Broadening Eligibility Criteria and Diversity among Patients for Cancer Clinical Trials.

BACKGROUND: Certain populations have been historically underrepresented in clinical trials. Broadening eligibility criteria is one approach to inclusive clinical research and achieving enrollment goals. How broadened trial eligibility criteria affect the diversity of eligible participants is unknown. METHODS: Using a nationwide electronic health record-derived deidentified database, we identified a retrospective cohort of patients diagnosed with 22 cancer types between April 1, 2013 and December 31, 2022 who received systemic therapy (N=235,234) for cancer. We evaluated strict versus broadened eligibility criteria using performance status and liver, kidney, and hematologic function around first line of therapy. We performed logistic regression to estimate odds ratios for exclusion by strict criteria and their association with measures of patient diversity, including sex, age, race or ethnicity, and area-level socioeconomic status (SES); estimated the impact of broadening criteria on the number and distribution of eligible patients; and performed Cox regression to estimate hazard ratios for real-world overall survival (rwOS) comparing patients meeting strict versus broadened criteria. RESULTS: When applying common strict cutoffs for eligibility criteria to patients with complete data and weighting each cancer type equally, 48% of patients were eligible for clinical trials. Female (odds ratio, 1.30; 95% confidence interval [CI], 1.25 to 1.35), older (age 75+ vs. 18 to 49 years old: odds ratio, 3.04; 95% CI, 2.85 to 3.24), Latinx (odds ratio, 1.46; 95% CI, 1.39 to 1.54), non-Latinx Black (odds ratio, 1.11; 95% CI, 1.06 to 1.16), and lower-SES patients were more likely to be excluded using strict eligibility criteria. Broadening criteria increased the number of eligible patients by 78%, with the strongest impact for older, female, non-Latinx Black, and lower-SES patients. Patients who met only broadened criteria had worse rwOS versus those with strict criteria (hazard ratio, 1.31; 95% CI, 1.27 to 1.34). CONCLUSIONS: Data-driven evaluation of clinical trial eligibility criteria may optimize the eligibility of certain historically underrepresented groups and promote access to more inclusive trials. (Sponsored by Flatiron Health.).

Sex Differences in Odds of Brain Metastasis and Outcomes by Brain Metastasis Status after Advanced Melanoma Diagnosis.

Sex differences in cancer are well-established. However, less is known about sex differences in diagnosis of brain metastasis and outcomes among patients with advanced melanoma. Using a United States nationwide electronic health record-derived de-identified database, we evaluated patients diagnosed with advanced melanoma from 1 January 2011-30 July 2022 who received an oncologist-defined rule-based first line of therapy (n = 7969, 33% female according to EHR, 35% w/documentation of brain metastases). The odds of documented brain metastasis diagnosis were calculated using multivariable logistic regression adjusted for age, practice type, diagnosis period (pre/post-2017), ECOG performance status, anatomic site of melanoma, group stage, documentation of non-brain metastases prior to first-line of treatment, and BRAF positive status. Real-world overall survival (rwOS) and progression-free survival (rwPFS) starting from first-line initiation were assessed by sex, accounting for brain metastasis diagnosis as a time-varying covariate using the Cox proportional hazards model, with the same adjustments as the logistic model, excluding group stage, while also adjusting for race, socioeconomic status, and insurance status. Adjusted analysis revealed males with advanced melanoma were 22% more likely to receive a brain metastasis diagnosis compared to females (adjusted odds ratio [aOR]: 1.22, 95% confidence interval [CI]: 1.09, 1.36). Males with brain metastases had worse rwOS (aHR: 1.15, 95% CI: 1.04, 1.28) but not worse rwPFS (adjusted hazard ratio [aHR]: 1.04, 95% CI: 0.95, 1.14) following first-line treatment initiation. Among patients with advanced melanoma who were not diagnosed with brain metastases, survival was not different by sex (rwOS aHR: 1.06 [95% CI: 0.97, 1.16], rwPFS aHR: 1.02 [95% CI: 0.94, 1.1]). This study showed that males had greater odds of brain metastasis and, among those with brain metastasis, poorer rwOS compared to females, while there were no sex differences in clinical outcomes for those with advanced melanoma without brain metastasis.

