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

Objectives: With increasing use of minimally invasive surgical techniques and same-day discharges, the need to predict pain medication use on the day of surgery is critical to post-operative pain control, patient satisfaction and public health concerns. Our goal was to develop and externally validate a statistical model for predicting postoperative opioid use following gynecologic surgery in an increasingly minimally invasive surgical population, incorporating patient-reported surgical concerns. Methods: We prospectively enrolled 382 women scheduled for abdominal surgeries (including laparotomies and minimally invasive approaches [MIS]) in an academic gynecologic-oncology practice to a study to develop and validate a predictor of outpatient opioid pill use. Negative binomial, zero-inflated negative binomial, and ordinal regression models were developed using an initial cohort of 216 women enrolled from February 2018-March 2019 and followed for 6 weeks postoperatively. A total of 39 candidate predictors were considered, including preoperative assessments of anxiety and anticipated pain as well as intra-operative factors. The primary model outcome was the number of opioid pills used postoperatively. After fitting models using best predictors, all models were internally validated with 1000 bootstrap samples to obtain bias-corrected accuracy using ordinal concordance index and calibration curves. All models’ predictions were then externally validated using a second cohort (n=166) enrolled from May 2019-February 2020. The best model (GO-POP) was updated by combining cohorts and an online calculator and nomogram were created. GO-POP included 7 predictors: age, total operating time, patient's self-reported pre-operative anticipated need for pain medication, whether pregabalin was administered preoperatively, patient educational attainment, smoking history and patients’ self-reported preoperative anxiety. Results: Most surgeries were performed using MIS approaches (276; 72.3%) while 52 (13.6%) patients underwent planned laparotomies and 14.1% had planned MIS approaches converted to laparotomies. Median total number of opioid pills was 7 in the combined cohort. Nearly 40% of subjects used 0 pills after hospital discharge. After external validation, an updated combined model had the best fit, with ordinal concordance of 0.646 (95% CI:0.615, 0.679). Over 1/3rd of patients were either not planning to dispose of unused opioids or had not yet decided how to handle unused pills. A nomogram was created to facilitate clinical use of the model. Download : Download high-res image (71KB) Download : Download full-size image Conclusions: A prospectively constructed and validated model accurately estimates the number of opioid pills used by women after gynecologic surgery. Use of the GO-POP nomogram enables providers to tailor prescriptions using information available immediately following surgery. More work is needing to educate patients on the importance of disposal of unused opioids post-operatively to protect our communities.

Highlights • The CISNE score is able to accurately identify a cohort of gynecologic oncology patients with low-risk febrile neutropenia. • The CISNE performs similarly to the MASCC score when low-risk and intermediate-risk patients are grouped together. • Lowering the CISNE threshold for low-risk febrile neutropenia may be a safer method of caring for gynecologic patients. • Using the MASCC followed by CISNE with the lower threshold yielded the most favorable performance characteristics., Objective Scoring systems have been developed to identify low risk patients with febrile neutropenia (FN) who may be candidates for outpatient management. We sought to validate the predictive accuracy of the Clinical Index of Stable Febrile Neutropenia (CISNE) score alone and in conjunction with alternative scoring systems for risk of complications among gynecologic oncology patients. Methods We conducted a single institution retrospective cohort study of patients admitted to an academic gynecologic oncology service for FN. We examined the performance characteristics (sensitivity, specificity, positive and negative predictive value) of three scoring systems (Multinational Association of Supportive Care in Cancer (MASCC), CISNE cut-off 1 (Low risk = 0), CISNE cut-off 2 (Low risk =

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

Purpose Prior studies have demonstrated the importance of treatment duration (TD) in radiation therapy (RT) for cervical cancer, with an 8-week goal based primarily on RT alone. This study uses a contemporary cohort to estimate the time point by which completion of chemoradiation therapy is most critical. Patients and Methods The National Cancer Database was queried for women with nonmetastatic cervical cancer diagnosed from 2004 to 2012 who underwent chemotherapy, external beam RT, and brachytherapy. Data-derived TD cut points for overall survival (OS) were computed by using recursive partitioning analysis with bootstrapped aggregation (bagging) and 10-fold cross-validation. Models were independently trained with 70% of the population and validated on 30% of the population by log-rank test with and without propensity matching. Multivariable Cox proportional hazards regression was performed for the entire cohort. Results In all, 7,355 women were identified with a median TD of 57 days. Bagged recursive partitioning analysis converged to a mean cut point of 66.6 days (median, 64.5 days; interquartile range, 63.5 to 68.5 days). Cross-validation yielded a cut point of 63.3 days. Both cut points differentiated OS in validation. Younger age, recent diagnosis, geographic region, nongovernment insurance, shorter distance to treatment facility, metropolitan location, lower comorbidity, squamous cell carcinoma, lower stage, negative lymph nodes, and shorter TD were independently associated with longer OS. With adjustment, TD within the mean cut point (64.9 days; hazard ratio, 0.79; 95% CI, 0.73 to 0.87) and 56 days (hazard ratio, 0.87; 95% CI, 0.80 to 0.95) were associated with longer OS. Exploratory stratification suggested increasing OS detriment beyond 64 days. Conclusion Shorter chemoradiation TD in cervical cancer is associated with longer survival, and TD should be minimized as much as possible. The data-derived cut point was distributed around 64 days, with a continuous relationship between shorter TD and longer OS.

Evaluate association between baseline quality of life (QOL) and changes in QOL measured by FACT-O TOI with progression-free disease (PFS) and overall survival (OS) in advanced epithelial ovarian cancer (EOC).Patients enrolled in GOG-0218 with completed FACT-O TOI assessments at baseline and at least one follow-up assessment were eligible. Baseline FACT-O TOI scores were sorted by quartiles (Q1-4) and outcomes compared between Q1 and Q2-4 with log-rank statistic and multivariate Cox regression adjusting for age, stage, post-surgical residual disease size, and performance status (PS). Trends in FACT-O TOI scores from baseline to the latest follow-up assessment were evaluated for impact on intragroup (Q1 or Q2-4) outcome by log-rank analysis.Of 1152 eligible patients, 283 formed Q1 and 869 formed Q2-4. Mean baseline FACT-O TOI scores were 47.5 for Q1 vs. 74.7 for Q2-4 (P0.001). Q1 compared to Q2-4 had worse median OS (37.5 vs. 45.6months, P=0.001) and worse median PFS (12.5 vs. 13.1months, P=0.096). Q2-4 patients had decreased risks of disease progression (HR 0.974, 95% CI 0.953-0.995, P=0.018), and death (HR 0.963, 95% CI 0.939-0.987, P=0.003) for each five-point increase in baseline FACT-O TOI. Improving versus worsening trends in FACT-O TOI scores were associated with longer median PFS (Q1: 12.7 vs. 8.6months, P=0.001; Q2-4: 16.7 vs. 11.1months, P0.001) and median OS (Q1: 40.8 vs. 16months, P0.001; Q2-4: 54.4 vs. 33.6months, P0.001).Baseline FACT-O TOI scores were independently prognostic of PFS and OS while improving compared to worsening QOL was associated with significantly better PFS and OS in women with EOC.

