Abstract 6: Interim Report of the Weave Trial: First 102 Consecutive on Label Patients

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Michael J Alexander ◽  
John C Chaloupka ◽  
Alois Zauner ◽  
Blaise Baxter ◽  
Richard Callison ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Best Practice ◽  
Therapy Resistance ◽  
Resistance Testing ◽  
P Value ◽  
Primary Analysis ◽  
Exact Test ◽  
Off Label ◽  
Analysis Group ◽  
Intracranial Atherosclerotic Disease

Purpose: The initial FDA approval trial of the self-expanding Wingspan stent for symptomatic intracranial atherosclerotic disease demonstrated a 4.5% periprocedural complication rate. Subsequently, similar on-label registry data was reported. The WEAVE Trial is a prospective, consecutive enrollment, single-arm, post-market surveillance trial evaluating periprocedural outcomes in patients with the revised FDA indications for use. Methods: Data for the first 102 on-label patients for which completed data is available are included in this report. The primary analysis endpoints included periprocedural stroke, death, or symptomatic bleed within 72 hours of the stenting procedure in patients who were treated on label. A subgroup of the participating sites included anti-platelet therapy resistance testing and correction, if needed, in their treatment of the patient. All patient outcomes were separately adjudicated by a stroke Neurologist by 72 to 96 hours post procedure. Results: In the initial 122 consecutive patients enrolled with completed data, 102 patients were treated on label and are included in the primary analysis, and 20 patients were treated off label and were part of secondary analyses. The mean stenosis in the primary analysis group was 83% with target artery break down as follows: 40.2% MCA, 25.5% ICA, 19.6% Basilar, 14.7% Vertebral or VB junction. Of the 102 patients in the primary analysis, 3 patients (2.9%) reached a primary endpoint of stroke, symptomatic bleed, or death within 72 hours. In the off label group, 4 of the 20 patients (20%) reached a primary endpoint within that period. Conclusions: The early interim analysis of the first 102 patients of WEAVE trial has demonstrated a very low periprocedural morbidity and mortality of 2.9%. This is lower than the high periprocedural event rate in the SAMMPRIS trial, and statistically better than the outcomes in the off label group (Fisher’s Exact test p value 0.014). This early data provides impetus to continue to collect data in this trial, and lends support to the concept that refined patient selection criteria and establishment of best practice techniques and management for these patients can substantially decrease the peri-procedural risk of intracranial stenting.

A Subgroup Analysis of Patients Undergoing Autologous and Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Deflect-1: A Double-Blind, Randomized Study of Fidaxomicin Vs. Placebo for Prophylaxis Against C. Difficile Infection

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 390-390 ◽  
Author(s):  
Michael J Dugan ◽  
Drew Winston ◽  
Michele I Morris ◽  
James E Williams ◽  
Natasha Broyde ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Endpoint ◽  
Research Funding ◽  
Post Treatment ◽  
Sensitivity Analyses ◽  
P Value ◽  
Primary Analysis ◽  
Hematopoietic Stem ◽  
Once Daily ◽  
Antibiotic Effect