Systemic Anticancer Therapy and Overall Survival in Patients With Very Advanced Solid Tumors.

Importance: Two prominent organizations, the American Society of Clinical Oncology and the National Quality Forum (NQF), have developed a cancer quality metric aimed at reducing systemic anticancer therapy administration at the end of life. This metric, NQF 0210 (patients receiving chemotherapy in the last 14 days of life), has been critiqued for focusing only on care for decedents and not including the broader population of patients who may benefit from treatment. Objective: To evaluate whether the overall population of patients with metastatic cancer receiving care at practices with higher rates of oncologic therapy for very advanced disease experience longer survival. Design, Setting, and Participants: This nationwide population-based cohort study used Flatiron Health, a deidentified electronic health record database of patients diagnosed with metastatic or advanced disease, to identify adult patients (aged ≥18 years) with 1 of 6 common cancers (breast cancer, colorectal cancer, non-small cell lung cancer [NSCLC], pancreatic cancer, renal cell carcinoma, and urothelial cancer) treated at health care practices from 2015 to 2019. Practices were stratified into quintiles based on retrospectively measured rates of NQF 0210, and overall survival was compared by disease type among all patients treated in each practice quintile from time of metastatic diagnosis using multivariable Cox proportional hazard models with a Bonferroni correction for multiple comparisons. Data were analyzed from July 2021 to July 2023. Exposure: Practice-level NQF 0210 quintiles. Main Outcome and Measure: Overall survival. Results: Of 78 446 patients (mean [SD] age, 67.3 [11.1] years; 52.2% female) across 144 practices, the most common cancer types were NSCLC (34 201 patients [43.6%]) and colorectal cancer (15 804 patients [20.1%]). Practice-level NQF 0210 rates varied from 10.9% (quintile 1) to 32.3% (quintile 5) for NSCLC and 6.8% (quintile 1) to 28.4% (quintile 5) for colorectal cancer. No statistically significant differences in survival were observed between patients treated at the highest and the lowest NQF 0210 quintiles. Compared with patients seen at practices in the lowest NQF 0210 quintiles, the hazard ratio for death among patients seen at the highest quintiles varied from 0.74 (95% CI, 0.55-0.99) for those with renal cell carcinoma to 1.41 (95% CI, 0.98-2.02) for those with urothelial cancer. These differences were not statistically significant after applying the Bonferroni-adjusted critical P = .008. Conclusions and Relevance: In this cohort study, patients with metastatic or advanced cancer treated at practices with higher NQF 0210 rates did not have improved survival. Future efforts should focus on helping oncologists identify when additional therapy is futile, developing goals of care communication skills, and aligning payment incentives with improved end-of-life care.

Systemic Anticancer Therapy at the End of Life-Changes in Usage Pattern in the Immunotherapy Era.

This cohort study evaluates the rate of systemic anticancer therapy use among patients dying of cancer.

Why it's hard to see a dermatologist for a skin exam: the patient perspective.

BACKGROUND: In-office skin exams are recommended at least annually for patients who are diagnosed with a basal cell carcinoma or squamous cell carcinoma, but it is unknown what proportion of these patients are receiving skin exams. There are a multitude of reasons why patients have difficulty getting skin exams. AIM: To assess the proportion of patients at our institution who received a skin exam in the 12 months following removal of a basal cell carcinoma or squamous cell carcinoma by Mohs micrographic surgery and to assess the barriers to care that patients faced in receiving a skin exam. METHODS: We conducted an IRB-approved online patient survey. RESULTS: 161 survey respondents said they were able to get a skin exam and 14 said they were not. Patients who did not receive a skin exam agreed significantly more often with the following barriers to care: patient's own schedule, dermatologists' availability, and not knowing a skin exam was recommended (p < 0.005). Patients who did not receive a skin exam said that a reminder text/email/phone call would make them more likely to receive a skin exam. CONCLUSIONS: Patients identify their own schedule, the provider's schedule, and not knowing that a skin exam is recommended as factors making it more difficult for them to receive a skin exam. It is likely that further emphasis about the importance of skin exams, written instructions, or text/email/phone call reminders would make patients who have been previously diagnosed with basal cell carcinoma or squamous cell carcinoma more likely to receive skin exams.

