Effect of Medicaid expansion on cancer treatment and survival among Medicaid beneficiaries and the uninsured.

BACKGROUND: The Affordable Care Act expanded Medicaid coverage for people with low income in the United States. Expanded insurance coverage could promote more timely access to cancer treatment, which could improve overall survival (OS), yet the long-term effects of Medicaid expansion (ME) remain unknown. We evaluated whether ME was associated with improved timely treatment initiation (TTI) and 3-year OS among patients with breast, cervical, colon, and lung cancers who were affected by the policy. METHODS: Medicaid-insured or uninsured patients aged 40-64 with stage I-III breast, cervical, colon, or non-small cell lung cancer within the National Cancer Database (NCDB). A difference-in-differences (DID) approach was used to compare changes in TTI (within 60 days) and 3-year OS between patients in ME states versus nonexpansion (NE) states before (2010-2013) and after (2015-2018) ME. Adjusted DID estimates for TTI and 3-year OS were calculated using multivariable linear regression and Cox proportional hazards regression models, respectively. RESULTS: ME was associated with a relative increase in TTI within 60 days for breast (DID = 4.6; p < 0.001), cervical (DID = 5.0 p = 0.013), and colon (DID = 4.0, p = 0.008), but not lung cancer (p = 0.505). In Cox regression analysis, ME was associated with improved 3-year OS for breast (DID hazard ratio [HR] = 0.82, p = 0.009), cervical (DID-HR = 0.81, p = 0.048), and lung (DID-HR = 0.87, p = 0.003). Changes in 3-year OS for colon cancer were not statistically different between ME and NE states (DID-HR, 0.77; p = 0.075). CONCLUSIONS: Findings suggest that expanded insurance coverage can improve treatment and survival outcomes among low income and uninsured patients with cancer. As the debate surrounding ME continues nationwide, our findings serve as valuable insights to inform the development of policies aimed at fostering accessible and affordable healthcare for all.

Long-term follow-up of levonorgestrel intrauterine device for atypical hyperplasia and early endometrial cancer reveals relapse characterized by immune exhaustion.

BACKGROUND: Nonsurgical treatment options are increasingly needed for endometrial atypical hyperplasia (AH) and endometrioid endometrial cancer (EEC). Despite promising initial response rates, prospective long-term data and determinants for relapse are limited. METHODS: Follow-up data from patients in our prospective phase II trial of LIUD for AH/G1EEC were collected from medical records. Spatial transcriptomics (Nanostring GeoMX digital spatial profiling) with in silico cell type deconvolution and pathway analyses were employed on longitudinal biopsy samples from five patients across pre-treatment, on-treatment, and relapse. RESULTS: Of 43 participants exhibiting initial response to LIUD, 41 had follow-up data. Sixteen (39%) experienced relapse. Clinical factors associated with shorter response duration included younger age, initial diagnosis of G1EEC, lack of response at six months, premenopausal status, and Hispanic ethnicity (p<0.05), but only six-month response status remained a significant predictor in a multivariate model (p=0.023). LIUD increased abundance of NK cells (DMCP-counter score=46.13, FDR=0.004) and cytotoxic lymphocytes (DMCP-counter score=277.67, FDR=0.004), as well as lymphocyte cytotoxicity markers PRF1 (log2FC=1.62, FDR=0.025) and GZMA (log2FC=2.47, FDR=0.008). NK cells were reduced at relapse (DMCP-counter score=-55.96, FDR=0.02). Immune-related pathways (IFNα-response and TGFß-signaling) were enriched at relapse (FDR<0.05). IDO1 expression, reflecting immune exhaustion, was upregulated at relapse (FDR<0.05). CONCLUSIONS: Upfront resistance and relapse after initial response to LIUD for AH/G1EEC impacts nearly half of patients, remaining a major hurdle for non-surgical treatment of AH/G1EEC. Molecular studies evaluating longitudinal biopsies from a small cohort implicate immune mechanisms at relapse, including reversal of progestin-related immunomodulation and increased immune exhaustion.

Randomized phase 2 trial of tremelimumab and durvalumab in combination versus sequentially in recurrent platinum-resistant ovarian cancer.

