Scalp hypothermia to reduce chemotherapy-induced alopecia: A systematic review and meta-analysis.

BACKGROUND: Chemotherapy-induced alopecia (CIA) is a common and emotionally-taxing side effect of chemotherapy, including taxane agents used frequently in treatment of gynecologic cancers. Scalp hypothermia, also known as "cold caps", is a possible method to prevent severe CIA, studied primarily in the breast cancer population. OBJECTIVES: To compile existing data on scalp hypothermia in cancer patients receiving taxane chemotherapy in order to investigate its application to the gynecologic cancer population. SEARCH STRATEGY: MEDLINE, Embase, CINAHL, ClinicalTrials.gov, and Cochrane were searched through January 31, 2023. SELECTION CRITERIA: Full-text manuscripts reporting on the results of scalp hypothermia in patients receiving taxane-based chemotherapy. DATA COLLECTION AND ANALYSIS: Binomial proportions were summed, and random-effects meta-analyses performed. MAIN RESULTS: From 1424 records, we included 31 studies, representing 14 different countries. Only 5 studies included gynecologic cancer patients. We extracted the outcome of the proportion of patients with <50% hair loss. Among 2179 included patients, 60.7% were reported to have <50% hair loss (meta-analysis: 60.6%, 95% confidence interval [CI] 54.9-66.1%). Among the 28 studies reporting only on taxane-based chemotherapy, the rate of <50% hair loss was 60.0% (meta-analysis: 60.9%, (95% CI: 54.9-66.7%). In comparative studies, hair loss was significantly less in patients who received scalp hypothermia versus those who did not (49.3% versus 0% with <50% hair loss; OR 40.3, 95% CI: 10.5-154.8). Scalp cooling achieved <50% hair loss in patients receiving paclitaxel (67.7%; meta-analysis 69.9%, 95% CI 64.1-75.4%) and docetaxel (57.1%; meta-analysis 60.5%, 95% CI 50.0-71.6%). Meta-analysis on patient satisfaction in regard to scalp cooling found a satisfaction rate of 78.9% (95% CI 69.1-87.4%). CONCLUSION: Scalp hypothermia may be an effective method to reduce some cases of CIA due to taxane chemotherapy, especially paclitaxel. More trials need to be done to determine the precise effects of scalp hypothermia in gynecologic cancer patients.

Catastrophic health expenditures, insurance churn, and non-employment among women with breast cancer.

BACKGROUND: Breast cancer treatment and survivorship entails a complex and expensive continuum of subspecialty care. Our objectives were to assess catastrophic health expenditures, insurance churn, and non-employment among women younger than 65 years who reported a diagnosis of breast cancer. We also evaluated changes in these outcomes related to implementation of the Affordable Care Act. METHODS: The data source for this study was the Medical Expenditure Panel Survey (2005-2019), which is a national annual cross-sectional survey of families, providers, and insurers in the United States. To assess the impact of breast cancer, comparisons were made with a matched cohort of women without cancer. We estimated predicted marginal probabilities to quantify the effects of covariates in models for catastrophic health expenditures, insurance churn, and non-employment. RESULTS: We identified 1490 respondents younger than 65 years who received care related to breast cancer during the study period, representing a weight-adjusted annual mean of 1 062 129 patients. Approximately 31.8% of women with breast cancer reported health expenditures in excess of 10% of their annual income. In models, the proportion of women with breast cancer who experienced catastrophic health expenditures and non-employment was inversely related to increasing income. During Affordable Care Act implementation, mean number of months of uninsurance decreased and expenditures increased among breast cancer patients. CONCLUSIONS: Our study underscores the impact of breast cancer on financial security and opportunities for patients and their families. A multilevel understanding of these issues is needed to design effective and equitable strategies to improve quality of life and survivorship.

Efficacy of cyclin-dependent kinase 4/6 inhibitors in combination with hormonal therapy in patients with recurrent granulosa cell tumor of the ovary: A case series.

Cyclin-dependent kinase inhibitors are approved in combination with hormonal therapy for treatment of hormone receptor expressing breast cancers. Activity in hormone receptor expressing gynecologic cancers has been postulated. Granulosa cell tumor of the ovary is one such cancer, which is relatively resistant to traditional cytotoxic chemotherapy. We report a case series of 7 heavily pre-treated patients with recurrent granulosa cell tumor of the ovary with a cyclin-dependent kinase inhibitor in combination with hormonal therapy, with 3 patients demonstrating partial response and 2 with stable disease. As of the data cutoff, 3 patients remained on treatment and 5 were alive, with true medians for duration of treatment and overall survival not reached (medians at data cutoff of 64 weeks and 62 months respectively). The treatment was generally well tolerated, with 1 patient choosing to discontinue treatment due to grade 3 fatigue. This regimen represents a possible option in the treatment of granulosa cell tumor of the ovary, warranting further prospective study for this unmet need in this indolent disease which often requires many lines of treatment.

