Glioma patterns of care in Victoria from 1998–2000

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 11521-11521
Author(s):  
M. Rosenthal ◽  
K. Drummond ◽  
M. Dally ◽  
M. Murphy ◽  
L. Cher ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multidisciplinary Approach ◽  
Standard Of Care ◽  
The Elderly ◽  
Population Based ◽  
Histologic Diagnosis ◽  
Patient Demographics ◽  
Areas Of Concern ◽  
Adult Glioma

11521 Background: The management of Gliomas is complex and requires a multidisciplinary approach. The care of such patients (pts) may be variable. The State of Victoria has a population of approximately 4 million people and over 300 new glioma cases diagnosed annually. Methods: This was a retrospective cohort study conducted by surveying doctors involved in managing incident adult glioma cases identified from the population based Victorian Cancer Registry during 1998–2000. The survey was conducted in 2004–5 obtaining at least four years follow-up data on all pts. Results: 828 pts were considered eligible for this study. 264 pts (32%) were aged over 70 years and 92 (11%) were aged over 80 years. 105 (13%) did not have a histologic diagnosis and 473 (57%) had glioblastoma multiforme (GBM). Complete macroscopic resection was performed in 209 pts (25%). Of all pts with a glioma, 612 (74%) and 326 (54%) were referred at initial diagnosis for consideration of radiotherapy and chemotherapy respectively. In 473 pts with GBM, 406 (86%) and 147 (31%) pts were initially referred for consideration of radiotherapy and chemotherapy respectively. Only 39 pts(5%) were enrolled on a clinical trial. The median survival for pts with a GBM was 7.4 months with a 3% five-year survival. Conclusions: This is one of the largest ever-reported glioma management surveys. Much of the patient demographics and approach to treatment were expected and represent a reasonable “standard of care”. Importantly, this study emphasises the elderly nature of this patient population and identifies areas of concern including: absence of histologic diagnosis, lack of multi-disciplinary care and low clinical trial enrolment. No significant financial relationships to disclose.

scholarly journals National Bariatric Surgery Registries: an International Comparison

2021 ◽  
Author(s):  
Erman O. Akpinar ◽  
Perla J. Marang- van de Mheen ◽  
Simon W. Nienhuijs ◽  
Jan Willem M. Greve ◽  
Ronald S. L. Liem
Keyword(s):  
Standard Of Care ◽  
Population Based ◽  
Substantial Agreement ◽  
Perfect Agreement ◽  
Moderate Agreement ◽  
Real World Evidence ◽  
International Collaborations ◽  
Global Registry ◽  
Registry Report

Abstract Introduction Pooling population-based data from all national bariatric registries may provide international real-world evidence for outcomes that will help establish a universal standard of care, provided that the same variables and definitions are used. Therefore, this study aims to assess the concordance of variables across national registries to identify which outcomes can be used for international collaborations. Methods All 18 countries with a national bariatric registry who contributed to The International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Global Registry report 2019 were requested to share their data dictionary by email. The primary outcome was the percentage of perfect agreement for variables by domain: patient, prior bariatric history, screening, operation, complication, and follow-up. Perfect agreement was defined as 100% concordance, meaning that the variable was registered with the same definition across all registries. Secondary outcomes were defined as variables having “substantial agreement” (75–99.9%) and “moderate agreement” (50–74.9%) across registries. Results Eleven registries responded and had a total of 2585 recorded variables that were grouped into 250 variables measuring the same concept. A total of 25 (10%) variables have a perfect agreement across all domains: 3 (18.75%) for the patient domain, 0 (0.0%) for prior bariatric history, 5 (8.2%) for screening, 6 (11.8%) for operation, 5 (8.8%) for complications, and 6 (11.8%) for follow-up. Furthermore, 28 (11.2%) variables have substantial agreement and 59 (23.6%) variables have moderate agreement across registries. Conclusion There is limited uniform agreement in variables across national bariatric registries. Further alignment and uniformity in collected variables are required to enable future international collaborations and comparison. Graphical abstract

scholarly journals Comparative Study of Internal Fixation of the Ulna and Distal Ulna Resection in Patients Older Than 70 Years With Distal Radius and Distal Metaphyseal Ulna Fractures

