Sociodemographic Factors Associated with Antenatal Steroid Use among Late Preterm Births.

In 2016, the Antenatal Late Preterm Steroid (ALPS) Trial demonstrated the benefit of antenatal steroids in reducing respiratory morbidity among late preterm singleton births ("LPB," 34-36 weeks of gestation).1 Prior studies have shown that this trial and its dissemination resulted in increased steroid use in the late preterm period; however, adoption was not uniform, with regional variation noted throughout the US.2-4 As the risk of preterm birth is known to vary widely by maternal characteristics and providers are encouraged to engage in shared decision-making around its use,5,6 we aimed to determine if antenatal steroid exposure among LPBs also varied based on sociodemographic characteristics.

Incidence of induced abortion among commercially insured pregnant patients with cancer.

OBJECTIVES: This study aimed to characterize pregnancy outcomes and the incidence of induced abortion among pregnant people with a diagnosis of malignancy. STUDY DESIGN: We conducted a retrospective cohort study among privately insured people aged 12 to 55 years from the fourth quarter of 2015-2020 using US claims data from Merative MarketScan Research Databases. We included pregnancies from seven states with favorable policies for private insurance coverage of abortion. RESULTS: There were 1471 of 183,685 (0.8%) pregnancies with a cancer diagnosis. Among those receiving anticancer therapy, 21.6% (95% CI: 14.4-30.4%) underwent induced abortion compared with 10.9% (95% CI: 10.8-11.1%) of pregnant patients without a cancer diagnosis. CONCLUSIONS: Abortion restrictions may affect many pregnant women requiring cancer treatment in early pregnancy.

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.

Utilization and Surgical Outcomes of Sentinel Lymph Node Biopsy for Endometrial Intraepithelial Neoplasia.

OBJECTIVE: To describe the rate and surgical outcomes of sentinel lymph node (SLN) biopsy in patients with endometrial intraepithelial neoplasia (EIN). METHODS: We conducted a cohort study that used the prospective American College of Surgeons National Surgical Quality Improvement Program database. Women with EIN on postoperative pathology who underwent minimally invasive hysterectomy from 2012 to 2020 were included. The cohort was dichotomized based on the performance of SLN biopsy. Patients' characteristics, perioperative morbidity, and mortality were compared between patients who underwent SLN biopsy and those who did not. Postoperative complications were defined using the Clavien-Dindo classification system. RESULTS: Overall, 4,447 patients were included; of those, 586 (13.2%) underwent SLN biopsy. The proportion of SLN biopsy has increased steadily from 0.6% in 2012 to 26.1% in 2020 (P<.001), with a rate of 16% increase per year. In a multivariable regression that included age, body mass index (BMI), and year of surgery, a more recent year of surgery was independently associated with an increased adjusted odds ratio of undergoing SLN biopsy (1.51, 95% CI, 1.43-1.59). The mean total operative time was longer in the SLN biopsy group (139.50±50.34 minutes vs 131.64±55.95 minutes, P=.001). The rate of any complication was 5.9% compared with 6.7%, the rate of major complications was 2.3% compared with 2.4%, and the rate of minor complications was 4.1% compared with 4.9% for no SLN biopsy and SLN biopsy, respectively. In a single complications analysis, the rate of venous thromboembolism was higher in the SLN biopsy group (four [0.7%] vs four [0.1%], P=.013). In a multivariable regression analysis adjusted for age, BMI, American Society of Anesthesiologists classification, uterus weight, and preoperative hematocrit, the performance of SLN biopsy was not associated with any complications, major complications, or minor complications. CONCLUSION: The performance of SLN biopsy in EIN is increasing. Sentinel lymph node biopsy for EIN is associated with an increased risk of venous thromboembolism and a negligible increased surgical time.

Primary Cytoreduction and Survival for Patients With Less-Common Epithelial Ovarian Cancer.

This cohort study examines the association between primary cytoreduction status and survival for patients with less-common, advanced-stage epithelial ovarian carcinoma.

Understanding sex and gender: concepts and terminology for gender affirming care.