Abstract Introduction: Clostridium difficile-associated diarrhea (CDAD) is a common complication during HSCT that has been associated with increased morbidity and mortality. CDAD has been reported to occur in 6 to 30% of HSCT patients. An ideal agent for prevention of CDAD has not been established. Fidaxomicin (FDX) is bactericidal against C. difficile, has low systemic absorption, provides a prolonged post-antibiotic effect, and is currently approved for the treatment of CDAD. The efficacy and safety of low dose FDX (200mg once daily) for prevention of CDAD were evaluated in both autologous (AUTO) and allogenic (ALLO) HSCT patients receiving fluoroquinolone (FQ) prophylaxis. Methods: HSCT patients were randomized to receive FDX 200 mg once daily (QD) or placebo (PLA) from start of conditioning therapy or FQ prophylaxis until 7 days after post-transplant engraftment (ANC >500/mm3) or completion of FQ prophylaxis. Randomization was stratified by type of HSCT (AUTO vs. ALLO). Patients were contacted twice weekly for 30 days and then weekly through 60 days post-prophylaxis for symptoms; CDAD was confirmed by toxin testing or PCR. The incidence of CDAD from start of prophylaxis up to 30 days and 60 days post-treatment were primary and secondary endpoints, respectively. For the primary analysis, failures were defined as patients with confirmed CDAD, as well as those who had missing data for the primary endpoint assessment (due to death or discontinuations resulting from adverse events, protocol non-compliance, lost follow-up, or any other reasons) and those who received any CDAD-effective medication (without confirmed CDAD). Sensitivity analyses, including an analysis that defined failure as confirmed CDAD, were prospectively defined for the overall population. These same analyses were performed for the ALLO and AUTO subgroups. Results: Of 611 enrolled patients, 600 were evaluable: 352 (59%) in AUTO and 248 (41%) in ALLO subgroups. The primary analysis for the primary endpoint did not show a significant reduction in incidence of CDAD with FDX prophylaxis (28.6% FDX vs. 30.8% PLA, p = 0.28). Secondary endpoint results were similar. However, the incidence of confirmed CDAD for up to 30 days was significantly lower in AUTO, ALLO, and overall in HSCT patients receiving prophylactic FDX versus PLA (see table). There were similar trends for 60 day post-treatment results. Overall, serious adverse events (AEs) and AEs resulting in death were more frequent in the ALLO vs. AUTO subgroup. In both subgroups, no differences in drug-related serious and non-serious AEs were seen between FDX and PLA. Table. Incidence of Confirmed CDAD, 30d Post-treatment AUTO ALLO Total FDX (%) 5/176 (2.8%) 8/125 (6.4%) 13/301 (4.3%) PLA (%) 14/176 (8.0%) 18/123 (14.6%) 32/299 (10.7%) PLA-FDX, % 5.1 8.2 6.4 Wald p-value 0.0163 0.0166 0.0014 Incidence of Confirmed CDAD, 60d Post-treatment FDX (%) 6/176 (3.4%) 11/125 (8.8%) 17/301 (5.6%) PLA (%) 14/176 (8.0%) 18/123 (14.6%) 32/299 (10.7%) PLA-FDX, % 4.5 5.8 5.1 Wald p-value 0.0321 0.0759 0.0117 Conclusions: For the primary endpoint (failure of prophylaxis due to confirmed CDAD or non-CDAD events), the efficacy of FDX and PLA were similar. However, in both AUTO and ALLO HSCT patients, prophylactic FDX significantly reduced the incidence of confirmed CDAD and was not associated with drug-related adverse events. Disclosures Dugan: Cubist/Merck & Co., Inc.: Research Funding. Winston:Cubist/Merck & Co., Inc.: Research Funding. Morris:Cubist/ Merck & Co., Inc.: Research Funding. Williams:Merck & Co., Inc.: Employment. Broyde:Merck & Co., Inc.: Employment. Sears:Merck & Co., Inc.: Employment.

scholarly journals Hip and distal femur fracture outcomes over three successive UK lockdown periods during the COVID-19 pandemic: what have we learnt?

2021 ◽  
Vol 2 (12) ◽  
pp. 1017-1026
Author(s):  
Salman Sadiq ◽  
Caroline Lipski ◽  
Umar-Khetaab Hanif ◽  
Faizan Arshad ◽  
Muhammad Chaudary ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Best Practice ◽  
Distal Femur ◽  
Femur Fracture ◽  
Kidney Injury ◽  
Control Group ◽  
P Value ◽  
Exact Test ◽  
Distal Femur Fracture ◽  
The Impact

