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Author(s):  
Briana M. Domenegato ◽  
Etienne Côté ◽  
Deepmala Agarwal ◽  
M. Lynne O’Sullivan ◽  
Elaine D. Reveler ◽  
...  

OBJECTIVE To compare potassium concentrations in feline plasma and serum samples analyzed promptly after collection or after 20 to 28 hours of refrigerated storage. ANIMALS 41 cats. PROCEDURES A venous blood sample was obtained from each cat. Aliquots were placed in 2 tubes without anticoagulant (blood was allowed to clot to derive serum) and 2 tubes with heparin (to derive plasma). One serum and 1 plasma sample were kept at room temperature and analyzed within 60 minutes after collection (baseline); the other serum and plasma samples were analyzed after 20 to 28 hours of refrigerated storage. At both time points, serum and plasma potassium concentrations were measured. RESULTS Median baseline serum potassium concentration (4.3 mmol/L) was significantly higher than median baseline plasma potassium concentration (4.1 mmol/L). The median difference between those values was 0.4 mmol/L (95% CI, 0.2 to 0.5 mmol/L). Compared with their respective baseline measurements, the median serum plasma concentration (4.8 mmol/L) and median plasma potassium concentration (4.6 mmol/L) were higher after 20 to 28 hours of refrigeration. CLINICAL RELEVANCE Results indicated that with regard to potassium concentration in feline blood samples, clotting or refrigerated storage for 20 to 28 hours results in a significant artifactual increase. Detection of an unexpectedly high potassium concentration in a cat may represent pseudohyperkalemia, especially if the blood sample was placed in a no-additive tube, was stored for 20 to 28 hours prior to analysis, or both.


2021 ◽  
Vol 10 (22) ◽  
pp. 5454
Author(s):  
Babak Monshi ◽  
Christina Ellersdorfer ◽  
Michael Edelmayer ◽  
Gabriella Dvorak ◽  
Clemens Ganger ◽  
...  

Topical cyclosporine (CSA) has been reported as an alternative treatment in steroid-refractory oral lichen planus (OLP), but evidence is limited and conflicting. An N-of-1 trial setting could be appropriate to evaluate interindividual differences in treatment response. We studied a series of 21 open-label, biphasic single-patient observations. Patients (15 women, 6 men) with OLP recalcitrant to topical steroids received four weeks of CSA mouth rinse (200 mg/twice daily) followed by four weeks of drug withdrawal. Pain (visual analogue scale (VAS) score), disease extent (physicians’ global assessment (PGA) score) and quality of life (Dermatology Life Quality Index (DLQI) score,) were assessed at baseline (T0), after four weeks of treatment (T1) and after another four weeks without treatment (T2). Median age was 58 years (interquartile range/IQR = 52–67) and median disease duration was 18 months (IQR = 12–44). Median baseline VAS score decreased significantly at T1 (p = 0.0003) and increased at T2 (p = 0.032) (T0 = 5 (IQR = 3–6.5); T1 = 2 (IQR = 0.5–3.4); T2 = 3 (IQR = 2–4.8)). Similarly, median baseline PGA score decreased significantly at T1 (p = 0.001) and increased at T2 (p = 0.007) (T0 = 2 (IQR = 1.3–2.5); T1 = 1 (IQR = 1–2); T2 = 2 (IQR = 1–2)). Median baseline DLQI score also decreased significantly at T1 (p =.027) but did not change at T2 (p = 0.5) (T0 = 2.5 (IQR = 1–5.8); T1 = 1 (IQR = 0–3); T2 = 1 (IQR = 1–4)). CSA responders (n = 16) had significantly higher median baseline VAS scores (5.2 (IQR = 5–6.5)) than nonresponders (n =5) (2 (IQR = 2–3.5) (p = 0.02). In our study, pain, disease extent and quality of life of patients with OLP improved significantly during therapy with low-dose CSA mouth rinse and exacerbated after drug withdrawal. Remarkably, patients with high initial VAS scores seemed to profit most.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5034-5034
Author(s):  
Patrick Daniele ◽  
Pranav Abraham ◽  
Arianna Kee ◽  
Gabriel Tremblay ◽  
Shelonitda Rose ◽  
...  