Lesbian, gay, bisexual, trans, queer, intersex, asexual, and other diverse individuals (LGBTQIA+) people face lower healthcare utilization rates due to discrimination, poor experiences in healthcare, and barriers to accessing care. There is an increasing need to improve care and reduce health care disparities for the LGBTQIA+ population. The medical community can begin by educating themselves on LGBTQIA+ terminology, using inclusive language and developing cultural competence in clinical settings. In order to achieve this, it is first important to understand that sex and gender are distinct and that both sex and gender exist on continuums. This article will build on this understanding by introducing basic and widely accepted terminology that will provide a foundation for providing care to LGBTQIA+ populations. By thoughtfully incorporating this knowledge into our research and clinical practice, the radiology community will enhance the healthcare experiences of all patients.

Disparities in PI3K/mTOR inhibitor use, toxicities, and outcomes among patients with metastatic breast cancer.

PURPOSE: Novel agents such as PI3K and mTOR inhibitors (PI3K/mTORi) have expanded treatment options in metastatic breast cancer (MBC). Nevertheless, mortality rates remain disproportionately high for Black patients and patients with lower socioeconomic status. Furthermore, clinical trials for these novel agents lacked diversity, so their toxicity profile in minority populations is uncertain. METHODS: We conducted a retrospective analysis of EHR-derived data from the Flatiron Health Database for patients with HR+, HER2- MBC. Multivariable logistic regression was used to evaluate factors associated with PI3K/mTORi use and toxicity outcomes. RESULTS: A total of 9169 patients with MBC were included in our analysis, of which 1780 (19.4%) received a PI3K/mTORi. We estimated the conditional total effect of insurance through Medicaid, and found lower odds of use of PI3K/mTORi among patients on Medicaid compared to those with commercial insurance (OR 0.73, 95% CI 0.54-0.99, p = 0.049). Odds of PI3K/mTORi use were higher for patients treated at an academic center (OR 1.28, CI 1.06-1.55, p = 0.01). Modeled as a controlled direct effect, Black/African American (Black/AA) race had no impact on odds of PI3K/mTOR use. Black/AA patients had twice the odds of developing hyperglycemia on PI3K/mTORi compared to White patients (OR 2.02, CI 1.24-3.39, p < 0.01). CONCLUSION: This analysis of real-world data suggests that the use of PI3K/mTORi is influenced by socioeconomic factors. We also found racial disparities in toxicity outcomes, with Black/AA patients having twice the risk of hyperglycemia. Our findings call for greater efforts to ensure access to novel treatments and improve their tolerability in diverse populations.

Trends in uterine cancer incidence in the United States: The contribution of age, period and cohort effects.

OBJECTIVE: In the U.S., uterine cancer incidence is rising, with racial and ethnic minorities experiencing the largest increases. We performed age-period-cohort analyses using novel methods to examine the contribution of age at diagnosis (age), year of diagnosis (period), and birth cohort (cohort), to trends in uterine cancer incidence. METHODS: We used uterine cancer incidence data from the Surveillance, Epidemiology, and End Result (SEER) 12 database (1992-2019), and performed hysterectomy-correction. We generated hexamaps to visualize age, period, and cohort effects, and used mutual information to estimate the percent contribution of age, period, and cohort effects, individually and combined, on uterine cancer incidence, overall and by race and ethnicity and histology. RESULTS: Hexamaps showed an increase in uterine cancer in later time periods, and a cohort effect around 1933 showing a lower incidence compared with earlier and later cohorts. Age, period, and cohort effects combined contributed 86.6% (95% CI: 86.4%, 86.9%) to the incidence. Age effects had the greatest contribution (65.1%, 95% CI: 64.3%, 65.9), followed by cohort (20.7%, 95% CI: 20.1%, 21.3%) and period (14.2%, 95% CI: 13.7%, 14.8%) effects. Hexamaps showed higher incidence in recent years for non-Hispanic Blacks and non-endometrioid tumors. CONCLUSIONS: Age effects had the largest contribution to uterine cancer incidence, followed by cohort and period effects overall and across racial and ethnic groups and histologies. IMPACT: These findings can inform uterine cancer modeling studies on the effects of interventions that target risk factors which may vary across age, period, or cohort.

Fertility-Sparing Surgery for Stage I Epithelial Ovarian Cancer.

