Maryland's Global Budget Revenue Payment Model and Shifts in the Surgical Site of Care Among Medicare Beneficiaries.

OBJECTIVE: To assess the association between the Global Budget Revenue (GBR) payment model and shifts to the outpatient setting for surgical procedures among Medicare fee-for-service beneficiaries in Maryland versus control states. SUMMARY BACKGROUND DATA: The GBR model provides fixed global payments to hospitals to reduce spending growth and incentivize hospitals to reduce the costs of care while improving care quality. Since surgical care is a major contributor to hospital spending, the GBR model might accelerate the ongoing shift from the inpatient to the outpatient setting to generate additional savings. METHODS: A difference-in-differences (DiD) design was used to compare changes in surgical care settings over time from pre-GBR (2011-2013) to post-GBR (2014-2018) for Maryland versus control states for common surgeries that could be performed in the outpatient setting. A cross-sectional approach was used to compare the difference in care settings in 2018 for total knee arthroplasty which was on Medicare's Inpatient-Only List before then. RESULTS: We studied 47,542 surgical procedures from 44,410 beneficiaries in Maryland and control states. GBR's 2014 implementation was associated with an acceleration in the shift from inpatient to outpatient settings for surgical procedures in Maryland (DiD: 3.9 percentage points, 95% CI: 2.3, 5.4). Among patients undergoing total knee arthroplasty in 2018, the proportion of outpatient surgeries in Maryland was substantially higher than that in control states (difference: 27.6 percentage points, 95% CI: 25.6, 29.6). CONCLUSIONS: Implementing Maryland's GBR payment model was associated with an acceleration in the shift from inpatient to outpatient hospital settings for surgical procedures.

Neighborhood economic vulnerability as a predictor for patterns of care and outcomes for patients with uterine cancer.

OBJECTIVE: To quantify the effect of neighborhood socioeconomic vulnerability as it relates to racial disparity in uterine cancer treatment and survival. METHODS: Patients with a diagnosis of uterine cancer who underwent hysterectomy in New York State from 2004 to 2017 were included in this retrospective cohort study. Neighborhood socioeconomic vulnerability as quantified by the Area Deprivation Index was calculated. Primary outcome was guideline adherent treatment; secondary outcome was 5 year overall survival. RESULTS: A total of 34,356 patients were included in the final cohort. Residence within a vulnerable neighborhood was associated with a lower likelihood of receiving appropriate adjuvant chemotherapy (59.7% vs 75.7% with aRR = 0.81; 95% CI, 0.77-0.86) and timely surgery (63.7% vs. 74.5% with aRR = 0.85; 95% CI, 0.82-0.87). All-cause mortality was 24% higher for those who resided in vulnerable neighborhoods compared to affluent neighborhoods (aHR = 1.24; 95% CI, 1.16-1.32). The greatest Black/White racial disparity in 5 year overall survival was seen in the most affluent neighborhoods at 18.6%, with survival being 79.8% for White patients and 61.2% for Black patients (aHR 1.31; 95% CI 1.14-1.51). For patients with advanced stage disease, this disparity was driven by improved survival for White patients with increasing neighborhood affluence but no change in survival for Black patients. On adjusted analysis controlling for age, comorbidities, insurance, tumor histology, stage, and grade, the disparity remained widest in the most affluent neighborhoods in NYC (aHR = 1.59; 95%CI 1.26-1.2.01). CONCLUSIONS: Neighborhood socioeconomic vulnerability is associated with poor outcomes for patients with uterine cancer. The greatest Black/White survival disparities are in the wealthiest neighborhoods. Neighborhood affluence may not affect survival of Black patients with advanced stage endometrial cancer.

Comparing survival of older ovarian cancer patients treated with neoadjuvant chemotherapy versus primary cytoreductive surgery: Reducing bias through machine learning.