Hand ◽  
2018 ◽  
Vol 14 (4) ◽  
pp. 540-546
Author(s):  
Jorge G. Boretto ◽  
Ezequiel E. Zaidenberg ◽  
Gerardo L. Gallucci ◽  
Alejandro Sarme ◽  
Pablo De Carli
Keyword(s):  
Internal Fixation ◽  
Distal Radius ◽  
The Elderly ◽  
Acute Management ◽  
Distal Ulna ◽  
Radiographic Appearance ◽  
Patient Demographics ◽  
Ulna Fractures

Background: Acute management of fractures of the distal ulna that are associated with fractures of the distal radius remains difficult, particularly in the elderly. Methods: In this study, we investigated whether internal fixation of the distal ulna is associated with a higher rate of complications than resection of the distal ulna in patients older than 70 years. Twenty-four consecutive patients were included in this study, 12 of whom had undergone open reduction and internal fixation (ORIF) of the distal ulna, and 12 who had undergone distal ulna resection. Patients were retrospectively assessed for range of motion, grip strength, pain, and radiographic appearance. The functional outcome was evaluated by the Mayo Wrist Score. Complications were classified according to the Classification of Surgical Complications. Results: There were no differences in patient demographics between the 2 groups, except patient age. Clinical evaluation showed no difference at follow-up; however, there were significantly more complications associated with ORIF compared with resection. Conclusions: The results from our study show that women older than 70 years with fracture of the distal radius and distal ulna have a higher rate of complications if ORIF of the distal ulna is performed. Patients should be warned, by surgeons, of this in cases where ORIF of the distal ulna is suggested.

scholarly journals Atrial Fibrillation Increases the Risk of Early-Onset Dementia in the General Population: Data from a Population-Based Cohort

2020 ◽  
Vol 9 (11) ◽  
pp. 3665
Author(s):  
Dongmin Kim ◽  
Pil-Sung Yang ◽  
Gregory Y.H. Lip ◽  
Boyoung Joung
Keyword(s):  
Atrial Fibrillation ◽  
Early Onset ◽  
Late Onset ◽  
Population Data ◽  
The Elderly ◽  
Population Based ◽  
Early Onset Dementia ◽  
Increased Risk ◽  
Late Onset Dementia

Atrial fibrillation (AF) is considered a risk factor for dementia, especially in the elderly. However, the association between the two diseases is not well identified in different age subgroups. The association of incident AF with the development of dementia was assessed from 1 January 2005, to 31 December 2013, in 428,262 participants from a longitudinal cohort (the Korea National Health Insurance Service-Health Screening cohort). In total, 10,983 participants were diagnosed with incident AF during the follow-up period. The incidence of dementia was 11.3 and 3.0 per 1000 person-years in the incident-AF and without-AF groups, respectively. After adjustment for clinical variables, the risk of dementia was significantly elevated by incident AF, with a hazard ratio (HR) of 1.98 (95% confidence interval [CI]: 1.80–2.17, p < 0.001), even after censoring for stroke (HR: 1.74, 95% CI: 1.55–1.94, p < 0.001). The HRs of incident AF for dementia onset before the age of 65 (early-onset dementia) and for onset after the age of 65 (late-onset dementia) were 2.91 (95% CI: 1.93–4.41) and 1.67 (95% CI: 1.49–1.87), respectively. Younger participants with AF were more prone to dementia development than older participants with AF (p for trend < 0.001). AF was associated with an increased risk of both early- and late-onset dementia, independent of clinical stroke.

scholarly journals Falls and Depression in Men: A Population-Based Study

2015 ◽  
Vol 12 (1) ◽  
pp. 14-18 ◽  
Author(s):  
Amanda L. Stuart ◽  
Julie A. Pasco ◽  
Felice N. Jacka ◽  
Michael Berk ◽  
Lana J. Williams
Keyword(s):  
Body Mass Index ◽  
Drug Use ◽  
Body Mass ◽  
Psychotropic Drug ◽  
Smoking Status ◽  
The Elderly ◽  
Population Based ◽  
Psychotropic Drug Use ◽  
Geelong Osteoporosis Study