OBJECTIVE: To describe population-level utilization of fertility-sparing surgery and outcome of reproductive-aged patients with early epithelial ovarian cancer who underwent fertility-sparing surgery in the United States. METHODS: This retrospective study queried the National Cancer Institute's Surveillance, Epidemiology, and End Result Program. The study included 3,027 patients younger than age 50 years with stage I epithelial ovarian cancer receiving primary surgical therapy from 2007 to 2020. Fertility-sparing surgery was defined as preservation of one ovary and the uterus for unilateral lesion and preservation of the uterus for bilateral lesions. Temporal trend of fertility-sparing surgery was assessed with linear segmented regression with log-transformation. Overall survival associated with fertility-sparing surgery was assessed with Cox proportional hazard regression model. RESULTS: A total of 534 patients (17.6%) underwent fertility-sparing surgery. At the cohort level, the utilization of fertility-sparing surgery was 13.4% in 2007 and 21.8% in 2020 ( P for trend=.009). Non-Hispanic White individuals (2.8-fold), those with high-grade serous histology (2.2-fold), and individuals with stage IC disease (2.3-fold) had a more than twofold increase in fertility-sparing surgery utilization during the study period (all P for trend<.05). After controlling for the measured clinicopathologic characteristics, patients who received fertility-sparing surgery had overall survival comparable with that of patients who had nonsparing surgery (5-year rates 93.6% vs 92.1%, adjusted hazard ratio 0.87, 95% CI, 0.57-1.35). This survival association was consistent in high-grade serous (5-year rates 92.9% vs 92.4%), low-grade serous (100% vs 92.2%), clear cell (97.5% vs 86.1%), mucinous (92.1% vs 86.6%), low-grade endometrioid (95.7% vs 97.7%), and mixed (93.3% vs 83.7%) histology (all P >.05). In high-grade endometrioid tumor, fertility-sparing surgery was associated with decreased overall survival (5-year rates 71.9% vs 93.8%, adjusted hazard ratio 2.90, 95% CI, 1.09-7.67). Among bilateral ovarian lesions, fertility-sparing surgery was not associated with overall survival (5-year rates 95.8% vs 92.5%, P =.364). Among 41,914 patients who had epithelial ovarian cancer with any age and stage, those younger than age 50 years with stage I disease increased from 8.6% to 10.9% during the study period ( P for trend=.002). CONCLUSION: Nearly one in five reproductive-aged patients with stage I epithelial ovarian cancer underwent fertility-sparing surgery in recent years in the United States. More than 90% of reproductive-aged patients with stage I epithelial ovarian cancer who underwent fertility-sparing surgery were alive at the 5-year timepoint, except for those with high-grade endometrioid tumors.

Prognostic performance of the 2023 FIGO staging schema for endometrial cancer.

OBJECTIVE: To assess the prognostic performance of the 2023 International Federation of Gynecology and Obstetrics (FIGO) endometrial cancer staging schema. METHODS: This retrospective cohort study queried the Commission-on-Cancer's National Cancer Database. Study population was 129,146 patients with stage I-IV endometrial cancer per the 2009 FIGO staging schema. Stage-shifting and overall survival (OS) were assessed according to the 2023 FIGO staging schema. RESULTS: Upstage (IA → II, 21.4 %; IB → II, 53.0 %) and downstage (IIIA→IA3, 22.2 %) occurred in both early and advanced diseases. Inter-stage prognostic performance improved in the 2023 schema with widened 5-year OS rate difference between the earliest and highest stages (68.2 % to 76.9 %). Stage IA1-IIB and IIC had distinct 5-year OS rate differences (85.8-96.1 % vs 75.4 %). The 5-year OS rate of the 2009 stage IIIA disease was 63.9 %; this was greater segregated in the 2023 schema: 88.0 %, 62.4 %, and 55.7 % for IIIA→IA3, IIIA1, and IIIA2, respectively (inter-substage rate-difference, 32.3 %). This 5-year OS rate of stage IA3 disease was comparable to the 2023 stage IB-IIB diseases (88.0 % vs 85.8-89.5 %). In the 2023 stage IIIC schema (micrometastasis rates: 29.6 % in IIIC1 and 15.6 % in IIIC2), micrometastasis and macrometastasis had the distinct 3-year OS rates in both pelvic (IIIC1-i vs IIIC1-ii, 84.9 % vs 71.1 %; rate-difference 13.8 %) and para-aortic (IIIC2-i vs IIIC2-ii, 82.9 % vs 65.2 %; rate-difference 17.7 %) nodal metastasis cases. The 5-year OS rate of the 2009 stage IVB disease was 23.4 %; this was segregated to 25.4 % for stage IVB and 19.2 % for stage IVC in the 2023 staging schema (rate-difference, 6.2 %). CONCLUSION: The 2023 FIGO endometrial cancer staging schema is a major revision from the 2009 FIGO schema. Almost doubled enriched sub-stages based on detailed anatomical metastatic site and incorporation of histological information enable more robust prognostication.