OBJECTIVE: To develop and evaluate a multidimensional comorbidity index (MCI) that identifies ovarian cancer patients at risk of early mortality more accurately than the Charlson Comorbidity Index (CCI) for use in health services research. METHODS: We utilized SEER-Medicare data to identify patients with stage IIIC and IV ovarian cancer, diagnosed in 2010-2015. We employed partial least squares regression, a supervised machine learning algorithm, to develop the MCI by extracting latent factors that optimally captured the variation in health insurance claims made in the year preceding cancer diagnosis, and 1-year mortality. We assessed the discrimination and calibration of the MCI for 1-year mortality and compared its performance to the commonly-used CCI. Finally, we evaluated the MCI's ability to reduce confounding in the association of neoadjuvant chemotherapy (NACT) and all-cause mortality. RESULTS: We included 4723 patients in the development cohort and 933 in the validation cohort. The MCI demonstrated good discrimination for 1-year mortality (c-index: 0.75, 95% CI: 0.72-0.79), while the CCI had poor discrimination (c-index: 0.59, 95% CI: 0.56-0.63). Calibration plots showed better agreement between predicted and observed 1-year mortality risk for the MCI compared with CCI. When comparing all-cause mortality between NACT with primary cytoreductive surgery, NACT was associated with a higher hazard of death (HR: 1.13, 95% CI: 1.04-1.23) after controlling for tumor characteristics, demographic factors, and the CCI. However, when controlling for the MCI instead of the CCI, there was no longer a significant difference (HR: 1.05, 95% CI: 0.96-1.14). CONCLUSIONS: The MCI outperformed the conventional CCI in predicting 1-year mortality, and reducing confounding due to differences in baseline health status in comparative effectiveness analysis of NACT versus primary surgery.

The association of maintenance hormone therapy with overall survival in advanced-stage low-grade serous ovarian carcinoma: A risk-set matched retrospective study.

OBJECTIVE: We conducted a multi-institutional observational study to investigate whether maintenance hormone therapy following primary treatment of low-grade advanced-stage ovarian cancer (LGSOC) is associated with an overall survival advantage. METHODS: We included patients with histologically confirmed stage III or IV LGSOC diagnosed between Jan 1, 2004, and Dec 31, 2019, treated in Commission on Cancer-accredited cancer programs in the US. Patients who received hormone therapy within six months of diagnosis were matched to controls who did not initiate hormone therapy during this timeframe by risk-set propensity score matching. The primary outcome was the risk of death from any cause within five years of initiation of HT or observation. RESULTS: There were 296 patients who initiated maintenance hormone therapy within six months of diagnosis and 2805 potential controls. Patients who received hormone therapy were more often treated in academic medical centers (55% vs. 44%), diagnosed later in the study period (62% vs. 23% diagnosed in 2018-2019), and frequently received no chemotherapy during initial treatment (45% vs. 17%). After risk set propensity score matching, we identified 225 patients treated with HT and 225 untreated controls who were otherwise similar with respect to measured covariates. In the matched cohort, hormone therapy was associated with a reduction in the risk of death (hazard ratio 0.60; 95% CI 0.38-0.94), corresponding to a 60-month survival of 75% compared with 65%. CONCLUSIONS: Following primary management of LGSOC, maintenance hormone therapy was associated with improved overall survival compared with observation.

Weight-loss therapy in patients with obesity with endometrial intraepithelial neoplasia and uterine cancer.

OBJECTIVE: Although obesity is an important risk factor for endometrial intraepithelial neoplasia (EIN) and uterine cancer, little is known about the trends in use of weight-loss therapy for patients with obesity with EIN and uterine cancer. We examined the use of weight-loss therapy among patients with obesity with EIN and uterine cancer. METHODS: The Merative MarketScan Database was used to identify patients aged 18-70 years who were obese and diagnosed with EIN or uterine cancer. The primary treatment for EIN or uterine cancer was categorized as either primary hysterectomy or hormonal therapy. Nutrition counseling, bariatric surgeries, and weight-management medications were identified as weight-loss therapy. We analyzed trends in the use of any weight-loss therapies with Cochran-Armitage tests. A multivariable logistic regression model was developed to examine factors associated with weight-loss therapy use. RESULTS: Overall, 15,374 patients were identified, including 5561 (36.2%) patients with EIN and obesity, and 9813 (63.8%) patients with uterine cancer and obesity. Weight-loss therapy was utilized within 1 year after diagnosis in 480 (8.6%) patients with EIN and in 802 (8.2%) patients with uterine cancer. Use of any weight-loss therapy after diagnosis of EIN increased from 4.1% in 2009 to 12.6% in 2020 (P < .001), and the use of any weight-loss therapy after diagnosis of uterine cancer increased from 4.9% in 2009 to 11.4% in 2020 (P < .001). In a multivariable regression model, younger age and patients with high comorbidity score were associated with a higher likelihood of using any weight-loss therapy. CONCLUSIONS: Use of weight-loss therapy has increased, however there is still a significant underuse of this adjunctive therapy in patients with obesity with EIN or uterine cancer.