Geographic variation in the rate and route of hysterectomy for benign disease in the USA: A retrospective cross-sectional study.

OBJECTIVES: To describe population rate of hysterectomy for benign disease in the USA, including geographic variation across states and Hospital Service Areas (HSAs; areas defined by common patient flows to healthcare facilities). DESIGN: Cross-sectional study. SETTING: Four US states including 322 HSAs. POPULATION: A total of 316 052 cases of hysterectomy from 2012 to 2016. METHODS: We compiled annual hysterectomy cases, merged female populations, and adjusted for reported rates of previous hysterectomy. We assessed small-area variation and created multi-level Poisson regression models. MAIN OUTCOME MEASURES: Prior-hysterectomy-adjusted population rates of hysterectomy for benign disease. RESULTS: The annual population rate of hysterectomy for benign disease was 49 per 10 000 hysterectomy-eligible residents, declining slightly over time, mostly among reproductive-age populations. Rates peaked among residents ages 40-49 years, and declined with increasing age, apart from an increase with universal coverage at age 65 years. We found large differences in age-standardised population rates of hysterectomy across states (range 42.2-69.0), and HSAs (range: overall 12.9-106.3; 25th-75th percentile 44.0-64.9). Among the non-elderly population, those with government-sponsored insurance had greater variation than those with private insurance (coefficient of variation 0.61 versus 0.32). Proportions of minimally invasive procedures were similar across states (71.0-74.8%) but varied greatly across HSAs (27-96%). In regression models, HSA population characteristics explained 31.8% of observed variation in annual rates. Higher local proportions of government-sponsored insurance and non-White race were associated with lower population rates. CONCLUSIONS: We found substantial variation in rate and route of hysterectomy for benign disease in the USA. Local population characteristics explained less than one-third of observed variation.

Treatments and outcomes in high-risk gestational trophoblastic neoplasia: A systematic review and meta-analysis.

BACKGROUND: High-risk gestational trophoblastic neoplasia (GTN) is rare and treated with diverse approaches. Limited published institutional data has yet to be systematically reviewed. OBJECTIVES: To compile global high-risk GTN (prognostic score ≥7) cohorts to summarise treatments and outcomes by disease characteristics and primary chemotherapy. SEARCH STRATEGY: MEDLINE, Embase, Scopus, ClinicalTrials.gov and Cochrane were searched through March 2021. SELECTION CRITERIA: Full-text manuscripts reporting mortality among ≥10 high-risk GTN patients. DATA COLLECTION AND ANALYSIS: Binomial proportions were summed, and random-effects meta-analyses performed. MAIN RESULTS: From 1137 records, we included 35 studies, representing 20 countries. Among 2276 unique high-risk GTN patients, 99.7% received chemotherapy, 35.8% surgery and 4.9% radiation. Mortality was 10.9% (243/2236; meta-analysis: 10%, 95% confidence interval [CI] 7-12%) and likelihood of complete response to primary chemotherapy was 79.7% (1506/1890; meta-analysis: 78%, 95% CI: 74-83%). Across 24 reporting studies, modern preferred chemotherapy (EMA/CO or EMA/EP) was associated with lower mortality (overall: 8.8 versus 9.5%; comparative meta-analysis: 8.1 versus 12.4%, OR 0.42, 95% CI: 0.20-0.90%, 14 studies) and higher likelihood of complete response (overall: 76.6 versus 72.8%; comparative meta-analysis: 75.9 versus 60.7%, OR 2.98, 95% CI: 1.06-8.35%, 14 studies), though studies focused on non-preferred regimens reported comparable outcomes. Mortality was increased for ultra-high-risk disease (30 versus 7.5% high-risk; meta-analysis OR 7.44, 95% CI: 4.29-12.9%) and disease following term delivery (20.8 versus 7.3% following molar pregnancy; meta-analysis OR 2.64, 95% CI: 1.10-6.31%). Relapse rate estimates ranged from 3 to 6%. CONCLUSIONS: High-risk GTN is responsive to several chemotherapy regimens, with EMA/CO or EMA/EP associated with improved outcomes. Mortality is increased in patients with ultra-high-risk, relapsed and post-term pregnancy disease.

BAP1 Tumor Predisposition Syndrome Presenting as a Recurrent Ovarian Sex Cord-Stromal Tumor.