Study Objective Despite clear data demonstrating feasibility, safety, and cost-effectiveness of same-day discharge after minimally invasive hysterectomy, a paucity of data suggests ways to increase same-day discharge rates. Our objectives were to promote same-day discharge after minimally invasive hysterectomy using preoperative patient education videos, provider same-day discharge awareness initiatives, and standardization of postoperative management and to investigate reasons for overnight admission after surgery (non–same-day discharge). Design A quality improvement project measured rates of same-day discharge, patient satisfaction, and readmission during the 5 months before and after video implementation. Readmission rates were calculated as a surrogate for safety. A retrospective chart review was conducted of patients who underwent minimally invasive hysterectomy during the 5 months after video implementation, comparing 43 same-day discharges to 26 non–same-day discharge patients who met criteria for same-day discharge. Differences between groups were analyzed using 2-tailed t tests or logistic regression (continuous variables) and Fisher's exact test or χ 2 test (categorical variables). Next, providers were educated about same-day discharge, and initiatives were implemented to standardize postoperative care. Same-day discharge rates were then calculated to evaluate these additional interventions (Canadian Task Force classification II-2). Setting A gynecologic oncology division based at an academic institution and performing surgery at 2 hospitals. Patients All patients undergoing minimally invasive hysterectomy for both benign and malignant disease, using robot-assisted, straight laparoscopic, and radical hysterectomy procedures. Interventions Patient education video, provider education about same-day discharge, and initiatives to standardize postoperative care. Measurements and Main Results Overall, same-day discharge rates decreased from 47% to 35% and readmission rates from 1.7% to 0% after video implementation. Greater than 87% of both groups were very or somewhat satisfied with their care (p = .71). Excluding patients who did not qualify for same-day discharge, the prevideo implementation same-day discharge rate was 72% (n = 78) and the postvideo implementation same-day discharge rate was 62% (n = 69). Higher patient complexity (p = .003), later case end time (p = .001), longer operative time (p = .001), and robot-assisted cases (p = .002) significantly predicted non–same-day discharge. After implementing initiatives to increase provider same-day discharge awareness and to standardize postoperative management, in addition to video implementation, the same-day discharge rate increased to 86% (n = 51). Conclusion Same-day discharge in a select population is safe and feasible, with at least similar patient satisfaction as non–same-day discharge patients. Shorter operative time, earlier case end time, lower patient complexity, and non–robot-assisted approach increase the likelihood of same-day discharge. Patient education videos alone did not increase same-day discharges but maintained acceptable readmission rates. Communication with providers regarding the same-day discharge initiative and standardization of postoperative management with preoperative video implementation may lead to increased same-day discharge rates.

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

The aim of this study is to evaluate utilization of intensity modulated radiation therapy (IMRT) for vulvar cancer between 2004 and 2012, and determine the survival impact of IMRT and 2D/3D radiation therapy (RT) for women treated with postoperative, preoperative, or primary radiation. Women with vulvar carcinoma who received IMRT or 2D/3D RT were identified in the National Cancer Data Base (NCDB) between 2004 and 2012. Patient characteristics were compared between those that received IMRT and 2D/3D RT using chi-square, Fisher’s exact, and Mann-Whitney tests. Women were stratified by treatment approach, and overall survival (OS) was estimated via the Kaplan-Meier method and compared using the log-rank test. Factors associated with OS were determined using univariate and multivariate Cox proportional hazards regression models. A total of 6027 women were included (median age 67 years). Women received either 2D/3D RT (n = 4723) or IMRT (n = 1304). A total of 3.3% of women received IMRT in 2004, compared to 19.3% in 2008 and 43.0% in 2012. More women in the IMRT cohort received radiation doses >55 Gy compared to the 2D/3D RT cohort (47.5 vs. 40.3%, p 0.05). IMRT utilization for vulvar cancer increased between the years 2004 and 2012. Survival was not significantly compromised with the use of IMRT compared to conventional 2D/3D RT techniques and may have allowed for dose escalation in some situations.

ObjectiveThe aim of the study was to assess interaction of lymph node dissection (LND), adjuvant chemotherapy (CT), and radiotherapy (RT) in stage I uterine papillary serous carcinoma (UPSC) and uterine clear cell carcinoma (UCC).Methods/MaterialsThe National Cancer Data Base was queried for women diagnosed with International Federation of Gynecology and Obstetrics stage I UPSC and UCC from 1998 to 2012. Overall survival (OS) was estimated for combinations of RT and CT by the Kaplan-Meier method stratified by histology and LND. Multivariate Cox proportional hazard models were generated.ResultsUterine papillary serous carcinoma: 5432 women with UPSC were identified. Uterine papillary serous carcinoma had the highest 5-year OS with CT + RT with (83%) or without LND (76%). On multivariate analyses, CT [hazard ratio (HR), 0.77; P = 0.01] and vaginal cuff brachytherapy (HR, 0.68; P = 0.003) with LND were independently associated with OS. Without LND, vaginal cuff brachytherapy (HR, 0.53; P = 0.03), but not CT (HR, 1.21; P = 0.92), was associated with OS. Uterine clear cell carcinoma: 2516 women with UCC were identified. Uterine clear cell carcinoma with and without LND had comparable 5-year OS for all combinations of CT and RT on univariate and multivariate analyses.ConclusionsIn stage I papillary serous uterine cancer, brachytherapy and CT were associated with increased survival; however, the benefit of chemotherapy was limited to those with surgical staging. In contrast, no adjuvant therapy was associated with survival in stage I uterine clear cell carcinoma, and further investigation to identify more effective therapies is warranted.

Objectives To evaluate progression-free survival (PFS) and overall survival (OS) outcomes in women diagnosed with uterine papillary serous carcinoma (UPSC) who have had (UPSCBR+) or have not had (UPSCBR−) an antecedent history of breast cancer and to correlate their outcomes to prior tamoxifen exposure. Methods Data were collected for women diagnosed with UPSC at two academic institutions between January 1997 and July 2012. Patient demographics, tumor histology, stage, and treatments were recorded. Patients were divided into two groups: those with and without a personal history of breast cancer. Within the UPSCBR+ cohort, we identified those with a history of tamoxifen use. Cox regression modeling was used to explore associations between selected covariates of interest and the time-to-event outcomes of PFS and OS. Results Of 323 patients with UPSC, 46 (14%) were UPSCBR+. Of these, 15 (33%) had a history of tamoxifen use. UPSCBR+ patients were older than UPSCBR− (median years, 72 vs. 68, p=0.004). UPSCBR+ women showed no significant difference in PFS or OS compared to UPSCBR− (p=0.64 and p=0.73 respectively), even after controlling for age (p=0.15 and p=0.48 respectively). Within the UPSCBR+ cohort, there was no difference in PFS or OS with or without tamoxifen exposure (p=0.98 and p=0.94 respectively). Conclusions There was no difference in PFS or OS between the UPSCBR+ and UPSCBR− cohorts. We did not demonstrate significant OS or PFS differences in women who took tamoxifen prior to their endometrial cancer diagnosis. These findings have implications for counseling, and should be encouraging to women who are facing their second cancer diagnosis.