Abstract Introduction: Myelofibrosis (MF) is a Philadelphia chromosome-negative myeloproliferative neoplasm with an estimated prevalence of 4-6/100,000 persons in the USA. Patients with MF experience aberrant hematopoiesis, bone marrow fibrosis, splenomegaly, and cytopenias, including thrombocytopenia, as well as diminished survival ranging from months to years, depending on risk status. Symptoms progressively worsen, underscoring the need for effective treatments across heterogeneous risk statuses and patient dispositions. Among intermediate- to high-risk patients, Janus kinase 2 (JAK2) inhibitors are the primary treatment for MF. Fedratinib was approved by the US Food and Drug Administration (FDA) based on the results of the JAKARTA trials (NCT01437787; NCT01523171), and a new drug application for pacritinib has been submitted to the FDA for the treatment of MF in patients with severe thrombocytopenia. A head-to-head trial of fedratinib and pacritinib for the treatment of MF has not been conducted. Moreover, there is a paucity of evidence evaluating these agents in patients with MF and thrombocytopenia (platelets < 100 × 10 9/L). Therefore, indirect treatment comparisons (ITCs) are required to assess the comparative efficacy of fedratinib and pacritinib in this population. Methods: A systematic literature review (SLR) was conducted to identify all clinical evidence in patients with MF and thrombocytopenia. Based on the SLR results, the JAKARTA, JAKARTA-2, and PERSIST-2 (NCT01773187) trials were identified as the studies to form the basis of the ITC. A pooled analysis data set was developed based on individual patient-level data from the fedratinib 400-mg arms of the JAKARTA and JAKARTA-2 trials including patients with platelets < 100 × 10 9/L. Published summary data from the pacritinib 200-mg arm of the PERSIST-2 trial served as the comparator. Simulated treatment comparisons (STCs) were used to compare spleen volume reduction (SVR) ≥ 35% while adjusting for mutually reported baseline patient characteristics such as age, sex, Dynamic International Prognostic Scoring System, Eastern Cooperative Oncology Group (ECOG) performance status (PS), JAK2 V617F mutation status, prior ruxolitinib exposure, and laboratory tests. Final adjustment models were selected based on fit statistics and the literature review. Indirect relative risk (RR) was estimated with 95% confidence intervals (CIs) using unanchored naive ITC (unadjusted) and STC (adjusted) methodologies. The PERSIST-2 trial included patients with baseline platelets < 50 × 10 9/L, but did not report median baseline counts. Therefore, a sensitivity analysis was conducted to evaluate the impact of differential median baseline platelet counts. In the sensitivity analysis, an outcome model was generated in the full pooled JAKARTA trial population irrespective of platelet count, and platelet count was forced into the multivariable adjustment model. Outcomes were simulated at 3 median baseline platelet counts (25, 50, and 75 × 10 9/L) and compared using similar methodology to the main analysis. Results: The main analysis suggests that fedratinib is associated with a greater proportion of SVR ≥ 35% than pacritinib (Table, A). According to the naive ITC, fedratinib was numerically favored over pacritinib in terms of SVR ≥ 35% (RR, 1.67 [95% CI, 0.94-2.97]). After adjustment for ECOG PS, JAK2 V6127F mutation status, and prior ruxolitinib exposure, fedratinib was statistically favored relative to pacritinib for SVR ≥ 35% (RR, 1.76 [95% CI, 1.00-3.10]). Results of the platelet-count-adjusted sensitivity analysis showed that a significant difference was observed in favor of fedratinib with respect to SVR ≥ 35% (Table, B). The resulting indirect RRs were similar regardless of simulated median baseline platelet count, which suggest that differential baseline platelet count has a minimal impact on the ITC results. Conclusion: This analysis used a population-adjusted ITC to assess the comparative efficacy of pacritinib and fedratinib in patients with MF and thrombocytopenia. Following population adjustment, fedratinib was associated with a greater proportion of patients achieving SVR ≥ 35% than pacritinib. In lieu of a head-to-head clinical trial, further real-world evidence studies should be conducted to assess the effectiveness of these treatments in the clinical setting. Figure 1 Figure 1. Disclosures Daniele: BMS/Celgene: Consultancy; Purple Squirrel Economics: Current Employment. Abraham: Bristol Myers Squibb: Current Employment. Kee: Bristol Myers Squibb: Current Employment. Tremblay: Cytel: Consultancy; Purple Squirrel Economics: Current Employment. Rose: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. McBride: BMS: Current Employment.