Dermoid cyst management and outcomes: a review of over 1000 cases at a single institution.

BACKGROUND: Mature cystic teratomas represent nearly 60% of benign ovarian neoplasms across all age groups. OBJECTIVE: This study aimed to update existing descriptive studies of ovarian teratomas, including the epidemiology, rate of torsion or malignancy, and treatment modalities in a large modern cohort of patients. STUDY DESIGN: This was a retrospective cross-sectional study of all pathology-confirmed cases of ovarian teratoma that underwent surgery at 1 tertiary care institution from 2004 to 2015. Patient demographics, ovarian cyst characteristics, surgical approach and timing, rate of spillage, and surgical complications were examined. RESULTS: A total of 1054 cases of ovarian teratoma were identified during the study period. There were 113 cases (10.7%) of bilateral teratoma. The mean age at diagnosis was 38 years. The average cyst size was 6.26 cm. The overall rate of torsion was 5.6%, with a higher rate of torsion with increasing cyst size. More than 70% of cases were treated with minimally invasive surgery, which was associated with decreased perioperative complications but an increased risk of cyst spillage. Among 394 patients with cyst spillage, only 1 patient developed chemical peritonitis. The malignant transformation rate of mature cystic teratoma in this cohort was 1.1%. This cohort included 100 pregnant women with mature teratoma. Pregnant patients were more likely to have minimally invasive surgery in the first trimester of pregnancy and more likely to undergo laparotomy in the second or third trimester of pregnancy. CONCLUSION: Similar rates of bilaterality, torsion, malignant transformation, and struma ovarii in ovarian teratomas were found in this large modern cohort compared with previous literature. Most cases of ovarian teratoma can be managed laparoscopically, which is associated with a lower surgical complication rate. Despite the increased risk of cyst spillage with a minimally invasive approach, chemical peritonitis is a rare complication.

Fertility-sparing surgery vs standard surgery for early-stage cervical cancer: difference in 5-year life expectancy by tumor size.

BACKGROUND: Cervical cancer incidence among premenopausal women is rising, and fertility-sparing surgery serves as an important option for this young population. There is a lack of evidence on what tumor size cutoff should be used to define candidacy for fertility-sparing surgery. OBJECTIVE: We sought to describe how the association between fertility-sparing surgery (compared with standard surgery) and life expectancy varies by tumor size among patients with cervical cancers measuring ≤4 cm in largest diameter. Our secondary objective was to quantify the probability of undergoing adjuvant radiotherapy among patients who underwent fertility-sparing surgery as a function of tumor size. STUDY DESIGN: We identified patients in the National Cancer Database aged ≤45 years, diagnosed with stage I cervical cancer with tumors ≤4 cm between 2006 and 2018, who received no preoperative radiation or chemotherapy, and who underwent either fertility-sparing surgery (cone or trachelectomy, either simple or radical) or standard surgery (simple or radical hysterectomy) as their primary treatment. Propensity-score matching was performed to compare patients who underwent fertility-sparing surgery with those who underwent standard surgery. A flexible parametric model was employed to quantify the difference in life expectancy within 5 years of diagnosis (restricted mean survival time) based on tumor size among patients who underwent fertility-sparing and those who underwent standard surgery. In addition, among those who underwent fertility-sparing surgery, a logistic regression model was used to explore the relationship between tumor size and the probability of receiving adjuvant radiation. RESULTS: A total of 11,946 patients met the inclusion criteria of whom 904 (7.6%) underwent fertility-sparing surgery. After propensity-score matching, 897 patients who underwent fertility-sparing surgery were matched 1:1 with those who underwent standard surgery. Although the 5-year life expectancy was similar among patients who had fertility sparing surgery and those who had standard surgery regardless of tumor sizes, the estimates of life-expectancy differences associated with fertility-sparing surgery were more precise among patients with smaller tumors (1-cm tumor: restricted mean survival time difference, -0.10 months; 95% confidence interval, -0.67 to 0.47) than among those with larger tumors (4-cm tumor: restricted mean survival time difference, -0.11 months; 95% confidence interval, -3.79 to 3.57). The probability of receiving adjuvant radiation increased with tumor size, ranging from 5.6% (95% confidence interval, 3.9-7.9) for a 1-cm tumor to 37% (95% confidence interval, 24.3-51.8) for a 4-cm tumor. CONCLUSION: Within 5 years of diagnosis, young patients with stage I cancers measuring ≤4 cm had similar survival outcomes after either fertility-sparing surgery or standard surgery. However, because few patients with tumors >2 cm underwent fertility-sparing surgery, a clinically important survival difference could not be excluded in this population.