Background Chemotherapy plays a role in the treatment of endometrioid endometrial cancer (EEC); however, tumor grade may affect response. Our objective was to evaluate associations between tumor grade and in vitro chemoresponse. Methods We conducted an analysis of primary tumor samples from women with EEC undergoing in vitro chemoresponse testing. Results were classified as sensitive (S), intermediate (I), or resistant (R) to each drug tested. Correlations between tumor grade and response were examined. Results Data was collected from 159 patients: 28 with grade 1 (18%), 52 with grade 2 (32%), and 79 (50%) with grade 3 tumors. Median age of patients was 62 (range 31–92). Most patients were Caucasian (83%) with advanced disease (Stage III: 50.9%; Stage IV: 13.2%). Overall chemoresponse was similar across all grades. Fifty percent, 56 and 51% for grade 1, 2, and 3 tumors, respectively, demonstrated S results to at least 1 agent. There was no association between grade and in vitro response to chemotherapy agents (p > 0.05) except a marginal association between grade and doxorubicin response (p = 0.08). Grade 1 and 2 cancers were more likely to demonstrate R results for doxorubicin compared to grade 3 cancers (G1: 19% vs G2: 25% vs G3: 8%; p = 0.08). In a subset tested for all 7 agents, only one patient tumor was pan-R and 4 were pan-S. Conclusions Based on our data, grades 1–3 EEC have similar in vitro chemoresponse. These findings suggest that chemotherapy may be useful in advanced low grade EECs, but further clinical correlation is needed.

Background Randomized trials have reported conflicting findings on survival for advanced-stage ovarian cancer treated with primary debulking surgery (PDS) versus neoadjuvant chemotherapy with interval debulking; surgical complications and mortality are higher with PDS. We assessed women's preferences for tradeoffs related to this important clinical decision. Methods Ovarian cancer patients were recruited to complete a discrete-choice experiment (DCE) consisting of 8 choice tasks presenting experimentally designed treatment alternatives in terms of treatment order, extent of surgery including risk of ostomy, chance of death from surgical complications (1%-10%), readmission for surgical complications (5%-50%), progression-free survival (1-3 years), and overall survival (3-5 years). Random-parameters logit regression was applied to model participants' choices as a function of attribute levels. Results A total of 101 ovarian cancer survivors completed the DCE survey; of these participants, 30% were receiving chemotherapy at the time, and 33% had prior recurrence. Overall survival was of greatest importance to participants (36/100), followed by risk of readmission due to complications (23/100), progression-free survival (19/100), surgical mortality (16/100), extent of surgery (4/100), and order of surgery and chemotherapy (2/100). Overall, the participants would tolerate a 15-percentage point increase in risk of major complications (95% confidence interval [CI], 3%-29%) or a 4-percentage point increase in the risk of surgical mortality (95% CI, 2%-13%) in order to increase their expected overall survival from 3 to 3.5 years. Conclusions Patients would accept a moderately higher risk of perioperative complications and surgical mortality in exchange for substantial gains in survival. These quantitative findings provide clinicians with a framework to discuss preferences with patients and to incorporate preferences into clinical trial design.

Objectives Lymphovascular space invasion (LVSI) is an independent risk factor for recurrence and poor survival in early-stage endometrioid endometrial cancer (EEC), but optimal adjuvant treatment is unknown. We aimed to compare the survival of women with early-stage EEC with LVSI treated postoperatively with observation (OBS), radiation (RAD, external beam and/or vaginal brachytherapy), or chemotherapy (CHEMO)+/−RAD. Methods This was a multi-institutional, retrospective cohort study of women with stage I or II EEC with LVSI who underwent hysterectomy+/−lymphadenectomy from 2005 to 2015 and received OBS, RAD, or CHEMO+/−RAD postoperatively. Progression-free survival and overall survival were evaluated using Kaplan-Meier estimates and Cox proportional hazards models. Results In total, 478 women were included; median age was 64 years, median follow-up was 50.3 months. After surgery, 143 (30%) underwent OBS, 232 (48.5%) received RAD, and 103(21.5%) received CHEMO+/−RAD (95% of whom received RAD). Demographics were similar among groups, but those undergoing OBS had lower stage and grade. A total of 101 (21%) women recurred. Progression-free survival (PFS) was improved in both CHEMO+/−RAD (HR = 0.18, 95% CI: 0.09–0.39) and RAD (HR = 0.31, 95% CI: 0.18–0.54) groups compared to OBS, though neither adjuvant therapy was superior to the other. However, in grade 3 tumors, the CHEMO+/−RAD group had superior PFS compared to both RAD (HR 0.25; 95% CI: 0.12–0.52) and OBS cohorts (HR = 0.10, 95% CI: 0.03–0.32). Overall survival did not differ by treatment. Conclusions In early-stage EEC with LVSI, adjuvant therapy improved PFS compared to observation alone. In those with grade 3 EEC, adjuvant chemotherapy with or without radiation improved PFS compared to observation or radiation alone.

PURPOSE: Efforts to curb the rising costs of cancer care while improving quality include alternative payment models (APMs), which offer incentives to reduce avoidable spending and provide high-quality and cost-efficient care. The impact of proposed APMs has not been quantified in real-world practice. In this study, we evaluated ASCO’s Patient-Centered Oncology Payment (PCOP) model in existing fee-for-service (FFS) Medicare beneficiaries to understand the magnitude of potential cost savings. MATERIALS AND METHODS: SEER-Medicare data were used to identify women with advanced ovarian cancer diagnosed between 2000 and 2012 who either (1) underwent primary debulking surgery followed by chemotherapy or (2) received neoadjuvant chemotherapy followed by surgery. Medicare payments in each cohort were used to compare FFS and PCOP and to estimate the potential for cost savings across health care services received, including outpatient emergency department visits, hospitalizations, and imaging. RESULTS: Three thousand seven hundred seventy-seven primary debulking surgery and 866 neoadjuvant chemotherapy patients were included in the study, with mean total costs of $75,433 and $95,138 in 2016 US$, respectively Most costs were related to chemotherapy or hospitalization. Additional PCOP-related payments would be offset if hospitalizations could be reduced by 11.6% or imaging claims by 88%. CONCLUSION: APMs have the potential to reduce costs of current FFS reimbursement via either a large reduction in imaging or a modest reduction in hospitalizations during treatment of ovarian cancer. PCOP is a reasonable payment structure for oncologists if the additional payments can provide the necessary resources to invest in improved coordination of care.

Objectives Intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and interval tumor reductive surgery (TRS) for advanced ovarian cancer is feasible, however, the impact on disease outcomes remains unclear. We compare outcomes of patients treated with IP chemotherapy versus intravenous (IV) chemotherapy following NACT and interval TRS. Methods In this retrospective review, patients with advanced ovarian cancer were included if they received NACT followed by optimal interval TRS between 1/2004 and 4/2017. Patients were excluded if they had an ECOG PS >1, received >6 cycles of NACT or postoperative chemotherapy, and/or received bevacizumab during primary therapy. Primary outcomes were progression free survival (PFS) and overall survival (OS). Results There were 134 patients included in this study, 37 (28%) received IP and 97 (72%) received IV chemotherapy postoperatively. Patients in the IV group were older (median 66.3 vs 59.7 years, p = 0.0039) though there were no differences in BMI, race, BRCA status, stage, or histology. Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS. On univariate analysis, increasing number of NACT cycles (HR 1.914, 95% CI 1.024–3.497) and residual disease at completion of TRS (HR 1.541, 95% CI 1.042–2.248) were associated with decreased PFS; IP chemotherapy was associated with increased PFS (HR 0.633, 95% CI 0.414–0.944). These associations remained on multivariate analysis. Toxicity was comparable between the groups. Conclusions IP after NACT and optimal interval TRS was associated with in improved PFS compared to IV chemotherapy without significant differences in toxicity.

