scholarly journals 1013 Dupuytren’s Contracture Treatment with XIAPEX Injection: Reviewing A Single Surgeon's Experience

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
M Malik ◽  
B Fourie
Keyword(s):  
Retrospective Review ◽  
Progressive Disease ◽  
Small Sample Size ◽  
Important Change ◽  
Small Sample ◽  
Dupuytren’S Disease ◽  
Dupuytren's Disease ◽  
Post Procedure ◽  
Clinically Significant ◽  
Clinically Important Change

Abstract Aim To review a single surgeon's experience for the treatment of Dupuytren's disease with XIAPEX injection and the clinical outcomes as measured by a URAM score. Method Retrospective review of patient notes, clinical photography and URAM scores for patients who underwent the procedure between August 2013 and October 2016. Results 33 patients underwent the procedure. 25 patients completed pre and post URAM scores. Average pre procedure score was 19.4 and avergae post procedure score was 3.28 a difference of 16.12 (clinically important change for URAM score is 2.9). Average pre procedure MCPJ contracture was 46.67 degrees and average post procedure contracture was 3.3 degrees. Average pre procedure PIPJ contracture was 66.8 degrees and average post procedure contracture was 8.2 degrees. Where both MCPJ and PIPJ affected of the same digit average pre procedure MCPJ and PIPJ contracture was 60 degrees. The post procedure contracture was 0 degrees in the MCPJ and 29.7 degrees in the PIPJ. 1 patient underwent surgery for progressive disease. Conclusions XIAPEX injection has shown a clinically significant result in the treatment of Dupuytren's disease. There were minimal complications and only 1 patient needed further surgery. However, a small sample size thus conclusions have to be cautious.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

Salvage combination ipilimumab and nivolumab after failure of prior checkpoint inhibitor therapy in patients with advanced melanoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21009-e21009 ◽  
Author(s):  
Elizabeth Mary Gaughan ◽  
Gina R. Petroni ◽  
William W. Grosh ◽  
Craig L. Slingluff
Keyword(s):  
Combination Therapy ◽  
Small Sample Size ◽  
Objective Response ◽  
Initial Therapy ◽  
Subsequent Treatment ◽  
Advanced Melanoma ◽  
Small Sample ◽  
Treatment Naïve ◽  
Clinicopathologic Factors ◽  
Clinically Significant

e21009 Background: The combination of Ipilimumab and Nivolumab is standard initial therapy in patients with advanced melanoma based on trials involving treatment-naïve patients. The benefit in those previously managed with checkpoint monotherapy is not well defined. Methods: We identified metastatic melanoma patients from our Immunotherapy database managed with combination Ipilimumab/Nivolumab after progression on prior checkpoint monotherapy. Baseline clinical factors, treatment history, combination therapy outcome by RECIST v1.1 and toxicity data were collected. Descriptive statistics were used to summarize the data. Given the small sample size and limited numbers of deaths, it is too early to look for preliminary associations between outcomes and clinicopathologic factors. Results: We identified 19 patients treated with combination Ipilimumab/Nivolumab after progression on prior checkpoint monotherapy. The cohort included 15 men and 4 women with an average age of 63 years. Thirteen patients had M1c disease, and 7 had a BRAF mutation. Patients had received up to four lines of prior immunotherapy including 9 treated with both prior anti-PD1 and anti-CTLA4 monotherapy. Seven patients completed all four doses of combination therapy with 6 proceeding onto maintenance nivolumab. Eight patients stopped treatment due to toxicity and 4 due to progressive disease. Thirteen patients had clinically significant toxicity, with rash, colitis, hepatitis, and hypophysitis reported most frequently. There were no treatment-related deaths. Overall, 2/19 patients (10.5%, 95% CI [1.3% to 33.1%]) had an objective response (CR+PR) and 9/19 patients (47.4%, 95% CI [24.5% to 71.1%]) had disease control (CR+PR+SD). Four of the patients had stable disease for over 6 months. Six of the 19 patients went on to receive subsequent treatment. Median follow-up for patients still alive was 7 months (range 1 to 20 months) and median survival was not reached. Six-month survival was 68.5% (95% CI [39.3% to 85.8%]) Conclusions: The combination of Ipilimumab and Nivolumab can result in melanoma control in patients with progression on prior checkpoint monotherapy with an expected toxicity profile.