Cochlear Implantation in Patients With Menière's Disease: Does Disease Activity Affect the Outcome?

OBJECTIVE: Menière's disease (MD) is characterized by episodes of vertigo, tinnitus, and sensorineural hearing loss. In the setting of bilateral deafness due to MD alone or contralateral pathology, cochlear implantation (CI) improves hearing. Active MD is characterized by fluctuating auditory symptoms and vertigo; whereas remittance of vertiginous symptoms and severe, permanent sensorineural hearing loss characterizes the inactive disease state. This study evaluates outcomes for MD patients compared with the general CI population and assesses if disease activity affects implant outcomes. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: Twenty-four patients with MD that received CI (7 active, 16 inactive, and 1 Probable Menière's), and 24 age-matched controls. INTERVENTIONS: Cochlear implantation. MAIN OUTCOME MEASURES: Word Recognition Score, Sentence Recognition Score (SRS), and Speech Reception Threshold. RESULTS: Best-aided preoperative and postoperative audiometric data were compared per ear between MD patients and controls and stratified by disease status using descriptive statistics with mixed-effects modeling. Patients with MD derived significantly more benefit from CI than controls when comparing differences between preoperative and postoperative levels for Word Recognition Score (12.2%, p = 0.0236), SRS (12.8%, p = 0.0375), and Speech Reception Threshold (-14.4 dB, p = 0.0188). Active disease status does not negatively impact CI outcomes and patients with active MD may benefit from greater gains in SRS (23.5%, p = 0.0107). CONCLUSIONS: CI provides greater gains in functional hearing for patients with MD compared with age-matched controls. Patients with active MD seem to perform better with respect to SRS following CI than patients with inactive status.

Impact of multidisciplinary engagement in a quality improvement blood conservation protocol for craniosynostosis.

OBJECTIVE: Patients undergoing open cranial vault remodeling for craniosynostosis frequently experience substantial blood loss requiring blood transfusion. Multiple reports in the literature have evaluated the impact of individual blood conservation techniques on blood transfusion rates during craniosynostosis surgery. The authors engaged a multidisciplinary team and assessed the impact of input from multiple stakeholders on the evolution of a comprehensive quality improvement protocol aimed at reducing or eliminating blood transfusion in patients undergoing open surgery for craniosynostosis. METHODS: Over a 4-year period from 2012 to 2016, 39 nonsyndromic patients were operated on by a single craniofacial plastic surgeon. Initially, no clear blood conservation protocol existed, and specific interventions were individually driven. In 2014, a new pediatric neurosurgeon joined the craniofacial team, and additional stakeholders in anesthesiology, transfusion medicine, critical care, and hematology were brought together to evaluate opportunities for developing a comprehensive blood conservation protocol. The initial version of the protocol involved the standardized administration of intraoperative aminocaproic acid (ACA) and the use of a cell saver. In the second version of the protocol, the team implemented the preoperative use of erythropoietin (EPO). In addition, intraoperative and postoperative resuscitation and transfusion guidelines were more clearly defined. The primary outcomes of estimated blood loss (EBL), transfusion rate, and intraoperative transfusion volume were analyzed. The secondary impact of multidisciplinary stakeholder input was inferred by trends in the data obtained with the implementation of the partial and full protocols. RESULTS: Implementing the full quality improvement protocol resulted in a 66% transfusion-free rate at the time of discharge compared to 0% without any conservation protocol and 27% with the intermediate protocol. The administration of EPO significantly increased starting hemoglobin/hematocrit (11.1 g/dl/31.8% to 14.7 g/dl/45.6%, p < 0.05). The group of patients receiving ACA had lower intraoperative EBL than those not receiving ACA, and trends in the final-protocol cohort, which had received both preoperative EPO and intraoperative ACA, demonstrated decreasing transfusion volumes, though the decrease did not reach statistical significance. CONCLUSIONS: Patients undergoing open calvarial vault remodeling procedures benefit from the input of a multidisciplinary stakeholder group in blood conservation protocols. Further research into comprehensive protocols for blood conservation may benefit from input from the full surgical team (plastic surgery, neurosurgery, anesthesiology) as well as additional pediatric subspecialty stakeholders including transfusion medicine, critical care, and hematology.