Objectives Although studies including TCGA have selected for pure tumors to enhance detection of cancer-related biomarkers, many impure tumors are associated with poor prognosis raising concerns over historical selection bias. Enrichment techniques to prep tumor micro-compartments was aligned with comprehensive proteogenomic analysis in an advanced stage high grade serous ovarian cancer (HGSOC) patient cohort to detect novel, clinically-relevant alterations. Methods 87 fresh-frozen tumor specimens were selected from a cohort of over 630 patients to reflect a continuum of tumor purity balanced by progression and disease distribution. A whole tumor (WT) specimen and one enriched for tumor epithelium was prepared for each case using laser microdissection (LMD). Specimens were analyzed by whole genome sequencing (WGS), mRNA-seq, quantitative global/phosphoproteomics, and reverse phase protein array. Results LMD enrichment increased median tumor purity estimated by WGS from 56% in WT to 79% (P Conclusions These data demonstrate feasibility of cohort-level proteogenomic characterization of the tumor microenvironment and establishes a non-restrictive paradigm for patient inclusion and specimen prep in support of the prospective mission-scale analyses associated with APOLLO.

Objective Determine cost differences between cell-free DNA (cfDNA) and serum integrated screening (INT) in obese women given the limitations of aneuploidy screening in this population. Methods Using a decision-analytic model, we estimated the cost-effectiveness of trisomy 21 screening in class III obese women using cfDNA compared with INT. Primary outcomes of the model were cost, number of unnecessary invasive tests, procedure-related fetal losses, and missed cases of trisomy 21. Results In base case, the mean cost of cfDNA was $498 greater than INT ($1399 vs $901). cfDNA resulted in lower probabilities of unnecessary invasive testing (2.9% vs 3.5%), procedure-related loss (0.015% vs 0.019%), and missed cases of T21 (0.00013% vs 0.02%). cfDNA cost $87 485 per unnecessary invasive test avoided, $11 million per procedure-related fetal loss avoided, and $2.2 million per missed case of T21 avoided. In sensitivity analysis, when the probability of insufficient fetal fraction is assumed to be >25%, cfDNA is both costlier than INT and results in more unnecessary invasive testing (a dominated strategy). Conclusion When the probability of insufficient fetal fraction more than 25% (a maternal weight of ≥300 lbs), cfDNA is costlier and results in more unnecessary invasive testing than INT.

OBJECTIVE: Adjuvant management of women with high-intermediate- and high-risk early-stage endometrial cancer remains controversial. Recently published results of GOG 249 revealed that vaginal brachytherapy plus chemotherapy (VBT+CT) was not superior to whole pelvic radiation therapy (WPRT) and was associated with more toxicities and higher nodal recurrences. This study examined off-study utilization of VBT+CT among women who met criteria for GOG 249 in the period prior to study publication. METHODS: Women diagnosed with FIGO IA-IIB endometrioid, serous, or clear cell uterine cancer between 2004-2015 and treated with hysterectomy and radiotherapy (RT) were identified in the National Cancer Database. Cochrane-Armitrage trend test was used to assess trends over time. Univariate and multivariate Cox analyses were performed to calculate odds ratio (OR) of VBT+CT receipt and hazard ratio (HR) of OS. Propensity-score matched analysis was conducted to account for baseline differences. RESULTS: 9,956 women met inclusion criteria. 7,548 women (75.8%) received WPRT while 2,408 (24.2%) received VBT+CT in the study period. From 2004-2015, there was a significant increase in VBT+CT use (p

Background Randomized trials have reported conflicting findings on survival for advanced-stage ovarian cancer treated with primary debulking surgery (PDS) versus neoadjuvant chemotherapy with interval debulking; surgical complications and mortality are higher with PDS. We assessed women's preferences for tradeoffs related to this important clinical decision. Methods Ovarian cancer patients were recruited to complete a discrete-choice experiment (DCE) consisting of 8 choice tasks presenting experimentally designed treatment alternatives in terms of treatment order, extent of surgery including risk of ostomy, chance of death from surgical complications (1%-10%), readmission for surgical complications (5%-50%), progression-free survival (1-3 years), and overall survival (3-5 years). Random-parameters logit regression was applied to model participants' choices as a function of attribute levels. Results A total of 101 ovarian cancer survivors completed the DCE survey; of these participants, 30% were receiving chemotherapy at the time, and 33% had prior recurrence. Overall survival was of greatest importance to participants (36/100), followed by risk of readmission due to complications (23/100), progression-free survival (19/100), surgical mortality (16/100), extent of surgery (4/100), and order of surgery and chemotherapy (2/100). Overall, the participants would tolerate a 15-percentage point increase in risk of major complications (95% confidence interval [CI], 3%-29%) or a 4-percentage point increase in the risk of surgical mortality (95% CI, 2%-13%) in order to increase their expected overall survival from 3 to 3.5 years. Conclusions Patients would accept a moderately higher risk of perioperative complications and surgical mortality in exchange for substantial gains in survival. These quantitative findings provide clinicians with a framework to discuss preferences with patients and to incorporate preferences into clinical trial design.

Objective We sought to determine whether use of a poly (ADP-ribose) polymerase inhibitor is cost effective for maintenance treatment of platinum-sensitive recurrent ovarian cancer. Methods A decision analysis model compared four maintenance strategies: 1) observation, 2) BRCA germline mutation testing and selective treatment of carriers (gBRCA only), 3) BRCA germline and tumor homologous recombination deficiency testing and selective treatment of either BRCA carriers or those with tumor HRD (gBRCA and HRD only), and 4) treat all with niraparib to progression (treat all). Costs were estimated in 2016 U.S. dollars. Incremental cost-effectiveness ratios were in dollars per progression-free quality-adjusted life-year (QALY). One-way sensitivity analyses tested multiple assumptions. Results Maintenance poly (ADP-ribose) polymerase inhibitor was costlier and more effective than observation. Mean costs and progression-free QALYs were $827 and 3.4 months for observation, $46,157 and 5.7 for a BRCA-only strategy, $109,368 and 8.5 for a gBRCA and homologous recombination deficiency-only strategy, and $169,127 and 8.8 for a treat-all strategy. gBRCA-only had an incremental cost-effectiveness ratio of $243,092/progression-free QALY compared with observation; other strategies did not approach cost effectiveness. Using the current U.S. Food and Drug Administration label for maintenance poly (ADP-ribose) polymerase inhibitor regardless of biomarker status, the third-party payer cost per month (28-day supply) would need to be reduced from approximately $14,700 to $3,600 to be considered cost effective compared with observation using a willingness to pay threshold of $100,000/progression-free QALY. Conclusion Maintenance poly (ADP-ribose) polymerase inhibitor therapy for platinum-sensitive recurrent ovarian cancer is not cost effective. Treatment of patients with BRCA mutation alone or with homologous recombination deficiency-positive tumors are preferred strategies compared with a treat-all strategy. Lowering the cost may make selective niraparib maintenance therapy cost effective compared with observation.