Aims This study assessed the impact of COVID-19 on hip and distal femur fracture patient outcomes across three successive UK lockdown periods over one year. Methods A single-centre retrospective cohort study was performed at an acute NHS Trust. Hip and distal femur fracture patients admitted within the first month from each of the three starting dates of each national lockdown were included and compared to a control group in March 2019. Data were collected as per the best practice tariff outcomes including additional outcomes as required. Data collection included COVID-19 status, time to theatre, 30-day mortality, presence of acute kidney injury (AKI) and pneumonia, and do not attempt cardiopulmonary resuscitation (DNACPR) status. Data were analyzed using an independent-samples t-test or chi-squared test with Fisher’s exact test where applicable. A p-value of < 0.05 was considered statistically significant. Results A total of 95 patients during the pandemic were included and 20 were COVID-positive. Patients experienced a statistically significant increase in time to theatre in Lockdown 1 compared to 2019 (p = 0.039) with a decrease with successive lockdown periods by Lockdown 3. The 30-day mortality increased from 8.8% in 2019 to 10.0% to 14.8% in all lockdown periods. COVID-positive patient mortality was 30.0% (p = 0.063, odds ratio (OR) = 4.43 vs 2019). The rates of AKI and pneumonia experienced were higher for patients during the pandemic. The highest rates were experienced in COVID-positive patients, with 45.0% of patients with AKI versus 27.0% in 2019 (p = 0.38, OR = 1.80), and 50.0% of patients diagnosed with pneumonia versus 16.2% in 2019 (p = 0.0012, OR = 5.17). The percentage of patients with a DNACPR increased from 30.0% in 2019 to 60.7% by Lockdown 3 (p = 0.034, OR = 3.61). Conclusion COVID-positive hip and distal femur fracture patients are at a higher risk of mortality due to AKI and pneumonia. Patient outcomes have improved with successive lockdowns to pre-pandemic levels. Cite this article: Bone Jt Open 2021;2(12):1017–1026.

Addition of Oblimersen (Bcl-2 Antisense) to Fludarabine/Cyclophosphamide for Relapsed/Refractory Chronic Lymphocytic Leukemia Extends Survival in Patients Who Achieve CR/nPR: Results from a Randomized Phase 3 Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 751-751
Author(s):  
Susan O’Brien ◽  
Joseph Moore ◽  
Lily Ding ◽  
Steven Novick ◽  
Kanti Rai
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Primary Endpoint ◽  
Survival Data ◽  
Critical Role ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
P Value ◽  
Dependent Manner ◽  
Phase 3 ◽  
Exact Test

Abstract Background: Up-regulation of Bcl-2 protein plays a critical role in the pathogenesis and progression of chronic lymphocytic leukemia (CLL). Oblimersen (OBL [Genasense®]) decreases Bcl-2 protein in a concentration- and time- dependent manner and enhances the cytotoxic activity of agents commonly used for CLL, including fludarabine (F) and cyclophosphamide (C). A recent randomized, controlled, Phase 3 study of FC ± OBL showed that patients (pts) who received OBL achieved a significantly greater rate of complete response (CR, defined as CR plus nPR), which was the trial’s primary endpoint (O’Brien et al, J Clin Oncol 2007). Since duration of CR was also superior for OBL-treated pts, we evaluated whether extended followup would indicate that these benefits would translate into improved survival for pts who achieved CR. Methods: Pts with relapsed/refractory CLL received up to six 28-day cycles of FC (25 mg/m2/d and 250 mg/m2/d x 3d, respectively) with or without OBL (3 mg/kg/d x 7d by continuous IV infusion beginning 4 days before FC). NCI-WG response was determined by a clinical expert blinded to treatment assignment and independent blinded review of bone marrow. CT was required to confirm CR in pts with baseline abnormalities. All pts were followed for at least 3 years from randomization, or until death or withdrawal of consent. Survival data were collected through May 2007 and landmark analysis (at yearly time points) of the probability of achieving a CR and surviving was performed for up to 4 years for the intent-to-treat (ITT) population. Results: OBL combined with FC significantly increased the CR rate (17% [20 of 120 pts] compared with pts treated with FC alone (7% [8 of 121 pts]) (P = 0.025). CR duration was also significantly greater for OBL-treated pts (median not reached [estimated 36+ mos] compared with pts treated with FC alone (22 mos) (P=0.031). In both treatment groups, achievement of CR was associated with relief from all predefined CLL symptoms for ≥ 180 days (Pearson chi-square test, P<0.0001). Pts with CR surviving: OBL + FC (N=120) n FC (N=121) n Nominal P value (Fisher’s exact test) * *Two sided; ITT comparisons of probability of achieving CR and surviving to specified time At least 1 year 20 8 0.016 At least 2 years 17 8 0.060 At least 3 years 16 4 0.005 At least 4 years 12 2 0.006 Exploratory analysis showed that OBL-treated pts survived significantly longer (see table). Twelve of the 20 pts in CR in the OBL group and 4 of the 8 pts in CR in the FC-only group were alive. Median survival time among pts in CR on this trial had not been reached in the OBL group (estimated to exceed 49 months), compared with 35 months in the FC-only group. Survival durations ranged from 48 to 64 months among the 12 surviving pts in the OBL group, and from 47 to 65 months among the 4 surviving pts in the FC-only group. Conclusions: The addition of OBL to FC significantly increased percent CR and CR duration. Pts who achieved CR with OBL also achieved significantly longer survival compared with pts treated with FC chemotherapy alone. These data strongly confirm that CR is a valuable primary endpoint for therapeutic trials in relapsed/refractory CLL and supports the clinical benefit associated with durable CR in this setting.