Disparities in the use of stereotactic radiosurgery for the treatment of lung cancer brain metastases: a SEER-Medicare study.

Stereotactic radiosurgery (SRS) is a costly procedure used to irradiate disease tissue while sparing healthy tissue, ideally limiting the side effects of treatment. SRS is frequently used in the setting of lung cancer, which is associated with greater rates of BM, though its cost may lead to potentially inequitable use across patient populations. This study investigates potential disparities in the use of SRS to treat Medicare patients. Surveillance, Epidemiology, and End-Results cancer registry data for patients diagnosed between the years 2010 and 2012 were examined to identify lung cancer patients diagnosed with BM at the same time as their primary cancer (SBM). Medicare claims for SRS were identified; the odds of having SRS claims and hazards of mortality associated with those odds were examined with respect to various clinical and demographic characteristics. Of 74,142 Medicare-enrolled patients diagnosed with lung cancer, 9192 were diagnosed with SBM and 3259 of those patients received SRS. Adjusting for clinical and demographic characteristics, males with SBM had 0.85 times the odds of SRS compared to females with SBM. Black patients and those of other race had significantly lower odds of evidence of SRS compared to WNH patients. SRS may not be delivered equitably among Medicare patients. Males and minority patients may have decreased odds of SRS and worse survival compared to female and WNH patients, respectively.

Revisiting the "July Effect" in Plastic Surgery: New Data to Support Resident Autonomy.

BACKGROUND: The "July Effect" represents a topic of considerable interest across residency programs. This study investigated the frequency of postoperative complications following procedures with plastic surgery resident participation (all postgraduate year [PGY] levels) during the first (quarter 3, July-September) and last academic quarters. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to calculate complication rates from 2006 to 2010. Resident involvement was analyzed as a categorical variable consisting of "juniors" (PGY1-PGY3), and "seniors" (PGY4-PGY6). Outcomes from procedures during Q3 were compared with all quarters. Propensity score matching and adjustment enabled logistic regression identifying the effect of resident involvement and admission. RESULTS: Among all cosmetic and reconstructive procedures (n = 6625), mean operative time was not significantly greater in Q3 compared with all other quarters (P = 0.069); no significant differences in complication rates were observed between Q3 and all other quarters, though superficial surgical site infection (SSI) approached significance (3.3% of procedures in Q3 vs 2.5% in all other quarters, P = 0.063). Among reconstructive procedures only (n = 5677), mean operative time was not significantly greater in Q3 compared with all other quarters (P = 0.119); the same held true for cosmetic procedures only (P = 0.275). Surgical site infection, however, was significantly more likely to occur with reconstructive procedures only, in Q3 compared with all other quarters (3.5% of cases vs 2.3%, P = 0.024). When adjusting for PGY status and matching populations, superficial SSI and return to the operating room were not significantly more common in Q3. When adjusting for quarter of admission, however, superficial SSI was significantly more common among the overall and noncosmetic cases with participation by junior residents (P = 0.013 and 0.020, respectively). CONCLUSIONS: This may represent the first fully reproducible, transparent National Surgical Quality Improvement Program study in plastic surgery that demonstrates the absence of a clinically significant "July Effect," and suggests that an appropriate degree of resident autonomy may pose minimal risk during both cosmetic and reconstructive procedures in residency training. Additionally, the findings encourage the development a plastic surgery-specific database to remedy inherent difficulties with larger, more comprehensive surgical databases.

Bevacizumab for the treatment of non-small cell lung cancer patients with synchronous brain metastases.