BACKGROUND: Single-agent immune checkpoint inhibitors (ICIs) have demonstrated limited responses in recurrent ovarian cancer; however, 30%-40% of patients achieve stable disease. The primary objective was to estimate progression-free survival (PFS) after sequential versus combination cytotoxic T-lymphocyte antigen 4 and programmed death ligand 1 ICIs in patients with platinum-resistant high-grade serous ovarian cancer (HGSOC). METHODS: Patients were randomized to a sequential arm (tremelimumab followed by durvalumab on progression) or a combination arm (tremelimumab plus durvalumab, followed by durvalumab) via a Bayesian adaptive design that made it more likely for patients to be randomized to the more effective arm. The primary end point was immune-related PFS (irPFS). RESULTS: Sixty-one subjects were randomized to sequential (n = 38) or combination therapy (n = 23). Thirteen patients (34.2%) in the sequential arm received durvalumab. There was no difference in PFS in the sequential arm (1.84 months; 95% CI, 1.77-2.17 months) compared with the combination arm (1.87 months; 95% CI, 1.77-2.43 months) (p = .402). In the sequential arm, no responses were observed, although 12 patients (31.6%) demonstrated stable disease. In the combination arm, two patients (8.7%) had partial response, whereas one patient (4.4%) had stable disease. Adverse events were consistent with those previously reported for ICIs. Patient-reported outcomes were similar in both arms. CONCLUSIONS: There was no difference in irPFS for combination tremelimumab plus durvalumab compared to tremelimumab alone (administered as part of a sequential treatment strategy) in a heavily pretreated population of patients with platinum-resistant HGSOC. Response rates were comparable to prior reports, although the combination regimen did not add significant benefit, as has been previously described.

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer.

Hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment modality that aims to target the main site of tumor dissemination in ovarian cancer, the peritoneum, by combining the benefits of intraperitoneal chemotherapy with the synergistic effects of hyperthermia all during a single administration at the time of cytoreductive surgery. High-quality evidence currently only supports the use of HIPEC with cisplatin at the time of interval cytoreduction after neoadjuvant chemotherapy for stage III epithelial ovarian cancer. Many questions remain, including HIPEC's role at other timepoints in ovarian cancer treatment, who are optimal candidates, and specifics of HIPEC protocols. This article reviews the history of normothermic and hyperthermic intraperitoneal chemotherapy in ovarian cancer and evidence regarding HIPEC implementation and patient outcomes. Additionally, this review explores details of HIPEC technique and perioperative care, cost considerations, complication and quality of life data, disparities in HIPEC use, and unresolved issues.

Assessing the predictive accuracy of the new vaginal birth after cesarean delivery calculator.

BACKGROUND: The vaginal birth after cesarean delivery calculator by the Maternal-Fetal Medicine Units Network was created to help providers counsel patients on predicted success of trial of labor after cesarean delivery using individualized risk assessment. The inclusion of race and ethnicity as predictors of vaginal birth after cesarean delivery in the 2007 calculator was problematic and potentially exacerbated racial disparities in obstetrics. Thus, a modified calculator without race and ethnicity was published in June 2021. OBJECTIVE: This study aimed to assess the accuracy of the 2007 and 2021 Maternal-Fetal Medicine Units vaginal birth after cesarean delivery calculators in predicting vaginal birth after cesarean delivery success among racial/ethnic minority patients receiving obstetrical care at a single urban tertiary medical center. STUDY DESIGN: All patients with 1 previous low transverse cesarean delivery who underwent a trial of labor at term with a vertex singleton gestation at an urban tertiary medical center from May 2015 to December 2018 were reviewed. Demographic and clinical data were collected retrospectively. Associations between maternal characteristics and success of vaginal birth after cesarean delivery were assessed using univariate and multivariable logistic regression. Predicted vaginal birth after cesarean delivery success rates using the Maternal-Fetal Medicine Units calculator were compared with actual outcomes (ie, successful trial of labor after cesarean delivery/vaginal birth after cesarean delivery vs repeated cesarean delivery) across each racial and ethnic group. RESULTS: A total of 910 patients met eligibility criteria and attempted trial of labor after cesarean delivery; 662 (73%) achieved vaginal birth after cesarean delivery. The rate of vaginal birth after cesarean delivery was highest among Asian women (81%) and lowest among Black women (61%). Univariate analyses demonstrated that success of vaginal birth after cesarean delivery was associated with maternal body mass index <30 kg/m2, history of vaginal delivery, and absence of indication of arrest of dilation or descent for previous cesarean delivery. Multivariate analyses evaluating predictors of vaginal birth after cesarean delivery reported in the 2021 calculator showed that maternal age, history of arrest disorder for previous cesarean delivery, and treated chronic hypertension were not significant in our patient population. Most patients who were of White, Asian, or "Other" race with a vaginal birth after cesarean delivery had a 2007 calculator-predicted probability of vaginal birth after cesarean delivery of >65%, whereas most Black and Hispanic patients with a vaginal birth after cesarean delivery were more likely to have a predicted probability of vaginal birth after cesarean delivery between 35% and 65% (P<.001). Most White, Asian, and Other-race patients with a repeated cesarean delivery had a 2007 calculator-predicted probability of vaginal birth after cesarean delivery of >65%, whereas most Black and Hispanic patients with a repeated cesarean delivery had a predicted probability of vaginal birth after cesarean delivery between 35% and 65%. Across all racial and ethnic groups, most patients with a vaginal birth after cesarean delivery had a 2021 calculator-predicted probability of vaginal birth after cesarean delivery of >65%. CONCLUSION: The inclusion of race/ethnicity in the 2007 Maternal-Fetal Medicine Units vaginal birth after cesarean delivery calculator underestimated predicted vaginal birth after cesarean delivery success rates among Black and Hispanic patients receiving obstetrical care at an urban tertiary medical center. Thus, we support the use of the 2021 vaginal birth after cesarean delivery calculator without race/ethnicity. Excluding race and ethnicity from vaginal birth after cesarean delivery counseling may be one way in which providers can ultimately contribute toward the reduction of racial and ethnic disparity in maternal morbidity in the United States. Further research is needed to understand the implications of treated chronic hypertension for the success of vaginal birth after cesarean delivery.