Isolated Liner Revision for Total Knee Arthroplasty Instability: A Road That Should Remain Less Taken

2020 ◽  
Author(s):  
Jason D. Tegethoff ◽  
Rafael Walker-Santiago ◽  
William M. Ralston ◽  
James A. Keeney
Keyword(s):  
Total Knee Arthroplasty ◽  
Femoral Component ◽  
Knee Arthroplasty ◽  
Primary Total Knee Arthroplasty ◽  
P Value ◽  
Surgical Morbidity ◽  
Exact Test ◽  
Total Knee ◽  
Component Revision

AbstractIsolated polyethylene liner exchange (IPLE) is infrequently selected as a treatment approach for patients with primary total knee arthroplasty (TKA) prosthetic joint instability. Potential advantages of less immediate surgical morbidity, faster recovery, and lower procedural cost need to be measured against reoperation and re-revision risk. Few published studies have directly compared IPLE with combined tibial and femoral component revision to treat patients with primary TKA instability. After obtaining institutional review board (IRB) approval, we performed a retrospective comparison of 20 patients treated with IPLE and 126 patients treated with tibial and femoral component revisions at a single institution between 2011 and 2018. Patient demographic characteristics, medical comorbidities, time to initial revision TKA, and reoperation (90 days, <2 years, and >2 years) were assessed using paired Student's t-test or Fisher's exact test with a p-value <0.01 used to determine significance. Patients undergoing IPLE were more likely to undergo reoperation (60.0 vs. 17.5%, p = 0.001), component revision surgery (45.0 vs. 8.7%, p = 0.002), and component revision within 2 years (30.0 vs. 1.6%, p < 0.0001). Differences in 90-day reoperation (p = 0.14) and revision >2 years (p = 0.19) were not significant. Reoperation for instability (30.0 vs. 4.0%, p < 0.001) and infection (20.0 vs. 1.6%, p < 0.01) were both higher in the IPLE group. IPLE does not provide consistent benefits for patients undergoing TKA revision for instability. Considerations for lower immediate postoperative morbidity and cost need to be carefully measured against long-term consequences of reoperation, delayed component revision, and increased long-term costs of multiple surgical procedures. This is a level III, case–control study.

scholarly journals Clinical significance of Q waves in ischemic cardiomyopathy

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
E Rodenas Alesina ◽  
P Jordan ◽  
L Herrador ◽  
C Espinet-Coll ◽  
N Pizzi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Primary Endpoint ◽  
Ischemic Cardiomyopathy ◽  
Cox Regression ◽  
Cox Model ◽  
Cardiovascular Death ◽  
P Value ◽  
Heart Failure Hospitalization ◽  
Total Cohort