Bevacizumab is FDA-approved in the treatment of primary brain tumors, but its efficacy in patients with brain metastases could be better-studied. This study examines a population of non-small cell lung cancer (NSCLC) patients with synchronous brain metastases to identify predictors of the decision to use bevacizumab and survival following bevacizumab treatment. Primary cancer registry data were used to determine which NSCLC patients diagnosed in the years 2010 through 2012 had synchronous brain metastases at the time of diagnosis, and Medicare claims used to identify a population of patients treated with bevacizumab. Record of bevacizumab treatment was found for 81 and 666 patients with and without brain metastases, respectively. After adjusting for clinical and demographic characteristics, bevacizumab was associated with 0.88 times the hazard of mortality in the elderly NSCLC population (95% CI: 0.81-0.96, p: 0.003) and a corresponding hazard ratio of 0.75 in the population of elderly NSCLC patients with synchronous brain metastases (95% CI: 0.59-0.96, p: 0.020). Bevacizumab may benefit NSCLC patients with synchronous brain metastases more than it does patients without intracranial disease, possibly as a result of its multiple potential mechanisms of action simultaneously inhibiting angiogenesis and minimizing vasogenic edema.

The Importance of Reproducibility in Plastic Surgery Research.

With the advent of big data and database-driven research, the need for reproducible methods has become especially relevant. Given the rise of evidence-based practice, it is crucial to ensure that findings making use of big data can be consistently replicated by other physician-scientists. A call for transparency and reproducibility must occur at the individual, institutional, and national levels. Given the rising popularity of national and large databases in research, the responsibility of authors to ensure reproducibility of clinical research merits renewed discussion. In this article, the authors offer strategies to increase clinical research reproducibility at both the individual and institutional levels, within the context of plastic surgery.

Lifetime Occurrence of Brain Metastases Arising from Lung, Breast, and Skin Cancers in the Elderly: A SEER-Medicare Study.

BACKGROUND: The Surveillance, Epidemiology, and End Results (SEER) Program recently released data on brain metastases (BM) diagnosed during primary cancer staging workup ("synchronous" BM, or SBM); this study examines the incidence of SBM compared with that of lifetime BM (LBM) identified using Medicare claims for patients diagnosed with lung cancer, breast cancer, or melanoma. METHODS: Incidence proportions (IP) and age-adjusted rates for each of SEER SBM and Medicare LBM are presented along with measures of concordance between the two sources of data, where Medicare LBM were defined by several combinations of diagnosis and putative diagnostic imaging procedure codes. RESULTS: The SBM IP in lung, breast, and melanoma cancers were 9.6%, 0.3%, and 1.1%, respectively; the corresponding LBM IP were 13.5%, 1.8%, and 3.6%. The greatest SBM IP among patients with lung cancer was 13.4% for non-small cell lung cancer, and among patients with breast cancer was 0.7% for triple-negative breast cancer. The greatest LBM IP among lung cancers was 23.1% in small-cell lung cancer, and among breast cancers was 4.2% for cases of the triple negative subtype. CONCLUSIONS: Using a large dataset that is representative of the elderly population in the United States, these analyses estimate synchronous and lifetime incidence of BM in lung cancers, breast cancers, and melanomas. IMPACT: These and other population-based estimates may be used to guide development of BM screening policy and evaluation of real-world data sources.

Sex-specific enlarged vestibular aqueduct morphology and audiometry.

OBJECTIVE: Enlargement of the vestibular aqueduct (EVA) is one of the most common congenital malformations in pediatric patients presenting with sensorineural or mixed hearing loss. The relationship between vestibular aqueduct (VA) morphology and hearing loss across sex is not well characterized. This study assesses VA morphology and frequency-specific hearing thresholds with sex as the primary predictor of interest. MATERIALS AND METHODS: A retrospective, longitudinal, and repeated-measures study was used. 47 patients at an academic tertiary care center with hearing loss and a record of CT scan of the internal auditory canal were candidates, and included upon meeting EVA criteria after confirmatory measurements of vestibular aqueduct midpoint and operculum widths. Audiometric measures included pure-tone average and frequency-specific thresholds. RESULTS: Of the 47 patients (23 female and 24 male), 79 total ears were affected by EVA; the median age at diagnosis was 6.60 years. After comparing morphological measurements between sexes, ears from female patients were observed to have a greater average operculum width (3.25 vs. 2.70 mm for males, p = 0.006) and a greater average VA midpoint width (2.80 vs. 1.90 mm for males, p = 0.004). After adjusting for morphology, male patients' ears had pure-tone average thresholds 17.6 dB greater than female patients' ears (95% CI, 3.8 to 31.3 dB). CONCLUSIONS: Though females seem to have greater enlargement of the vestibular aqueduct, this difference does not extend to hearing loss. Therefore, our results indicate that criteria for EVA diagnoses may benefit from re-evaluation. Further exploration into morphological and audiometric discrepancies across sex may help inform both clinician and patient expectations.