2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Matthew D. Tucker ◽  
Landon C. Brown ◽  
Yu-Wei Chen ◽  
Chester Kao ◽  
Nathan Hirshman ◽  
...  

Abstract Background The identification of biomarkers to select patients with metastatic renal cell carcinoma (mRCC) most likely to respond to combination immunotherapy (IO) is needed. We sought to investigate an association of the baseline neutrophil-to-eosinophil ratio (NER) with outcomes to nivolumab plus ipilimumab for patients with mRCC. Methods We performed a retrospective review of patients with clear cell mRCC treated with nivolumab plus ipilimumab from Vanderbilt-Ingram Cancer Center and Duke Cancer Institute. Patients with prior receipt of immunotherapy and those without available baseline complete blood count with differential were excluded. Patients were divided into groups by the median baseline NER and analyzed for overall survival (OS), progression free survival (PFS), and objective response rate (ORR). Patients were also divided by median baseline neutrophil-to-lymphocyte ratio (NLR) and analyzed for clinical outcome. Further analyses of patients above/below the median NER and NLR were performed in subgroups of IMDC intermediate/poor risk, IMDC favorable risk, and treatment naïve patients. Results A total of 110 patients were included: median age was 61 years and 75% were treatment naïve. The median NER (mNER) at baseline was 26.4. The ORR was 40% for patients with <mNER compared to 21.8% among patients with >mNER (OR 2.39, p = 0.04). The median PFS for patients with <mNER was significantly longer at 8.6 months (mo) compared to 3.2 mo for patients with >mNER (HR 0.50, p < 0.01). Median OS was not reached (NR) for patients with <mNER compared with 27.3 mo for patients with >mNER (HR 0.31, p < 0.01). The median NLR (mNLR) was 3.42. While patients with <mNLR showed improvement in OS (HR 0.42, p = 0.02), PFS and ORR did not differ compared with patients in the >mNLR group. Conclusions A lower baseline NER was associated with improved clinical outcomes (PFS, OS, and ORR) in patients with mRCC treated with nivolumab plus ipilimumab, and prospective validation of the baseline NER as a predictive biomarker for response to immunotherapy-based combinations in mRCC is warranted.


2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A49-A49
Author(s):  
Betul Gok Yavuz ◽  
Elshad Hasanov ◽  
Lianchun Xiao ◽  
Yehia Mohamed ◽  
Sunyoung Lee ◽  
...  

BackgroundCurrently, there is no standard biomarker that predict immunotherapy response in hepatocellular carcinoma (HCC). Here, we aim to investigate the role of tissue stiffness measured by magnetic resonance elastography (MRE) in predicting neoadjuvant immunotherapy response in patients with resectable HCC.MethodsThis was a study of 15 patients with HCC treated with immune checkpoint blockade (ICB) therapy, nivolumab ± ipilimumab, followed by surgical resection. HCC MRE assessment was performed at baseline and after 6 weeks of therapy. HCC stiffness (kPa) was measured on MRE elastograms (liver stiffness maps). Baseline stiffness and changes in stiffness were compared with treatment response to ICB. Treatment response was defined as a tumor with more than 60% necrosis which was the major pathological response. Analysis was performed using descriptive statistics, Fisher’s exact test, and Wilcoxon rank sum test; p-value <0.05 was considered statistically significant.ResultsFifteen patients were evaluable for MRE assessment. The median age was 67 years. Etiology of liver disease was NASH (n=4), HCV (n=3), HBV (n=2) and unknown (n=6). Three out of 15 patients (20%) achieved a major pathological response (MPR). Median baseline HCC stiffness and change in stiffness were 4.6 kPa and –0.2 kPa, respectively. Among the 4 patients with stiffness increase, 3 (75%) of them achieved MPR and 1 (25%) did not achieve MPR. Among the patients without stiffness increase, none of them achieved MPR. Fisher’s exact test indicates that increase in stiffness was associated with a higher chance to achieve MPR than patients without stiffness increase (p=0.0088). Median baseline HCC stiffness for responders and non-responders was 6.8 (5.4, 9) kPa and 3.9 (2.2, 9.7) kPa, respectively (p=0.09). The median change in HCC stiffness for responders and non-responders was 1 (1, 1.4) kPa and -0.4 (-2.2, 0.7) kPa, respectively (p=0.02).ConclusionsPatients who achieved MPR inclined to have a higher baseline stiffness than patients who did not achieve MPR. Regarding the changes in stiffness between the two arms, patients with MPR group had a greater increase than that in the non-MPR group. In conclusion, baseline and change in MRE stiffness may be a useful biomarkers in predicting response to ICB therapy in HCC.Ethics ApprovalThis was an Institutional Review Board approved study (MDACC 2017–0972). All patients provided written informed consent.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Helen V. Alderson ◽  
Rajkumar Chinnadurai ◽  
Sara T. Ibrahim ◽  
Ozgur Asar ◽  
James P. Ritchie ◽  
...  