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): CIBER-CV AIMS The scintigraphic translation of Q waves in patients with ischemic cardiomyopathy and LVEF &lt; 40% has not yet been assessed. The aim of this study was to explore the relationship between Q waves and necrotic tissue and to analyze their impact in prognosis. METHODS AND RESULTS A retrospective study enrolling 487 consecutive patients (67,0 [57,4 – 75,4] years), with ischemic cardiomyopathy, LVEF &lt;40% and narrow QRS who underwent stress-rest SPECT was conducted. Patients with Q waves (320 patients [65,7%]) had less comorbidity and ischemia, but more necrosis. Q waves correlated poorly with lack of viability (AUC = 0,63) and were independently associated with the subendocardial extent of the necrosis. After a follow-up of 5,07 years, the primary outcome (cardiovascular death, heart failure hospitalization or myocardial infarction) occurred in 192 (39,4%) patients, without differences between groups in multivariate analysis. After accounting for non-cardiovascular death as a competitive risk, the interaction between &gt;10% of ischemia and revascularization remained in Cox model both in the total cohort (aHR= 0,46 [0,24 – 0,86]), and in patients with Q waves (aHR = 0,27 [0,11–0,69]). CONCLUSION Patients with ischemic cardiomyopathy with Q waves have larger subendocardial scarring and more transmural necrosis, although correlation between Q waves and transmural scarring is poor. Revascularization if &gt;10% ischemia is present is associated with a better prognosis. Ischemia burden should be assessed and accordingly treated in these patients, and no differences in management should be made in the presence of Q waves. Table 1. Cox proportional hazards model Total cohort (N = 471) Patients with Q waves (N = 315) aHR p-value 95% CI aHR p-value 95% CI Age (per year) 1,02 0,007 1,01 - 1,04 n.s. Diabetes mellitus 1,35 0,047 1,00 - 1,81 1,54 0,016 1,09 - 2,20 eGFR &lt; 60 ml/min 1,59 0,005 1,15 - 2,21 1,96 &lt;0,001 1,36 - 2,82 Previous HF hospitalization 1,71 0,002 1,23 - 2,38 1,76 0,007 1,17 - 2,64 Previous PCI 1,32 0,069 0,98 - 1,78 n.s. Previous CABG n.s. 1,77 0,009 1,15 - 2,72 Angina or dyspnea 1,68 0,001 1,24 - 2,28 1,71 0,004 1,19 - 2,46 Indexed TDV (per quartile) 1,16 0,047 1,02 - 1,33 n.s. Revascularization*ischemia &gt; 10% 0,46 0,015 0,24 - 0,86 0,27 0,006 0,11 - 0,69 Cox regression for the primary endpoint (cardiovascular death, heart failure hospitalization or myocardial infarction), accounting for non-cardiovascular death as a competitive risk. Abstract Figure. Survival for the primary endpoint

scholarly journals Synergistic effect of genetic polymorphisms in TLR6 and TLR10 genes on the risk of pulmonary tuberculosis in a Moldavian population

2021 ◽  
pp. 175342592110299
Author(s):  
Alexander Varzari ◽  
Igor V. Deyneko ◽  
Elena Tudor ◽  
Harald Grallert ◽  
Thomas Illig
Keyword(s):  
Pulmonary Tuberculosis ◽  
Interaction Analysis ◽  
P Value ◽  
Fisher Exact Test ◽  
Snp Analysis ◽  
Nucleotide Polymorphism ◽  
Single Nucleotide ◽  
Exact Test ◽  
Pulmonary Tb ◽  
The Republic

Polymorphisms in genes that control immune function and regulation may influence susceptibility to pulmonary tuberculosis (TB). In this study, 14 polymorphisms in 12 key genes involved in the immune response ( VDR, MR1, TLR1, TLR2, TLR10, SLC11A1, IL1B, IL10, IFNG, TNF, IRAK1, and FOXP3) were tested for their association with pulmonary TB in 271 patients with TB and 251 community-matched controls from the Republic of Moldova. In addition, gene–gene interactions involved in TB susceptibility were analyzed for a total of 43 genetic loci. Single nucleotide polymorphism (SNP) analysis revealed a nominal association between TNF rs1800629 and pulmonary TB (Fisher exact test P = 0.01843). In the pairwise interaction analysis, the combination of the genotypes TLR6 rs5743810 GA and TLR10 rs11096957 GT was significantly associated with an increased genetic risk of pulmonary TB (OR = 2.48, 95% CI = 1.62–3.85; Fisher exact test P value = 1.5 × 10−5, significant after Bonferroni correction). In conclusion, the TLR6 rs5743810 and TLR10 rs11096957 two-locus interaction confers a significantly higher risk for pulmonary TB; due to its high frequency in the population, this SNP combination may serve as a novel biomarker for predicting TB susceptibility.

scholarly journals HEALTH LITERACY OF INDIVIDUALS UNDERGOING DIALYSIS THERAPY

2019 ◽  
Vol 28 ◽  
Author(s):  
Jéssica Naylla de Melo Bezerra ◽  
Sara Rebeca de Oliveira Lessa ◽  
Marcelo Francisco do Ó ◽  
Givaneide Oliveira de Andrade Luz ◽  
Anna Karla de Oliveira Tito Borba
Keyword(s):  
Health Literacy ◽  
Univariate Analysis ◽  
Cross Sectional Study ◽  
Functional Health ◽  
P Value ◽  
Functional Health Literacy ◽  
Cross Sectional ◽  
Exact Test ◽  
Independent Variables ◽  
Adequate Health Literacy