A review of the utility of tacrolimus in the management of adults with autoimmune hepatitis.

BACKGROUND: There is paucity of data on alternative drug therapies for patients with autoimmune hepatitis (AIH). Tacrolimus (TAC) is a promising salvage agent. We present a review of TAC therapy in AIH patients. METHODS: A search for studies with keywords 'autoimmune hepatitis' and 'tacrolimus' was performed. Reviews, studies of AIH post-transplant and AIH in children were excluded. Diagnosis of AIH was based on criteria established by the International Autoimmune Hepatitis Group. Complete biochemical response was defined as normalisation of aspartate aminotransferase (AST <45) and alanine aminotransferase (ALT <50). No biochemical response was defined as failure to return to normalisation at the end of follow-up. Demographic information and details of pre- and post-treatment liver biopsy were collected. RESULTS: Seven articles achieved the inclusion criteria and reported data for a total of 162 adult patients. The majority of studies reported average ages approximately 35 years old. Treatment duration ranged from 1 to 136 months. Indications for therapy were mostly AIH refractory to steroid treatment or inability to tolerate standard steroid treatment. Eighty-three patients (51.2%) were reported to have pre-therapy liver biopsy. Of 49 patients for whom stage was reported, 6 patients were stage 1, 16 were stage 2, 14 were stage 3 and 13 were stage 4. Of 40 patients for whom grade was reported, 1 patient was grade 0, 3 were grade 1, 9 were grade 2, 14 were grade 3 and 13 were grade 4. Dosing regimens were between 1 and 8 mg/day. Target trough TAC serum concentrations ranged from 0.5 to 10.7 ng/mL TAC was discontinued in 28 (17.3%) patients for various reasons. Renal function remained stable in most patients. One hundred and twenty-one patients (74.7%) demonstrated complete biochemical response to treatment. Post-therapy liver biopsy was obtained for 30 (18.5%) patients, and 25 (15.4%) of these patients were noted to have histological remission according to the grade of inflammation or stage of fibrosis. CONCLUSION: TAC is relatively effective in the treatment of AIH refractory to traditional therapy. It appears that liver function can be enhanced at a minimal cost to renal function. Key Points There is a cohort of patients with autoimmune hepatitis (AIH) who do not respond to standard therapy. Alternative treatment options for these patients have been explored, but outcomes have not been comprehensively examined. We report the use and efficacy of tacrolimus (TAC) in patients with AIH. We found that TAC can be safely and effectively used in patients with AIH with minimal side effects. TAC can be a potential treatment option for patients with AIH refractory to standard therapy.

Morphology and cochlear implantation in enlarged vestibular aqueduct.

PURPOSE: The purpose of this work is to explore audiometry following cochlear implantation (CI) in patients with enlarged vestibular aqueduct (EVA) and to investigate the effects of inner ear morphological variation on post CI audiometry. METHODS: This was a retrospective review of both natural and cochlear-implant-aided audiometry results, using all available measurements in a mixed-effects model accounting for longitudinal change and the grouping structure of ears. Patients who visited our tertiary academic medical center between 2000 and 2016 were identified as having EVA according to Cincinnati criteria on radiological examination; patients eligible for CI were then selected for analysis. RESULTS: Multivariable modeling showed a statistically significant hearing improvement in ears with EVA undergoing CI with regards to pure tone average (-64.0 dB, p < 0.0001), speech reception threshold (-57.90 dB, p < 0.0001), and word score (34.8%, p > 0.0001). Vestibular aqueduct midpoint size and the presence of incomplete partition type II (IP II) did not have significant independent associations with audiometric findings. However, multivariable modeling revealed a statistically significant interaction between IP II and CI such that IP II ears demonstrated a decrease in WS improvement of 30.2% (p = 0.0059) compared to non-IP II ears receiving CI. CONCLUSION: There is a statistically significant audiometric benefit to ears with EVA receiving CI. Morphology, specifically the presence of IP II, may hinder CI benefit in terms of word score however this finding needs clinical validation. This data improves personalization of surgical counseling and planning for patients with EVA considering CI.