Minimally invasive interval cytoreductive surgery for advanced ovarian cancer.

With the increasing use of neoadjuvant chemotherapy, it has also become apparent that some patients will require a less extensive interval cytoreductive surgery which could be performed as a minimally invasive procedure. This observation, and expertise with minimally invasive surgery for other indications in gynecologic oncology, has driven surgeons in the United States and other countries to perform an increasing portion of interval cytoreductive surgery using minimally invasive techniques. Further observational and trial data will continue to inform which patients are best suited for this approach.

Patterns of use of primary and first-line chemotherapy for recurrence among patients with cervical cancer.

BACKGROUND: Little is known about real-world patterns of chemotherapy use in patients with cervical cancer. OBJECTIVE: To examine the patterns of chemotherapy use in patients with cervical cancer METHODS: We identified patients with cervical cancer in the IBM MarketScan Database who underwent primary hysterectomy or radiation therapy between 2011 and 2020 and described their treatment in the primary setting and at first recurrence. RESULTS: We identified 5390 patients: 2667 (49.5%) underwent primary hysterectomy and 2723 (50.5%) primary radiotherapy. Among patients who underwent primary hysterectomy, 979 (36.7%) received adjuvant radiation, and 617 (23.1%) received primary chemotherapy. The most common chemotherapy regimens were single-agent platinum (51.7%), platinum combination therapy (42.9%), and non-platinum (3.4%). Among patients treated with primary radiation, 73.6% received primary/concurrent chemotherapy, either platinum alone (66.4% of those who received chemotherapy), platinum combinations (32.2%), or non-platinum (1.4%). The median duration of primary chemotherapy was 1.2 months. Therapy for recurrent cervical cancer was initiated in 959 patients. The most common regimens were platinum combination (63.9%), non-platinum cytotoxic agents (16.5%), single-agent platinum (14.9%), targeted therapy with bevacizumab (6.0%), and immunotherapy with pembrolizumab (3.2%). Overall, the proportion of patients treated with single-agent platinum therapy increased from 17.4% in 2011 to 32.1% in 2019, while platinum combinations decreased from 64.1% to 41.5% over the same years. Use of non-platinum agents increased from 18.5% in 2011 to 32.9% in 2018 and 26.4% in 2019. CONCLUSIONS: Platinum-based chemotherapy is the most commonly used therapy in patients with cervical cancer in the primary setting and at the time of recurrence. The rate of use of non-platinum agents at first recurrence has increased over time.

Racial and sociodemographic disparities in the use of targeted therapies in advanced ovarian cancer patients with Medicare.

OBJECTIVE: To describe sociodemographic and racial disparities in receipt of poly ADP-ribose polymerase inhibitors (PARPi) and bevacizumab among insured patients with ovarian cancer. METHODS: This retrospective study used the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to identify patients with advanced stage, high grade serous ovarian cancer diagnosed between 2010 and 2019. The primary outcome of interest was receipt of PARPi or bevacizumab at any time after diagnosis. χ2 tests were used to compare categorical variables. Factors independently associated with the receipt of PARPi and/or bevacizumab were identified using a multivariable logistic regression. RESULTS: The cohort included 6242 patients; 276 (4.4%) received PARPi, 2142 (34.3%) received bevacizumab, and 389 (6.2%) received both. Receipt of either targeted treatment increased over the study period. On univariate analysis, patients who received either targeted therapy were younger (63% vs 48% aged <75 years; p<0.001), had a lower comorbidity index (86% vs 80% Charlson Comorbidity Index 0-1; p<0.001), and higher socioeconomic status (74% vs 71% high socioeconomic status; p=0.047) compared with those who did not receive targeted therapy. In the multivariable model, non-Hispanic black patients were less likely than non-Hispanic white patients to receive either targeted therapy (odds ratio 0.77; 95% confidence interval 0.61 to 0.98; p=0.032). Older patients (aged >74 years) were also less likely to receive PARPi or bevacizumab compared with those aged 65-69 years (all p<0.001). CONCLUSION: Sociodemographic and racial disparities exist in receipt of PARPi and bevacizumab among patients with advanced ovarian cancer insured by Medicare. As targeted therapies become more commonly used, a widening disparity gap is likely.