ABSTRACT Objective: to assess the functional levels of health literacy in individuals undergoing dialysis. Method: a cross-sectional study with 42 patients of the Nephrology Unit of a public hospital in Recife, Brazil, from May to August 2016. Data were collected through scripted interviews and chart analysis. Functional health literacy was measured using the Brazilian version of the Short-Test of Functional Health Literacy in Adults questionnaire. Data analysis was performed using the Statistical Package for Social Sciences (SPSS®) software, version 18.0, with a univariate analysis to verify the association between independent variables and functional health literacy levels using Fisher's exact test. Results: 80.9% of the patients presented inadequate health literacy and 19.1% presented adequate health literacy. The number of correct answers remained between 0-18 in the reading comprehension and in the scheduling appointment card. Among the independent variables, only marital status (p-value=0.018) and personal income (p-value=0.009) were factors associated with the worst scores in the test, indicating that these variables influence the increase in inadequate literacy. Conclusion: the prevalence of inadequate functional literacy was high, reflecting difficulties in understanding and processing health information, which may interfere with therapeutic management and self-care.

Innovative Technique to Reduce Incidence of Frey's Syndrome after Parotid Surgery

2011 ◽  
Vol 77 (3) ◽  
pp. 351-354 ◽  
Author(s):  
Neeraj Singh ◽  
Monica Kohli ◽  
Harjeet Kohli
Keyword(s):  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Control Group ◽  
Regenerated Cellulose ◽  
P Value ◽  
Frey’S Syndrome ◽  
Exact Test ◽  
Parotid Surgery ◽  
Frey's Syndrome ◽  
Aberrant Regeneration

Frey's syndrome was first described by Lucia Frey, a Polish neurologist in 1923. It is well accepted that it involves injury to the branches of the auriculotemporal nerve with subsequent aberrant regeneration. Due to this abnormal communication, the skin glands and vessels are always stimulated at the same time as eating and mastication, which results in symptoms such as flushing and sweating. The incidence of Frey's syndrome in the literature has been variously described from 6 to 96 per cent. We analyzed the chart of 18 patients who had parotidectomy from March 2002 to December 2009. All procedures were performed by a single surgeon at the same facility. A total of 16 superficial and three total parotidectomies were done; one patient had bilateral parotidectomy. Oxidized regenerated cellulose (Interceed) was used after 10 surgeries (study group) and no adjuvant was used after nine surgeries (control group). All of the surgeries were done using similar technique. All the patients were followed-up with for a period of about 6 months postoperatively. The absolute risk reduction associated with the placement of an Interceed was 11 per cent. The small number of cases (n = 19) and an empty cell limits statistical analysis (a Fisher's exact test revealed a P value of 0.44). Clearly the low number of procedures restricted the power to test these differences. The development of Frey's syndrome is a very disabling but under-reported complication. The placement of a temporary barrier like Interceed may help in the prevention of Frey's syndrome without increasing any complications.

Updated results of European Organization for Research and Treatment of Cancer (EORTC) phase 2 trial 1202 cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11518-11518
Author(s):  
Roberta Sanfilippo ◽  
Richard L Hayward ◽  
Jammbe Musoro ◽  
Charlotte Benson ◽  
Michael Gordon Leahy ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Dedifferentiated Liposarcoma ◽  
Study Endpoint ◽  
Primary Study ◽  
Primary Analysis ◽  
European Organization ◽  
Experimental Drugs