The BRCA1-associated protein 1 ( BAP1 ) gene encodes a tumor suppressor that functions as a ubiquitin hydrolase involved in DNA damage repair. BAP1 germline mutations are associated with increased risk of multiple solid malignancies, including mesothelioma, uveal melanoma, renal cell carcinoma, and high-grade rhabdoid meningiomas. Here, we describe the case of a 52-yr-old woman who experienced multiple abdominal recurrences of an ovarian sex cord-stromal tumor that was originally diagnosed at age 25 and who was found to have a germline mutation in BAP1 and a family history consistent with BAP1 tumor predisposition syndrome. Recurrence of the sex cord-stromal tumor demonstrated loss of BAP1 expression by immunohistochemistry. Although ovarian sex cord-stromal tumors have been described in mouse models of BAP1 tumor predisposition syndrome, this relationship has not been previously described in humans and warrants further investigation. The case presentation, tumor morphology, and immunohistochemical findings have overlapping characteristics with peritoneal mesotheliomas, and this case represents a potential pitfall for surgical pathologists.

Catastrophic Health Expenditures With Pregnancy and Delivery in the United States.

OBJECTIVE: To describe prevalence, trends, and risk factors for catastrophic health expenditures in the year of delivery among birth parents (delivering people). METHODS: We conducted a retrospective, cross-sectional study of the Medical Expenditure Panel Survey from 2008-2016. We identified newborn birth parents and a 2:1 nearest-neighbor propensity-matched control cohort of nonpregnant reproductive-aged individuals, then assessed for catastrophic health expenditures (spending greater than 10% of family income) in the delivery year. We applied survey weights to extrapolate to the noninstitutionalized U.S. population and used the adjusted Wald test for significance testing. We compared risk of catastrophic health expenditures between birth parents and the control cohort and described time trends and risk factors for catastrophic spending with subgroup comparisons. RESULTS: We analyzed 4,056 birth parents and 7,996 reproductive-aged females without pregnancy in a given year. Birth parents reported higher rates of unemployment (52.6% vs 46.6%, P<.001), and high rates of gaining (22.4%) and losing (25.6%) Medicaid in the delivery year. Birth parents were at higher risk of catastrophic health expenditures (excluding premiums: 9.2% vs 6.8%, odds ratio [OR] 1.95, 95% CI 1.61-2.34; including premiums: 21.3% vs 18.4%, OR 1.53, 95% CI 1.32-1.82). Birth parents living on low incomes had the highest risk of catastrophic health expenditures (18.8% vs 0.7% excluding premiums for 138% or less vs greater than 400% of the federal poverty level, relative risk [RR] 26.9; 29.8% vs 5.9% including premiums, RR 5.1). For birth parents living at low incomes, public insurance was associated with lower risks of catastrophic health expenditures than private insurance, particularly when including premium spending (incomes 138% of the federal poverty level or lower: 18.8% public vs 67.9% private, RR 0.28; incomes 139-250% of the federal poverty level: 6.5% public vs 41.1% private, RR 0.16). The risk of catastrophic spending for birth parents did not change significantly over time from before to after Affordable Care Act implementation. CONCLUSION: Pregnancy and delivery are associated with increased risk of catastrophic health expenditures in the delivery year. Medicaid and public coverage were more protective from high out-of-pocket costs than private insurance, particularly among low-income families.

Catastrophic health expenditures, insurance churn, and nonemployment among gynecologic cancer patients in the United States.