Cesarean hysterectomy for placenta accreta spectrum: Surgeon specialty-specific assessment.

OBJECTIVE: To assess (i) clinical and pregnancy characteristics, (ii) patterns of surgical procedures, and (iii) surgical morbidity associated with cesarean hysterectomy for placenta accreta spectrum based on the specialty of the attending surgeon. METHODS: The Premier Healthcare Database was queried retrospectively to study patients with placenta accreta spectrum who underwent cesarean delivery and concurrent hysterectomy from 2016 to 2020. Surgical morbidity was assessed with propensity score inverse probability of treatment weighting based on surgeon specialty for hysterectomy: general obstetrician-gynecologists, maternal-fetal medicine specialists, and gynecologic oncologists. RESULTS: A total of 2240 cesarean hysterectomies were studies. The most common surgeon type was general obstetrician-gynecologist (n = 1534, 68.5%), followed by gynecologic oncologist (n = 532, 23.8%) and maternal-fetal medicine specialist (n = 174, 7.8%). Patients in the gynecologic oncologist group had the highest rate of placenta increta or percreta, followed by the maternal-fetal medicine specialist and general obstetrician-gynecologist groups (43.4%, 39.6%, and 30.6%, P < .001). In a propensity score-weighted model, measured surgical morbidity was similar across the three subspecialty groups, including hemorrhage / blood transfusion (59.4-63.7%), bladder injury (18.3-24.0%), ureteral injury (2.2-4.3%), shock (8.6-10.5%), and coagulopathy (3.3-7.4%) (all, P > .05). Among the cesarean hysterectomy performed by gynecologic oncologist, hemorrhage / transfusion rates remained substantial despite additional surgical procedures: tranexamic acid / ureteral stent (60.4%), tranexamic acid / endo-arterial procedure (76.2%), ureteral stent / endo-arterial procedure (51.6%), and all three procedures (55.4%). Tranexamic acid administration with ureteral stent placement was associated with decreased bladder injury (12.8% vs 23.8-32.2%, P < .001). CONCLUSION: These data suggest that patient characteristics and surgical procedures related to cesarean hysterectomy for placenta accreta spectrum differ based on surgeon specialty. Gynecologic oncologists appear to manage more severe forms of placenta accreta spectrum. Regardless of surgeon's specialty, surgical morbidity of cesarean hysterectomy for placenta accreta spectrum is significant.

Nationwide assessment of practice variability in the utilization of hysteropexy at laparoscopic apical suspension for uterine prolapse.