Background: Chorioamnionitis affects 1–4% of pregnancies, and patients who undergo cesarean delivery in the setting of chorioamnionitis have an increased risk of endometritis and surgical site infe...

Background Although genetic testing is recommended for women with epithelial ovarian cancer (EOC), little is known about patient preferences for various testing options. We measured relative preferences for attributes of testing in women with EOC referred for genetic counseling. Methods Subjects were recruited to participate in a discrete-choice-experiment survey to elicit preferences for attributes of genetic testing: out-of-pocket cost ($0, $100, $250, or $1000), probability of a deleterious mutation (60, 80%, or 88%), probability of a variant of uncertain significance (VUS) result (5, 20%, or 40%), sample requirements (blood or saliva), and turn-around time (1, 2 or 4 weeks). Subjects viewed educational videos followed by a series of choices between pairs of constructed genetic tests with varying attribute levels. Random-parameters logit was used to estimate preference weights for attribute levels. Relative importance weights and money-equivalent values were calculated. Results Ninety-four patients were enrolled; 68 (76.4%) presented for genetic counseling. Test cost was the most important attribute to subjects (importance weight = 41 out of 100) followed by probability to detect deleterious mutations (36) and probability of a VUS result (20). Sample requirements and turnaround time did not drive test choices. Subjects were willing to pay an additional $155 and $70 for incremental 5% improvements in the probability to detect deleterious mutations and probability of a VUS result. At genetics consultation, 55/68 (80.9%) subjects chose multigene testing. Conclusions Low out-of-pocket cost, high probability of detecting deleterious mutations and high probability of a VUS result are preferred by patients with EOC considering genetic testing. Electronic supplementary material The online version of this article (10.1186/s40661-019-0066-8) contains supplementary material, which is available to authorized users.

ObjectiveEnhanced Recovery After Surgery (ERAS) protocols are designed to mitigate the physiologic stress response created by surgery, to decrease the time to resumption of daily activities, and to improve overall recovery. This study aims to investigate postoperative recovery outcomes following gynecologic surgery before and after implementation of an ERAS protocol.MethodsA retrospective chart review was performed of patients undergoing elective laparotomy at a major academic center following implementation of an ERAS protocol (11/4/2014–7/27/2016) with comparison to a historical cohort (6/23/2013–9/30/2014). The primary outcome was length of hospital stay. Secondary outcomes included surgical variables, time to recovery of baseline function, opioid usage, pain scores, and complication rates. Statistical analyses were performed using Wilcoxon rank sum, Fisher’s exact, and chi squared tests.ResultsOne hundred and thirty-three women on the ERAS protocol who underwent elective laparotomy were compared with 121 historical controls. There was no difference in length of stay between cohorts (median 4 days; P = 0.71). ERAS participants had lower intraoperative (45 vs 75 oral morphine equivalents; P < 0.0001) and postoperative (45 vs 154 oral morphine equivalents; P < 0.0001) opioid use. ERAS patients reported lower maximum pain scores in the post-anesthesia care unit (three vs six; P < 0.0001) and on postoperative day 1 (four vs six; P = 0.002). There was no statistically significant difference in complication or readmission rates.ConclusionsERAS protocol implementation was associated with decreased intraoperative and postoperative opioid use and improved pain scores without significant changes in length of stay or complication rates.

Objectives A recent randomized controlled trial demonstrated an overall survival benefit to the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to neoadjuvant chemotherapy (NACT) for stage III epithelial ovarian cancer (EOC). The objective of the current study was to quantify the cost-effectiveness of HIPEC in this setting. Methods A decision analytic cost-effectiveness model was designed from a payer perspective to compare 2 surgical management strategies for EOC: (1) interval cytoreductive surgery (ICS); (2) ICS + HIPEC. Overall survival and ostomy rates with HIPEC were modeled from published studies. We assumed that 25% of each arm would later undergo secondary cytoreductive surgery, with the ICS arm eligible for HIPEC at that time. Costs were obtained from Medicare data, published studies, and the financial department of an academic hospital. Quality of life was not different between the arms; we assigned utilities based on a prior time-trade off study of ovarian cancer treatment. A Monte Carlo probabilistic sensitivity analysis was performed in the base case; primary outcome was the incremental cost-effectiveness ratio (ICER), expressed in 2017 US Dollars/quality-adjusted life years (QALYs). Results ICS was the least costly strategy at $78,849, compared to ICS + HIPEC at $79,954. ICS + HIPEC was more effective than ICS (2.9 QALYs versus 2.45 QALYs for ICS). ICS + HIPEC was highly cost-effective, with an ICER of $2436/QALY compared to ICS. In one-way sensitivity analyses, probability of ostomy reversal and use of HIPEC at secondary cytoreduction did not substantially impact the cost-effectiveness of ICS + HIPEC. Conclusion ICS + HIPEC constitutes cost-effective management of stage III EOC when NACT is performed.

e17565 Background: Understanding the incidence and timing of venous thromboembolic (VTE) events among patients receiving treatment for advanced endometrial cancer (EC) may help to inform VTE risk stratification and consideration of thromboprophylaxis. We aimed to describe the rate of VTE at each stage of primary treatment for advanced EC as well as the baseline Khorana Score (KS) distribution in this population. Methods: This was a retrospective cohort study of patients diagnosed with stage IVB EC from January 2001 to July 2020 at a single academic institution. The primary outcome was VTE incidence at each stage of primary treatment (at diagnosis, during neoadjuvant chemotherapy [NACT] if applicable, post-operatively [< 30 days from surgery], or during adjuvant chemotherapy). Subjects who were anticoagulated at EC diagnosis were excluded. Khorana score was calculated according to established parameters (1 point each for gynecologic malignancy, pre-chemotherapy platelet count ≥ 350, hemoglobin < 10 or use of red blood cell growth factors, leukocyte count >11, and BMI ≥ 35). Descriptive statistics were used for analysis. Results: There were 76 patients diagnosed with stage IVB EC, 2 of whom were excluded for anticoagulation at cancer diagnosis. Of the remaining 74 patients, 58 underwent primary surgery (78%) and 16 received NACT (22%). A total of 59 received adjuvant chemotherapy after either primary or interval debulking surgery. The two predominant tumor histologies were serous (48%) and endometrioid (20%).A total of 16 VTE occurred during the primary treatment course (22%), 11 among the cohort receiving primary surgery (19%) and 5 among the cohort receiving NACT (31%). The distribution of VTE by stage of primary treatment is shown in Table. The rate of VTE was highest during adjuvant chemotherapy. There were 62 patients for whom a Khorana score could be calculated either before NACT or adjuvant chemotherapy. The distribution of KS was: 17 (27%) with KS 1 (low risk) and 45 (73%) with KS ≥ 2 (intermediate – high risk). Of the 11 non-postoperative VTE, 3 patients (27%) had KS 1 and 8 (73%) had KS ≥ 2. Conclusions: The incidence of VTE among patients with advanced EC was high regardless of whether treatment was initiated with NACT or primary surgery. The majority of VTE occurred among patients with a high KS, but those with a low KS remained at risk. Thromboprophylaxis among all patients with advanced EC may be warranted, and larger studies are needed to determine the performance of KS as a VTE predictor in advanced EC.[Table: see text]

