Objectives: Low molecular weight heparin and vitamin K antagonists are commonly used in cirrhotic patients requiring anticoagulation. However, their monitoring with anti-factor Xa and international normalized ratio (INR) may not be reliable in cirrhosis. Direct oral anticoagulants (DOACs) do not need laboratory monitoring, making these agents a favorable alternative. However, apixaban and rivaroxaban have been avoided in advanced liver disease due to their metabolism in the liver. The purpose of this medication use evaluation was to assess the use of DOACs, specifically apixaban and rivaroxaban, in patients with cirrhosis. Methods: We performed a retrospective, single-center study. Inpatients who had a diagnosis of cirrhosis and received at least one dose of a DOAC (apixaban or rivaroxaban) from April 2016 through June 2020 at our hospital were included in the analysis. Data collected included the reason for admission, Child-Pugh classification, renal function, if this was a home medication or newly started as an inpatient medication, indication, and dosing. The clinical efficacy outcome (new venous thromboembolic event (VTE) or progression of old VTE), and clinical safety outcome (bleeding event) were analyzed. Results: 41 patients with cirrhosis were treated with apixaban or rivaroxaban. Based on the Child-Pugh classification, 29.3% (n=12/41) were placed on a DOAC outside of the FDA prescribing recommendations. In this subpopulation, 8.3% (n=1/12) patients had venous thromboembolism (VTE) and 16.6% (n=2/12) had bleeding events. Overall, 7.3% patients (n=3/41) had VTE and 4.8% (n=2/41) had bleeding events. In the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) trial comparing the efficacy and safety profile of apixaban with enoxaparin/warfarin therapy in acute VTE, 2.3% of patients had VTE and 15% had bleeding events. Conclusion: Our study demonstrated that it may be possible to safely use DOACs in patients with advanced cirrhosis. Further studies are needed to evaluate the safety and efficacy of DOACs in this patient population, as our study was limited by the small sample size and its retrospective design.
Primary chest wall abscess due to hematogenous spread is very rare and has seldom been documented in the literature, with most reported cases attributed to Mycobacterium tuberculosis. Prompt diagnosis and management with antibiotics, and evacuation of the abscess, is imperative as the infection can lead to systemic or disseminated infection, including erosion into surrounding bone if left untreated. We describe the case of a 67-year-old female with severe Crohn's disease receiving anti-tumor necrosis factor-alpha (TNF-α) therapy, Etanercept presenting with localized Escherichia coli (E. coli) chest wall abscess with erosion into the surrounding rib. This case highlights a rare clinical entity, chest wall abscess, which is also an unusual site of E. coli infection. Only three previous cases of E. coli primary chest wall abscess can be found in the published literature. This case also highlights a possible association of severe Crohn's disease predisposing to complicated soft tissue infection.
e14568 Background: In recent years, immune checkpoint inhibitors (ICIs) have been approved for a growing number of cancer types. Approximately 10-30% of cancer patients have a concomitant diagnosis of autoimmune disorders (AID). Activation of the immune system with ICIs poses a potential risk of AID worsening. The majority of the ICI clinical trials excluded these patients from the study. There is a paucity of data regarding the benefits and risks of ICIs in cancer patients with AIDs. The primary objectives of this study were to determine the incidence of immunotherapy related AID worsening and all immunotherapy related adverse events (irAEs). Secondary outcomes were time to AID worsening and survival difference. Methods: All adult patients (age ≥18 years) with solid malignancy who received ICIs between Jan 2016 to June 2019 were identified using the University of Louisville pharmacy database. Medical records were reviewed to include all the patients with preexisting AIDs. Descriptive statistics were used to determine the incidence of AID worsening and all irAEs. Baseline characteristics were compared between cancer patients with versus without AID worsening using Pearson chi2 and Student’s t-test, where appropriate. Multivariate Cox regression analysis was used to compared survival between the 2 groups. Results: A total of 40 patients with AIDs were identified during the study period. The cancer types were melanoma (57.5%), lung (15%), breast (5%), and others (22.5%). AIDs were rheumatological (52.5%), gastroenterological (12.5%), neurological (12.5%), dermatological (20%) and hematological (2.5%). The incidence of all irAEs was 60% (grade ≥3 in 20%) and AID worsening was 40% (grade ≥3 in 15%). Baseline characteristics of the 2 comparison groups are shown in table. The median time from ICI initiation to AID worsening was 94.5 (range 21-431) days. In multivariate Cox regression analysis, adjusted for demographics, cancer type, and stage, survival was similar for patients who had AID worsening versus those who did not (HR 0.30 (95%CI 0.06-1.40, p=0.128). Conclusions: In our single-institution study, cancer patients with preexisting AID do have an increased risk of irAEs with high-grade toxicities in 20% compared to historically reported 5% in the general cancer population; about 15% of patients reported grade ≥3 worsening of their AIDs. However, though the risk of irAEs is numerically higher in patients with AID, it may be acceptable to the patients if the potential benefits of ICIs outweigh the risks. Baseline demographics and clinical characteristics.[Table: see text]
Introduction: Circulating tumor DNA (ctDNA) derived from apoptotic tumor cells is rapidly emerging as a non-invasive biomarker to detect the presence of tumor at a molecular level and guide therapy. In this study, we present our experience with this novel marker in gastrointestinal malignancy (GIM) patients. Methods: We included all patients with GIM for whom ctDNA was ordered from January 2020 to July 2021 at our center. Patient demographics, tumor type, pathology, stage, and radiographic findings were collected. Descriptive statistics were employed to report findings. Results: We identified 62 GIM patients for whom ctDNA was ordered. Results for 6 patients were not reported due to insufficient tumor tissue. Of the 56 patients for whom ctDNA results were available, 46 (82%) had colorectal adenocarcinoma (CRC) and the rest had other GI malignancies. Of the overall cohort of 56 evaluable patients, 21 (37.5%) had metastatic disease. Imaging findings paralleled ctDNA levels and correlated with tumor burden in 30 patients (53.5%). In 13 patients (23.2%), undetectable CT DNA levels influenced decisions regarding systemic therapy in addition to acting as a surrogate for treatment response. We discontinued maintenance therapy in 5 metastatic CRC patients with negative ctDNA and imaging. These patients have been off treatment for . 12 months without evidence of recurrence. We also truncated or skipped adjuvant treatment in 6 Stage III CRC patients with negative ctDNA and imaging who had significant post-operative complications or were otherwise considered high risk for severe toxicity. In one CRC patient, ctDNA was found to be undetectable post neoadjuvant therapy which corroborated with pathological complete response on surgical pathology report. 5 patients (9.09 %) had false-negative results and 1 patient had falsely elevated levels. In 6 other patients, we could not draw significant conclusions due to the availability of only a single value. Conclusion: Our experience suggests that ctDNA is not only a sensitive tool to assess tumor burden, but can also help guide therapy in locally advanced and metastatic CRC patients. However, further prospective studies are needed to improve the accuracy of test results and integrate ctDNA in day-to-day clinical practice.
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