BACKGROUND: Although hysteropexy has been used to preserve the uterus during uterine prolapse surgery for a long time, there is a scarcity of data that describe the nationwide patterns of use of this surgical procedure. OBJECTIVE: This study aimed to examine the national-level use and characteristics of hysteropexy at the time of laparoscopic apical suspension surgery for uterine prolapse in the United States. STUDY DESIGN: This cross-sectional study used data from the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample. The study population included 55,608 patients with a diagnosis of uterine prolapse who underwent laparoscopic apical suspension surgery from 2016 to 2019. Patients who had a hysterectomy were assigned to the hysterectomy group, and those who did not have a hysterectomy were assigned to the hysteropexy group. The main outcome was clinical characteristics associated with hysteropexy, assessed using a multivariable binary logistic regression model. A classification tree was further constructed to assess the use pattern of hysteropexy during laparoscopic apical suspension procedures. The secondary outcome was surgical morbidity, including urinary tract injury, intestinal injury, vascular injury, and hemorrhage. RESULTS: A hysteropexy was performed in 6500 (11.7%) patients. In a multivariable analysis, characteristics associated with increased use of a hysteropexy included (1) patient factors, such as older age, Medicare coverage, private insurance, self-pay, and medical comorbidity; (2) pelvic floor dysfunction factor of complete uterine prolapse; and (3) hospital factors, including medium bed capacity center and location in the Southern United States (all P<.05). Conversely, (1) the patient factor of higher household income; (2) gynecologic factors such as uterine myoma, adenomyosis, and benign ovarian pathology; (3) pelvic floor dysfunction factor with stress urinary incontinence; and (4) hospital factors including Midwest and West United States regions and rural setting center were associated with decreased use of a hysteropexy (all P<.05). A classification tree identified a total of 14 use patterns for hysteropexies during laparoscopic apical suspension procedures. The strongest factor that dictated the use of a hysteropexy was the presence or absence of uterine myomas; the rate of hysteropexy use was decreased to 5.6% if myomas were present in comparison with 15% if there were no myomas (P<.001). Second layer factors were adenomyosis and hospital region. Patients who did not have uterine myomas or adenomyosis and who underwent surgery in the Southern United States had the highest rate of undergoing a hysteropexy (22.6%). Across the 14 use patterns, the percentage rate difference between the highest and lowest uptake patterns was 22.0%. Patients who underwent a hysteropexy were less likely to undergo anteroposterior colporrhaphy, posterior colporrhaphy, and sling procedures (all P<.05). Hysteropexy was associated with a decreased risk for measured surgical morbidity (3.0 vs 5.4 per 1000 procedures; adjusted odds ratio, 0.57; 95% confidence interval, 0.36-0.90). CONCLUSION: The results of these current, real-world practice data suggest that hysteropexies are being performed at the time of ambulatory laparoscopic apical suspension surgery for uterine prolapse. There is substantial variability in the application of hysteropexy based on patient, gynecologic, pelvic floor dysfunction, and hospital factors. Developing clinical practice guidelines to address this emerging surgical practice may be of use.

Cost-effectiveness of BRCA1 testing at time of obstetrical prenatal carrier screening for cancer prevention.

BACKGROUND: Improved technologies paired with an increase in access to genetic testing have led to the availability of expanded carrier screening evaluating hundreds of disorders. Currently, most autosomal dominant mutations, such as BRCA1, are not included in expanded carrier assays. Screening pregnant or preconception reproductive-aged women for BRCA1 may present a unique opportunity to perform population-based screening for patients at a time when precancer screening, chemoprevention, and/or risk-reducing surgery may be beneficial. OBJECTIVE: This study aimed to inform clinical decision-making as to whether the universal incorporation of BRCA1 testing at the time of obstetrical prenatal carrier screening is cost-effective. STUDY DESIGN: A decision analysis and Markov model was created. The initial decision point in the model was BRCA1 testing at the time of expanded carrier screening. Model probabilities, cost, and utility values were derived from published literature. For BRCA1-positive patients, the model simulated breast cancer screening and risk-reducing surgical interventions. A cycle length of 1 year and a time horizon of 47 years were used to simulate the lifespan of patients. The setting was obstetrical clinics in the United States, and the participants were a theoretical cohort of 1,429,074 pregnant patients who annually underwent expanded carrier screening. RESULTS: Among our cohort, BRCA1 testing resulted in the identification of an additional 3716 BRCA1-positive patients, the prevention of 1394 breast and ovarian cancer cases, and 1084 fewer deaths. BRCA1 testing was a cost-effective strategy compared with no BRCA1 testing with an incremental cost-effectiveness ratio of $86,001 per quality-adjusted life years. In a 1-way sensitivity analysis, we varied the prevalence of BRCA1 in the population from 0.00% to 20.00% and found that BRCA1 testing continued to be the cost-effective strategy until the prevalence rate was reduced to 0.16%. Multiple additional sensitivity analyses did not substantially affect the cost-effectiveness. CONCLUSION: The addition of BRCA1 testing to obstetrical prenatal carrier screening is a cost-effective management strategy to identify at-risk women at a time when cancer screening and preventive strategies can be effective. Despite the burden of additional genetic counseling, prenatal care represents a unique opportunity to implement population-based genetic testing.

Prevalence and Predictors of Follow-up Endoscopic Biopsy in Patients With Celiac Disease in the United States.

