherapy (NACT) for advanced ovarian cancer (AOC). MATERIALS AND METHODS: All patients undergoing PDS or DDS for stage III / IV AOC at a UK cancer centre between January 2014-October 2021 were included. Retrospective data was collected accessing an electronic gynaecological oncology database, operation and histology records. Comparative frequencies of surgical procedures performed were calculated for primary versus delayed cohorts; and correlation between intra-operative suspicion of disease and specimen histology at PDS and DDS compared. RESULTS: N=232. PDS was performed in 45.3% and DDS in 54.7% of patients; achieving complete cytoreduction in 77.2%. Appendicectomy, pelvic and para-aortic nodal dissection were undertaken significantly more often at primary surgery; whilst right diaphragm stripping, pelvic peritonectomy, splenectomy and cholecystectomy were more likely following NACT. We found no variation in bowel resection rates between cohorts. For the majority of specimens, there was no difference in correlation between intra-operative suspicion of disease and final histopathology - with a significantly lower positive predictive value for visual assessment demonstrated only for liver capsule and pelvic peritoneum at DDS. CONCLUSION: NACT does not appear to reduce the complexity of surgery, including rates of bowel resection; nor accuracy of intra-operative visual assessment of disease. We therefore caution against both deferring to NACT to facilitate less radical delayed debulking; and any presumption that macroscopically abnormal tissue at DDS may represent inert post-NACT 'burn-out', mitigating indication for excision. We instead suggest reservation of the neo-adjuvant pathway for patients with poor PS and radiologically-confirmed surgical stopping points; and advocate equivalent and maximal cytoreductive effort to remove all visibly abnormal tissue in both the upfront and delayed surgical settings.

Incidence and characteristics of ovarian cancer following endometrial cancer in the emerging era of conservative management of endometrial cancer-Implications for counseling-A SEER analysis.

OBJECTIVE: To assess the ovarian cancer (OC) risk following endometrial cancer (EC) in patients who underwent ovarian preservation as part of the EC staging. STUDY DESIGN: With permission of the Surveillance, Epidemiology and End Results (SEER) program of the United States National Cancer Institute, clinicopathological information of women diagnosed with EC and following OC were analyzed. Incidence of OC and survival according to the surgical approach were studied. Primary analysis was conducted in women up to and including the age of 49 years. RESULTS: A total of 116 patients up to the age of 49 years were diagnosed with EC and following OC. In this group of patients, no differences in incidence (IRR 0.9, CI 0.56-1.49, p = 0.66) or survival rates (p = 0.71) were found comparing ovarian preservation and bilateral salpingo-oophorectomy (BSO) performance. In an overall analysis of women diagnosed with EC and following OC at any age, incidence of OC did not differ between groups (IRR 1.07, CI 0.83-1.39, p = 0.59) yet when including patients older than 49 years old survival rates were shorter in ovarian preservation patients compared to patients with BSO performed as part of their EC treatment. CONCLUSION: Ovarian preservation in EC patients under the age of 49 years may be considered safe, with no impact on OC incidence or survival, benefiting longer natural hormonal status.

Disparities in refusal of surgery for gynecologic cancer.

OBJECTIVE: To identify sociodemographic and clinical factors associated with refusal of gynecologic cancer surgery and to estimate its effect on overall survival. METHODS: The National Cancer Database was surveyed for patients with uterine, cervical or ovarian/fallopian tube/primary peritoneal cancer treated between 2004 and 2017. Univariate and multivariate logistic regression were used to assess associations between clinico-demographic variables and refusal of surgery. Overall survival was estimated using the Kaplan-Meier method. Trends in refusal over time were evaluated using joinpoint regression. RESULTS: Of 788,164 women included in our analysis, 5875 (0.75%) patients refused surgery recommended by their treating oncologist. Patients who refused surgery were older at diagnosis (72.4 vs 60.3 years, p < 0.001) and more likely Black (OR 1.77 95% CI 1.62-1.92). Refusal of surgery was associated with uninsured status (OR 2.94 95% CI 2.49-3.46), Medicaid coverage (OR 2.79 95% CI 2.46-3.18), low regional high school graduation (OR 1.18 95% CI 1.05-1.33) and treatment at a community hospital (OR 1.59 95% CI 1.42-1.78). Patients who refused surgery had lower median overall survival (1.0 vs 14.0 years, p < 0.01) and this difference persisted across disease sites. Between 2008 and 2017, there was a significant increase in refusal of surgery annually (annual percent change +1.41%, p < 0.05). CONCLUSIONS: Multiple social determinants of health are independently associated with refusal of surgery for gynecologic cancer. Given that patients who refuse surgery are more likely from vulnerable, underserved populations and have inferior survival, refusal of surgery should be considered a surgical healthcare disparity and tackled as such.

