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Advances in Gerontology = Uspekhi... 2024A review of the use of comprehensive geriatric assessment and its components in oncology is introduced. The evidence base for the increasing incidence of cancer in the... (Review)
Review
A review of the use of comprehensive geriatric assessment and its components in oncology is introduced. The evidence base for the increasing incidence of cancer in the elderly worldwide also presented. The management of older adults with cancer is challenging. Comprehensive Geriatric Assessment (CGA) has been shown by many authors to be a strong predictor of adverse events in geriatric oncology patients. CGA is recommended in oncology practice for many reasons: to identify health problems not usually detected in routine oncologic screening, to perform non-oncologic interventions, and to modify the cancer treatment plan. Comprehensive geriatric assessment is the gold standard in geriatric oncology for identifying patients at high risk for adverse outcomes and optimizing cancer treatment and overall management. Nevertheless, it can be stated that the final point in the search for evidence-based and effective frailty assessment tools in the practice of geriatric oncology has not yet been reached. It is concluded that the development of new scales and index scores, as well as the application of the CGA model in general, can provide adequate care for elderly cancer patients.
Topics: Humans; Geriatric Assessment; Aged; Neoplasms; Medical Oncology; Frailty; Frail Elderly; Geriatrics
PubMed: 38944778
DOI: No ID Found -
Nature Communications Jun 2024The widespread administration of COVID-19 vaccines has prompted a need to understand their safety profile. This investigation focuses on the safety of inactivated and...
The widespread administration of COVID-19 vaccines has prompted a need to understand their safety profile. This investigation focuses on the safety of inactivated and mRNA-based COVID-19 vaccines, particularly concerning potential cardiovascular and haematological adverse events. A retrospective cohort study was conducted for 1.3 million individuals residing in Abu Dhabi, United Arab Emirates, who received 1.8 million doses of the inactivated BBIBP CorV (by SinoPharm) and mRNA-based BNT162b2 (Pfizer-BioNTech) vaccines between June 1, 2021, and June 30, 2022. The study's primary outcome was to assess the occurrence of selected cardiovascular and haematological events leading to hospitalization or emergency room visits within 21 days post-vaccination. Results showed no significant increase in the incidence rates of these events compared to the subsequent 22 to 42 days following vaccination. Analysis revealed no elevated risk for adverse outcomes following first (IRR 1·03; 95% CI 0·82-1·31), second (IRR 0·92; 95% CI 0·72-1·16) and third (IRR 0·82; 95% CI 0·66-1·00) doses of either vaccine. This study found no substantial link between receiving either mRNA and inactivated COVID-19 vaccines and a higher likelihood of cardiovascular or haematological events within 21 days after vaccination.
Topics: Humans; Retrospective Studies; United Arab Emirates; Male; Female; COVID-19 Vaccines; Middle Aged; Adult; COVID-19; Cardiovascular Diseases; BNT162 Vaccine; Vaccines, Inactivated; SARS-CoV-2; Vaccination; Aged; Young Adult; Hematologic Diseases; Adolescent
PubMed: 38944652
DOI: 10.1038/s41467-024-49744-6 -
Thoracic Surgery Clinics Aug 2024Surgery of the chest is high stakes, and adverse events are common. Given the frequency and severity of such complications, cardiothoracic surgeons are at particularly... (Review)
Review
Surgery of the chest is high stakes, and adverse events are common. Given the frequency and severity of such complications, cardiothoracic surgeons are at particularly high risk of becoming second victims. Even though our primary commitment as doctors is to take care of our patients, surgeons may fall into the emotional and intellectual trap of taking on the whole responsibility of a patient's poor outcome. This viewpoint may lead the physician to develop a heightened self-doubt, greater insecurity, and imposter syndrome, further affecting their ability to prevent complications and tackle difficult cases in the future.
Topics: Humans; Postoperative Complications; Burnout, Professional; Surgeons
PubMed: 38944447
DOI: 10.1016/j.thorsurg.2024.04.009 -
The Journal of Allergy and Clinical... Jun 2024Mesenchymal stem cells (MSCs) play important roles in therapeutic applications by regulating immune responses.
BACKGROUND
Mesenchymal stem cells (MSCs) play important roles in therapeutic applications by regulating immune responses.
OBJECTIVE
To investigate the safety and efficacy of allogenic human bone marrow-derived clonal MSCs (hcMSCs) in subjects with moderate to severe atopic dermatitis (AD).