Esophageal Squamous Cell Carcinoma Presenting with Streptococcus intermedius Cerebral Abscess.

BACKGROUND: Cerebral abscess is caused by inoculation of an organism into the brain parenchyma from a site distant from the central nervous system. Streptococcus intermedius (S. intermedius) is a commensal organism that is normally present in the aerodigestive tract and was reported to be the cause of brain abscesses after esophageal dilatation or upper endoscopy. CASE PRESENTATION: We report the case of a 53-year-old female who presented with hematemesis and melena followed by left-sided weakness. Initially, her hemiplegia was found to be secondary to a right thalamic brain abscess caused by S. intermedius. Investigations led to the diagnosis of a mid-esophageal squamous cell carcinoma. We hypothesize that the cause of the abscess with this bacterium that naturally resides in the digestive tract and oral cavity is secondary to hematogenous spread from breach in the mucosal integrity from ulceration due to the cancer. CONCLUSION: To our knowledge, our case is the first in the literature to describe a brain abscess caused by S. intermedius in association with a previously undiagnosed esophageal squamous cell carcinoma without any prior esophageal intervention.

Risk Factors for Melanoma in Renal Transplant Recipients.

Importance: Melanoma risk factors and incidence in renal transplant recipients can inform decision making for both patients and clinicians. Objective: To determine risk factors and characteristics of renal transplant recipients who develop melanoma. Design, Setting, and Participants: This cohort study of a large national data registry used a cohort of renal transplant recipients from the United States Renal Data System (USRDS) database from the years 2004 through 2012. Differences in baseline characteristics between those who did and did not develop melanoma were examined, and a survival analysis was performed. Patients with renal transplants who received a diagnosis of melanoma according to any inpatient or outpatient claim associated with a billing code for melanoma were included. A history of pretransplant melanoma, previous kidney transplantation, or transplantation after 2012 or before 2004 were exclusion criteria. The data analysis was conducted from 2015 to 2016. Exposure: Receipt of a renal transplant. Main Outcomes and Measures: Incidence and risk factors for melanoma. Results: Of 105 174 patients (64 151 [60.7%] male; mean [SD] age, 49.6 [15.3] years) who received kidney transplants between 2004 and 2012, 488 (0.4%) had a record of melanoma after transplantation. Significant risk factors for developing melanoma vs not developing melanoma included older age among recipients (mean [SD] age, 60.5 [10.2] vs 49.7 [15.3] years; P < .001) and donors (42.6 [15.0] vs 39.2 [15.1] years; P < .001), male sex (71.5% vs 60.7%; P < .001), recipient (96.1% vs 66.5%; P < .001) and donor (92.4% vs 82.9%; P < .001) white race, less than 4 HLA mismatches (44.9% vs 37.1%; P = .001), living donors (44.7% vs 33.7%; P < .001), and sirolimus (22.3% vs 13.2%; P < .001) and cyclosporine (4.9% vs 3.2%; P = .04) therapy. Risk factors significant on survival analysis included older recipient age (hazard ratio [HR] per year, 1.06; 95% CI, 1.05-1.06; P < .001), recipient male sex (HR, 1.53; 95% CI, 1.25-1.88; P < .001), recipient white race, living donors (HR, 1.35; 95% CI, 1.11-1.64; P = .002), and sirolimus (HR, 1.54; 95% CI, 1.22-1.94; P < .001) and cyclosporine (HR, 1.93; 95% CI, 1.24-2.99; P = .004) therapy. The age-standardized relative rate of melanoma in USRDS patients compared with Surveillance, Epidemiology, and End Results patients across all years was 4.9. A Kaplan-Meier estimate of the median time to melanoma among those patients who did develop melanoma was 1.45 years (95% CI, 1.31-1.70 years). Conclusions and Relevance: Renal transplant recipients had greater risk of developing melanoma than the general population. We believe that the risk factors we identified can guide clinicians in providing adequate care for patients in this vulnerable group.