A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk.

Aim: This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. Materials & methods: This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. Results: Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. Conclusion: This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.

Ovarian preservation compared to oophorectomy in premenopausal women with early-stage, low-grade endometrial Cancer: A cost-effectiveness analysis.

OBJECTIVES: Standard treatment for endometrial cancer is a hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment. In premenopausal women, removal of the ovaries may not be necessary and could increase the risk of all-cause mortality. We sought to estimate the outcomes, costs, and cost-effectiveness of oophorectomy versus ovarian preservation in premenopausal women with early-stage, low-grade endometrial cancer. METHODS: A decision-analytic model was designed using TreeAge software comparing oophorectomy to ovarian preservation in premenopausal women with early-stage, low-grade endometrial cancer. We used a theoretical cohort of 10,600 women to represent our population of interest in the United States in 2021. Outcomes included cancer recurrences, ovarian cancer diagnoses, deaths, rates of vaginal atrophy, costs, and quality-adjusted life years (QALYs). The cost-effectiveness threshold was set at $100,000/QALY. Model inputs were derived from the literature. Sensitivity analyses were conducted to evaluate the robustness of the results. RESULTS: Oophorectomy resulted in more deaths and higher rates of vaginal atrophy, while ovarian preservation resulted in 100 cases of ovarian cancer. Ovarian preservation resulted in lower costs and higher QALYs making it cost effective when compared to oophorectomy. Sensitivity analyses demonstrated the probability of cancer recurrence after ovarian preservation and probability of developing ovarian cancer were the most impactful variables in our model. CONCLUSION: Ovarian preservation is cost-effective in premenopausal women with early-stage, low-grade endometrial cancer when compared to oophorectomy. Ovarian preservation may prevent surgical menopause, which may improve quality of life and overall mortality without compromising oncologic outcomes, and should be strongly considered in premenopausal women with early stage disease.

Fertility and prognosis assessment between bleomycin/etoposide/cisplatin and paclitaxel/carboplatin chemotherapy regimens in the conservative treatment of malignant ovarian germ cell tumors: a multicenter and retrospective study.

OBJECTIVE: To evaluate the impact of bleomycin/etoposide/cisplatin (BEP) and paclitaxel/carboplatin (PC) chemotherapy regimens on the fertility and prognostic outcomes in malignant ovarian germ cell tumor (MOGCT) patients who underwent fertility-sparing surgery (FSS). METHODS: A propensity score matching algorithm was performed between the BEP and PC groups. The χ² test and the Kaplan-Meier method were used to compare the fertility outcome, disease-free survival (DFS) and overall survival (OS). The Cox proportional hazards regression analysis was used to identify risk factor of DFS. RESULTS: We included 213 patients, 185 (86.9%) underwent BEP chemotherapy, and 28 (13.1%) underwent PC chemotherapy. The median age was 22 years (range, 8-44 years), and the median follow-up period was 63 months (range, 2-191 months). Fifty-one (29.3%) patients had a pregnancy plan, and 35 (85.4%) delivered successfully. In the before and after propensity score matching cohorts, there were no significant differences in spontaneous abortion, selective termination of pregnancy, during-pregnancy status, and live birth between the BEP and PC groups (p>0.05). Fourteen (6.6%) patients experienced recurrence, including 11 (5.9%) in the BEP group and 3 (10.7%) in the PC group. Four (1.9%) patients in the BEP group died. Kaplan-Meier analysis revealed no significant differences in DFS (p=0.328) and OS (p=0.446) between the BEP and PC groups, and the same survival results were observed in the after matching cohort. CONCLUSION: The PC regimen is as safe as the BEP regimen for MOGCT patients with fertility preservation treatment, and no differences were observed in fertility and clinical prognosis.