Establishing an Association between Polycystic Ovarian Syndrome and Pilonidal Disease in Adolescent Females.

STUDY OBJECTIVE: We sought to determine whether pilonidal disease (PD) is associated with polycystic ovarian syndrome (PCOS) in adolescent females. DESIGN: Retrospective cohort study SETTING: Urban tertiary children's hospital PARTICIPANTS: All girls aged 12 to 21 who received a diagnosis of PD and/or PCOS from 2012 to 2019 INTERVENTIONS: Treatment for PCOS and PD MAIN OUTCOME MEASURES: The variables analyzed included age, race/ethnicity, body mass index, age at menarche, tobacco use, payer status, treatment of PCOS and PD, and serum markers of hyperandrogenism and metabolic syndrome. RESULTS: During the study period, 100,043 patients presented to an urban tertiary medical center. Of these patients, 966 were diagnosed with PD, and 219 were diagnosed with both PD and PCOS. Compared with patients with only PD, patients with both diagnoses had a higher body mass index (31.4 vs 27.4 kg/m2; P < .01) and were older (18.76 vs 18.30 years; P = .003). The prevalence ratio for patients with PD having PCOS per the original Rotterdam criteria was 26.1 (CI, 22.0-31.0) and 28.7 (CI, 24.3-33.9) for having PCOS per the modified Rotterdam criteria. Patients with both diagnoses were less likely to receive intervention for PD (OR = 0.22; CI, 0.13-0.37; P < .001). CONCLUSIONS: Adolescent females diagnosed with PD are likely to demonstrate features of PCOS. PCOS treatment could positively alter the disease course of PD. As such, surgical providers should consider referring adolescent females with PD to endocrinologists, gynecologists, and adolescent medicine specialists for evaluation of PCOS.

Systematic Literature Review of Pediatric Male and Female Genital Hair Thread Tourniquet Syndrome.

OBJECTIVE: The aim of this study was to describe genital hair thread tourniquet syndrome (HTTS) and its treatment by pediatric and adolescent health care providers through a systematic literature review. METHODS: We performed a systematic literature review on pediatric male and female genital HTTS. Studies were included if they involved genital HTTS in males or females 21 years and younger and were published in English. The main outcomes were body parts involved, symptoms, treatment, anesthetic type, providers involved in diagnosis and management, and implications of delayed or missed diagnosis. RESULTS: There were 38 female cases from 33 publications (1973-2020) and 147 male cases from 47 publications (1951-2019). The average age among females and males was 9.1 and 5.1 years, respectively. Among cases involving female patients, 93% of them were premenarchal; patients were circumcised in 90% of reviewed cases of male HTTS. The most commonly involved body parts were clitoris and labia minora in females, and penis and urethra in males. Males most commonly presented with edema and urinary symptoms, whereas females most commonly presented with edema and pain. General anesthesia was used for tourniquet excision in most cases. Male and female genital HTTS were mostly managed by urologists and emergency medicine physicians, respectively. CONCLUSION: This systematic literature review of more than 150 cases of male and female genital HTTS describes evaluation and management of genital HTTS spanning 7 decades. The main treatment of genital HTTS remains prompt diagnosis and removal of the tourniquet, as well as education on prevention strategies. Delayed diagnosis due to lack of recognition of the HTTS can lead to serious sequelae. Development of national guidelines regarding best practices in management of genital HTTS disseminated to all providers taking care of pediatric and adolescent patients will lead to improved patient care.