Adjuvant external beam radiotherapy combined with brachytherapy for intermediate-risk cervical cancer.

OBJECTIVE: Patients with intermediate-risk cervical cancer receive external beam radiotherapy (EBRT) as adjuvant treatment. It is commonly administered with brachytherapy without proven benefits. Therefore, we evaluated the frequency of brachytherapy use, the doses for EBRT administered alone or with brachytherapy, and the overall survival impact of brachytherapy in patients with intermediate-risk, early-stage cervical cancer. METHODS: This retrospective cohort study was performed using data collected from the National Cancer Database. Patients diagnosed with cervical cancer from 2004 to 2019 who underwent a radical hysterectomy and lymph node staging and had disease limited to the cervix but with tumors larger than 4 cm or ranging from 2 to 4 cm with lymphovascular space invasion (LVSI) were included. Patients with distant metastasis or parametrial involvement were excluded. Patients who underwent EBRT alone were compared with those who also received brachytherapy after 2:1 propensity score matching. RESULTS: In total, 1174 patients met the inclusion criteria, and 26.7% of them received brachytherapy. After 2:1 propensity score matching, we included 620 patients in the EBRT group and 312 in the combination treatment group. Patients who received brachytherapy had higher equivalent doses than those only receiving EBRT. Overall survival did not differ between the two groups (hazard ratio (HR) 0.88 (95% confidence interval (CI), 0.62 to 1.23]; p=0.45). After stratification according to tumor histology, LVSI, and surgical approach, brachytherapy was not associated with improved overall survival. However, in patients who did not receive concomitant chemotherapy, the overall survival rate for those receiving EBRT and brachytherapy was significantly higher than that for those receiving EBRT alone (HR, 0.48 (95% CI, 0.27 to 0.86]; p=0.011). CONCLUSION: About one-fourth of the study patients received brachytherapy and EBRT. The variability in the doses and radiotherapy techniques used highlights treatment heterogeneity. Overall survival did not differ for EBRT with and without brachytherapy. However, overall survival was longer for patients who received brachytherapy but did not receive concomitant chemotherapy.

Secondary databases in gynecologic cancer research.

Observational and cohort studies using large databases have made important contributions to gynecologic oncology. Knowledge of the advantages and potential limitations of commonly used databases benefits both readers and reviewers. In this review, researchers familiar with National Cancer Database (NCDB), Surveillance, Epidemiology, and End Results Program (SEER), SEER-Medicare, MarketScan, Healthcare Cost and Utilization Project (HCUP), National Surgical Quality Improvement Program (NSQIP), and Premier, describe each database, its included data, access, management, storage, highlights, and limitations. A better understanding of these commonly used datasets can help readers, reviewers, and researchers to more effectively interpret and apply study results, evaluate new research studies, and develop compelling and practice-changing research.

Opportunistic Salpingectomy at the Time of Laparoscopic Cholecystectomy for Ovarian Cancer Prevention: A Cost-effectiveness Analysis.

OBJECTIVE: To perform a cost-effectiveness analysis to examine the utility and effectiveness of OS performed at the time of elective cholecystectomy [laparoscopic cholecystectomy (LAP-CHOL)]. SUMMARY BACKGROUND DATA: OS has been adopted as a strategy to reduce the risk of ovarian cancer in women undergoing hysterectomy and tubal sterilization, although the procedure is rarely performed as a risk reducing strategy during other abdominopelvic procedures. METHODS: A decision model was created to examine women 40, 50, and 60 years of age undergoing LAP-CHOL with or without OS. The lifetime risk of ovarian cancer was assumed to be 1.17%, 1.09%, and 0.92% for women age 40, 50, and 60 years, respectively. OS was estimated to provide a 65% reduction in the risk of ovarian cancer and to require 30 additional minutes of operative time. We estimated the cost, quality-adjusted life-years, ovarian cancer cases and deaths prevented with OS. RESULTS: The additional cost of OS at LAP-CHOL ranged from $1898 to 1978. In a cohort of 5000 women, OS reduced the number of ovarian cancer cases by 39, 36, and 30 cases and deaths by 12, 14, and 16 in the age 40-, 50-, and 60-year-old cohorts, respectively. OS during LAP-CHOL was cost-effective, with incremental cost-effectiveness ratio of $11,162 to 26,463 in the 3 age models. In a probabilistic sensitivity analysis, incremental cost-effectiveness ratio for OS were less than $100,000 per quality-adjusted life-years in 90.5% or more of 1000 simulations. CONCLUSIONS: OS at the time of LAP-CHOL may be a cost-effective strategy to prevent ovarian cancer among average risk women.