Abstract Background Fibroblast growth factor23 (FGF23) is elevated in CKD and has been associated with outcomes such as death, cardiovascular (CV) events and progression to Renal Replacement therapy (RRT). The majority of studies have been unable to account for change in FGF23 over time and those which have demonstrate conflicting results. We performed a survival analysis looking at change in c-terminal FGF23 (cFGF23) over time to assess the relative contribution of cFGF23 to these outcomes. Methods We measured cFGF23 on plasma samples from 388 patients with CKD 3-5 who had serial measurements of cFGF23, with a mean of 4.2 samples per individual. We used linear regression analysis to assess the annual rate of change in cFGF23 and assessed the relationship between time-varying cFGF23 and the outcomes in a cox-regression analysis. Results Across our population, median baseline eGFR was 32.3mls/min/1.73m2, median baseline cFGF23 was 162 relative units/ml (RU/ml) (IQR 101-244 RU/mL). Over 70 months (IQR 53-97) median follow-up, 76 (19.6%) patients progressed to RRT, 86 (22.2%) died, and 52 (13.4%) suffered a major non-fatal CV event. On multivariate analysis, longitudinal change in cFGF23 was significantly associated with risk for death and progression to RRT but not non-fatal cardiovascular events. Conclusion In our study, increasing cFGF23 was significantly associated with risk for death and RRT.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Matthew Machin ◽  
Laura Hayward ◽  
Lindsey Harris ◽  
Vijay Gadhvi ◽  
Ankur Thapar

Abstract Aim To assess feasibility of a novel remotely-supervised exercise programme at a vascular hub during the COVID-19 lockdown. Methods Participants with arterial claudication (ABPI &lt;0.90) who were able to walk 50m were enrolled into a 3-month programme by a vascular specialist nurse. The initial appointment addressed smoking cessation and best medical therapy. Baseline walking distance, ABPI and quality of life (QoL) were measured using the Intermittent Claudication Questionnaire. Following this, up to 8 WhatsApp video calls with a vascular specialist physiotherapist were undertaken to provide a tailored exercise programme. The Mapmywalk© App, or a pedometer, were used to monitor walking distances. Participants were instructed to record their daily longest walk and email results to their physiotherapist before each consultation. Results 12 participants were enrolled, of these 2 participants were unsuitable. Median age was 63 years and 2 (20%) were female. Baseline median ABPI was 0.7 (IQR 0.5-0.8), median baseline absolute walking distance was 75m (IQR 50-140) and median baseline QoL was 51/80 (IQR 15-79). 7 participants (70%) successfully completed the programme and were discharged. Their median daily longest walk was 2000m (IQR 200-4000) and QoL scores improved to 6/80 (IQR 2-20) (p = 0.02). Remaining 3 participants required revascularisation for disease progression. Reimbursement tariffs for the supervised exercise programme were £700 per patient, whereas for revascularisation were £2000 - £5000. Conclusion Remotely supervised exercise was feasible and improved walking distance and quality of life in 70% of participants. Approximately £3000 per patient was saved from a reduction in revascularisation procedures in our unit.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 124-124
Author(s):  
Michael Durkin ◽  
Dominic Pilon ◽  
Carmine Rossi ◽  
Ibrahim Khilfeh ◽  
Frederic Kinkead ◽  
...  