OBJECTIVE: To characterize the frequency and predictors of follow-up endoscopic biopsy in patients with celiac disease. BACKGROUND: The utility of routine follow-up biopsy in patients after a diagnosis of celiac disease is uncertain, especially in patients whose symptoms resolve on the gluten-free diet. PATIENTS AND METHODS: Using the Merative MarketScan U.S. commercial insurance and Medicare databases, we identified 30,737 patients with biopsy-diagnosed celiac disease. We followed them until they had a second duodenal biopsy (our primary outcome) or insurance coverage ended. RESULTS: Among the patients with celiac disease we identified, 5976 (19.4%) underwent a follow-up biopsy. The median time between initial and follow-up biopsies was 16.8 months. Compared with younger patients, those aged 20 years or older had an increased likelihood of undergoing a follow-up biopsy (cumulative incidence rate at 5 y for patients age ≥20 y was 36.0%, 95% CI: 35.0%-37.1% vs 21.9%, 95% CI: 20.5%-23.4% in patients age ≤19 y). Follow-up biopsies occurred less frequently in more recent calendar years. Follow-up biopsy was more common among patients with an Elixhauser Comorbidity Index of 1 (hazard ratio: 1.09; 95% CI: 1.01-1.17) or ≥2 (hazard ratio: 1.28; 95% CI: 1.20-1.37) compared with patients with an index of zero. Among patients who had a follow-up biopsy, 57% had a celiac disease-related symptom recorded in the 30 days before the procedure. CONCLUSIONS: Follow-up duodenal biopsy is performed in a substantial minority of U.S. patients with celiac disease. Adult age and increased comorbidity burden were associated with a greater likelihood of follow-up biopsy. Just under half of follow-up biopsies are performed for routine surveillance, in the absence of persistent symptoms.

Advocacy in gender affirming care.

Healthcare advocacy is the duty and privilege of all healthcare providers, but especially for those who care for children. Intersex and gender diverse youth face significant barriers across many aspects of life, with access to competent gender affirming healthcare chief among them. Understanding the importance of both institutional and individual efforts in healthcare advocacy is paramount to improving healthcare access and outcomes for this population.

Cost sharing for oral lenvatinib among commercially insured patients.

OBJECTIVE: To use a nationwide pharmaceutical claims database to evaluate cost-sharing trends for commercially insured patients with cancer who were prescribed lenvatinib (Lenvima). STUDY DESIGN: IBM MarketScan databases were used to evaluate lenvatinib costs for patients with employer-based commercial insurance, and for patients 65 years and older, Medicare claims for fee-for-service plans. METHODS: Patients were included if they had least 1 outpatient pharmaceutical claim for lenvatinib paid on a noncapitated basis from 2015 to 2019. Median and IQR costs were estimated and inflation adjusted to 2019 US$ for 30-day supplies and reported as total, insurance liability, coordination of benefits, and out-of-pocket costs. RESULTS: A total of 685 patients had at least 1 pharmaceutical claim for lenvatinib, which included patients with thyroid (n = 251; 36.6%), renal cell (n = 202; 29.5%), hepatocellular (n = 160; 23.4%), and endometrial (n = 48; 7.0%) cancer. The median (IQR) number of prescriptions per patient was 3 (2-7), and the median (IQR) total days of supply was 90 (45-210) days. The median (IQR) 30-day cost of lenvatinib was $17,253 ($15,597-$18,120). Median (IQR) 30-day insurance liability was $16,847 ($15,000-$17,981). Median (IQR) 30-day coordination of benefits was $0 ($0-$0). Median (IQR) 30-day patient out-of-pocket cost was $32 ($0-$100). However, the maximum 30-day out-of-pocket cost in our patient cohort was $12,538. CONCLUSIONS: In this cohort, insurance was liable for the majority of total lenvatinib drug costs, and 75% of patients paid $100 or less per month out of pocket. This information can be used by care teams to counsel insured patients. Health systems and drug manufacturers must identify patients with high out-of-pocket costs and provide convenient access to financial assistance programs so that patients are not forced to forgo the benefits of these drugs due to financial barriers. Value-based payment models and drug pricing reform are also needed to address underlying drivers of high drug costs.

Increasing utilization of intrauterine device insertion at hysteroscopic endometrial evaluation for patients with endometrial hyperplasia.