The link between falls and depression has been researched in the elderly; however, little information is available on this association in younger adults, particularly men. This study sought to investigate the link between major depressive disorder (MDD) and falls in a population-based sample of 952 men (24-97 years). MDD was diagnosed utilizing the Structured Clinical Interview for DSM-IV-TR Research Version, Non-Patient edition, and categorized as 12-month/past/never. Body mass index and gait were measured; falls, smoking status, psychotropic medication use, and alcohol intake were self-reported as part of the Geelong Osteoporosis Study 5-year follow-up assessment. Thirty-four (3.6%) men met criteria for 12-month MDD, and 110 (11.6%) for past MDD. Of the 952 men, 175 (18.4%) reported falling at least once during the past 12 months. Fallers were older (66 [interquartile range: 48-79] vs. 59 [45-72] years, p = .001) and more likely to have uneven gait ( n = 16, 10% vs. n = 31, 4%, p = .003) than nonfallers. Participants with 12-month MDD had more than twice the odds of falling (age-adjusted odds ratio: 2.22, 95% confidence interval [1.03, 4.80]). The odds of falling were not associated with past depression ( p = .4). Further adjustments for psychotropic drug use, gait, body mass index, smoking status, blood pressure, and alcohol did not explain these associations. Given the 2.2-fold greater likelihood of falling associated with depression was not explained by age or psychotropic drug use, further research is warranted.

Total Lymphoid Irradiation and High-Dose Chemotherapy with Autologous Blood Stem-Cell Transplantation for Relapsed and Refractory Hodgkin Lymphoma: Excellent Disease Control and Long-Term Survival Rates

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2024-2024
Author(s):  
Ryan D. Gentzler ◽  
Andrew M. Evens ◽  
Alfred W. Rademaker ◽  
Bharat B Mittal ◽  
Adam M. Petrich ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Survival Rates ◽  
Standard Of Care ◽  
High Dose Chemotherapy ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
Term Survival

Abstract Abstract 2024 Background: For patients with relapsed or refractory HL, salvage chemotherapy followed by aHSCT is the standard of care. Our group previously reported excellent clinical outcomes with accelerated hyperfractionated TLI followed by high-dose chemotherapy and aHSCT (Ann of Oncol. 16:679, 2007). This strategy has been adopted as the standard at our institution for eligible individuals and we now report long-term outcomes of patients previously reported on the phase I/II clinical trial in addition to those who were subsequently treated as standard of care. Patients and methods: Patients with biopsy confirmed relapsed/refractory classical HL who previously received no more than 20 Gy were eligible. Salvage chemotherapy was chosen by the patient's treating physician. All patients received accelerated hyperfractionated TLI prior to transplantation administered twice daily at 150 cGy, five days/week for 10 days. The morning dose was delivered to all nodal sites including the spleen, and the afternoon dose was delivered to all sites of previous and current disease. The goal was to treat uninvolved nodal sites and spleen to 1500 cGy and sites of current and previous disease to 3000 cGy. Conditioning chemotherapy consisted of high-dose carboplatin, cyclophosphamide, and etoposide. All patients received carboplatin 450 mg/m2 by continuous intravenous infusion (CIV) on days –6 to –4 (total dose = 1350 mg/m2) and cyclophosphamide 60 mg/kg/day over 1 h on days –3 and –2 (total dose = 120 mg/kg). Patients on the phase I portion of the trial received escalating doses of etoposide by CIV from days –6 to –4. Initial dosing levels were 400 mg/m2/day, 450 mg/m2/day, 500 mg/m2/day, 600 mg/m2/day and 700 mg/m2/day. Those treated on the phase II portion of the clinical trial or subsequent to the closing of the trial were treated with etoposide 700 mg/m2/day for a total of 2100 mg/m2. Results: 52 patients with relapsed/refractory HL at Northwestern University were treated with TLI and aHSCT from 1993 to January 2011. One patient was lost to follow-up immediately post-transplant. 51 patients were included in this analysis and had a median follow-up of 47 months (range: 0.07–204 months). Thirty patients were treated on a previously reported prospective phase I/II clinical trial. Most patients had nodular sclerosis histology (n=39, 76%) and more than half had primary induction failure (PIF; n=29). Among patients who achieved a CR with induction, 62% relapsed within one year. The most common salvage regimens were ESHAP and ICE chemotherapy and most had received two lines of chemotherapy prior to aHSCT. Only 21 patients (41%) achieved a complete response (CR) with salvage therapy and in most cases (n=31, 61%), response was determined by functional imaging prior to aHSCT. The 10-year PFS and OS for all patients were 56% and 54%, respectively. Ten-year PFS and OS for patients with PIF was 53%, compared with 63% and 59%, respectively, for those with relapsed disease (p=0.13 and p=0.20, respectively). Patients who had incomplete responses to salvage therapy had a 10-year PFS and OS of 41% and 39%, respectively, compared to 76% and 81%, respectively, for those who achieved a CR (p=0.1 and p=0.056, respectively). Treatment-related mortality within the first 100 days was observed in one patient. Five patients (10%) developed secondary malignancies; three developed MDS (one who had received MOPP induction died with MDS; one had relapsed HL post-aHSCT and died of AML and one is alive with MDS 3+ yrs post-diagnosis). There was one case each of T-cell lymphoma (7 months post-aHSCT) and melanoma. Conclusions: Sequential TLI/chemotherapy conditioning for relapsed/refractory HL for patients with limited or no prior radiotherapy continues to be associated with excellent disease control and long-term survival rates including high-risk populations such as PIF and chemotherapy-resistant disease. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Survival of Mantle Cell Lymphoma in the Era of Bruton Tyrosine Kinase Inhibitors: A Population-Based Analysis