scholarly journals Elderly AML: A Five-Year Retrospective Review on Prognostic Features

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5187-5187
Author(s):  
Akshay Amaraneni ◽  
Jennifer Segar ◽  
Trace Bartels ◽  
Onyemaechi Okolo ◽  
Andrew C Rettew ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Retrospective Review ◽  
Myeloid Leukemia ◽  
Small Sample Size ◽  
Small Sample ◽  
Risk Category ◽  
Elderly Aml ◽  
Acute Myeloid

Abstract Background: Acute Myeloid Leukemia (AML) is a disease of the elderly with a median age of diagnosis of 70 years. Prognosis in this age group is poor, with median overall survival of those undergoing treatment ranging from seven to twelve months. Treatment is difficult for a variety of reasons, including - higher incidence of co-morbid conditions (including frailty and decline in functional status), decreased ability to tolerate infections, socioeconomic considerations, and more aggressive disease phenotype. We present a single-institution retrospective review of acute myeloid leukemia outcomes with respect to these and other variables. Methods: A retrospective chart review was performed on all patients with a new diagnosis of AML from November 2013 through October 2017. Descriptive statistics were performed using excel, inferential statistics including Kaplan-Meier with comparison of survival curves by Logrank test and Cox-proportional hazard regression analysis, and correlation coefficients were performed using MEDCALC statistical software package. Results: Eighty-four AML patients in total were diagnosed with acute myeloid leukemia within the specified time frame, of these, 45 patients were age 65 or older (elderly) and were included in further analysis. Median age of elderly AML patients in this study was 70 years. Six of these patients were diagnosed with secondary AML (having arisen from MDS (N = 4), or other hematologic malignancy (N=2), and two had therapy-related AML. Eight patients had favorable risk disease, 13 intermediate risk, and 24 adverse risk according to ELN 2017 criteria. The median survival of all elderly patients was 322 days. Median survival of elderly AML according to ELN 2017 risk category criteria (Favorable, Intermediate, or Poor) was not reached (mean 880 days), 390 days, and 117 days, respectively (p = 0.0368 by cox hazard regression). Survival was not affected by type of treatment (induction vs hypomethylating agent (HMA); median 579 and 166 days (p = 0.1378) and mean 1552 and 364 days, respectively. This is likely due to small sample size, although survival does appear to favor intensive induction. Survival was not affected by number of medical co-morbidities (p = 0.66), presence of infectious complications (p=0.152), or unplanned hospitalization (p = 0.144). Overall use of clinical trials (N=3) and transplant (N=2) were low, precluding meaningful statistical analysis. However, both patients undergoing transplant exceeded the median OS (579 and 4745 days). Median OS of patients identified as White/Caucasian was greater than those identified as Hispanic/Latino (166 days vs 66 days, respectively), this did not reach statistical significance. Conclusion: Given the limitations of a retrospective review and relatively small sample size, our data shows that the 2017 ELN risk category is the strongest predictor of overall survival. Statistically, those undergoing intensive induction did not have a longer overall survival than those treated with HMAs, highlighting the need for careful selection of induction therapy candidates, and the need for clinical trials investigating other less intense treatment options for patients in this category. Interestingly, number of medical co-morbidities did not influence overall survival, nor did unplanned hospitalizations, presence/absence of significant infections during therapy, or race/ethnicity. Our data suggest an under-utilization of clinical trials and allogeneic hematopoietic stem cell transplant, both of which may serve to improve prognosis. Disclosures No relevant conflicts of interest to declare.

CD14 and Tissue Factor Positive Extracellular Vesicles Predict Response to Dovitinib in Patients with GBM: A Pilot Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4999-4999
Author(s):  
Nikolaos Papadantonakis ◽  
Manmeet S Ahluwalia ◽  
Micheal Khoury ◽  
Shruti Chaturvedi ◽  
Keith R. McCrae
Keyword(s):  
Growth Factor ◽  
Sample Size ◽  
Progressive Disease ◽  
Small Sample Size ◽  
Small Sample ◽  
Malignant Cells ◽  
Angiogenic Therapy ◽  
Pre Treatment ◽  
Group 2 ◽  
Group 1