BACKGROUND: In recent years, there has been growing recognition of the financial burden of severe illness, including associations with higher rates of nonemployment, uninsurance, and catastrophic out-of-pocket health spending. Patients with gynecologic cancer often require expensive and prolonged treatments, potentially disrupting employment and insurance coverage access, and putting patients and their families at risk for catastrophic health expenditures. OBJECTIVE: This study aimed to describe the prevalence of insurance churn, nonemployment, and catastrophic health expenditures among nonelderly patients with gynecologic cancer in the United States, to compare within subgroups and to other populations and assess for changes associated with the Affordable Care Act. STUDY DESIGN: We identified respondents aged 18 to 64 years from the Medical Expenditure Panel Survey, 2006 to 2017, who reported care related to gynecologic cancer in a given year, and a propensity-matched cohort of patients without cancer and patients with cancers of other sites, as comparison groups. We applied survey weights to extrapolate to the US population, and we described patterns of insurance churn (any uninsurance or insurance loss or change), catastrophic health expenditures (>10% annual family income), and nonemployment. Characteristics and outcomes between groups were compared with the adjusted Wald test. RESULTS: We identified 683 respondents reporting care related to a gynecologic cancer diagnosis from 2006 to 2017, representing an estimated annual population of 532,400 patients (95% confidence interval, 462,000-502,700). More than 64% of patients reported at least 1 of 3 primary negative outcomes of any uninsurance, part-year nonemployment, and catastrophic health expenditures, with 22.4% reporting at least 2 of 3 outcomes. Catastrophic health spending was uncommon without nonemployment or uninsurance reported during that year (1.2% of the population). Compared with patients with other cancers, patients with gynecologic cancer were younger and more likely with low education and low family income (≤250% federal poverty level). They reported higher annual risks of insurance loss (8.8% vs 4.8%; P=.03), any uninsurance (22.6% vs 14.0%; P=.002), and part-year nonemployment (55.3% vs 44.6%; P=.005) but similar risks of catastrophic spending (12.6% vs 12.2%; P=.84). Patients with gynecologic cancer from low-income families faced a higher risk of catastrophic expenditures than those of higher icomes (24.4% vs 2.9%; P<.001). Among the patients from low-income families, Medicaid coverage was associated with a lower risk of catastrophic spending than private insurance. After the Affordable Care Act implementation, we observed reductions in the risk of uninsurance, but there was no significant change in the risk of catastrophic spending among patients with gynecologic cancer. CONCLUSION: Patients with gynecologic cancer faced high risks of uninsurance, nonemployment, and catastrophic health expenditures, particularly among patients from low-income families. Catastrophic spending was uncommon in the absence of either nonemployment or uninsurance in a given year.

Out-of-network bills among privately insured patients undergoing hysterectomy.

BACKGROUND: In recent years, the issue of out-of-network billing for privately insured patients has been highlighted as a source of unexpected out-of-pocket charges for patients, even in the setting of an in-network primary surgeon. The Congress recently passed the No Surprises Act to curtail these practices. However, the new law contains exceptions, and its regulatory system has yet to be established. As one of the most frequently performed major surgical procedures, hysterectomy represents a significant exposure to out-of-network bills among nonelderly females in the United States. OBJECTIVE: To describe the extent and nature of out-of-network bills at the time of hysterectomy among privately insured patients in the context of the recently passed No Surprises Act. STUDY DESIGN: We performed a retrospective cohort study of women aged 18 to 64 years who underwent simple hysterectomy from 2008 to 2018 with an in-network primary surgeon in the IBM Watson Marketscan claims database, which includes data from over 350 different payers. We identified out-of-network claims for facility or professional services and analyzed the frequency, size, and source of the payments. We used multivariable logistic regression to assess for patient, procedure, and facility characteristics associated with the risk of out-of-network claims. RESULTS: We identified 585,223 hysterectomy cases meeting all the inclusion criteria, and they were evenly split between inpatient (49.6%) and outpatient (50.4%) procedures. Overall, 8.8% of cases included at least 1 out-of-network claim, with median out-of-network expenditures of $553 for inpatient procedures and $438 for outpatient procedures. Compared with professional out-of-network claims, facility out-of-network claims were less common (2.3% vs 7.4%) but far greater in the amount billed (median $8,307 vs $400 inpatient, $3,281 vs $407 outpatient). Among the professional claims, those from midlevel surgical assistants were most frequently out-of-network when present (13.8% inpatient; 20.0% outpatient), whereas out-of-network claims from anesthesia were most common overall and largest (median $890 inpatient, $1,021 outpatient) when present. In a multivariable model, older age, increasing comorbidity, and complications during the stay were associated with higher odds of any out-of-network claim. In contrast, the risk of facility out-of-network claims was more strongly associated with the facility region and the surgical approach, with the highest odds for cases in the North Central region and those using robotic approach. CONCLUSION: Out-of-network bills for privately insured patients at the time of hysterectomy occurred in 8.8% of cases. Approximately one-quarter of these included out-of-network facility claims tended to have higher payments than out-of-network professional claims and may not be prevented by the No Surprises Act. Gynecologic surgeons should be aware of the potential out-of-network charges for ancillary services at the time of surgery, particularly the network status of the facility, to provide maximal transparency and financial protection to our patients.

Employment outcomes among cancer patients in the United States.