METHODS
The study included a phase I open-label trial followed by a phase II randomized, double-blind, placebo-controlled trial that involved 72 subjects with moderate to severe AD.
RESULTS
In phase I, intravenous (IV) administration of hcMSCs at two doses (1×10 and 5×10 cells/kg) was safe and well-tolerated in 20 subjects. Since there was no difference between the two dosage groups (P=0.9), it was decided to administer low-dose hcMSCs only for phase II. In phase II, subjects receiving three weekly IV infusions of hcMSCs at 5x10 cells/kg showed a higher proportion of an eczema area and severity index (EASI)-50 response at week 12 compared to the placebo group (P=0.038). The differences between groups in the dermatology life quality index and pruritus numerical-rating scale scores were not statistically significant. Most adverse events were mild or moderate and resolved by the end of the study period.
CONCLUSIONS
Our findings demonstrate that hcMSCs treatment resulted in a significantly higher rate of achieving EASI-50 at 12 weeks compared to the control group in subjects with moderate to severe AD. The safety profile of hcMSCs treatment was acceptable. Further larger-scale studies are necessary to confirm these preliminary findings.
PubMed: 38944393
DOI: 10.1016/j.jaci.2024.06.013 -
Journal of Stroke and Cerebrovascular... Jun 2024-Patients with atrial fibrillation (AF) undergoing elective procedures are at risk for Major Adverse Cardiovascular Events (MACE) and symptomatic bleeding. We aimed to...
INTRODUCTION
-Patients with atrial fibrillation (AF) undergoing elective procedures are at risk for Major Adverse Cardiovascular Events (MACE) and symptomatic bleeding. We aimed to identify risk factors to guide perioperative risk stratification.
METHODS
-We conducted a post-hoc analysis of the "Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery" randomized trial. The primary outcomes were MACE and symptomatic bleeding. Our statistical approach encompassed standard univariate analysis, logistic stepwise regression, and Cox regression models. Additional interaction analyses evaluated the interplay between low-molecular-weight heparin bridge therapy and other identified risk factors.
RESULTS
-Among A total of 1,813 participants (mean age 71.6±8.8, 73.3% male), MACE occurred in 25 (1.4%) individuals, with pre-procedure clopidogrel use (adjusted hazard ratio [aHR] 7.73, 95% CI 2.63-22.72, p<0.001) and CHADS-VASc score ≥ 5 (aHR 2.89, 95% CI 1.26-6.63, p=0.012) identified as risk factors. Symptomatic bleeding occurred in 57 (3.1%) individuals, with bridge therapy (aHR 1.84, 95% CI 1.07-3.19, p=0.029), renal disease (aHR 2.50, 95% CI 1.34-4.67, p=0.004), post-procedure aspirin use (aHR 2.86, 95% CI 1.66-4.91, p<0.001), post-procedure nonsteroidal anti-inflammatory drug use excluding aspirin (aHR 3.40, 95% CI 1.22-9.43, p=0.019), and major surgery (aHR 3.94, 95% CI 2.26-6.85, p<0.001) identified as risk factors. The interactions between risk factors and bridging therapy on MACE and symptomatic bleeding outcomes were not significant (p>0.05).
CONCLUSION
-We identified predictors for MACE and symptomatic bleeding in AF patients undergoing elective procedures. These insights may help guide perioperative decisions to reduce the risk of adverse outcomes.
PubMed: 38944363
DOI: 10.1016/j.jstrokecerebrovasdis.2024.107839 -
International Journal of Cardiology Jun 2024Bempedoic acid exhibits promising potential in hyperlipidemia therapy and preventing cardiovascular events. However, investigations into its adverse drug reactions...
BACKGROUND
Bempedoic acid exhibits promising potential in hyperlipidemia therapy and preventing cardiovascular events. However, investigations into its adverse drug reactions remain scant. This study seeks to utilize data mining techniques with the FDA Adverse Event Reporting System (FAERS) database to assess adverse drug events (ADEs) linked to bempedoic acid.
METHODS
Based on the drug's market release timeline, we extracted data from the FAERS database covering the fourth quarter of 2020 through the fourth quarter of 2023 for disproportionality analysis.