To estimate the cost-effectiveness of the levonorgestrel intrauterine device (IUD) as an endometrial cancer prevention strategy in obese women.A modified Markov model was used to compare IUD placement at age 50 with usual care among women with a body mass index (BMI, kg/m) 40 or greater or BMI 30 or greater. The effects of obesity on incidence and survival were incorporated. The IUD was assumed to confer a 50% reduction in cancer incidence over 5 years. Costs of IUD and cancer care were included. Clinical outcomes were cancer diagnosis and deaths from cancer. Incremental cost-effectiveness ratios were calculated in 2015 U.S. dollars per year of life saved. One-way and two-way sensitivity analyses and Monte Carlo probabilistic analyses were performed.For a 50 year old with BMI 40 or greater, the IUD strategy is costlier and more effective than usual care with an incremental cost-effectiveness ratio of $74,707 per year of life saved. If the protective effect of the levonorgestrel IUD is assumed to be 10 years, the incremental cost-effectiveness ratio decreases to $37,858 per year of life saved. In sensitivity analysis, a levonorgestrel IUD that reduces cancer incidence by at least 68% in women with BMIs of 40 or greater or costs less than $500 is potentially cost-effective. For BMI 30 or greater, the incremental cost-effectiveness ratio of IUD strategy is $137,223 per year of life saved compared with usual care. In Monte Carlo analysis, IUD placement for BMI 40 or greater is cost-effective in 50% of simulations at a willingness-to-pay threshold of $100,000 per year of life saved.The levonorgestrel IUD is a potentially cost-effective strategy for prevention of deaths from endometrial cancer in obese women.

This selection from the NCCN Guidelines for Ovarian Cancer focuses on the less common ovarian histopathologies (LCOHs), because new algorithms were added for LCOHs and current algorithms were revised for the 2016 update. The new LCOHs algorithms include clear cell carcinomas, mucinous carcinomas, and grade 1 (low-grade) serous carcinomas/endometrioid epithelial carcinomas. The LCOHs also include carcinosarcomas (malignant mixed Müllerian tumors of the ovary), borderline epithelial tumors (also known as low malignant potential tumors), malignant sex cord-stromal tumors, and malignant germ cell tumors.

ObjectivesThe aim of this study was to determine the necessary reduction in recurrence rate that would make postchemoradiation positron emission tomography (PET)/computed tomography (CT) to direct completion hysterectomy for locally advanced cervical cancer (LACC) cost-effective.MethodsA decision model evaluated costs and recurrence rates of 2 posttreatment surveillance strategies in LACC: (1) routine surveillance without PET/CT and (2) PET/CT after 3 months to triage to completion hysterectomy. Incremental cost-effectiveness ratios were expressed in dollars per additional cancer recurrence avoided. Model parameters included expected rates of recurrence using each strategy, true- and false-positive rates of posttreatment PET/CT, and major complications of completion hysterectomy. From published data, we modeled an LACC baseline recurrence rate of 32%, PET/CT false-positive rate of 33%, and false-negative rate of 19%. We assumed that PET/CT revealed persistent local cervical cancer in 16% and progressive or distant disease in 6%. Costs of PET/CT, hysterectomy, and treatment for recurrence were based on Medicare reimbursements. A 50% salvage rate with hysterectomy was assumed and varied in sensitivity analysis.ResultsRoutine use of PET/CT to direct completion hysterectomy was associated with a higher average cost ($16,579 vs $15,450) and a lower recurrence rate (26% vs 32%). The incremental cost-effectiveness ratio of PET was $20,761 per recurrence prevented. When the probability of recurrence after hysterectomy dropped to 25% or less, PET/CT was a dominant strategy.ConclusionsRoutine use of PET/CT to determine which patients may benefit from a completion hysterectomy after chemoradiation for LACC has the potential to be highly cost-effective.

OBJECTIVE. To evaluate the association between body mass index (BMI) and mortality in women with endometrial cancer. METHODS. A systematic review was performed utilizing a Medline search with Mesh keywords ‘endometrial neoplasms’ and (‘body mass index’ or ‘obesity’) and (‘survival analysis’ or ‘mortality’ or ‘survivor’ or ‘survival’) for studies published prior to June 2013. Inclusion criteria included studies that assessed associations between BMI and survival in endometrial cancer patients. Two investigators independently reviewed the title and abstract and full-text of articles for inclusion or exclusion decision; discordant decisions were adjudicated by a third reviewer. A random-effects model was constructed that was comparable to the standard random-effects models used in the meta-analysis of odds ratios. The model was fitted using SAS PROC NLMIXED. RESULTS. 1451 studies were identified and reviewed in duplicate, 18 met inclusion criteria. A random-effects meta-analysis demonstrated significantly higher odds of mortality with increasing BMI in endometrial cancer patients. Specifically the odds ratios were 1.01, 1.17, 1.26, and 1.66 for BMI categories of 25–29.9, 30–34.9, 35–39.9, and 40+, respectively. The odds ratio for all-cause mortality in endometrial cancer patients with a BMI ≥ 40 compared to those with a BMI < 25 was 1.66 (CI: 1.10–2.51, p = 0.02). A single dose–response model indicated that a 10% increase in BMI resulted in a 9.2% increase in the odds of all-cause mortality (p = 0.007). CONCLUSION. Increased BMI is significantly associated with increased all-cause mortality in women with endometrial cancer, with the highest risk for those with a BMI ≥ 40.

Changes in cognitive function have been identified in and reported by many cancer survivors. These changes have the potential to impact patient quality of life and functional ability. This prospective longitudinal study was designed to quantify the incidence of change in cognitive function in newly diagnosed ovarian cancer patients throughout and following primary chemotherapy.Eligible patients had newly diagnosed, untreated ovarian cancer and had planned to receive chemotherapy. Web-based and patient reported cognitive assessments and quality of life questionnaires were conducted prior to chemotherapy, prior to cycle four, after cycle six, and six months after completion of primary therapy.Two-hundred-thirty-one evaluable patients entered this study between May 2010 and October 2011. At the cycle 4 time point, 25.2% (55/218) of patients exhibited cognitive impairment in at least one domain. At the post-cycle 6 and 6-month follow up time points, 21.1% (44/208) and 17.8% (30/169) of patients, respectively, demonstrated impairment in at least one domain of cognitive function. There were statistically significant, but clinically small, improvements in processing speed (p0.001) and attention (p0.001) but not in motor response time (p=0.066), from baseline through the six-month follow up time period.This was a large, prospective study designed to measure cognitive function in ovarian cancer. A subset of patients had evidence of cognitive decline from baseline during chemotherapy treatment in this study as measured by the web-based assessment; however, changes were generally limited to no more than one domain.