Postpartum Opportunistic Salpingectomy Compared With Bilateral Tubal Ligation After Vaginal Delivery for Ovarian Cancer Risk Reduction: A Cost-Effectiveness Analysis.

OBJECTIVE: To compare the cost effectiveness of opportunistic salpingectomy and bilateral tubal ligation for sterilization immediately after vaginal delivery. METHODS: A cost-effectiveness analytic decision model was used to compare opportunistic salpingectomy with bilateral tubal ligation during vaginal delivery admission. Probability and cost inputs were derived from local data and available literature. Salpingectomy was assumed to be performed with a handheld bipolar energy device. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2019 U.S. dollars per quality-adjusted life-year (QALY) at a cost-effectiveness threshold of $100,000/QALY. Sensitivity analyses were performed to determine the proportion of simulations in which salpingectomy would be cost effective. RESULTS: Opportunistic salpingectomy was more cost effective than bilateral tubal ligation with an ICER of $26,150/QALY. In 10,000 patients desiring sterilization after vaginal delivery, opportunistic salpingectomy would result in 25 fewer ovarian cancer cases, 19 fewer ovarian cancer deaths, and 116 fewer unintended pregnancies than bilateral tubal ligation. In sensitivity analysis, salpingectomy was cost effective in 89.8% of simulations and cost saving in 13% of simulations. CONCLUSION: In patients undergoing sterilization immediately after vaginal deliveries, opportunistic salpingectomy is more cost effective and may be more cost saving than bilateral tubal ligation for reducing ovarian cancer risk.

Factor Analysis of Health Care Access With Ovarian Cancer Surgery and Gynecologic Oncologist Consultation.

Importance: Poor health care access (HCA) is associated with racial and ethnic disparities in ovarian cancer (OC) survival. Objective: To 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 Participants: This 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. Exposures: The 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 Measures: The 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. Results: The 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 Relevance: In 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.

Assessment of Hospital Volume in the Surgical Management of Endometrial and Ovarian Cancer: A Polish Population-Based Study.

BACKGROUND Surgery is a cornerstone in management of ovarian and endometrial cancer. The European Society of Gynecological Oncology introduced quality indicators to improve management of these cancers. The optimal annual number of surgeries per unit was established for high-quality surgical treatment. MATERIAL AND METHODS The database of the National Health Fund on surgical management of endometrial and ovarian cancer was analyzed. Patients treated between 2017 and 2020 were included. Departments where patients underwent surgery were divided according to number of surgeries performed per year in endometrial cancer: ≥80, 79-50, 49-20, 19-0; and ovarian cancer: ≥100, 99-50, 49-20, 19-0. Optimal number of surgeries per center was defined as at least 100 and 80 surgeries per year in ovarian and endometrial cancer, respectively. RESULTS Totally, there were 22 325 surgeries in 316 units and 10 381 surgeries in 251 units due to endometrial and ovarian cancer, respectively. Most surgeries in endometrial cancer (n=15 077; 67.5%) and ovarian cancer (n=9642; 92.88%) were performed in departments that did not meet optimal criteria in number of surgeries. Between 2017 and 2019, an increasing trend in number of surgeries per year in endometrial and ovarian cancer was found. In 2020, there was a decrease in the number of surgeries by 7.8% (n=453) and 8.6% (n=234) in endometrial and ovarian cancer, respectively. CONCLUSIONS In Poland, surgical treatment of ovarian and endometrial cancer is decentralized. Most cancer patients underwent surgery in low-volume general gynecologic departments. The COVID-19 pandemic impaired cancer management, leading to a decreased number of surgeries.

