Population-level trends and outcomes of sentinel lymph node biopsy in vulvar cancer surgery in the United States.

OBJECTIVE: To examine population-level trends, characteristics, and outcomes related to nodal assessment for vulvar cancer surgery in the United States. METHODS: This is a retrospective cohort study querying the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. The study population was 5604 women with T1b or T2-smaller(≤4 cm) squamous cell carcinoma of the vulva who underwent primary vulvectomy from 2003 to 2018. The exposure allocation was based on nodal evaluation type: lymphadenectomy (LND; n = 3319, 59.2%), sentinel lymph node (SLN) biopsy (n = 751, 13.4%), or no surgical nodal evaluation (n = 1534, 27.4%). The main outcomes were (i) trends and characteristics related to SLN biopsy assessed by multinomial regression model, and (ii) vulvar cancer-specific survival assessed by competing risk analysis and inverse probability of treatment weighting propensity score. Sensitivity analysis included evaluation of external cohort with T1a disease (n = 1291). RESULTS: The utilization of SLN biopsy increased from 5.7% to 23.3% in 2006-2018, while the proportion of LND decreased from 64.1% to 48.8% in 2010-2018, and these associations remained independent in multivariable analysis (adjusted-P < 0.05). In the propensity score weighted model, 5-year cumulative rate for vulvar cancer-specific mortality was 15.2% (interquartile range 12.1-18.9) for the SLN biopsy group and 16.9% (interquartile range 15.6-18.3) for the LND group (subdistribution-hazard ratio 0.90, 95% confidence interval 0.76-1.06, P = 0.217). The increasing SLN biopsy use was also observed in T1a disease from 1.3% to 7.3% during the study period (P < 0.001). CONCLUSION: The landscape of surgical nodal evaluation is shifting from lymphadenectomy to SLN biopsy in vulvar cancer surgery in the United States. SLN biopsy-incorporated treatment approach was not associated with worse survival compared to LND.

Population incidence and characteristics of secondary breast cancer after uterine cancer: a competing risk analysis.

PURPOSE: To examine incidence and characteristics of women who developed secondary breast cancer after uterine cancer. METHODS: This is a population-based retrospective cohort study utilizing the National Cancer Institute's Surveillance, Epidemiology, and End Result Program from 1973 to 2013. Women with uterine cancer who did not have synchronous or a history of breast cancer were followed after their uterine cancer diagnosis (N = 236,561). A time-dependent competing risk analysis was performed to examine cumulative incidences and clinico-pathological characteristics of those who subsequently developed breast cancer. RESULTS: There were 7110 (3.0%) women who developed secondary breast cancers after uterine cancer with 5-, 10-, and 20-year cumulative incidence rates of 1.5, 2.8, and 4.7%, respectively. The increase in the rate of secondary breast cancer was particularly high in the first 3 years after a uterine cancer diagnosis (annual percent change [APC] 4.9), followed by 3-7 years (APC 1.6) after diagnosis (P < 0.001). The median time to develop secondary breast cancer was 6.4 years. Older women had significantly shorter time intervals between uterine and breast cancer diagnoses (3.7 years for aged > 71, 5.9 for aged 64-71, 7.6 for aged 56-63, and 9.4 for aged < 56, P < 0.001). In a multivariable analysis, older age, White race, married status, endometrioid, serous, and mixed histology types, and early-stage tumors remained as independent factors of developing secondary breast cancer (all, P < 0.05). CONCLUSION: Tumor factors with endometrioid and serous histology types and early-stage disease were the factors associated with secondary breast cancer after uterine cancer diagnosis. Older women had shorter time to develop secondary breast cancer.

Real World Experience With Natalizumab at a Tertiary Care Pediatric IBD Center.