11518 Background: Treatment options for patients with unresectable and/or metastatic dedifferentiated liposarcoma (DDLPS) are limited. The most effective agents include doxorubicin, ifosfamide, trabectedin and eribulin, but, in general, objective response rates (ORR) and progression free survival (PFS) are modest. Cabazitaxel exerts its effect through inhibition of microtubular disassembly and has been shown to be relatively safe, effective and well-tolerated. EORTC 1202 assessed whether cabazitaxel demonstrated sufficient antitumor activity in patients with metastatic or inoperable locally advanced DD LPS to justify further investigation in a phase III setting. Methods: This was an international multi-center, open label single arm phase II trial. The clinical cut-off date for the primary analysis was performed on August 31, 2020. Data base lock was performed on February 2, 2021. Eligible patients with metastatic or inoperable locally advanced DD LPS, after a centralized pathological review, were treated with cabazitaxel 25mg/m² IV infusion over 1 hour every 21 days. Primary endpoint was PFS rate at 12 weeks assessed by local investigator per RECIST 1.1. Based on a Simon two-stage design, at least 4 out of 17 (Stage 1) and 11 out of 37 (Stage 2) eligible and evaluable patients who are progression-free at 12 weeks were needed. Currently, a centralized radiological assessment is ongoing. Results: Forty patients were registered by 10 institutions in 4 countries between March 2015 and March 2019, with 2 patients being ineligible. One patient was still on treatment at the clinical cut-off date. The number of cycles ranged from 1 to 30, with a median of 5; 26 patients (65%) received at least 4 cycles of cabazitaxel. PFS at 12 weeks was 55% (conditional 1-sided 95% CI 40.8-100), achieving the primary study endpoint. The median FU was 21.6 months, median PFS was 6 months and median OS 21 months. RR was 8% with one CR and two PR. Twenty-three(60.5%) pts had a SD. Disease control (PR+SD) was achieved in 26 patients (68%). The most common cabazitaxel -related grade >3 adverse events in all 40 registered patients were Neutrophil count decreased (50%), febrile neutropenia (25%), fatigue (12.5%), and anemia (10%). There were no cabazitaxel-related deaths. Conclusions: EORTC 1202 met its primary endpoint, with 21/38 pts (55%) being progression-free at 12 weeks. Results of this trial confirm activity of cabazitaxel in patients with metastatic or inoperable locally advanced DD LPS and looks interesting if compared to the other available options and experimental drugs recently reported in this patient population. Clinical trial information: NCT01913652.

THE RELATIONSHIP BETWEEN THE ONSET OF SEVERE PREECLAMPSIA AND PERINATAL COMPLICATIONS AT RUMKITAL Dr. RAMELAN IN SURABAYA

2021 ◽  
Vol 5 (2) ◽  
pp. 139
Author(s):  
Widya Retno ◽  
Ivon Diah Wittiarika ◽  
Muhammad Aldika Akbar
Keyword(s):  
Preterm Delivery ◽  
Early Onset ◽  
Late Onset ◽  
Previous History ◽  
Severe Preeclampsia ◽  
P Value ◽  
Chronic Hypertension ◽  
Perinatal Complications ◽  
Exact Test ◽  
The Relationship

 Abstract Background: Preeclampsia is one of the biggest causes of maternal-fetal morbidity and mortality. Based on the prognosis, the classification of Preeclampsia is early onset (<34 weeks) and late onset (> 34 weeks). Purpose: to investigate the relationship between the onset of severe Preeclampsia and perinatal complications. Method: This research is a quantitative study with a retrospective observational analytic study type and collected medical record data. The study population was severe Preeclampsia  patients who gave birth at RUMKITAL Dr. Ramelan Surabaya for the period January 2018 - June 2020 and has no previous history of chronic hypertension. The research sample was 79 subjects with 44 subjects early onset, and 35 subjects late onset. Perinatal complications  examined are preterm delivery, asphyxia, LBW, IUGR, stillbirth. The chi-square test or Fisher’s Exact Test was used to analyze relationships. Result: From the results of the study, the comparison of the percentage from early onset and late onset that experienced complications was 93.2% vs 48.6%, p-value = 0.000, OR = 14.5, CI = 3,764–55,635.  At preterm delivery, it was found that 75% vs 28.6%, p-value = 0.000,  OR = 7.5, CI = 2,754-20,422. . In asphyxia, it was found 41.7% vs 31.4%, p-value = 0.46. At LBW, it was found 72.7% vs 17.1%, p-value = 0,000, OR = 12.9, CI = 4,285-38,771. In IUGR, it was found that 15.9% vs 2.9%, p-value = 0.000. In stillbirth, it was found 18.2% vs 0% and p-value = 0.008. Conclusion: the onset of severe Preeclampsia is related with perinatal complications. Complications associated with the onset severe Preeclampsia are preterm, LBW, stillbirth. Meanwhile, complications that are not related with the onset severe Preeclampsia are asphyxia and IUGR  

Sign in / Sign up

Export Citation Format

Share Document