BACKGROUND: Cancer diagnosis and treatment can lead to disruptions in employment, which can, in turn, lead to financial problems and uninsurance. We used a nationally representative survey to describe predictors of non-employment among cancer patients compared to a matched cohort of individuals without cancer. METHODS: This was a retrospective study of the 2005-2018 nationally representative Medical Expenditure Panel Survey. We included respondents aged 18-64 and identified the cohort with current cancer by healthcare utilization related to a cancer diagnosis in the given year. We propensity-score matched controls to cancer cases in a 2:1 ratio. Survey weights were applied to generate national estimates of non-employment among the study cohort compared to the overall U.S. POPULATION: The Adjusted Wald test was used to compare employment outcomes between groups. Weighted multivariable linear regression was utilized to assess factors independently associated with non-employment. RESULTS: An estimated annual mean of 3.9 million cancer patients in the U.S. were included. Relative to controls, cancer patients had higher rates of part-year (36.0% vs 28.3%, P < 0.0001) and full-year non-employment (22.7% vs 17.5%, P < 0.0001). In a multivariable model, cancer diagnosis was associated with a 6.8% higher risk of part-year non-employment, 4.1% higher risk of full-year non-employment, and 14.8% lower individual earnings relative to the matched U.S. POPULATION: Sub-groups of cancer patients at high risk of negative employment outcomes included those enrolled in Medicaid, those without a high school degree, and those with high healthcare utilization. Low family income was the strongest predictor of non-employment. CONCLUSION: Cancer patients were at greater risk of non-employment relative to matched controls and adverse employment outcomes disproportionately affected cancer patients from vulnerable populations.

Adjuvant treatment and outcomes for patients with stage IIIA grade 1 endometrioid endometrial cancer.

OBJECTIVE: The role and type of adjuvant therapy for patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIA grade 1 endometrioid endometrial adenocarcinoma are controversial. This retrospective cohort study aimed to determine associations between adjuvant therapy use and survival among patients with stage IIIA grade 1 endometrial cancer. METHODS: Patients who underwent primary surgery for stage IIIA (FIGO 2009 staging) grade 1 endometrial cancer between January 2004 and December 2016 were identified in the National Cancer Database. Demographics and receipt of adjuvant therapy were compared. Overall survival was analyzed using Kaplan-Meier curves, log-rank test, and multivariable Cox proportional hazard models. RESULTS: Of 1120 patients, 248 (22.1%) received no adjuvant treatment, 286 (25.5%) received chemotherapy alone, 201 (18.0%) radiation alone, and 385 (34.4%) chemotherapy and radiation. Five-year overall survival rate was 83.0% (95% CI 80.1% to 85.6%). Older age, increasing comorbidity count, and lymphovascular space invasion status were significant negative predictors of survival. Over time, there was an increasing rate of chemotherapy (45.4% in 2004-2009 vs 69.2% in 2010-2016; p<0.001). In the multivariable analysis, chemotherapy was associated with significantly improved overall survival compared with no adjuvant therapy (HR 0.49 (95% CI 0.31 to 0.79); p=0.003). There was no survival association when comparing radiation alone with no treatment, and none when adding radiation to chemotherapy compared with chemotherapy alone. Those with lymphovascular space invasion (n=124/507) had improved overall survival with chemotherapy and radiation (5-year overall survival 91.2% vs 76.7% for chemotherapy alone and 27.3% for radiation alone, log-rank p<0.001), but there was no survival difference after adjusting for age and comorbidity (HR 0.25 (95% CI 0.05 to 1.41); p=0.12). CONCLUSIONS: The use of adjuvant chemotherapy for the treatment of stage IIIA grade 1 endometrial cancer increased over time and was associated with improved overall survival compared with radiation alone or chemoradiation. Patients with lymphovascular space invasion may benefit from combination therapy.

Neoadjuvant chemotherapy for advanced stage endometrial cancer: A systematic review.

OBJECTIVE: While primary cytoreductive surgery (PCS) is considered the standard of care for women who present with stage IV endometrial cancer, neoadjuvant chemotherapy (NACT) followed by interval cytoreductive surgery (ICS) has emerged as an alternative treatment strategy. We summarized the literature and compared outcomes of PCS compared to NACT and ICS. METHODS: We conducted a systematic search on PubMed, Embase, Web of Science, and Scopus for articles published from January 1, 1990 to December 31, 2020. Key search terms included multiple descriptors of advanced disease status in combination with "endometrial cancer" and "neoadjuvant chemotherapy". Our review included studies that examined survival and surgical outcomes of patients with stage III or IV endometrial cancer treated with neoadjuvant chemotherapy followed by interval cytoreductive surgery versus those who received primary cytoreductive surgery. We excluded studies examining only patients with leiomyosarcomas, carcinosarcomas, and stromal sarcomas due to the biologic heterogeneity of these malignancies. RESULTS: The nine included studies encompassed 5,844 patients, of which 1,317 (22.5%) received NACT and 4,527 received PCS (77.5%). With the exception of a single study, all were retrospective observational studies or case series. Use of NACT in patients with stage IV EC increased from 16.0% in 2010 to 23.9% in 2015. Five studies analyzed median overall survival and all but one reported no significant difference between NACT + ICS vs. PCS. Optimal cytoreduction (<1 cm of residual disease) rates were similar across both treatment groups in three separate analyses, however pooled data suggest improved rates of optimal cytoreduction for NACT + ICS vs. PCS patients (81.9% vs. 51.5% respectively). Patients receiving NACT experienced significantly shorter hospital admissions and lower operative times compared to PCS counterparts. CONCLUSIONS: NACT followed by ICS reduces perioperative morbidity while offering similar overall survival.