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 182-182
Author(s):  
Mengyang Di ◽  
Can Cui ◽  
Shalin K. Kothari ◽  
Amer M. Zeidan ◽  
Nikolai Podoltsev ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Funding ◽  
Age Groups ◽  
Population Based ◽  
Sensitivity Analyses ◽  
Mantle Cell ◽  
All Cause Mortality ◽  
Bruton Tyrosine Kinase ◽  
Support Research

Abstract Background: Despite advances in chemoimmunotherapy and stem cell transplantation, mantle cell lymphoma (MCL) has historically been difficult to treat. Patients with advanced age and high-risk features (e.g. blastoid/pleomorphic features, high MIPI score, complex karyotype, TP53 mutation) face particularly poor outcomes with standard chemoimmunotherapy. Ibrutinib, a Bruton tyrosine kinase inhibitor (BTKi), was approved for second-line use in MCL in 2013. Other BTKis - acalabrutinib and zanubrutinib were approved in 2017 and 2019, respectively. BTKi provides a well-tolerated chemotherapy-free option for these hard-to-treat subgroups, especially the older patients. In this population-based study, we evaluated survival outcomes prior to and after the approval of ibrutinib, and hypothesized that survival benefit observed early after approval would be greatest in older patients not typically candidates for consolidative transplantation in the first-line setting. Methods: Using the Surveillance, Epidemiology, and End Results database, we included all adult patients diagnosed with MCL in the years 2007-2018 and followed them to the end of 2018 or death, whichever came first. The pre-BTKi era was defined by year of diagnosis 2007-2011, and the BTKi era was between 2014 and 2018. The years 2012-2013 were considered as a "washout" period to allow practice change related to the approval of ibrutinib. As age plays an important role in treatment decisions, including whether to use consolidative transplantation, patients were divided based on age at diagnosis: &lt;60, 60-69, 70-79, and ≥80 years. Outcomes of interest included all-cause mortality, and mortality from MCL (MFM). We applied multivariable Cox proportional hazards regression model for all-cause mortality, adjusting for age, sex, race, stage, and median household income at census level, and reported adjusted hazard ratio (HR) with 95% confidence interval (CI). We also conducted multivariable competing risk analyses for MFM, considering all other causes of death as the competing events, and reported subhazard ratio (sHR) with 95% CI. To eliminate potential confounding by duration of follow-up among patients diagnosed in different periods, we used only three-year follow-up data for primary analyses, and all available follow-up data for sensitivity analyses. Results: We identified 7,625 individuals diagnosed with MCL during our study period (3,424 and 4,201 diagnosed during 2007-2011 and 2014-2018, respectively). The majority were male (71%) and white (90%), with 49% of patients 70 years or older. The median follow-up was 9.2 and 2.4 years for patients diagnosed during 2007-2011 and 2014-2018, respectively. The 3-year all-cause mortality and 3-year MFM rates were 39.8% and 27.3%, respectively, in the overall population. Both the 3-year all-cause mortality and MFM increased as age increased. The 3-year all-cause mortality was lower in the BTKi era among all age groups, except patients &lt;60 years old, and