RESULTS
This study gathered a total of 5,797,543 adverse event case reports, of which 735 were linked to bempedoic acid. These reports covered 19 System Organ Classes (SOCs) and 22 Preferred Terms (PTs). Predominantly, the musculoskeletal and nervous systems were implicated in these adverse events. By conducting PT-level screening, various signals for ADEs were detected, including myalgia (ROR 30.33, PRR 28.51, IC 4.83, EBGM 28.47), arthralgia (n = 34, ROR 6.34, PRR 6.09, IC 2.61, EBGM 6.09), tendon disorders (ROR 99.57, PRR 98.75, IC 6.62, EBGM 98.28), and dizziness (ROR 3.18, PRR 3.13, IC 1.65, EBGM 3.13). Particularly noteworthy was the hypertensive crisis (ROR 28.63, PRR 28.51, IC 4.83, EBGM 28.47), which exhibited a robust signal strength, an observation previously unreported in clinical studies and drug labeling.
CONCLUSION
While our results are largely consistent with the drug's specifications, several new adverse reaction signals, such as hypertensive crisis, have not been previously documented. Therefore, further investigations are necessary to assess these unlabeled adverse reactions, offering crucial support for the clinical utilization of bempedoic acid.
PubMed: 38944350
DOI: 10.1016/j.ijcard.2024.132305 -
The Journal of Thoracic and... Jun 2024This study aimed to compare the difference in perioperative outcomes and prognosis between neoadjuvant immunochemotherapy (nICT) and neoadjuvant chemoradiotherapy (nCRT)...
OBJECTIVE
This study aimed to compare the difference in perioperative outcomes and prognosis between neoadjuvant immunochemotherapy (nICT) and neoadjuvant chemoradiotherapy (nCRT) for locally advanced esophageal squamous cell carcinoma (LA-ESCC).
METHODS
The LA-ESCC patients receiving nICT or nCRT were identified from a prospectively maintained database at Zhongshan Hospital of Fudan University between Jan 2018 and March 2022. Propensity score matching (PSM) was performed to balance the two groups.
RESULTS
A total of 124 patient pairs were enrolled in the final analysis. The complete pathological response rate (20.2% vs. 29.0%, p=0.140) was similar in the two groups while the lower major pathological response rate (44.4% vs. 61.3%, p=0.011) was observed in the nICT group. nICT was associated with a lower rate of adverse events (42.7% vs. 55.6%, p=0.047) without additional postoperative complications (38.7% vs. 35.5%, p=0.693). The nICT group had lower distant metastasis (6.5% vs. 16.1%, p=0.027) and overall recurrence (11.3% vs. 23.4%, p=0.019) in the postoperative 1 year. Also, nICT was associated with better progression-free survival (HR=0.50; 95% CI: 0.32-0.77; p=0.002). Cox proportional hazard analysis showed that nICT (univariable: HR=0.55; 95% CI: 0.37-0.82; p=0.003; multivariable: HR=0.44; 95% CI: 0.29-0.65; p<0.001) was one of the independent prognostic factors for progression-free survival. The two groups had similar overall survival (HR=0.62; 95%CI: 0.36-1.09; p=0.094) at the latest follow-up.
CONCLUSION
This retrospective study showed that nICT was safe and effective for LA-ESCC patients. Further verification is needed in the randomized controlled trials.
PubMed: 38944271
DOI: 10.1016/j.jtcvs.2024.06.020 -
Journal of Vascular and Interventional... Jun 2024To Describe 6-Month safety, efficacy and multimodal imageability after imageable glass Yttrium-90 radioembolization for unresectable Hepatocellular Carcinoma (HCC) in a...
PURPOSE
To Describe 6-Month safety, efficacy and multimodal imageability after imageable glass Yttrium-90 radioembolization for unresectable Hepatocellular Carcinoma (HCC) in a First-in Human Trial METHODS: Eye90 microspheres® (Eye90), an FDA Breakthrough Designated Device, are glass radiopaque Y-90 microspheres visible on CT and SPECT/CT. Six subjects with unresectable HCC underwent selective (≤ 2 segments) Eye90 treatment in a prospective open-label pilot trial. Key inclusion criteria included liver only HCC, ECOG ≤ 1, total lesion length ≤ 9 cm and Child-Pugh A. Prospective partition dosimetry was utilized. Safety, biochemistry, toxicity, adverse events (AE), multimodal imageability on CT and SPECT/CT and 3 and 6-month MRI local modified RECIST (mRECIST) response was evaluated.
RESULTS
6 subjects with HCC (7 lesions) were treated with Eye90 and followed to 180 days. Administration success was 100%. Eye90 CT radiopacity distribution correlated with SPECT/CT. Target lesion complete response was observed in 3 of 6 subjects (50%) and partial response in 2 (33.3%). Two subjects could not be assessed at 180 days. At 180 days, target lesion complete response was maintained in 3 subjects (50%) and partial response in 1 (16.7%). All subjects reported AEs, and 5 reported AEs related to treatment. There were no treatment related serious AEs.