Associations of Insurance Churn and Catastrophic Health Expenditures With Implementation of the Affordable Care Act Among Nonelderly Patients With Cancer in the United States.

Importance: Health insurance coverage is dynamic in the United States, potentially changing from month to month. The Patient Protection and Affordable Care Act (ACA) aimed to stabilize markets and reduce financial burden, particularly among those with preexisting conditions. Objective: To describe the risks of insurance churn (ie, gain, loss, or change in coverage) and catastrophic health expenditures among nonelderly patients with cancer in the United States, assessing for changes associated with ACA implementation. Design, Setting, and Participants: This retrospective, cross-sectional study uses data from the Medical Expenditure Panel Survey, a representative sample of the US population from 2005 to 2018. Respondents included were younger than 65 years, identified by health care use associated with a cancer diagnosis code in the given year. Statistical analysis was conducted from July 30, 2020, to January 5, 2021. Exposures: The Patient Protection and Affordable Care Act. Main Outcomes and Measures: Survey weights were applied to generate estimates for the US population. Annual risks of insurance churn (ie, any uninsurance or insurance change or loss) and catastrophic health expenditures (spending >10% income) were calculated, comparing subgroups with the adjusted Wald test. Weighted multivariable linear regression was used to assess for changes associated with ACA implementation. Results: From 6069 respondents, we estimated a weighted mean of 4.78 million nonelderly patients (95% CI, 4.55-5.01 million; female patients: weighted mean, 63.9% [95% CI, 62.2%-65.7%]; mean age, 50.3 years [95% CI, 49.7-50.8 years]) with cancer annually in the United States. Patients with cancer experienced lower annual risks of insurance loss (5.3% [95% CI, 4.5%-6.1%] vs 7.6% [95% CI, 7.4%-7.8%]) and any uninsurance (14.6% [95% CI, 13.3%-16.0%] vs 24.1% [95% CI, 23.5%-24.7%]) but increased risk of catastrophic health expenditures (expenses alone: 12.4% [95% CI, 11.2%-13.6%] vs 6.3% [95% CI, 6.2%-6.5%]; including premiums: 26.6% [95% CI, 25.0%-28.1%] vs 16.5% [95% CI, 16.1%-16.8%]; P < .001) relative to the population without cancer. Patients with cancer from low-income families and with full-year private coverage were at particularly high risk of catastrophic health expenditures (including premiums: 81.7% [95% CI, 74.6%-88.9%]). After adjustment, low income was the factor most strongly associated with both insurance churn and catastrophic spending, associated with annual risk increases of 6.5% (95% CI, 4.2%-8.8%) for insurance loss, 17.3% (95% CI, 13.4%-21.2%) for any uninsurance, and 37.4% (95% CI, 33.3%-41.6%) for catastrophic expenditures excluding premiums (P < .001). In adjusted models relative to 2005-2009, full ACA implementation (2014-2018) was associated with a decreased annual risk of any uninsurance (-4.2%; 95% CI, -7.4% to -1.0%; P = .01) and catastrophic spending by expenses alone (-3.0%; 95% CI, -5.3% to -0.8%; P = .008) but not including premiums (0.4%; 95% CI, -2.8% to 4.5%; P = .82). Conclusions and Relevance: In this cross-sectional study, US patients with cancer faced significant annual risks of insurance churn and catastrophic health spending. Despite some improvements with ACA implementation, large burdens remained, and further reform is needed to protect this population from excessive hardship.

Medicaid Expansion Reduced Uninsured Surgical Hospitalizations And Associated Catastrophic Financial Burden.

An important function of health insurance is protecting enrollees from excessively burdensome charges for unanticipated medical events. Unexpected surgery can be financially catastrophic for uninsured people. By targeting the low-income uninsured population, Medicaid expansion had the potential to reduce the financial risks associated with these events. We used two data sources (state-level data for forty-four states and patient-level data for four states) to estimate the association of Medicaid expansion with uninsured surgical hospitalizations among nonelderly adults. Uninsured surgery cases were typically admitted through the emergency department-often for common emergency procedures-and 99 percent of them were estimated to be associated with financially catastrophic visit charges. We found that Medicaid expansion was associated with reductions in both the share (6.20 percent) and the population rate (7.85 per 10,000) of uninsured surgical discharges in expansion versus nonexpansion states. Our estimates suggest that in 2019 alone, adoption of Medicaid expansion in nonexpansion states could have prevented more than 50,000 incidences of catastrophic financial burden resulting from uninsured surgery.