Abstract BACKGROUND: Glioblastoma (GBM) is most common primary malignant brain tumor, and has a median survival of 15-18 months. Dovitinib, an oral multi-tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF) is currently under study in a phase II trial for GBM at the Cleveland Clinic. Dovitinib is administrated 5 days on and 2 days off every 4 weeks until progressive disease (PD) or intolerable toxicity are observed. Extracellular vesicles (EV) are submicron particles that express or contain cellular proteins and nucleic acids and are released from a variety of non-malignant cells (e.g. endothelial cells, platelets, leucocytes) and malignant cells. In some settings, EV may serve as biomarkers of inflammation, thrombosis and tumor spread/burden. OBJECTIVE: The aim of our study was to characterize levels of circulating EV and their relation to disease course in patients with GBM enrolled in the Dovitinib study (with or without prior treatments with anti-angiogenic agents). We also examined the association between EV levels and the development of venous thromboembolism (VTE). METHODS: Patients previously treated with anti-angiogenic therapy (Group 1, n=14) or without prior anti-angiogenic treatment (Group 2, n=14) were examined separately. EV were measured at study enrollment (pre-treatment), at the end of cycle 1 (day 28), and at PD. EV were isolated from citrated whole blood by differential centrifugation and incubated with fluorochrome-conjugated monoclonal antibodies to CD144-PE (endothelial cells), CD41-PECy4 (platelets), CD14-PE (monocytes) and CD142 (tissue factor, Alexa Fuor 647), then analyzed by flow cytometry. Depending on sample size, the Student t-test or Wilcoxon test was used to compare EV levels (due to the small sample size and skewed distribution of EV levels). P<0.05 was considered significant for all analyses. RESULTS: Three patients from group 1 and 6 patients from group 2 were not included in the analysis secondary to lack of an EV sample, withdrawal of consent or complications leading to early drug discontinuation. Of theremaining 11 patients in Group 1, 3 had PD and 8 had stable disease (SD) at the end of cycle 1. Of the 8 patients in group 2 available for analyses after cycle 1, 2 had PD and 6 had SD (one of these developed VTE but continued on the study). In the pretreatment sample of patients from group 1, patients who developed PD had significantly higher levels of CD14+ EV (89977±12121 vs. 42237±27651, p =0.048) and CD142+ EV (68701±9010 vs. 9695±12462, p=0.048) compared to those with SD. However, there was no statistically significant difference in EV levels (all sub-populations) from pre-treatment to the end of cycle 1 in patents with either PD or SD. EV levels did not correlate with peripheral blood counts. Due to the small number of patients in group 2 with progressive disease, we were unable to assess the correlation with EV. Six (2 in group 1, 4 in group 2) of the 27 patients for which pre-treatment EV were available developed VTE during the study. The EV levels were not significantly different between patients who developed VTE compared to those who did not both at pretreatment and at the day 28 evaluation. However, most patients who developed VTE demonstrated profound increases in EV before or in association with their thrombotic event. CONCLUSIONS: In patients with GBM receiving Dovitinib without prior exposure to anti-angiogenic therapy, elevated pre-treatment levels of CD14+ and CD142+ EV were associated with progressive disease, suggesting their potential role as a predictor of poor response to Dovitinib. Due to the relatively small sample size, no significant differences were observed between patients that developed VTE and those that did not, either pretreatment or at the Day 28 evaluation; however, these studies are ongoing. In the majority of patients with VTE, EV levels increased substantially before or in association with VTE development. Acknowledgment: This work was supported by a grant from the Scott Hamilton Cares Initiative Disclosures No relevant conflicts of interest to declare.

scholarly journals SURG-09. CHANGING PARADIGMS IN THE MANAGEMENT OF CEREBRAL METASTASES

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi241-vi241
Author(s):  
Edvin Telemi ◽  
James Snyder ◽  
Ian Lee ◽  
Adam Robin
Keyword(s):  
Disease Progression ◽  
Cause Of Death ◽  
Small Sample Size ◽  
Expectant Management ◽  
Initial Therapy ◽  
Small Sample ◽  
Cerebral Metastases ◽  
Extracranial Disease ◽  
The Mean ◽  
Clinically Significant