All-cause and cancer-specific mortality after fertility-sparing surgery for stage IA and IC epithelial ovarian cancer.

OBJECTIVE: To compare all-cause and cancer-specific mortality between women who underwent fertility-sparing surgery (FSS) versus standard surgery for stage IA and IC epithelial ovarian cancer. METHODS: Reproductive aged patients (18-45) with stage IA or IC epithelial ovarian cancer diagnosed between 2000 and 2015 were identified in the California Cancer Registry. FSS was defined as retention of the contralateral ovary and the uterus, and standard surgery included at least removal of both ovaries and the uterus. The primary outcome was all-cause mortality and the secondary outcome was cancer-specific mortality. Inverse probability of treatment weighting (IPTW) was used to create two groups balanced on covariates of interest. The Kaplan-Meier method and Cox proportional hazards analysis were used to model survival outcomes. RESULTS: Among 1119 women who met inclusion criteria, 390 (34.9%) underwent FSS. IPTW yielded a balanced cohort of 394 women who underwent FSS and 723 women who underwent standard surgery. Among patients who underwent FSS, there were 45 deaths corresponding to an 85.4% (95% confidence interval [CI] 0.79-0.92) 10-year all-cause survival probability, compared to 81 deaths and 86.4% 10-year all-cause survival probability (95% CI 0.83-0.90) among patients who underwent standard surgery. FSS was not associated with increased all-cause mortality (HR 1.04, 95% CI 0.72-1.49) or cancer-specific mortality (HR 1.50, 95%CI 0.97-2.31). CONCLUSIONS: Among reproductive-aged patients with early-stage epithelial ovarian cancer fertility-sparing surgery was not associated with an increased risk of death compared to standard surgery.

Patterns of cervical cancer screening follow-up in the era of prolonged screening intervals.

INTRODUCTION: Little is known as to how prolonged screening recommendations for cervical cancer have affected compliance. OBJECTIVE: We examined compliance with repeat cervical cancer screening among U.S. women aged 30-64 who underwent index screening between 2013 and 2019. STUDY DESIGN: The IBM Watson Health MarketScan Database was used to identify commercially-insured women 30-64 years old who underwent cervical cancer screening from 2013 to 2019. The cohort was limited to women with continuous insurance 12 months before and ≥ 2 months after index testing. Patients with prior hysterectomy, more frequent surveillance needs, or a history of abnormal cytology, histology, or HPV test were excluded. Index screening included cytology, co-testing, or primary HPV testing. Cumulative incidence curves described screening intervals. Compliance was considered if repeat screening occurred 2.5-4 years after index cytology and 4.5-6 years after index co-testing. Cause-specific hazard models examined factors associated with compliance. RESULTS: Of 5,368,713 patients identified, co-testing was performed in 2,873,070 (53.5%), cytology in 2,422,480 (45.1%), and primary HPV testing in 73,163 (1.4%). The cumulative incidence of repeat screening among all women by seven years was 81.9%. Of those who underwent repeat screening, 85.7% with index cytology and 96.6% with index co-testing were rescreened early. Only, 12.2% with index cytology had appropriate rescreening and 2.1% had delayed rescreening. Among the index co-testing group, 3.2% had appropriate rescreening and 0.3% had delayed rescreening. CONCLUSION: Appropriate cervical cancer follow-up screening is highly variable. The cumulative incidence rate of repeat screening was 81.9% and among women rescreened, the vast majority are tested earlier than recommended by current guidelines.

Minimally invasive interval debulking surgery for advanced ovarian cancer after neoadjuvant chemotherapy.