Use and outcomes of neoadjuvant chemotherapy for metastatic uterine cancer.

OBJECTIVE: Neoadjuvant chemotherapy (NACT) has emerged as an alternative to primary cytoreductive surgery (PCS) for stage IV uterine cancer. We examined utilization, perioperative outcomes and survival for NACT and PCS for stage IV uterine cancer. METHODS: The Surveillance, Epidemiology, End Results-Medicare database was used to identify women with stage IV uterine cancer treated from 2000 to 2015. Women were classified as NACT or PCS. Interval cytoreductive surgery (after NACT) or chemotherapy (after PCS) were recorded. The extent of surgery and perioperative outcomes were estimated for the groups. Multivariable proportional hazards models and Kaplan-Meier analyses were used to examine survival. RESULTS: Among 3037 women, 1629 (53.6%) were treated with primary cytoreductive surgery, 554 (18.2%) with NACT, and 854 (28.1%) received no treatment. Use of NACT increased from 9.5% to 29.2%. After NACT, interval hysterectomy was performed in 159 (28.6%), while within the PCS group, 1052 (64.6%) received chemotherapy. Extended cytoreductive procedures were performed in 71.7% of women who received NACT vs. 79.1% after PCS (P = 0.03). The complication rate was 52.8% for NACT versus 56.2% for PCS (P = 0.42); medical complications were more frequently seen in the PCS group (39.4% versus 28.9%; P = 0.01). There was no difference in cancer specific (P = 0.48) or overall survival (P = 0.25) in women who received both chemotherapy and surgery regardless of whether the initial treatment was NACT or PCS. CONCLUSION: Use of NACT is increasing for advanced stage uterine cancer. There was no difference in survival between NACT and primary cytoreductive surgery and NACT was associated with fewer perioperative medical complications.

Surveillance for gestational trophoblastic neoplasia following molar pregnancy: a cost-effectiveness analysis.

BACKGROUND: Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare. OBJECTIVE: We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy. STUDY DESIGN: A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold. RESULTS: Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to >$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of <$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783). CONCLUSION: Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.

Primary cytoreductive surgery for advanced stage endometrial cancer: a systematic review and meta-analysis.

OBJECTIVE: Endometrial cancer uncommonly presents at an advanced stage and little prospective evidence exists to guide the management thereof. We aimed to summarize the evidence about primary cytoreductive surgery in the treatment of advanced stage endometrial cancer. DATA SOURCES: MEDLINE, Embase, and Scopus databases were searched from inception to September 11, 2020, using search terms representing the themes "endometrial cancer," "advanced stage," and "primary cytoreductive surgery." STUDY ELIGIBILITY CRITERIA: We included full-text, English reports that included ≥10 patients undergoing primary cytoreductive surgery for advanced stage endometrial cancer and that reported on the outcomes of primary cytoreductive surgery and survival rates based on the residual disease burden. METHODS: Two reviewers independently screened the studies and with disagreements between the reviewers resolved by a third reviewer. Data were extracted using a standardized form. The percentage of cases reaching maximal (no gross residual disease) and optimal (<1 cm or <2 cm residual disease) cytoreduction were assessed by summing binomials proportions, and the association with survival was assessed using an inverse variance-weighted meta-analysis of logarithmic hazard ratios. RESULTS: From 1219 unique records identified, 34 studies were selected for inclusion. Studies consisted of single or multi-institutional cohorts of patients collected over a period of 6 to 24 years and included various mixes of histologies (endometrioid, serous, clear cell, and carcinosarcoma) and disease stages (III or IV). In a meta-analysis of the extent of residual disease after primary cytoreductive surgery, we found that 52.1% of cases reached no gross residual disease status (n=18 studies; 1329 patients) and 75% reached <1 cm residual disease status (n=27 studies; 2343 patients). The proportion of cytoreduction for both thresholds was lower for studies of stage IV vs stage III to IV disease (41.4% vs 69.8% for no gross residual disease; 63.2% vs 82.2% for <1 cm residual disease) but did not vary notably by histology. In a meta-analysis of the reported hazard ratios, submaximal (any gross residual disease vs no gross residual disease) and suboptimal (≥1 cm vs <1 cm) cytoreduction thresholds were associated with worse progression-free survival (submaximal hazard ratio, 2.16; 95% confidence interval, 1.45-3.21; I2=68%; suboptimal hazard ratio, 2.55; 95% confidence interval, 1.93-3.37; I2=63%) and overall survival rates (submaximal hazard ratio, 2.57; 95% confidence interval, 2.13-3.10; I2=1%; suboptimal hazard ratio, 2.62; 95% confidence interval, 2.20-3.11; I2=15%). Sensitivity analyses limited to high-quality studies demonstrated consistent results. CONCLUSION: Among cases of advanced stage endometrial cancer undergoing primary cytoreductive surgery, a significant proportion of patients are left with residual disease, which is associated with worse survival outcomes. Further investigations about the roles of neoadjuvant chemotherapy and primary cytoreductive surgery in prospective trials is warranted in this population.