Abstract INTRODUCTION Paradigms in the management of cerebral metastases (CM) are evolving, in part due to the expanded use of laser interstitial thermal therapy or LITT in lesion ablation, with treatment of CM comprising up to 34% of all LITT cases. Currently, CM are treated with LITT largely in the setting of disease progression after initial therapy with focused radiation with no standard for performing biopsy prior to LITT. In this study we aim to assess the significance of the pathology of the lesion at the time of LITT on survival. METHODS We conducted a retrospective review of our institution’s LITT/brain tumor database and identified patients who underwent LITT with concurrent biopsy. For deceased patients, we identified cause of death if secondary to neurologic causes defined as death either due to direct intracranial disease progression leading to rapid neurologic decline or due to progressive neurologic decline without significant extracranial disease burden. RESULTS We identified 16 progressive CM lesions in 15 adults treated with LITT with concurrent biopsy, predominantly with non-small cell lung cancer. The mean age at LITT was 62, median follow-up was 8.5 months and thirteen of fifteen patients had previous focused radiation therapy. Eleven of sixteen lesions demonstrated radiation necrosis(RN) without tumor and 5 with tumor progression(TP). The mean survival in patients with RN was 548 days compared with 285 days in patients with TP (p=0.15). Of the 9 deceased, 2 of 5 patients with RN and 3 of 4 patients with TP died of neurologic causes. CONCLUSIONS Although statistically not significant due to the small sample size, this preliminary analysis suggests that clinically significant differences in survival and cause of death may exist between patients with RN and TP. Further evaluation with implications for treatment, prognosis and the expectant management of the patient with CM is warranted.

scholarly journals The contribution of Australian research to Dupuytren’s disease

2020 ◽  
Vol 3 (1) ◽  
pp. 39-46
Author(s):  
Robert Phan ◽  
David Hunter-Smith ◽  
Warren Rozen
Keyword(s):  
Progressive Disease ◽  
English Literature ◽  
Dupuytren’S Disease ◽  
Treatment Modalities ◽  
Dupuytren's Disease ◽  
Library Search ◽  
Multiple Treatment ◽  
Conference Presentations ◽  
To Come ◽  
Royal Australasian College

Introduction: While the history and epidemiology of Dupuytren's disease (DD) is well documented, its aetiology and risk factors, pathogenesis and treatment to this day are still being studied. This paper explores and summarises the significant contributions Australian researchers have made to the understanding of DD and its treatment methodologies.  Methods: We performed a systematic search on EMBASE from 1947 until March 2019 to identify all English literature using keywords: ‘Dupuytren/Dupuytrens/Dupuytren’s disease’ and ‘Australia/Australian/Australasian’. Relevant articles were also identified through bibliographic links. A separate search was conducted using Google Scholar, Research Gate and PubMed using the same keywords. In total, 40 articles were identified. A library search was also conducted, with one book identified with an Australian author. The Royal Australasian College of Surgeons Journal of Surgery was also analysed for published abstracts pertaining to DD from conference presentations between 2014 to 2019. Results and discussion: We present a narrative discussion of Australian research that has contributed to the understanding of DD from its aetiology to treatment methodologies.  Conclusion: Numerous Australians have made significant contributions to the understanding of DD, its pathogenesis, development and multiple treatment modalities, both non-surgical and surgical. Dupuytren’s disease is a progressive disease that reoccurs despite our best efforts and will continue to be a topic of focus for some time to come.

scholarly journals Early Spirometry Following Bronchoscopic Lung Volume Reduction with Endobronchial Valves

2022 ◽  
Vol 11 (2) ◽  
pp. 440
Author(s):  
Pascal Bezel ◽  
Jasmin Wani ◽  
Gilles Wiederkehr ◽  
Christa Bodmer ◽  
Carolin Steinack ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Lung Volume ◽  
Small Sample Size ◽  
Treatment Success ◽  
Standard Operating Procedure ◽  
Small Sample ◽  
Volume Reduction ◽  
University Hospital ◽  
Lung Volume Reduction ◽  
Post Procedure