OBJECTIVE: Assess outcomes of interval debulking surgery (IDS) after neoadjuvant chemotherapy via minimally invasive surgery (MIS) compared with laparotomy in patients with advanced epithelial ovarian cancer. METHODS: Patients diagnosed with stage IIIC or IV epithelial ovarian cancer between 2013 and 2018 who received neoadjuvant chemotherapy and IDS were identified in the National Cancer Database. Primary outcome was overall survival. Secondary outcomes were 5-year survival, 30- and 90-day postoperative mortality, extent of surgery, residual disease, hospitalization duration, surgical conversions, and unplanned readmissions. Propensity score matching was used to compare MIS and laparotomy for IDS. Association of treatment approach with overall survival was assessed using Kaplan-Meier method and Cox regression. Sensitivity analysis was conducted for effect of unmeasured confounders. RESULTS: A total of 7897 patients met inclusion criteria; 2021 (25.6%) underwent MIS. Percentage undergoing MIS increased from 20.3%-29.0% over the study period. After propensity score matching, median overall survival was 46.7 months in the MIS group versus 41.0 months in the laparotomy group [hazard ratio (HR) 0.86 (95%CI 0.79-0.94)]. Five-year survival probability was higher in MIS versus laparotomy (38.3% vs 34.8%, p < 0.01). There was lower 30- and 90-day mortality (0.3% vs 0.7% [p = 0.04] and 1.4% vs 2.5% [p = 0.01], respectively), shorter length of stay (median 3 vs 5 days, p < 0.01), lower residual disease (23.9% vs 26.7%, p < 0.01), and lower additional cytoreductive procedures (59.3% vs 70.8%, p < 0.01) in MIS compared to laparotomy, with similar rates of unplanned readmission (2.7% vs 3.1%, p = 0.39). CONCLUSIONS: Patients who undergo IDS by MIS have similar overall survival and decreased morbidity compared with laparotomy.

Association of hospital-level factors with utilization of sentinel lymph node biopsy in patients with early-stage vulvar cancer.

OBJECTIVE: To evaluate utilization of sentinel lymph node biopsy (SLNB) for early-stage vulvar cancer at minority-serving hospitals and low-volume facilities. METHODS: Between 2012-2018, individuals with T1b vulvar squamous cell carcinoma were identified using the National Cancer Database. Patient, facility, and disease characteristics were compared between patients undergoing SLNB or inguinofemoral lymph node dissection (IFLD). Multivariable logistic regression, adjusted for patient, facility, and disease characteristics, was used to evaluate factors associated with SLNB. Kaplan-Meier survival analysis using log rank test and Cox regression was performed. RESULTS: Of the 3,532 patients, 2,406 (68.1%) underwent lymph node evaluation, with 1,704 (48.2%) undergoing IFLD and 702 (19.8%) SLNB. In a multivariable analysis, treatment at minority-serving hospitals (OR 0.39, 95% CI 0.19-0.78) and low-volume hospitals (OR 0.44, 95% CI 0.28-0.70) were associated with significantly lower odds of undergoing SLNB compared to receiving care at non-minority-serving and high-volume hospitals, respectively. While SLNB utilization increased over time for the entire cohort and stratified subgroups, use of the procedure did not increase at minority-serving hospitals. After controlling for patient and tumor characteristics, SLNB was not associated with worse OS compared to IFLD in patients with positive (HR 1.02, 95% CI 0.63-1.66) or negative (HR 0.92, 95% CI 0.70-1.21) nodal pathology. CONCLUSIONS: For patients with early-stage vulvar cancer, treatment at minority-serving or low-volume hospitals was associated with significantly decreased odds of undergoing SLNB. Future efforts should be concentrated toward ensuring that all patients have access to advanced surgical techniques regardless of where they receive their care.

Heterogeneity of outcomes of endometrial cancer patients included in prospective clinical trials.

OBJECTIVE: To assess heterogeneity in five-year overall survival of patients with endometrial cancer using a large retrospective database with cohorts defined by recent prospective clinical trials. METHODS: The National Cancer Database was used to identify patients with endometrial cancer who underwent hysterectomy from 2004 to 2016. The reported inclusion criteria for GOG-249, PORTEC-3, and GOG-258 were used to define the respective cohorts. Five-year overall survival for each cohort was stratified by tumor characteristics and adjuvant therapy regimens. RESULTS: A total of 89,133 patients were identified who would have fulfilled the entry criteria to GOG-249, PORTEC-3, or GOG-258. When stratified by tumor characteristics, irrespective of adjuvant therapy, five-year overall survival ranged from 59.9%-81.7% for patients meeting GOG-249 inclusion criteria, 40.2%-81.8% for patients meeting PORTEC-3 inclusion criteria, and 17.5%-75.0% for those meeting GOG-258 inclusion criteria. Analysis of subgroups by adjuvant therapy regimen revealed significant improvement in five-year overall survival for chemoradiotherapy compared to chemotherapy or radiotherapy alone for endometroid stage III and stage IVA disease and for some stages of serous and clear cell histology. CONCLUSIONS: Recent prospective trials of adjuvant therapy for endometrial cancer have included heterogeneous cohorts of patients based on five-year overall survival rates when the populations are stratified by tumor characteristics. The variation in expected five-year overall survival for subsets of patients may result in underpowered studies or misleading results.