Microtubule-Interfering Drugs: Current and Future Roles in Epithelial Ovarian Cancer Treatment.

Taxanes and epothilones are chemotherapeutic agents that ultimately lead to cell death through inhibition of normal microtubular function. This review summarizes the literature demonstrating their current use and potential promise as therapeutic agents in the treatment of epithelial ovarian cancer (EOC), as well as putative mechanisms of resistance. Historically, taxanes have become the standard of care in the front-line and recurrent treatment of epithelial ovarian cancer. In the past few years, epothilones (i.e., ixabepilone) have become of interest as they may retain activity in taxane-treated patients since they harbor several features that may overcome mechanisms of taxane resistance. Clinical data now support the use of ixabepilone in the treatment of platinum-resistant or refractory ovarian cancer. Clinical data strongly support the use of microtubule-interfering drugs alone or in combination in the treatment of epithelial ovarian cancer. Ongoing clinical trials will shed further light into the potential of making these drugs part of current standard practice.

Trastuzumab tolerability in the treatment of advanced (stage III-IV) or recurrent uterine serous carcinomas that overexpress HER2/neu.

OBJECTIVE: Due to previously reported trastuzumab safety concerns and the scant data available in endometrial cancer patients, we sought to assess the safety, tolerability and toxicity profile of trastuzumab in patients with advanced/recurrent uterine serous carcinoma (USC) that overexpress HER2/neu in our multicenter randomized phase II trial. METHODS: Patients were randomized 1:1 to receive carboplatin/paclitaxel (C/P) for 6 cycles ± trastuzumab (T) with the experimental arm continuing to receive single agent trastuzumab maintenance treatment until disease progression/toxicity. Progression-free-survival was the primary endpoint; overall-survival and toxicity were secondary endpoints. Adverse events (AEs) were compared between treatment arms. RESULTS: There were 28 patients in the C/P arm and 32 patients in the experimental (C/P + T) arm. Fifty-eight patients (97%) experienced 977 treatment-related AEs of which 875 (89.6%) were low-grade (grade 1-2) and 102 (10.4%) were high-grade (grade 3-5). The mean ± standard deviation of AEs per patient was 15.5 ± 16.3 in the C/P arm and 17.0 ± 16.0 in the C/P + T arm. Gastrointestinal AEs were the most common in both arms (n = 155, 15.7%) of which 94.2% were low-grade (n = 146). Importantly, no significant difference between treatment arms was detected in any system-organ class of AE including cardiac AE. Five (17%) of 29 patients who received prolonged trastuzumab maintenance therapy had no sign of cumulative toxicity after an average (range) of 5.1 (4.2-6.3) years. CONCLUSIONS: Trastuzumab appears to be safe and has a manageable toxicity profile both when used in combination with chemotherapy and when used for single agent maintenance in patients with HER2/neu positive USC. This safety profile is reassuring given the proven efficacy of trastuzumab in advanced/recurrent HER2/neu positive USC.

Diagnosis of dengue fever in a patient with early pregnancy loss.

Dengue is a mosquito-borne virus that causes an influenza-like illness ranging in severity from asymptomatic to fatal. Dengue in pregnancy has been associated with adverse outcomes including miscarriage, preterm birth and fetal and neonatal death. We present the case of a multiparous woman who presented at 9 weeks' gestation with vaginal bleeding and abdominal cramping after a 1 month stay in Mexico. She was initially diagnosed with miscarriage with plan for outpatient follow-up. She was readmitted 3 days later with fever, retro-orbital pain, arthralgia, rash, pancytopenia and transaminitis and managed with intravenous fluids and acetaminophen. Of note, dengue serology was initially negative but retesting 2 days later was positive. It is imperative that clinicians have heightened suspicion for dengue in pregnant women with history of travel to or residence in a dengue-endemic area and consistent clinical evidence.

Medically Indicated Labiaplasty in a Case of Recurrent Labial Hair Thread Tourniquet Syndrome in a Premenarchal Girl.

BACKGROUND: Despite controversy surrounding labiaplasty in adolescent girls, labiaplasty might be indicated in the case of recurrent labial hair thread tourniquet syndrome (HTTS). CASE: We describe a case of an 11-year-old girl with recurrent labial HTTS who underwent labiaplasty. SUMMARY AND CONCLUSION: Recurrent labial HTTS can lead to disfigurement and partial loss of labium. Labiaplasty can restore normal anatomy of the labia and prevent further recurrence in select cases.