Accuracy of IOTA Simple Rules, IOTA ADNEX Model, RMI, and Subjective Assessment for Preoperative Adnexal Mass Evaluation: The Experience of a Tertiary Care Referral Hospital.

OBJECTIVES: The aim of this study was to evaluate the accuracy of IOTA Simple Rules (SR), IOTA ADNEX model, Risk of Malignancy Index (RMI), and subjective assessment (SA) which is used for adnexal mass assessment in our institution. DESIGN: This is a prospective observational study. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included patients with at least one adnexal mass who needed elective surgical evaluation based on clinical and laboratory findings. Patients admitted to Clinic for Gynecology and Obstetrics, University Clinical Center of Serbia, were recruited for the study between January 2019 and June 2021. Level II ultrasonographers performed a gray scale and Doppler exam for each patient. Preoperative classification of adnexal masses (benign or malignant) was performed by SA, the International Ovarian Analysis Group (IOTA) SR, IOTA ADNEX model, and Risk of Malignancy Index (RMI). Postoperatively obtained histological findings were used as a reference. RESULTS: During the study period, we enrolled 179 premenopausal and 217 postmenopausal patients, representing 396 patients in our sample. Prevalence of malignant disease in pre- and postmenopausal groups was 16.2% (29/179) and 41% (89/217), respectively. Malignant disease was diagnosed in 29.8% (118/396) of patients. SA achieved the highest discrimination accuracy between benign and malignant tumors (area under the curve [AUC] of 0.928, 95% CI [0.898-0.952]). For SA, the overall diagnostic accuracy, sensitivity, specificity, positive likelihood ratio (LR+), and negative likelihood ratio (LR-) were 91.4%, 88.1%, 92.8%, 12.25, and 0.13. The AUC for Simple Rules with subjective assessment in inconclusive cases (SR + SA) was 0.912 (95% CI [0.880-0.938]). Regarding SR + SA, diagnostic accuracy, sensitivity, specificity, LR+, and LR- were 92.4%, 88.1%, 94.2%, 15.31, and 0.13. The ADNEX model had the AUC of 0.914 (95% CI [0.882-0.940]). Binary classification using the ADNEX model at a cut-off value of 10% for malignancy had the sensitivity, specificity, LR+ and LR- of 92.4%, 73.0%, 3.42, and 0.10. This resulted in the lowest overall accuracy of 78.8%. The AUC for RMI was 0.854 (95% CI [0.815-0.887]), with overall accuracy, sensitivity, specificity, LR+ and LR- of 82.3%, 73.7%, 86.0%, 5.26, and 0.31. There was no difference in the AUCs of the SA and IOTA models for the whole group, premenopausal, and postmenopausal groups. RMI performed worse compared to SA and the IOTA models. The ADNEX model achieved the highest accuracy at the cut-off value of 35%. LIMITATIONS: The data generalizability is limited by a single institution-dependent sampling. CONCLUSIONS: The IOTA SR and ADNEX model were reliable and comparable with the SA and performed better than the RMI. The IOTA SR model offers the potential for immediate and reliable diagnosis, even in the hands of less experienced ultrasonographers. Both IOTA models studied can be a valuable adjunct to a clinician's decision-making process.

Association between CT-based body composition assessment and patient outcomes during neoadjuvant chemotherapy for epithelial ovarian cancer.