OBJECTIVES: Natalizumab is a humanized monoclonal antibody inhibiting lymphocyte migration and prescribed in patients with Crohn disease (CD) failing anti-tumor necrosis factor (TNF) therapies. Because of the risk of progressive multifocal leukoencephalopathy in patients with John Cunningham virus (JCV) positive, natalizumab is not widely used in clinical practice. Published experience of the use of natalizumab in pediatric patients is lacking. We aimed to describe the experience of natalizumab in patients with CD, including those who are JCV positive, at a tertiary care pediatric inflammatory bowel disease center. METHODS: A retrospective chart review was performed in patients with CD <21 years receiving natalizumab therapy before March 2014. Patient and disease information, prior treatments and response to natalizumab, including Harvey Bradshaw Index (HBI), were recorded. Descriptive statistics were computed. RESULTS: Nine patients received natalizumab with a median age at diagnosis of 10 (range 7-16) years and median disease duration 72 (range 13-156) months. All of the patients had failed at least 1 anti-TNF agent. At baseline, the median HBI was 8 (IQR 6.5-11). By week 10, the median HBI was 4.5 (IQR 2-6), with 4 of 8 (50%) patients with CD being in remission. Forty-four percent (4/9) of patients were JCV antibody positive at baseline and had anti-JCV antibody index >0.9 (median 3.36). There were no serious adverse events, including progressive multifocal leukoencephalopathy. All of the patients were transitioned to vedolizumab. CONCLUSIONS: In our experience, natalizumab is a safe and efficacious medication in pediatric in patients with inflammatory bowel disease. Given the favorable results with natalizumab, pediatric studies with the more gut targeted anti-integrin agent vedolizumab are warranted.

Incidence, characteristics, and maternal outcomes of pregnancy with uterine prolapse.

BACKGROUND: Gravid uterine prolapse refers to abnormal descent of the uterus during pregnancy. It is a rare pregnancy complication and its clinical characteristics and obstetrical outcomes are not well understood. OBJECTIVE: This study aimed to assess the national-level incidence, characteristics, and maternal outcomes of pregnancies complicated by gravid uterine prolapse. STUDY DESIGN: This retrospective cohort study queried the Healthcare Cost and Utilization Project's National Inpatient Sample. The study population was 14,647,670 deliveries from January 2016 to December 2019. The exposure assignment was the diagnosis of uterine prolapse. The coprimary outcome measures were incidence rate, clinical and pregnancy characteristics, and delivery outcomes of patients with gravid uterine prolapse. The inverse probability of treatment weighting cohort was created to mitigate the difference in prepregnancy confounding factors, followed by adjusting for pregnancy and delivery factors. RESULTS: The incidence of gravid uterine prolapse was 1 in 4209 deliveries (23.8 per 100,000). In a multivariable analysis, older age (≥40 years; adjusted odds ratio, 3.21; 95% confidence interval, 2.70-3.81); age from 35 to 39 years (adjusted odds ratio, 2.66; 95% confidence interval, 2.37-2.99); Black (adjusted odds ratio, 1.48; 95% confidence interval, 1.34-1.63), Asian (adjusted odds ratio, 1.45; 95% confidence interval, 1.28-1.64), and Native American (adjusted odds ratio, 2.17; 95% confidence interval, 1.63-2.88) race/ethnicity; tobacco use (adjusted odds ratio, 1.19; 95% confidence interval, 1.03-1.37); grand multiparity (adjusted odds ratio, 1.78; 95% confidence interval, 1.24-2.55); and history of pregnancy losses (adjusted odds ratio, 2.20; 95% confidence interval, 1.48-3.26) were the patient characteristics associated with increased risk of gravid uterine prolapse. Current pregnancy characteristics associated with gravid uterine prolapse included cervical insufficiency (adjusted odds ratio, 3.25; 95% confidence interval, 1.94-5.45), preterm labor (adjusted odds ratio, 1.53; 95% confidence interval, 1.18-1.97), preterm premature rupture of membranes (adjusted odds ratio, 1.40; 95% confidence interval, 1.01-1.94), and chorioamnionitis (adjusted odds ratio, 1.64; 95% confidence interval, 1.18-2.28). Delivery characteristics associated with gravid uterine prolapse included early-preterm delivery at <34 weeks' gestation (69.1 vs 32.0 per 1000; adjusted odds ratio, 1.86; 95% confidence interval, 1.34-2.59) and precipitate labor (35.2 vs 20.1; adjusted odds ratio, 1.73; 95% confidence interval, 1.22-2.44). Moreover, risks of postpartum hemorrhage (112.1 vs 44.4 per 1000; adjusted odds ratio, 2.70; 95% confidence interval, 2.20-3.32), uterine atony (32.0 vs 15.7; adjusted odds ratio, 2.10; 95% confidence interval, 1.46-3.03), uterine inversion (9.6 vs 0.3; adjusted odds ratio, 31.97; 95% confidence interval, 16.60-61.58), shock (3.2 vs 0.7; adjusted odds ratio, 4.18; 95% confidence interval, 1.41-12.40), blood product transfusion (22.4 vs 11.1; adjusted odds ratio, 2.06; 95% confidence interval, 1.34-3.18), and hysterectomy (7.5 vs 2.3; adjusted odds ratio, 3.02; 95% confidence interval, 1.40-6.51) were increased in the gravid uterine prolapse group compared with the nonprolapse group. Conversely, patients with gravid uterine prolapse were less likely to deliver via cesarean delivery compared with those without gravid uterine prolapse (200.6 vs 322.8 per 1000; adjusted odds ratio, 0.51; 95% confidence interval, 0.44-0.61). CONCLUSION: This nationwide analysis suggests that pregnancy with gravid uterine prolapse is uncommon but associated with several high-risk pregnancy characteristics and adverse delivery outcomes.