Bronchoscopic lung volume reduction (BLVR) by endobronchial valve (EBV) implantation has been shown to improve dyspnea, pulmonary function, exercise capacity, and quality of life in highly selected patients with severe emphysema and hyperinflation. The most frequent adverse event is a pneumothorax (PTX), occurring in approximately one-fifth of the cases due to intrathoracic volume shifts. The majority of these incidents are observed within 48 h post-procedure. However, the delayed occurrence of PTX after hospital discharge is a matter of concern. There is currently no approved concept for its prevention. Particularly, it is unknown whether and when respiratory manoeuvers such as spirometry post EBV treatment are feasible and safe. As per standard operating procedure at the University Hospital Zurich, early spirometry is scheduled after BLVR and prior to the discharge of the patient in order to monitor treatment success. The aim of our retrospective study was to investigate the feasibility and safety of early spirometry. In addition, we hypothesized that early spirometry could be useful to identify patients at risk for late PTX, which may occur after hospital discharge. All patients who underwent BLVR using EBVs between January 2018 and January 2020 at our hospital were enrolled in this study. After excluding 16 patients diagnosed post-procedure with PTX and four patients for other reasons, early spirometry was performed in 61 cases. There was neither a clinically relevant PTX during or after early spirometry nor a late PTX following hospital discharge. In conclusion, we found early spirometry, conducted not sooner than three days following EBV treatment, to be feasible and safe. Furthermore, early spirometry seems to be a useful predictor for successful BLVR, and it may help to decide whether a patient can be discharged. Given the small sample size and the retrospective design of our study, a prospective study that includes routine chest imaging after early spirometry to definitively exclude PTX is needed to recommend early spirometry as part of the standard protocol following EBV treatment.

PAIN AND FUNCTION ONE YEAR AFTER DECOMPRESSIVE DISC SURGERY: CASES AUGMENTED WITH THE DIAM INTERSPINOUS IMPLANT VERSUS THOSE RECEIVING MICRODISCECTOMY

2012 ◽  
Vol 15 (02) ◽  
pp. 1250013 ◽  
Author(s):  
R. J. Crawford ◽  
J. M. Lynn ◽  
Q. Malone ◽  
R. I. Price
Keyword(s):  
Nucleus Pulposus ◽  
Important Change ◽  
Leg Pain ◽  
Repeat Surgery ◽  
Patient Reported ◽  
Patient Groups ◽  
Clinically Significant ◽  
One Year ◽  
Clinically Important Change ◽  
Herniated Nucleus Pulposus

Purpose: To examine clinical outcomes after decompressive lumbar surgery for herniated nucleus pulposus (HNP) in two cohorts from a single surgeon: Microdiscectomy alone [MICRO] versus microdiscectomy augmented with the Device for Intervertebral Assisted Motion [DIAM™, Medtronic Sofamor Danek, Memphis, USA]. We hypothesized that DIAM-augmented microdiscectomy would provide superior outcomes to microdiscectomy alone given purported benefits for interspinous devices reported in the literature. Improvements would concur with clinically significant change. Methods: Two separate HNP patient groups were sourced from a single surgeon: MICRO [n = 47 (17F/30M); 45 years (SD 14.2; 22–75)] and DIAM [n = 29 (10F/19M); 42 years (SD 11.2; 20–64)]. Patient-reported outcomes for function [MICRO=Roland-Morris Questionnaire (RMQ); DIAM=Oswestry Disability Index (ODI)] and back and leg pain [visual analogue scale (VAS)] were serially examined at preoperative baseline, 4–6 weeks, 6 and 12 months postoperatively. Incidence of repeat surgery at the index segment was recorded. Data were reported using descriptive statistics, unpaired t-tests and repeated ANOVA (Scheffe's post-hoc test). Statistically meaningful differences were defined by p < 0.05. Results: MICRO cases had higher preoperative leg pain (by 19%; p < 0.01). Improvements in absolute function and leg pain at one year were better in the MICRO group (p < 0.01). Both groups showed clinically significant improvement for all variables at each time-point during the period of follow-up. MICRO cases had proportionally fewer repeat surgeries (3/47 versus 4/29). Conclusions: Significant improvements in function, back and leg pain were shown in both patient groups out to one year. Clinically important change to function, back and leg pain was achieved for the MICRO cases, while clinically important change to leg pain occurred in the DIAM group. MICRO cases required proportionally fewer repeat surgeries by one year postoperatively. Microdiscectomy augmented with DIAM did not result in superior outcomes in treatment of herniated nucleus pulposus compared with microdiscectomy alone.

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