e19288 Background: The Centers for Medicare and Medicaid services (CMS) has announced a new payment model for radiotherapy services, a Radiation Oncology Alternative Payment Model (ROAPM), for 17 malignancies. The data used to calculate the base payments were released with the program announcement. The purpose of this study was to analyze trends in treatment as well as payments for each treatment modality in an attempt to provide a baseline for future comparison once the ROAPM has been completed. Methods: The database, CY2015-2017, contains payment, site of service, anatomic site and limited patient data for 517,988 patients, 91,551 having a diagnosis of prostate cancer. Only CPT codes for radiotherapy were included in the calculation of payment and only codes registered 90 days after a treatment planning charge were included. Stata 15m College Station, Texas, was used to perform all statistical analysis. Chi squared test was used to determine associations between variables. The Kruskal-Wallis H test was used to determine the relationship of total payment to clinical variables. Results: Treatment included IMRT (66,663 patients[pts], conventional therapy[ceb] (8,942 pts), brachy therapy (7,156 pts), stereotactic radiotherapy (srs) (5,120 pts) and proton beam therapy [pbt] (3,661). A slight majority of patients, 51%, were treated in the outpatient setting. Patients treated in a freestanding center were significantly more likely to have more than 41 fractions (54%) as compared to patients treated in an outpatient setting (32%), P < 0.001. Patients receiving pbt were significantly younger when compared to patients receiving other therapies, p < 0.001. Pbt was significantly costlier, mean $45,606.85 when compared to IMRT, $26,33.14, ceb, $10,242.27, srs, $16,514.98, or brachytherapy, $15,615.44, p < 0.001. In addition, patients treated at an outpatient center with IMRT experienced higher cost compared to patients treated at a freestanding setting, $25,448.48 vs $22,934.69 p = 0.001. Conclusions: These data gives baseline treatment practice information prior to the implementation of a ROAPM. These data, however, are limited and do not give any indication as to the outcome, both disease specific metrics, and quality of life metrics. Post ROAPM analysis will be needed to determine the effect of a new payment paradigm on treatment practices of this malignancy.

1515 Background: Next generation sequencing (NGS) testing of tumor tissue or blood is performed to identify ‘actionable’ mutations that might guide patient care. NGS testing might incidentally identify germline mutations associated with cancer syndromes. No distinction is made between germline and somatic alterations on NGS reports, thus confirmatory germline testing is required. In this quality improvement (QI) initiative, we evaluated the frequency of referrals to genetic counseling (GC) for patients with potentially heritable germline mutations identified through NGS testing. Methods: We generated a list of high-risk mutations (HRMs) which merit GC referral based on NCCN guidelines. NGS test results for 3,400 consecutive patients with solid tumor malignancies were reviewed by the molecular tumor board from 1/2014-9/2019 and were screened for pathogenic HRMs. Basic demographic, oncologic, and GC data were retrospectively abstracted for each patient. The outcomes of interest were the frequency of HRMs identified through NGS testing, the proportion of patients subsequently referred to GC, and the proportion of patients ultimately diagnosed with a hereditary cancer syndrome. Results: 472 individual patients (14%) had NGS testing with one or more HRM identified; 465 patients were evaluable which corresponded to 519 HRMs that were included in the analysis (Table). Malignancies included were gastrointestinal 199 (42.8%), lung 83 (17.8%), genitourinary/renal 56 (12.0%), breast 49 (10.5%), gynecologic 35 (7.5%), and other 43 (9.2%). 75 (16.1%) patients had germline testing prior to NGS testing. Of those patients without prior germline genetic testing, 62 (15.9%) were referred to GC, and 19 (4.9%) patients were diagnosed with a hereditary cancer syndrome. Conclusions: Tumor NGS testing identifies HRMs that may represent an undiagnosed heritable germline mutation. Providers ordering NGS tests should review results for HRMs, refer to GC when appropriate, and offer confirmatory germline testing for patients and their families. [Table: see text]

7074 Background: Venous thromboembolism (VTE) is a major cause of morbidity and mortality among cancer patients. The Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients (AVERT) randomized controlled trial concluded that apixaban is a safe and effective option for VTE prophylaxis in high-risk ambulatory cancer patients initiating a new chemotherapy regimen. We performed a cost-effectiveness analysis from a health system perspective to determine if apixaban is a feasible prophylactic strategy for this population. Methods: A decision model was created from a third party payer perspective with a time horizon of 6 months, based on the treatment arms of the AVERT trial: (1) apixaban 2.5 mg twice daily for 6 months during active chemotherapy versus (2) placebo. Rates of VTE (4.2% apixaban vs 10.2% placebo), major bleeding (3.5% vs 1.8%) and clinically relevant nonmajor bleeding (CRNMB) (7.3% vs 5.5%) were modeled from the results of the AVERT trial. Cost estimates for treatments and events were obtained from wholesale drug costs, previously published studies and Medicare reimbursement data, and adjusted for inflation to 2018 dollars. Quality adjusted life years were calculated based on previously published utility values for the health states of advanced cancer, DVT, PE, and major bleeding events. An exploratory analysis was performed comparing prophylactic aspirin to no prophylaxis assuming a VTE rate of 7.2%, major bleeding rate of 3.5%, and CRNMB rate of 7.3%, based on the conservative assumptions that while aspirin may not be as effective at preventing VTE, the rate of clinically significant bleeding events would be similar or greater than that of apixaban. Results: In the base case model, apixaban is more costly and more effective than placebo (ICER = $5,013,190/QALY), and the cost per VTE prevented in the apixaban arm is $33,000. In one-way sensitivity analysis, if the cost of apixaban were reduced by 40% from $3,197 to $1,250 for a 6 month course, this could potentially be a cost-effective prophylaxis strategy with an ICER less than $100,000/QALY. In the alternative analysis, aspirin dominates placebo as it is both more effective and less expensive, and remains cost-effective even when the rate of clinically recognized bleeding with aspirin exceeds 15%. Conclusions: Further investigation into less costly prophylactic options such as generic direct oral anticoagulants (once available) and aspirin is warranted prior to broader implementation of a VTE prophylaxis strategy in this population.

800 Background: CMS announced plans to pilot an alternative payment model (APM) utilizing a fixed payment per ICD-10 code for 17 malignancies. CMS released payment data used to calculate the base payments. The purpose of this study was to analyze radiotherapy use in patients with gastrointestinal malignancies to obtain baseline utilization and payment prior to the APM start. Methods: The CMS database, CY2015-2017, contained payment, anatomic site and limited patient data on 517,988 patients, 48,032 of which were identified as gastrointestinal (GI) cancers, (Anal (A) Colorectal (CR), Pancreatic (P), Upper GI (UGI), or Liver(L) cancers) all histologies included. Stata 15, College Station, Texas, was used to perform all statistical analysis. Payments were calculated using only CPT codes for radiotherapy and only include the first 90 days after a treatment planning charge was registered. Results: Anatomic site breakdown was 4940 A, 16,099 CR, 6,970 P, 14,750 UGI and 5,273 L cancers. Patient treatments by year were15,697 in 2015, 16,309 in 2016 and 16,026 in 2017. Use of proton therapy and IMRT increased from 2015-2017 (193 (1.2%) to 302 (1.9%) and 8,107(52%) to 8838 (55%), respectively) whereas use of conventional external beam decreased from 6544 (42%) in 2015 to 5377(34%) in 2017. Of interest, 10,336 (668 A, 3363 CR, 2847 L, 1083 P, and 2375 UGI) of the 48,032 patients receiving radiotherapy were coded as not receiving chemotherapy. Mean professional and technical payments were $28,380.97 (SD $6779.18) for proton beam therapy, $18,186.77 (SD $4534.3) for IMRT, $10,724.88 ($4797.19) for conventional external beam therapy, $13,967.66 (SD $5186.92) for stereotactic, and $19,707 (SD$7393.81) for brachytherapy. Results by anatomic site will be presented. Conclusions: This study provides a baseline for comparison for treatment technique and payment once the APM has been completed. These claims are limited by the lack of available information on specific age, stage or other co-morbidities. Use of proton beam therapy has increased in this population, but remains a small percentage of radiotherapy technique used. 25% of patients receiving radiotherapy were not coded as receiving chemotherapy.