the 3-year MFM was lower in the BTKi era among all age groups. The numeric difference of 3-year outcomes was more substantial in patients aged 70-79 for both all-cause mortality (pre-BTKi era: 47.8%, BTKi era: 40.4%) and MFM (pre-BTKi era: 33.9%, BTKi era: 27.5%) (Table, Figure A and B). In the multivariable analyses, risk of death was significantly lower during the BTKi era in the 60-69 (HR:0.85, 95% CI: 0.72-1.00) and 70-79 (HR: 0.80, 95% CI: 0.70-0.92) age groups. MFM was also significantly lower during the BTKi era in these two age groups (60-69: sHR: 0.78, 95% CI: 0.64-0.94; 70-79: sHR: 0.76, 95% CI: 0.65-0.90, Table). The results were largely unchanged in sensitivity analyses (results not shown). Conclusion: In this large population-based cohort analysis of individuals diagnosed with MCL, overall and lymphoma-specific survival improved in the BTKi era. At a median follow up of 2.4 years in our BTKi cohort, significant survival benefits were observed in those older than 60 but less than 80 years of age, and the observed benefits were greatest in the 70-79 age group. Future real-world studies should examine the impact of novel agents on treatment patterns and outcomes of MCL over a longer follow up period. Figure 1 Figure 1. Disclosures Kothari: Incyte pharmaceuticals: Consultancy, Honoraria; Karyopharm pharmaceuticals: Consultancy, Honoraria. Zeidan: Amgen: Consultancy, Research Funding; Astellas: Consultancy; Jasper: Consultancy; BMS: Consultancy, Other: Clinical Trial Committees, Research Funding; Boehringer Ingelheim: Consultancy, Research Funding; BeyondSpring: Consultancy; Acceleron: Consultancy, Research Funding; BioCryst: Other: Clinical Trial Committees; Novartis: Consultancy, Other: Clinical Trial Committees, Travel support, Research Funding; AbbVie: Consultancy, Other: Clinical Trial Committees, Research Funding; Ionis: Consultancy; Loxo Oncology: Consultancy, Other: Clinical Trial Committees; Astex: Research Funding; AstraZeneca: Consultancy; Epizyme: Consultancy; Cardiff Oncology: Consultancy, Other: Travel support, Research Funding; Janssen: Consultancy; Agios: Consultancy; ADC Therapeutics: Research Funding; Jazz: Consultancy; Genentech: Consultancy; Gilead: Consultancy, Other: Clinical Trial Committees; Incyte: Consultancy, Research Funding; Geron: Other: Clinical Trial Committees; Pfizer: Other: Travel support, Research Funding; Daiichi Sankyo: Consultancy; Kura: Consultancy, Other: Clinical Trial Committees; Aprea: Consultancy, Research Funding. Podoltsev: PharmaEssentia: Honoraria; Incyte: Honoraria; Novartis: Honoraria; Bristol-Myers Squib: Honoraria; CTI BioPharma: Honoraria; Celgene: Honoraria; Blueprint Medicines: Honoraria; Pfizer: Honoraria. Neparidze: Janssen: Research Funding; Eidos Therapeutics: Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Research Funding. Shallis: Curis: Divested equity in a private or publicly-traded company in the past 24 months. Ma: Celgene/Bristol Myers Squibb: Consultancy, Research Funding. Huntington: AbbVie: Consultancy; TG Therapeutics: Research Funding; SeaGen: Consultancy; DTRM Biopharm: Research Funding; Flatiron Health Inc.: Consultancy; Novartis: Consultancy; Bayer: Honoraria; Pharmacyclics: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria; Genentech: Consultancy; Servier: Consultancy; Thyme Inc: Consultancy; Celgene: Consultancy, Research Funding.