Postpartum urinary retention: a survey of obstetrics and gynaecology residents in the United States.

Postpartum urinary retention (PUR) is a common and potentially morbid condition if not recognised and managed promptly. We surveyed obstetrics and gynaecology (OBGYN) residents to determine residents' knowledge of the management of PUR. A total of 168 OBGYN residents in ACGME accredited programmes in the United States completed the survey. A percentage of 30.3 reported having a PUR prevention protocol at their institution, 43.3% reported not having a protocol and 26.7% did not know whether a protocol existed. About 89.3% of participants reported having previously taken care of a patient with PUR and 17.1% reported prior formal teaching on the management of PUR. Those who reported having a protocol were more likely to report feeling comfortable managing PUR. Overall, knowledge was low for management of PUR. Given the potential morbidity associated with inadequate management of PUR, formal education and standardisation through national guidelines may help improve care of patients with PUR.Impact statementWhat is already known on this subject? PUR is a common condition and if left untreated may lead to long-term impacts on patients' health. Early recognition of the condition and appropriate management can prevent these complications. Protocols have been shown to improve patient outcomes. Thus, it has been postulated that the implementation of protocols could improve recognition of the condition.What do the results of this study add? No previous studies have looked at the impact of PUR management protocols on physicians in training. Because physicians in training are often the first-in-line to manage patients at academic institutions, we sought to determine the proportion of obstetrics and gynaecology residents in the United States who report having a PUR management protocol at their institution and how this impacts their reported comfort at caring for patients with PUR, knowledge on PUR risk factors and recognition of scenarios concerning for PUR. While awareness of a PUR protocol did not lead to increased knowledge of risk factors or increased recognition of scenarios concerning for PUR, it did increase resident comfort with managing PUR patients. We also found that overall PUR knowledge was low.What are the implications of these findings for clinical practice and/or further research? Based on our findings, OBGYN residents would benefit from having protocols at their institutions since it increased their comfort at managing patients with PUR. Further, formal education on PUR is likely needed to improve knowledge of risk factors and recognition of scenarios concerning for PUR.

Sex Ed by Brown Med: A Student-Run Curriculum and Its Impact on Sexual Health Knowledge.

BACKGROUND AND OBJECTIVES: Risky sexual behavior among adolescents is a public health crisis. We describe a novel approach to sexual health education where medical students manage a curriculum for an entire seventh grade in one Rhode Island city to better equip students with comprehensive knowledge about sexual health. METHODS: Medical students were trained to teach 12 sessions to seventh-grade students under the supervision of the classroom teacher using a curriculum designed by medical students and faculty (modeled on the Family Life and Sexual Health [FLASH] curriculum but tailored to meet the community's needs). Pre- and postassessment surveys were conducted during the 2015-2016 academic year. We analyzed survey data collected pre- and postprogram using IBM SPSS Statistics. RESULTS: Pre and postassessments were completed by 62% of students (74/120). Students completing the curriculum scored 8% higher on the postassessment vs the preassessment, (70.4% vs 62.32%, absolute difference=8.11%, P<0.001). Student knowledge improved in domains of pregnancy prevention, reproductive system/anatomy, general knowledge and prevention of sexually transmitted infections (STIs), safe sex practices, sexual assault, and sexual decision making. Respondents' perception of the importance of school-based sexual health lessons as well as their willingness to discuss sexual issues with an adult increased after completing the program. CONCLUSIONS: A year-long, middle school-based sexual health program taught by medical students showed significant improvements in sexual health knowledge and increased willingness to engage in dialogue about sex with trusted adults. Adolescents may benefit from long-term interaction and instruction about sexual education from medical students.

Medical students help bridge the gap in sexual health education among middle school youth.

BACKGROUND: School-based programs are important in addressing risky teenage sexual behavior. We implemented a sex education program using trained medical student volunteers. METHODS: Medical students (n=30) implemented a seven-session curriculum, designed by medical students and faculty, to 7th and 8th grade students (n=310) at a local school. Middle school students completed pre- and post-assessments. Teachers and medical students completed questionnaires relating their perceptions of students' attitudes and understanding of sexual health. RESULTS: Students completing the curriculum scored 5% higher on post- versus pre-assessment (84% vs 78.7%, p<0.001). Statistically significant gains were noted in knowledge of reproductive system anatomy, community resources, and sexual decision making. Sixty percent of middle school teachers compared to only 16.7% of medical student volunteers reported discomfort teaching sexual health. DISCUSSION: Sexual education delivered by trained medical student volunteers may improve middle schoolers' understanding of sexual health. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].