6588 Background: Minority races are often under-represented in cancer clinical trials as enrollment often occurs in large centers. Racial diversity may vary by geographical location and socio-economically backward areas may have a very different racial mix. This study explores the representation of different races in phase 3 clinical trials conducted in the past 10 years. Methods: Details about adult patients involved in phase 3 trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The racial distribution of the patient population in these trials was analyzed. Results: African American and Asian patients are under-represented in all phase 3 cancer clinical trials. The table shows the average racial distribution in clinical trials for each organ specific malignancy. Conclusions: Most phase 3 clinical trials except for lung cancer, predominantly consisted of Caucasian patients. Applying the results of these trails to patients of other races should be done with caution. This study highlights the disparity of race in patients enrolled in clinical trials when compared to diverse and different populations that are encountered in practice. [Table: see text]
Enasidenib is an FDA-approved isocitrate dehydrogenase 2 (IDH2) inhibitor, which is used in the treatment of acute myeloid leukemia (AML). We present a case of AML with an IDH2 mutation treated with a regimen of enasidenib and 5-azacitidine, where thyroiditis was noted to be a part of differentiation syndrome. The patient is a 77-year-old woman with IDH2-mutated AML who had initially been started on 100 mg of enasidenib and then presented with dyspnea and was diagnosed with pleural effusion-a common presentation with enasidenib-but was also noted to have thyroiditis. She was started on steroids, but due to continued hyperbilirubinemia and thyroiditis, her dose of enasidenib was reduced to half, which resulted in clinical improvement. This case demonstrates thyroiditis as one of the rare manifestations in the treatment of AML with enasidenib-induced differentiation syndrome.
Introduction: There is scarce evidence on the impact of biliary stents on endoscopic ultrasound (EUS) fine-needle biopsy (FNB) or fine-needle aspiration (FNA) of pancreatic head masses. Aim of this metaanalysis was to compare the diagnostic performance of EUS-guided tissue sampling in patients with or without biliary stents. Methods: We searched PubMed/Medline and Embase databases through March 2022 and identified 7 studies (2458 patients). Primary outcome was diagnostic accuracy. Secondary outcomes were sample adequacy, diagnostic sensitivity, specificity, and number of needle passes. We performed pairwise meta-analysis through a random effects model and expressed results as odds ratio (OR) or mean difference along with 95% confidence interval (CI). Results: Pooled accuracy was 85.4% (95% CI 78.8%-91.9%) and 88.1% (83.3%-92.9%) in patients with and without stent, respectively with no significant difference between the two approaches (OR 0.74, 95% CI 0.53-1.02; p50.07). No difference in patients with plastic stent was observed (OR 0.89, 0.51-1.54; p50.67) whereas a significant difference was observed in patients with metal stent (OR 0.54, 0.17-0.97; p50.05). Diagnostic accuracy with EUS-FNB was significantly lower in patients with biliary stents (OR 0.64, 0.43-0.95; p50.03) whereas no difference was observed with FNA. No difference in terms of sample adequacy was observed between the two groups (OR 1.06, 0.67-1.67; p50.81). Diagnostic sensitivity was significantly lower in patients with biliary stent (OR 0.59, 0.44-0.80; p, 0.001) and the number of needle passes was not significantly different between the two groups (mean difference -0.09, -0.30 to 0.11; p50.38). Conclusion:The presence of a metal stent negatively impacts on diagnostic yield of EUS tissue sampling for pancreatic head lesions, whereas no difference seems to be observed with plastic stents. Therefore, in jaundiced patients, EUS tissue sampling should precede ERCP, especially when metal stents are used.
Introduction:The pathogenesis of nonalcoholic fatty liver disease (NAFLD) has not been clearly understood, but several studies suggest intestinal bacteria may play a role. Similarly, diverticulitis is associated with changes in the gut microbiome. However, there is a lack of studies on how NAFLD affects the outcomes of diverticulitis. Thus, this study aims to assess the outcomes of diverticulitis among patients with NAFLD. Methods: Adult patients hospitalized with diverticulitis from the National Inpatient Sample (NIS), Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality 2014 were selected. Diagnoses were identified by using ICD-9 CM codes. Patient demographics and outcomes of diverticulitis were compared between the groups with and without NAFLD. The outcomes of interest were inpatient mortality, length of stay, total hospital charge, shock/hypotension, colectomy, abscess, obstruction, fistula, and perforation. Chi-squared tests and independent t-tests were used to compare proportions and means, respectively. Multivariate logistic regression analysis was performed to determine if NAFLD is an independent predictor for the outcomes, adjusting for age, sex, race, and the Charlson Comorbidity Index. Results: Among 48,214 patients with diverticulitis, 1,184 patients had a history of NAFLD. Patients with NAFLD had shorter length of stay (4.2 days vs. 4.7 days, p , 0.05), lower hospital charge ($34,392 vs. $38,652, p , 0.05), and lower mortality (0.0% vs. 0.4%, p , 0.05). After adjusting for age, sex, race, and the Charlson Comorbidity Index, NAFLD was an independent protective factor for colectomy (OR 0.44, 95% CI: 0.34-0.57, p , 0.05) and intestinal abscess (OR 0.67, 95% CI: 0.55-0.81, p , 0.05). Adjusted odds ratios of other outcomes were not statistically significant. Conclusion: Our study indicates that NAFLD is associated with better outcomes of diverticulitis, such as lower rates of colectomy and intestinal abscess among patients hospitalized with diverticulitis, in contrast with worse outcomes associated with NAFLD in many other conditions. The limitation of this study using the NIS database is the difficulty in comparing the severity of diverticulitis between the groups and exact treatment methods, which may have affected the results. Future studies to assess the potential protective effect of NAFLD on outcomes of diverticulitis and understand the pathophysiology of NAFLD and diverticulitis are warranted.
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