OBJECTIVE: The aim of this study was to characterize the body composition of patients undergoing neoadjuvant chemotherapy (NACT) for epithelial ovarian cancer (EOC), identify factors associated with sarcopenia at diagnosis, and evaluate the impact of pretreatment sarcopenia and changes in body composition parameters during therapy on perioperative and disease-related outcomes. METHODS: Patients undergoing NACT for EOC between 2008 and 2020 were identified. Pre-treatment and post-treatment contrast-enhanced CT scans were reviewed to determine skeletal muscle index (SMI) and visceral adipose tissue (VAT) area at the mid-fourth lumbar vertebral level. SMI and VAT were analyzed for association with clinical and treatment variables. RESULTS: 174 patients were identified. Mean pretreatment SMI and VAT were 38.3 cm2/m2 ± 7.9 and 51.2 cm2/m2 ± 34.3, respectively. Comparatively, mean post-treatment SMI and VAT were 37.8 cm2/m2 ± 7.9 and 43.7 cm2/m2 ± 29.7, respectively. Most patients exhibited an overall decrease in SMI from pretreatment to posttreatment scans. Caucasian race, older age, and lower body mass index at diagnosis were associated with lower pretreatment SMI. Lower pre-treatment SMI was associated with lower surgical complexity scores (p < 0.001) and estimated blood loss (p = 0.029). Decrease in SMI after NACT was associated with increased rates of ICU admissions and length of stay. While there was no association between SMI and overall survival (OS) or progression-free survival (PFS), >2% decrease per 100 days in VAT was significantly associated with worse OS. CONCLUSIONS: Patients with lower pretreatment SMI tend to undergo less complex surgery than those with higher SMI despite NACT. Decrease in VAT may be a potential indicator of worse OS. Information on body composition can aid in clinical decision making in patients with EOC.

Healthcare Access Domains Mediate Racial Disparities in Ovarian Cancer Treatment Quality in a US Patient Cohort: A Structural Equation Modelling Analysis.

BACKGROUND: Ovarian cancer survival disparities have persisted for decades, driven by lack of access to quality treatment. We conducted structural equation modeling (SEM) to define latent variables representing three healthcare access (HCA) domains: affordability, availability, and accessibility, and evaluated the direct and indirect associations between race and ovarian cancer treatment mediated through the HCA domains. METHODS: Patients with ovarian cancer ages 65 years or older diagnosed between 2008 and 2015 were identified from the SEER-Medicare dataset. Generalized SEM was used to estimate latent variables representing HCA domains by race in relation to two measures of ovarian cancer-treatment quality: gynecologic oncology consultation and receipt of any ovarian cancer surgery. RESULTS: A total of 8,987 patients with ovarian cancer were included in the analysis; 7% were Black. The affordability [Ω: 0.876; average variance extracted (AVE) = 0.689], availability (Ω: 0.848; AVE = 0.636), and accessibility (Ω: 0.798; AVE = 0.634) latent variables showed high composite reliability in SEM analysis. Black patients had lower affordability and availability, but higher accessibility compared with non-Black patients. In fully adjusted models, there was no direct effect observed between Black race to receipt of surgery [ß: -0.044; 95% confidence interval (CI), -0.264 to 0.149]; however, there was an inverse total effect (ß: -0.243; 95% CI, -0.079 to -0.011) that was driven by HCA affordability (ß: -0.025; 95% CI, -0.036 to -0.013), as well as pathways that included availability and consultation with a gynecologist oncologist. CONCLUSIONS: Racial differences in ovarian cancer treatment appear to be driven by latent variables representing healthcare affordability, availability, and accessibility. IMPACT: Strategies to mitigate disparities in multiple HCA domains will be transformative in advancing equity in cancer treatment.

Impact of robotic surgery on patient flow and resource use intensity in ovarian cancer.