To investigate trends in the representation of women as first, last, or co-authors in Gynecologic Oncology (GO) publications over the past 15 years. To compare rates of female authorship in GO versus general Obstetrics and Gynecology (Ob/Gyn) and with the gender distribution of membership in the Society of Gynecologic Oncology (SGO).Gender was determined for first and last authors of GO publications from three major journals for 2000, 2005, 2010, and 2015. The Z test was used to assess differences in proportions of female authors between 2000 and 2015 and first versus last female authors in each year. GO authorship trends were compared to those of general Ob/Gyn and new and total membership in SGO using the chi squared test.1815 publications were included. Percentages of female first, last, and co-authors increased over time (p 0.001), reaching 52%, 39%, and 23%, respectively, by 2015. Fewer women were listed as last than as first authors at each time point (p 0.01). Proportions of female authors in general Ob/Gyn exceeded those of GO. Women comprised a growing proportion of both new and total SGO members over time (p 0.01). New female SGO membership outpaced rates of female GO authorship, but GO female first authorship surpassed total female SGO membership (p 0.001).Women comprise a growing proportion of GO providers and SGO members and have become increasingly productive in academic GO. Differences in publication authorship alone cannot account for gender disparities in the distribution of academic rank and leadership positions in the field.

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

Purpose Uterine serous carcinoma is a rare, aggressive variant of endometrial cancer. Trastuzumab is a humanized monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2)/neu, a receptor overexpressed in 30% of uterine serous carcinoma. This multicenter, randomized phase II trial compared carboplatin-paclitaxel with and without trastuzumab in patients with advanced or recurrent uterine serous carcinoma who overexpress HER2/neu. Methods Eligible patients had primary stage III or IV or recurrent HER2/neu-positive disease. Participants were randomly assigned to receive carboplatin-paclitaxel (control arm) for six cycles with or without intravenous trastuzumab (experimental arm) until progression or unacceptable toxicity. The primary end point was progression-free survival, which was assessed for differences between treatment arms via one-sided log-rank tests. Results From August 2011 to March 2017, 61 patients were randomly assigned. Forty progression-free survival–related events occurred among 58 evaluable participants. Among all patients, median progression-free survival was 8.0 months (control) versus 12.6 months (experimental; P = .005; hazard ratio [HR], 0.44; 90% CI, 0.26 to 0.76). Similarly, median progression-free survival was 9.3 (control) versus 17.9 (experimental) months among 41 patients with stage III or IV disease undergoing primary treatment ( P = .013; HR, 0.40; 90% CI, 0.20 to 0.80) and 6.0 (control) versus 9.2 months (experimental), respectively, among 17 patients with recurrent disease ( P = .003; HR, 0.14; 90% CI, 0.04 to 0.53). Toxicity was not different between treatment arms, and no unexpected safety signals emerged. Conclusion Addition of trastuzumab to carboplatin-paclitaxel was well tolerated and increased progression-free survival. These encouraging results deserve further investigation to determine their impact on overall survival in patients with advanced or recurrent uterine serous carcinoma who overexpress HER2/neu.

Predictive models are increasingly being used in clinical practice. The aim of the study was to develop a predictive model to identify patients with platinum-resistant ovarian cancer with a prognosis of less than 6 to 12 months who may benefit from immediate referral to hospice care.A retrospective chart review identified patients with platinum-resistant epithelial ovarian cancer who were treated at our institution between 2000 and 2011. A predictive model for survival was constructed based on the time from development of platinum resistance to death. Multivariate logistic regression modeling was used to identify significant survival predictors and to develop a predictive model. The following variables were included: time from diagnosis to platinum resistance, initial stage, debulking status, number of relapses, comorbidity score, albumin, hemoglobin, CA-125 levels, liver/lung metastasis, and the presence of a significant clinical event (SCE). An SCE was defined as a malignant bowel obstruction, pleural effusion, or ascites occurring on or before the diagnosis of platinum resistance.One hundred sixty-four patients met inclusion criteria. In the regression analysis, only an SCE and the presence of liver or lung metastasis were associated with poorer short-term survival (P0.001). Nine percent of patients with an SCE or liver or lung metastasis survived 6 months or greater and 0% survived 12 months or greater, compared with 85% and 67% of patients without an SCE or liver or lung metastasis, respectively.Patients with platinum-resistant ovarian cancer who have experienced an SCE or liver or lung metastasis have a high risk of death within 6 months and should be considered for immediate referral to hospice care.

Importance The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is the largest randomized clinical trial to evaluate screening’s impact on ovarian cancer mortality, assigning women to multimodal screening (MMS) with serum cancer antigen 125 (CA-125) interpreted using a risk algorithm. If the MMS screening method is eventually shown to reduce mortality and be cost-effective, then it may be accepted by the medical community as a feasible screening tool. Objective To estimate the cost-effectiveness of an MMS screening program in the United States. Design, Setting, and Participants A Markov simulation model was constructed using data from UKCTOCS to compare MMS with no screening in the United States. Screening would begin at the age of 50 years for women in the general population. Published estimates of the long-term effect of MMS screening on ovarian cancer mortality and the trial’s published hazard ratios were used to simulate mortality estimates up to 40 years from start of screening. Base-case costs included CA-125, ultrasound, and false-positive work-up results, in addition to a risk algorithm cost estimate of $100. The utility and costs of ovarian cancer treatment were incorporated into the model. Interventions Screening strategies varied by costs of the algorithm and treatment for advanced ovarian cancer, rates of screening compliance, ovarian cancer incidence, and extrapolation of ovarian cancer mortality. Main Outcomes and Measures Costs, quality-adjusted life-years (QALYs), and mortality reduction of ovarian cancer screening. Results Multimodal screening is both more expensive and more effective in reducing ovarian cancer mortality over a lifetime than no screening. After accounting for uncertainty in the underlying parameters, screening women starting at age 50 years with MMS is cost-effective 70% of the time, when decision makers are willing to pay $150 000 per QALY. Screening reduced mortality by 15%, with an incremental cost-effectiveness ratio (ICER) ranging from $106 187 (95% CI, $97 496-$127 793) to $155 256 (95% CI, $150 369-$198 567). Conclusions and Relevance Ovarian cancer screening is potentially cost-effective in the United States depending on final significance of mortality reduction and cost of the CA-125 risk algorithm. These results are limited by uncertainty around the effect of screening on ovarian cancer mortality beyond the 11 years of UKCTOCS.