CTIM-13. PHASE 1 CLINICAL TRIAL OF ONCOLYTIC VIRAL IMMUNOTHERAPY WITH CAN-2409 + VALACYCLOVIR IN COMBINATION WITH NIVOLUMAB AND STANDARD OF CARE (SOC) IN NEWLY DIAGNOSED HIGH-GRADE GLIOMA (HGG)

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi52-vi52
Author(s):  
Patrick Wen ◽  
Laura Aguilar ◽  
Xiaobu Ye ◽  
David Reardon ◽  
Wenya Linda Bi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Phase 1 ◽  
Standard Of Care ◽  
Toxic Metabolite ◽  
Diffuse Astrocytoma ◽  
Newly Diagnosed ◽  
Phase 1 Clinical Trial

Abstract BACKGROUND CAN-2409 is a replication-deficient adenovirus that delivers HSV thymidine kinase to cancer cells, resulting in local conversion of orally administered valacyclovir into a toxic metabolite. Previously, a phase 1b/2 clinical trial of CAN-2409 combined with standard-of-care (SOC) demonstrated safety and improved survival in HGG patients. Addition of CAN-2409 to nivolumab has the potential to activate locally recruited lymphocytes and teach them to recognize tumor neoantigens, changing the ‘cold’ immunosuppressive tumor microenvironment, and synergizing with the activity mediated by immune checkpoint inhibitors. This notion is supported by preclinical experiments showing that the combination of CAN-2409 with anti-PD1 therapy was more effective than either treatment alone. METHODS This ongoing phase 1 clinical trial evaluates safety and initial efficacy of CAN-2409 combined with nivolumab and SOC in newly diagnosed HGG. CAN-2409 is injected during neurosurgery into the tumor bed, followed by 14-days of valacyclovir. Radiation starts within 8 (+/-4) days of surgery. Temozolomide is administered to MGMT-methylation positive patients only. Nivolumab is given every 2 weeks, up to 52-weeks. Deep immune profiling studies are ongoing and initial results will be available shortly. RESULTS From February 2019 to March 2021, 41 patients were enrolled and 35 were evaluable for safety from the combination of CAN-2409, nivolumab and SOC: 24 male and 11 female; 34 glioblastoma, 1 diffuse astrocytoma; 33 IDH-wildtype, 2 IDH-mutant; 15 MGMT-methylated, 20 unmethylated. Median age was 62-years (range 28-79), median KPS 90 (range 80-100). With 13 months median follow-up, no unexpected serious adverse events were observed, and 23 patients are still alive. The most frequent possibly related adverse events (&gt;10%) were nausea, fatigue, fever, headache, and increased ALT. CONCLUSIONS The combination of CAN-2409 + nivolumab + SOC was well tolerated. Clinical follow-up and extensive biomarker analyses will provide a better understanding of the therapeutic potential of this approach.

scholarly journals Effects of n-3 Fatty Acid Supplements in Elderly Patients after Myocardial Infarction: A Randomized Controlled Trial

Circulation ◽  
2020 ◽  
Author(s):  
Are Annesønn Kalstad ◽  
Peder Langeland Myhre ◽  
Kristian Laake ◽  
Sjur Hansen Tveit ◽  
Erik Berg Schmidt ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Trial ◽  
Fatty Acids ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Standard Of Care ◽  
Omega 3 Fatty Acids ◽  
Omega 3

Background: High intake of marine n-3 polyunsaturated fatty acids (PUFA) has been associated with reduced risk of cardiovascular events; however, this has not been confirmed in patients with a recent acute myocardial infarction (AMI). Elderly patients are at particularly increased cardiovascular risk after MI, but few trials address this group specifically. Omega-3 fatty acids hold the potential to reduce cardiovascular events with limited adverse effects in this vulnerable group. The hypothesis was that daily addition of 1.8g n-3 PUFA to standard of care secondary prophylaxis in elderly patients who have survived an AMI would reduce the risk of subsequent cardiovascular events during 2 years follow-up. Methods: The OMega-3 fatty acids in Elderly with Myocardial Infarction (OMEMI) trial is an investigator-initiated, multi-center, randomized clinical trial adding 1.8 g n-3 PUFA (930 mg EPA and 660 mg DHA) versus placebo (corn oil) daily to standard of care in 70-82 years old patients with recent (2-8 weeks) AMI. The primary endpoint was a composite of non-fatal AMI, unscheduled revascularization, stroke, all-cause death, heart failure hospitalization after two years. The secondary outcome was new atrial fibrillation. The safety outcome was major bleeding. Serum fatty acids were measured as biomarkers of adherence. Results: In total, 1,027 patients were randomized. Follow-up data were available for 1,014 patients who were included in the intention-to-treat analysis. Mean ± SD age was 75±3.6 years, 294 (29%) were female and mean triglycerides were 111.4±61.9 mg/dL. The primary endpoint occurred in 108 (21.4%) patients on n-3 PUFA vs 102 (20.0%) on placebo (HR 1.08 [95%CI 0.82-1.41], p=0.60). The secondary endpoint occurred in 28 (7.2%) patients on n-3 PUFA vs 15 (4.0%) on placebo (1.84 [0.98 -3.45], p=0.06). Median changes in EPA and DHA were +87% and +16% for n-3 PUFA vs -13% and -8% for placebo. Major bleeding occurred in 54 (10.7%) and 56 (11.0%) in the n-3 PUFA and placebo groups, respectively (p=0.87). Similar results were found in per-protocol analysis (n=893). Conclusions: We could not detect reduction in clinical events in our elderly patients with a recent AMI, treated with 1.8 g n-3 PUFAs daily for 2 years. Clinical Trial Registration: OMEMI Study; URL: https://clinicaltrials.gov Unique Identifier: NCT01841944

scholarly journals Association between smoking cessation and post-hospitalization healthcare costs: a matched cohort analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Margaret B. Nolan ◽  
Bijan J. Borah ◽  
James P. Moriarty ◽  
David O. Warner
Keyword(s):  
Clinical Trial ◽  
Hospital Discharge ◽  
Healthcare Costs ◽  
Smoking Status ◽  
Cohort Analysis ◽  
Secondary Analysis ◽  
Population Based ◽  
Point Prevalence ◽  
Point Prevalence Abstinence