Reconstructive Surgery at Hysterectomy for Patients With Uterine Prolapse and Gynecologic Malignancy.

In this cross-sectional study examining 211,708 patients with a diagnosis of uterine prolapse who underwent hysterectomy between 2016 and 2019 identified in the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample, co-diagnosis of gynecologic malignancy was reported in 2,398 (1.1%) patients, and they were less likely to receive reconstructive surgery at hysterectomy (odds ratio [OR] 0.90, 95% CI 0.84-0.96). This absence of reconstructive surgery was most pronounced among patients with complete uterine prolapse and gynecologic malignancy (OR 0.68, 95% CI 0.57-0.81). The association was also consistent in coexisting gynecologic premalignancy (n=3,357 [1.6%]). In conclusion, this national-level assessment suggests that patients with uterine prolapse and coexisting gynecologic malignancy or premalignancy may be less likely to receive reconstructive surgery for pelvic floor dysfunction at hysterectomy.

Benefits of the Enhanced Recovery After Surgery (ERAS) Pathway With Quadratus Lumborum Blocks for Minimally Invasive Gynecologic Surgery Patients: A Retrospective Cohort Study.

STUDY OBJECTIVE: This study aimed to determine the effect of the implementation of the Enhanced Recovery After Surgery (ERAS) protocol among patients receiving minimally invasive gynecologic surgery. DESIGN AND SETTING: This retrospective cohort study was performed in a tertiary care hospital. PATIENTS: A total of 328 females who underwent minimally invasive gynecologic surgeries requiring at least one overnight stay at Keck Hospital of University of Southern California (USC), California, USA, from 2016 to 2020 were included in this study. INTERVENTIONS: The institutional ERAS protocol was implemented in late 2018. A total of 186 patients from 2016 to 2018 prior to the implementation were compared to 142 patients from 2018 to 2020 after the implementation. Intraoperatively, the ERAS group received a multimodal analgesic regimen (including bilateral quadratus lumborum (QL) blocks) and postoperative care geared toward a satisfactory, safe, and expeditious discharge. MEASUREMENTS AND MAIN RESULTS: The two groups were similar in demographics, except for the shorter surgical time noted in the ERAS group. The median opioid use was significantly less among the ERAS patients compared with the non-ERAS patients on postoperative day 1 (7.5 vs. 14.3 mg; p<0.001) and throughout the hospital stay (17.4 vs. 36.2 mg; p<0.001). The ERAS group also had a shorter median hospital length of stay compared to the non-ERAS group (p<0.01). Among patients with a malignant diagnosis, patients in the ERAS group had significantly less postoperative day 1 and total opioid use and a shorter hospital stay (p<0.01). Within the ERAS group, 20% of the patients did not end up receiving a QL block. Opioid use and length of stay were similar between patients who did and did not receive the QL block. CONCLUSIONS: The ERAS pathway was associated with a reduction in opioid use postoperatively and a shorter length of hospital stay after minimally invasive gynecologic surgery. There was a more significant decrease in opioid use and hospital length of stay for patients with malignant diagnoses compared to patients with benign diagnoses. Further research can be done to fully delineate the effect of QL blocks in ERAS protocols.