PURPOSE: To examine the utilization and characteristics related to the use of hysteroscopy at the time of endometrial evaluation for endometrial hyperplasia in the outpatient surgery setting. METHODS: This cross-sectional study queried the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample. The study population was 3218 patients with endometrial hyperplasia who underwent endometrial evaluation from January 2016 to December 2019. Performance and clinical characteristics of hysteroscopic endometrial evaluation were assessed with multivariable binary logistic regression models. RESULTS: A total of 2654 (82.5%) patients had hysteroscopic endometrial tissue evaluation. Patients with postmenopausal bleeding, heavy menstrual bleeding, and polycystic ovary syndrome were more likely to undergo hysteroscopic endometrial evaluation in multivariable analysis (all, adjusted-P < 0.001). Uterine injury occurred in 4.9 per 1000 hysteroscopic endometrial evaluations; none had uterine injury in the non-hysteroscopy cohort. Among the 2654 patients who had hysteroscopic endometrial evaluation, 106 (4.0%) patients had intrauterine device insertion at surgery, and the utilization increased from 2.9 to 5.8% during the study period (P-trend < 0.001). Younger age, more recent year surgery, and obesity were independently associated with increased utilization of intrauterine device insertion at hysteroscopic endometrial evaluation (all, adjusted-P < 0.05). Among 2023 reproductive-age patients with endometrial hyperplasia, 1666 (82.4%) patients underwent hysteroscopic endometrial evaluation. On multivariable analysis, patients with heavy menstrual bleeding were more likely to have hysteroscopic endometrial evaluation (adjusted-P < 0.05). Intrauterine device insertion increased from 3.7% in 2016 to 8.0% in 2019 (P-trend = 0.007). CONCLUSION: This nationwide analysis suggests that the insertion of intrauterine devices at the time of hysteroscopic endometrial tissue evaluation for endometrial hyperplasia is increasing among reproductive-age population.

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.

Diagnosis Shift in Site of Origin of Tubo-Ovarian Carcinoma.

OBJECTIVE: To assess population-level trends, characteristics, and outcomes of high-grade serous tubo-ovarian carcinoma in the United States. METHODS: This retrospective cohort study queried the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. The study population was 27,811 patients diagnosed with high-grade serous tubo-ovarian carcinoma from 2004 to 2020. The exposure was the primary cancer site (ovary or fallopian tube). Main outcome measures were temporal trends, clinical characteristics, and overall survival associated with primary cancer site assessed in multivariable analysis. RESULTS: The study population comprised 23,967 diagnoses of high-grade serous ovarian carcinoma and 3,844 diagnoses of high-grade serous fallopian tubal carcinoma. The proportion of diagnoses of high-grade serous fallopian tubal carcinoma increased from 365 of 7,305 (5.0%) in 2004-2008 to 1,742 of 6,663 (26.1%) in 2017-2020. This increase was independent in a multivariable analysis (adjusted odds ratio [aOR] vs 2004-2008, 2.28 [95% CI, 1.98-2.62], 3.27 [95% CI, 2.86-3.74], and 6.65 [95% CI, 5.84-7.57] for 2009-2012, 2013-2016, and 2017-2020, respectively). This increase in high-grade serous fallopian tubal carcinoma was seen across age groups (4.3-5.8% to 22.7-28.3%) and across racial and ethnic groups (4.1-6.0% to 21.9-27.5%) (all P for trend <.001). Among the cases of tumors smaller than 1.5 cm, the increase was particularly high (16.9-67.6%, P for trend <.001). Primary-site tumors in the high-grade serous fallopian tubal carcinoma group were more likely to be smaller than 1.5 cm (aOR 8.26, 95% CI, 7.35-9.28) and unilateral (aOR 7.22, 95% CI, 6.54-7.96) compared with those in high-grade serous ovarian carcinoma. At the cohort level, the diagnosis shift to high-grade serous fallopian tubal carcinoma was associated with narrowing differences in survival over time between the two malignancy groups: adjusted hazard ratio 0.84 (95% CI, 0.74-0.96), 0.91 (95% CI, 0.82-1.01), 1.01 (95% CI, 0.92-1.12), and 1.12 (95% CI, 0.98-1.29) for 2004-2008, 2009-2012, 2013-2016, and 2017-2020, respectively. CONCLUSION: This population-based assessment suggests that diagnoses of high-grade serous tubo-ovarian carcinoma in the United States have been rapidly shifting from high-grade serous ovarian to fallopian tubal carcinoma in recent years, particularly in cases of smaller, unilateral tumors.