There is an emerging focus on the role of robotic surgery in ovarian cancer. To date, the operational and cost implications of the procedure remain unknown. The objective of the current study was to evaluate the impact of integrating minimally invasive robotic surgery on patient flow, resource utilization, and hospital costs associated with the treatment of ovarian cancer during the in-hospital and post-discharge processes. 261 patients operated for the primary treatment of ovarian cancer between January 2006 and November 2014 at a university-affiliated tertiary hospital were included in this study. Outcomes were compared by surgical approach (robotic vs. open surgery) as well as pre- and post-implementation of the robotics platform for use in ovarian cancer. The in-hospital patient flow and number of emergency room visits within 3 months of surgery were evaluated using multi-state Markov models and generalized linear regression models, respectively. Robotic surgery cases were associated with lower rates of postoperative complications, resulted in a more expedited postoperative patient flow (e.g., shorter time in the recovery room, ICU, and inpatient ward), and were between $10,376 and $7,421 less expensive than the average laparotomy, depending on whether or not depreciation and amortization of the robotic platform were included. After discharge, patients who underwent robotic surgery were less likely to return to the ER (IRR 0.42, p = 0.02, and IRR 0.47, p = 0.055, in the univariate and multivariable models, respectively). With appropriate use of the technology, the addition of robotics to the medical armamentarium for the management of ovarian cancer, when clinically feasible, can bring about operational efficiencies and entails cost savings.

Management of ovarian and breast cancer risk in non-BRCA HBOC pathogenic variant carriers in a large California health care system.

PURPOSE: To describe breast and ovarian cancer risk reduction strategies in the clinical management of women who test positive for non-BRCA hereditary breast and ovarian cancer (HBOC) pathogenic variants compared to those who test positive for pathogenic BRCA variants or have negative germline panel testing. METHODS: Examination of imaging and preventive surgeries in women undergoing HBOC genetic testing from 1/1/2015 to 12/31/2018, with follow up to 03/31/2020 in Kaiser Permanente Northern California. RESULTS: A total of 13,271 tests which included HBOC genes were identified. Rate of bilateral salpingo-oophorectomy after genetic testing were similar for BRCA and the non-BRCA moderate risk ovarian pathogenic variants (PVs) (47.4% vs 54%, p = 0.25). Rates were lower for low risk or unknownrisk non-BRCA PVs (12.8%, p < 0.001, 5.3% (p < 0.001). Rates of surveillance for ovarian cancer with ultrasound and CA 125 in the first year was 63.3% and 64.7% for BRCA PV, 37.5% and 27.1%, for non-BRCA moderate risk PVs and 13.7% and 4.6%, for low-risk PVs. Bilateral mastectomy rates were 19.7% for BRCA PV, 10.1% (p = 0.028) for non-BRCA breast high risk PVs, for moderate risk PVs 7.7% (p < 0.001) and for unknown risk 0.4% (p < 0.001). MRI surveillance rates in the first year similarly were 47.4% for non-BRCA BRCA PV, 43% for breast high risk PV, 39.4% for moderate risk and 4.9% for unknown risk PV. CONCLUSION: Surgical and surveillance strategies are underutilized for HBOC PV, however there is concordance of uptake of preventive strategies with specific risk associated with non-BRCA PVs.

Cost Study of the PlasmaJet Surgical Device Versus Conventional Cytoreductive Surgery in Patients With Advanced-Stage Ovarian Cancer.

PURPOSE: Adjuvant use of Neutral Argon Plasma (PlasmaJet Surgical Device) during cytoreductive surgery (CRS) for advanced-stage epithelial ovarian cancer improves surgical outcomes. The aim of this study is to examine the costs of adjuvant use of the PlasmaJet during surgery compared with conventional CRS in advanced-stage epithelial ovarian cancer. MATERIALS AND METHODS: The patients were randomly assigned to surgery with or without the PlasmaJet. Analysis of the intra- and extramural health care costs was performed. Costs were divided into three categories: costs of the diagnostic phase (T1), inpatient care up to discharge including costs of surgery (T2), and outpatient care including chemotherapy until 6 weeks after the last cycle of chemotherapy (T3). RESULTS: Overall, 327 patients underwent CRS (surgery with PlasmaJet: n = 157; conventional surgery: n = 170). The mean total health costs were significantly higher for CRS with adjuvant use of PlasmaJet compared with conventional CRS (€19,414 v €18,165, P = .017). Costs are divided into costs of the diagnostic phase (€2,034 v €1,974, P = .890), costs of inpatient care (€10,956 v €9,556, P = .003), and costs of outpatient care (€6,417 v €6,628, P = .147). CONCLUSION: Mean total health care costs of the use of PlasmaJet in CRS were significantly higher than those for conventional CRS. This difference is fully explained by the additional surgery costs of the use of PlasmaJet. However, surgery with the use of the PlasmaJet leads to a significantly higher percentage of complete CRS and a halving of stomas. A cost-effectiveness analysis will be performed once survival data are available (funded by ZonMw, Trial Register NL62035.078.17).