Trends in the use of neoadjuvant chemotherapy for low-grade serous ovarian cancer in the United States.

OBJECTIVE: To describe trends in neoadjuvant chemotherapy (NACT) use for low-grade serous ovarian carcinoma (LGSOC) and to quantify associations between NACT and extent of cytoreductive surgery. METHODS: We identified women treated for stage III or IV serous ovarian cancer in a Commission on Cancer accredited program between January 2004-December 2020. Regression models were developed to evaluate trends in NACT use for LGSOC, to identify factors associated with receipt of NACT, and to quantify associations between NACT and bowel or urinary resection at the time of surgery. Demographic and clinical factors were used for confounder control. RESULTS: We observed 3350 patients who received treatment for LGSOC during the study period. The proportion of patients who received NACT increased from 9.5% in 2004 to 25.9% in 2020, corresponding to an annual percent change of 7.2% (95% CI 5.6-8.9). Increasing age (rate ratio (RR) 1.15; 95% CI 1.07-1.24), and stage IV disease (RR 2.66; 95% CI 2.31-3.07) were associated with a higher likelihood of receiving NACT. For patients with high-grade disease, NACT was associated with a decrease in likelihood of bowel or urinary surgery (35.3% versus 23.9%; RR 0.68, 95% CI 0.65-0.71). For LGSOC, NACT was associated with a higher likelihood of these procedures (26.6% versus 32.2%; RR 1.24, 95% CI 1.08-1.42). CONCLUSION: NACT use among patients with LGSOC has increased from 2004 to 2020. While NACT was associated with a lower rate of gastrointestinal and urinary surgery among patients with high-grade disease, patients with LGSOC receiving NACT were more likely to undergo these procedures.

Diagnostic accuracy of sentinel lymph node frozen section analysis in patients with early-stage cervical cancer: A systematic review and meta-analysis.

OBJECTIVE: To assess the diagnostic accuracy of intraoperative SLN frozen section analysis compared with ultrastaging in patients with early-stage cervical cancer. METHODS: A systematic literature review was conducted following the PRISMA checklist. MEDLINE (via Ovid), Embase, and the Cochrane Central Register of Controlled Trials were searched from inception until February 2023. The inclusion criteria were patients with early-stage cervical cancer (2018 FIGO stage I-II), consisting of the histological subtype squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (≥90% of the patients in each study), who underwent SLN detection (with any tracer) and intraoperative frozen section followed by SLN ultrastaging. Randomized controlled trials, prospective and retrospective observational studies were considered. The detection rates and measures of diagnostic accuracy were pooled using a random effects univariate model. A preplanned subgroup meta-analysis was conducted, with isolated tumor cells excluded as positive lymph nodes. The review was registered in PROSPERO (CRD42023397147). RESULTS: The search identified 190 articles, with 153 studies considered potentially eligible after removing duplicates. Fourteen studies met the selection criteria, including a total of 1720 patients. Seven studies were retrospective, and the other seven were prospective. Frozen section analysis detected 159 of 292 (54.5%) patients with lymph node metastases. In 281 patients the type of volume metastasis was reported: 1 of 41 (2.4%) patients had isolated tumor cells, 21 of 78 (26.9%) patients had micrometastases, and 133 of 162 (82.1%) patients had macrometastases. The pooled sensitivity of intraoperative SLN frozen section analysis was 65% (95% CI, 51-77%) for macrometastases, micrometastases, and isolated tumor cells. When we excluded patients with isolated tumor cells, the pooled sensitivity increased to 72% (95% CI, 60-82%). CONCLUSION: SLN frozen section detects 65% of lymph node metastases compared with SLN ultrastaging and may prevent unnecessary radical surgery in some patients with early-stage cervical cancer.