Oncologic outcomes of minimally invasive versus open radical hysterectomy for early stage cervical carcinoma and tumor size <2 cm: a systematic review and meta-analysis.

OBJECTIVE: To investigate the oncologic outcomes of patients with early-stage cervical carcinoma and tumor size <2 cm who underwent open or minimally invasive radical hysterectomy. METHODS: The Pubmed/Medline, Embase, and Web-of-Science databases were queried from inception to January 2021 (PROSPERO CRD 42020207971). Observational studies reporting progression-free survival and/or overall survival for patients who had open or minimally invasive radical hysterectomy for early-stage cervical carcinoma and tumor size <2 cm were selected. Level of statistical heterogeneity was evaluated with the I2 statistic. A random-effects model was used to compare progression and overall survival between the two groups and HR with 95% confidence intervals were calculated with the Der Simonian and Laird approach. Risk of bias and quality of included studies was assessed with the Newcastle-Ottawa scale. RESULTS: A total of 10 studies that met the inclusion criteria were included encompassing 4935 patients. Of these, 2394 (48.5%) patients had minimally invasive and 2541 (51.5%) patients had open radical hysterectomy; respectively. Patients who underwent minimally invasive hysterectomy had worse progression-free survival than those who had open surgery (HR 1.68, 95% CI 1.20, 2.36, I2 26%). Based on five studies, patients who had minimally invasive (n=1808) hysterectomy had a trend towards worse overall survival than those who had open surgery (n=1853) (HR 1.64, 95% CI 1.00 to 2.68, I2 15%). CONCLUSION: Based on a systematic review of the literature and meta-analysis of studies that control for confounders, for patients with cervical cancer and tumor size <2 cm, minimally invasive radical hysterectomy was associated with worse progression-free survival than laparotomy.

Emergency department utilization by patients with gynecologic cancer in the United States.

INTRODUCTION: Payment reform will give oncologists increasing responsibility for how patients with cancer meet unexpected care needs. OBJECTIVE: To differentiate how patients with gynecologic cancers use emergency care, and to assess the characteristics associated with potentially avoidable treat-and-release visits. METHODS: We performed a retrospective cohort study using the Nationwide Emergency Department Sample, a stratified sample of visits in United States hospital-based emergency departments, from 2010 to 2014. Visits by patients with a diagnosis of gynecologic cancer were selected. Sample weights were applied to calculate national estimates of care patterns and trends. Associations with treat-and-release disposition were assessed with weighted logistic regression. RESULTS: In the study period, patients with gynecologic cancer made an estimated 370 104 annual emergency department visits (95% CI 351 997 to 388 211). A total of 50.2% of patients were treated and released, 48% were admitted, 1.6% were transferred, and 0.1% died. These visits corresponded to over US$1.27 billion in annual charges, with an average charge of US$3428 per visit (95% CI 3348 to 3509). Driven by growing treat-and-release utilization, annual visits increased, while admission rates fell over time. Patients with cervical cancer represented the plurality (36%) of visits; they were relatively younger, of lower socioeconomic status, and had fewer co-morbidities. Models for treat-and-release disposition did not vary significantly across different cancer populations. In the all-cancer model, increased odds of treat-and-release disposition was associated with cervical cancer diagnosis, younger age, lesser Elixhauser co-morbidity, Medicare coverage (OR=1.19; p<0.001), Medicaid coverage (OR=1.25; p<0.001), uninsured status (OR=1.70; p<0.001), and weekend visits. Visits in the northeast, at urban hospitals, and in winter months showed decreased odds of treat-and-release disposition. DISCUSSION: Patients with gynecologic cancers have been using the emergency department at increasing rates, primarily driven by treat-and-release visits that did not result in admission or death. Patients with cervical cancer have higher rates of treat-and-release utilization and may over-use emergency department care.