124 Background: Apalutamide (APA) is approved to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC) in the United States (US) but low enrollment of Black patients in clinical trials has led to limited clinical data about APA for this population. This study describes prostate-specific antigen (PSA) responses among Black and non-Black patients with nmCRPC or mCSPC treated with APA in a real-world community urology setting. Methods: Clinical data from 2/2018 to 3/2021 collected at 69 US urology practices were used to evaluate nmCRPC or mCSPC patients who received ≥1 APA prescription fill (index date). Baseline PSA was reported based with the most recent baseline PSA value and PSA doubling time (PSADT) in months (mo) was calculated in patients with at least 2 PSA tests before APA initiation. PSA response defined as the proportion of patients achieving either a reduction of 50% (PSA50) or 90% (PSA90) from baseline and was evaluated in patients with a PSA test result 8 weeks or later after initiating APA. Among patients with a response, the time from the index date to the response was also evaluated. Study results for Black and non-Black cohorts were summarized separately. Results: Data from 289 nmCRPC (19% Black) and 237 mCSPC (19% Black) patients were identified. Median baseline PSA, median baseline PSADT and post-index PSA responses are shown in Table. A PSA50 response was attained by numerically similar proportions of Black and non-Black patients with nmCRPC or mCSPC. A PSA90 response was observed in a numerically higher proportion of Black than non-Black nmCRPC patients. Median time to PSA50 and PSA90 was also similar between groups. Conclusions: This real-world study of nmCRPC and mCSPC patients demonstrates that PSA50 and PSA90 responses are achieved by high proportions of both Black and non-Black patients. Moreover, the PSA50 and PSA90 responses observed in this study are highly consistent with those observed in APA’s Phase 3 registrational trials for nmCRPC (SPARTAN)1 and for mCSPC (TITAN)2. References: 1Smith MR, et al. N Engl J Med. 2018;378:1408-1418. 2Chi KN, et al. N Engl J Med. 2019;381:13-24. Funding Source: Janssen Scientific Affairs, LLC.[Table: see text]


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Neelima Vidula ◽  
Sally Greenberg ◽  
Laura Petrillo ◽  
Jimmy Hwang ◽  
Michelle Melisko ◽  
...  

AbstractWe evaluated disseminated tumor cells (DTCs) and circulating tumor cells (CTCs) in patients with stage I-III breast cancer with >4 MM/mL DTC at baseline who received adjuvant zoledronic acid (ZOL). ZOL was administered every 4 weeks for 24 months, and patients underwent bone marrow aspiration at baseline, and 12 and 24 months of ZOL. Complete DTC response (<4 DTC/mL), serial CTCs, survival, recurrence, and toxicity were determined. Forty-five patients received ZOL. Median baseline DTC was 13.3/mL. Significant reduction in median DTC occurred from baseline to 12 months, and 24 months. Complete DTC response was seen in 32% at 12 months, and 26% at 24 months. Nine patients developed recurrence. Baseline DTC > 30/mL and CTC > 0.8/mL were significantly associated with recurrence and death. Serial reduction in DTCs occurred. Higher baseline DTC > 30/mL and CTC > 0.8/mL correlated with recurrence and death.


Author(s):  
H Hartley ◽  
S Lane ◽  
B Pizer ◽  
L Bunn ◽  
B Carter ◽  
...  

Abstract Purpose To report the course of ataxia in children up to 2 years post-operatively, following surgical resection of a posterior fossa tumour (PFT). Methods Thirty-five children, (median age 9 years, range 4–15) having resection of PFT, were assessed using the Scale for the Assessment and Rating of Ataxia (SARA), Brief Ataxia Rating Scale (BARS) and the mobility domain of the Paediatric Evaluation of Disability Index (PEDI-m) at initial post-operative period (baseline), 3 months, 1 year and 2 years post-operatively. Results Baseline median scores of the SARA and BARS were 8.5 (range 0–35.5), and 7 (0–25) respectively. Ataxia improved at 3 months (median SARA and BARS reduction 3.5 and 4, respectively). Additional gradual improvements in SARA were recorded at 1 (median reduction 2) and 2 years post-operatively (median reduction 0.5). Median baseline PEDI-m was 54.75 (range 15.2–100) with improvement at 3 months (median increase 36.95) and small improvement at 1 year (median increase 2.5) and 2 years (median increase 5.8). Children with medulloblastoma and midline tumours (median baseline SARA 10 and 11, respectively) demonstrated more severe ataxia than children with low-grade gliomas and unilateral tumours (median baseline SARA 7.5 and 6.5, respectively). Conclusion The largest improvement in ataxia scores and functional mobility scores is demonstrated within the first 3 months post-operatively, but ongoing gradual improvement is observed at 2 years. Children with medulloblastoma and midline tumour demonstrated higher ataxia scores long term.


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