CONCLUSIONS
Eye90 was safe and effective in six subjects with unresectable HCC up to 6 months. Eye90 was imageable via CT and SPECT/CT with correlation between CT radiopacity and SPECT/CT radioactivity distribution. Eye90 provided previously unavailable CT based tumor targeting information.
PubMed: 38944236
DOI: 10.1016/j.jvir.2024.06.023 -
Current Problems in Cardiology Jun 2024Individuals afflicted with heart failure (HF) with preserved ejection fraction (HFpEF) often exhibit obesity, a condition that is frequently associated with a pronounced... (Review)
Review
Individuals afflicted with heart failure (HF) with preserved ejection fraction (HFpEF) often exhibit obesity, a condition that is frequently associated with a pronounced prevalence of symptoms and physical constraints related to HF, alongside detrimental hemodynamic profiles and an elevated susceptibility to adverse cardiac events. The amelioration of health status is a pivotal objective in the management of HF, with extant research suggesting that a considerable number of patients with this condition place equal emphasis on the enhancement of these health dimensions as they do on the prolongation of life. The administration of a weekly subcutaneous dose of 2.4 mg Semaglutide has been observed to yield significant amelioration in symptomatology, physical limitations, and exercise capacity, alongside a reduction in inflammatory markers and a more pronounced reduction in body weight when compared to a placebo in the study's obese HFpEF cohort. Nevertheless, the extent to which these therapeutic benefits of Semaglutide manifest differentially in relation to the baseline severity of health status impairment remains to be elucidated. Additionally, a more nuanced comprehension of the impact of Semaglutide on the comprehensive spectrum of health status parameters, encompassing symptomatology, physical limitations, life quality, and social impediments, is warranted. This includes an assessment of the proportion of patients experiencing deterioration, as well as those attaining minimal, moderate, substantial, and marked improvements within these respective domains.
PubMed: 38944224
DOI: 10.1016/j.cpcardiol.2024.102736 -
International Immunopharmacology Jun 2024Several monoclonal antibodies (MoAbs) targeting specific type 2 immune reactions have been developed as innovative therapeutic approaches for chronic inflammatory airway...
OBJECTIVE
Several monoclonal antibodies (MoAbs) targeting specific type 2 immune reactions have been developed as innovative therapeutic approaches for chronic inflammatory airway diseases, such as chronic sinusitis with nasal polyps (CRSwNP) and asthma. However, the clinical safety of these MoAbs and how to choose them are not clear. Therefore, we aimed to assess the systemic drug- and dose-based safety of MoAbs in chronic airway inflammation using network meta-analysis (NMA).
METHODS
Electronic databases were systematically searched for relevant studies published in English between January 2009 and December 2022. Eligible studies must have clearly reported adverse events (AEs) among the MoAbs' safety data.
RESULTS
1). Regarding serious AEs, mepolizumab was significantly safer than placebo; in terms of permanent treatment discontinuation, reslizumab and dupilumab were significantly safer than benralizumab. 2). Regarding asthma worsening, dupilumab was associated with the best safety profile; was safer than dupilumab/300 mg/q2-4w. 3). In terms of injection-site reactions, dupilumab posed a higher risk than placebo; dupilumab/300 mg/qw posed a higher risk than dupilumab/300 mg/q2w and dupilumab/300 mg/q2-4w; lebrikizumab/250 mg/q4w posed a higher risk than lebrikizumab/37.5 mg/q4w; mepolizumab/100 mg/q4w posed a higher risk than mepolizumab/75 mg/q4w; benralizumab/30 mg/q4-8w posed a higher risk than benralizumab/20 mg/q4-8w. 4) In CRSwNP patients combined with asthma, the risks of experiencing AEs were not increased.
CONCLUSION
Overall, biologics are safe and well tolerated in chronic inflammatory airway disease. This drug- and dose-based NMA provides further evidence on the different safety profiles of different emerging MoAbs. This information may help guide rational drug use and provide clinical recommendations for choosing MoAbs.
TRIAL REGISTRATION
SYSTEMATIC REVIEW REGISTRATION (PROSPERO #CRD42023387610).
PubMed: 38943971
DOI: 10.1016/j.intimp.2024.112462