Abstract Background The potential economic benefit in terms of reduced healthcare costs when patients quit smoking after hospital discharge has not been directly measured. The aim of this study was to compare the costs for hospital admission and six-month follow-up for a cohort of patients who self-reported abstinence from cigarettes at 6 months after hospital discharge and a matched group of patients who reported continued smoking. Materials and methods This was a secondary analysis of a recent population-based clinical trial cohort (ClinicalTrials.gov ID: NCT01575145), with cohort membership determined by self-reported 7 day point prevalence abstinence at 6 months after the index hospital discharge. Participants were admitted to Mayo Clinic Hospital, Rochester, MN, between May 5, 2012 and August 10, 2014 for any indication and lived in the areas covered by postal codes included in Olmsted County, MN. Propensity score matching was used to control for differences between groups other than smoking status, and any residual imbalance was adjusted through generalized linear model with gamma distribution for cost and log-link transformation. Results Of 600 patients enrolled in the clinical trial, 144 could be contacted and self-reported 7 day point prevalence abstinence at 6 months after hospital discharge. Of these patients, 99 were successfully matched for this analysis. The cost for the index hospitalization was significantly greater in patients who abstained compared to those that did not abstain (mean difference of $3042, higher for abstainers, 95% CI $170 to $5913, P = 0.038). However, there was no difference between mean 6-month follow-up costs, number of inpatient hospitalizations, or number of emergency room visits for abstainers versus non-abstainers. Conclusion There was no evidence to support the hypothesis that abstinence at 6 months after hospital discharge is associated with a decrease in health care costs or utilization over the first 6 months after hospital discharge.

scholarly journals Frontline Therapy with Bendamustine-Rituximab (BR) in Patients with Treatment-Naïve Waldenstrom's Macroglobulinemia Confers Similar Long-Term Outcomes to R-CVP in a Real-World Setting: A Population-Based Analysis

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1353-1353
Author(s):  
Jowon Laura Kim ◽  
Alina S. Gerrie ◽  
Kerry J. Savage ◽  
Diego Villa ◽  
David W. Scott ◽  
...  
Keyword(s):  
Gene Expression ◽  
Clinical Trial ◽  
Gene Expression Profiling ◽  
Systemic Therapy ◽  
Expression Profiling ◽  
Research Funding ◽  
Population Based ◽  
Early Progression ◽  
Treatment Naïve