Ovarian Cancer-Self Assessment: An Innovation for Early Detection and Risk Assessment of Ovarian Cancer.

OBJECTIVE: The modality to detect ovarian cancer at an early stage is very limited. Early diagnosis determines the prognosis. This study aimed to develop a risk assessment tool for early detection of ovarian cancer using artificial intelligence. To accomplish this, the presence of ten signs and symptoms reported by patients with ovarian cancer was assessed. METHODS: This study was carried out as a cohort study of patients diagnosed with suspected ovarian tumors undergoing cytoreduction operation at Hasan Sadikin Hospital, Bandung, from December 2019 to September 2020. Compared to ovarian cancer self-assessment through questionnaire, postoperative histopathology in patients with suspected ovarian tumors. The questionnaire proceeded by artificial intelligence is grouped into risk and no risk. Statistical analyses were done using Chi-Square and Exact Fisher Test. RESULT: In total, 115 patients included in this study. The differences were statistically significant in terms of the six variables (abdominal bloating, nausea/vomiting, decreased of appetite, fullness, menstrual disturbance, and weight loss) ovarian cancer self-assessment compared to postoperative histopathology with a tendency towards benign ovarian tumors (p<0.05), while there was no statistically significant difference in the four variables (abdominal enlargement, abdominal pain, urinating disturbance, and defecation disturbance)  (p>0.05).  According to the artificial intelligence grouping, fifty-five patients were at risk, and sixty patients were not at risk. The Fifty-five risk patients were related  with postoperative histopathology diagnosis (with RR 0.682 and CI 95% 0.519-0.895). CONCLUSION: Risk assessments based on ovarian cancer self-assessment unfortunately were not comparable to postoperative histopathology as a single predictor. Ten variables in ovarian cancer artificial intelligence self-assessment for early detection needs improvement in adding another variable like tumor marker and ultrasonography assessment.

Cost analysis of the enhanced recovery after surgery protocol applied in advanced ovarian cancer: A secondary outcome of the PROFAST trial.

INTRODUCTION: A randomised trial implementing Enhanced Recovery After Surgery (ERAS) for high complexity advanced ovarian cancer (AOC) surgery (PROFAST) demonstrated a reduction of median length of stay and hospital readmissions when compared to patients managed conventionally. One secondary objective was to determine if an ERAS pathway in the perioperative management of advanced ovarian cancer patients led to cost savings. MATERIAL AND METHODS: Secondary objective of a prospective randomised trial of patients with suspected or diagnosed advanced ovarian cancer allocated to conventional or ERAS perioperative management, carried out at a referral centre from June 2014 to March 2018. Treatment was determined by a computer-generated random allocation system. METHODS: Gross counting was employed to estimate the cost of hospitalisation in wards, intensive care unit (ICU) and surgical care, while micro-costing was used to obtain image and laboratory test costs. Mean costs between trial arms were considered. Sensitivity analyses were performed. RESULTS: Ninety-nine patients (n = 50 ERAS group, n = 49 Conventional group) were included. Mean costs per patient were 10,719€ in the ERAS group and 11,028€ in the conventional group, leading to an average saving of 309€ per patient. These results were based on 96 patients, excluding 3 extreme outliers mainly related with very high ICU costs. Savings, which were significant for hospital ward costs (-33% total; 759€ per patient in first hospitalisation, and 914€ per partient/day of readmission) were found as robust in the sensitivity analysis. CONCLUSIONS: Implementation of an ERAS pathway leads to cost savings when compared to conventional management after AOC surgery.