Abstract Background: Waldenström macroglobulinemia (WM) is a rare, indolent B-cell lymphoproliferative disorder. After the STiL-1 trial (Rummel MJ. Lancet. 2013;381(9873):1203-1210) demonstrated significant benefit in a subgroup analysis as well as reduced toxicity using bendamustine and rituximab (BR) compared to R-CHOP (N=41 enrolled WM patients), BR became the preferred immunochemotherapy (IC) regimen for all patients with symptomatic treatment naïve (TN) WM in British Columbia (BC) since 2014. Prior to the introduction of BR, the combination of rituximab, cyclophosphamide, vincristine, and prednisone (RCVP), was the standard of care in BC for this population since 2004, given its widespread use across a broad range of indolent B-cell lymphomas. We report a population-based analysis evaluating outcomes in TN-WM patients comparing BR with RCVP. Methods: The BC Cancer Centre for Lymphoid Cancer Database was used to identify TN-WM patients treated with BR or RCVP as their first systemic therapy between August 1, 2004 - August 1, 2020. A period of observation but no prior to systemic therapy was permitted. All patients had clinicopathologically confirmed lymphoplasmacytic lymphoma and measurable monoclonal IgM. Event-free survival (EFS) was defined as time from start of IC to progression, relapse, initiation of alternative therapy, histologic transformation, or death due to any cause. Early progression (POD24) was defined as relapse or progression, death from lymphoma, or treatment toxicity within 24 months of initiation of systemic therapy. Outcomes were compared with a historical cohort of patients treated with frontline RCVP. Responding patients were eligible to receive maintenance rituximab (MR) every 3 months for 2 years since 2006; however this was discontinued in 2020 when a subgroup analysis of the MAINTAIN trial (Rummel MJ. Blood 2019; 134 (Supplement_1): 343), showed a lack of PFS benefit after BR, coupled with safety and vaccine response concerns during the COVID-19 pandemic. Results: A total of 111 patients with WM were identified; 57 treated with BR, 54 treated with RCVP. Median age was 69 years (range 33-89) and baseline characteristics (Table 1), were well-balanced. A higher proportion of RCVP-treated patients received &gt;4 cycles of chemotherapy (81% vs 65%, p=0.049). After IC, 75 (68%) received MR, with 36 (63%) and 39 (72%) in the BR and RCVP groups respectively (p=0.3). Median follow-up from diagnosis for all living patients was 5.9 years (range 0.8-19.2), with median 4.4y vs 9.8y for BR and RCVP respectively. EFS estimates at 4-years achieved with BR were 57% (95% CI 40-71%) compared to RCVP 60% (95% CI 45-72%), p=0.5 (Figure 1). Median EFS was established for RCVP due to longer duration of follow up at 6.3 years (95% CI 3.6-11.8y). Overall survival (OS) estimates at 4-years were 74% (95% CI 57-85%) and 81% (95% CI 67-89%) for BR and RCVP patients respectively, p=0.6. Worse performance status (≥2) was the only pre-treatment factor identified as significant for inferior EFS. A sub-analysis limited to patients that received &gt;4 cycles of IC also showed no clear difference in outcomes between BR and RCVP. Median time to transformation was 6.5y (5.5-13y), with only 3 late biopsy-proven events. Early progression (POD24) has occurred in 19 (18%) patients, with inferior survival observed in patients that had an early event compared with a reference cohort (2-years event free), however this did not reach statistical significance (p=0.3) (Figure 1). Conclusion: This population-based analysis of TN-WM patients treated with upfront IC confirms the excellent outcomes that can be achieved with a finite course of therapy. In contrast to prior studies, similar outcomes were observed with RCVP and BR. Further, regardless of front-line therapy, POD24 may be associated with inferior outcome but larger studies are needed. To our knowledge, this study is the first to make a direct comparison between BR and RCVP, and one of the largest restricted to IC-treated TN-WM. This data supports RCVP as a viable option, and should serve to inform clinicians, patients, and policy makers in decision-making when considering upfront therapeutic options, and when considering indefinite alternative regimens such as BTK inhibitors. Figure 1 Figure 1. Disclosures Gerrie: AbbVie: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Astrazeneca: Honoraria, Research Funding; Sandoz: Honoraria; Roche: Research Funding. Savage: Servier: Consultancy, Honoraria; Astra-Zeneca: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Other: Institutional clinical trial funding; Seattle Genetics: Consultancy, Honoraria; Merck: Consultancy, Honoraria, Other: Institutional clinical trial funding; Takeda: Other: Institutional clinical trial funding; AbbVie: Consultancy, Honoraria; Roche: Research Funding; Beigene: Other: Institutional clinical trial funding; Genentech: Research Funding. Villa: Roche: Honoraria; Janssen: Honoraria; Lundbeck: Honoraria; Celgene: Honoraria; Seattle Genetics: Honoraria; AbbVie: Honoraria; AstraZeneca: Honoraria; Gilead: Honoraria; NanoString Technologies: Honoraria. Scott: BC Cancer: Patents & Royalties: Patent describing assigning DLBCL COO by gene expression profiling--licensed to NanoString Technologies. Patent describing measuring the proliferation signature in MCL using gene expression profiling. ; Abbvie: Consultancy; Janssen: Consultancy, Research Funding; AstraZeneca: Consultancy; Rich/Genentech: Research Funding; Celgene: Consultancy; Incyte: Consultancy; NanoString Technologies: Patents & Royalties: Patent describing measuring the proliferation signature in MCL using gene expression profiling.. Craig: Bayer: Consultancy. Slack: Seagen: Consultancy, Honoraria. Sehn: Debiopharm: Consultancy; Novartis: Consultancy; Genmab: Consultancy. Freeman: Amgen: Honoraria; Celgene: Honoraria; Sanofi: Honoraria, Speakers Bureau; Incyte: Honoraria; Abbvie: Honoraria; Teva: Research Funding; Roche: Research Funding; Bristol Myers Squibb: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Seattle Genetics: Honoraria.

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