Real-world evidence of sorafenib for the treatment of hepatocellular carcinoma: A single-center study.

Context: Hepatocellular carcinoma is the third leading cause of cancer death. Currently, sorafenib is the treatment of choice in advanced hepatocarcinoma. Aims: Assessing the effectiveness and toxicity of sorafenib in real-word clinical practice in patients with hepatocarcinoma. Settings and Design: Single-centered observational retrospective study. Methods and Material: We included patients with hepatocarcinoma who began treatment with sorafenib between 2008 and 2018. We evaluated overall survival, time to progression, and response using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 5. 2020. Statistical Analysis Used: Kaplan-Meier curves and the log-rank test were used to determine the survival time and estimate factors associated with these events. Data were analyzed with SPSS 19.0 software. Results: We included 36 patients (88.9% male) with an average age of 64 ± 3.4 years. The tumor stage was advanced (C) in 21 patients (61.8%). We obtained a median overall survival of 8.5 months (IQR 3.14-18.9) and a time to progression of 4.5 months (IQR 2.4-8.8). The main degree of response was progression in 19 patients (36.1%), followed by stable disease in 13 (52.8%). The most commonly reported adverse reactions were: constitutional (83.3%), gastrointestinal (55%) and dermatological symptoms (50.0%). The development of grades 3 or 4 toxicity was not associated with increased overall survival (P = 0.719). Conclusions: The findings of the survival analysis obtained in real practice are similar to those obtained in pivotal clinical trials. Adverse reactions were different from those expected.

Coronary Artery Disease in Very Young Patients: Analysis of Risk Factors and Long-Term Follow-Up.

Coronary artery disease (CAD) is a common chronic condition in the elderly. However, the earlier CAD begins, the stronger its impact on lifestyle and costs of health and social care. The present study analyzes clinical and angiographic features and the outcome of very young patients undergoing coronary angiography due to suspected CAD, including a nested case-control study of ≤40-year-old patients referred for coronary angiography. Patients were divided into two groups: cases with significant angiographic stenosis, and controls with non-significant stenosis. Of the 19,321 coronary angiographies performed in our center in a period of 10 years, 504 (2.6%) were in patients ≤40 years. The most common cardiovascular risk factors for significant CAD were smoking (OR 2.96; 95% CI 1.65-5.37), dyslipidemia (OR 2.18; 95% CI 1.27-3.82), and family history of CAD (OR 1.95; 95% CI 1.05-3.75). The incidence of major adverse cardiovascular events (MACE) at follow-up was significantly higher in the cases compared to controls (HR 2.71; 95% CI 1.44-5.11). Three conventional coronary risk factors were directly related to the early signs of CAD. MACE in the long-term follow-up is associated to dyslipidaemia and hypertriglyceridemia. Focusing efforts for the adequate control of CAD in young patients is a priority given the high socio-medical cost that this disease entails to society.

Impact of COVID-19 on Eye Care in Spain during the First Phase of the Pandemic.

BACKGROUND: The declaration of the first state of alarm for COVID-19 in March 2020 provoked changes in ophthalmological care. The objective of this study was to assess its impact on reorganising care activities, the mental health of ophthalmologists and the training of residents. METHODS: We sent an anonymous online questionnaire between August and October 2020 to consultant ophthalmologists and residents who were active during the state of alarm in Spain. We used Google Forms® software for data collection. We analysed responses according to the degree of regional impact. RESULTS: We received a total of 328 responses from the 17 Autonomous Communities. We saw that 99.4% of respondents changed their work activities with 50% reductions in surgery (94.5%) and consultations (93.0%). Furthermore, 58.8% of respondents reported increased anxiety, and 29.9% transferred to support other services, with this number reaching 49.6% in the hardest-hit regions. Training programs were greatly reduced in external consultations (90.7%), and surgical training was completely cancelled (100%). Additionally, 56.5% of trainees wanted to prolong their residence periods. CONCLUSIONS: The first wave of the pandemic produced significant changes in ophthalmology services, and these changes were more pronounced in the most affected regions. It caused a negative psychological impact on a high rate of respondents and an interruption of the training of ophthalmology residents. Predictably, the negative consequences of this delay in ophthalmological care on patients will be uneven between regions.

Salivary DNA Methylation as an Epigenetic Biomarker for Head and Neck Cancer. Part I: A Diagnostic Accuracy Meta-Analysis.

DNA hypermethylation is an important epigenetic mechanism for gene expression inactivation in head and neck cancer (HNC). Saliva has emerged as a novel liquid biopsy representing a potential source of biomarkers. We performed a comprehensive meta-analysis to evaluate the overall diagnostic accuracy of salivary DNA methylation for detecting HNC. PubMed EMBASE, Web of Science, LILACS, and the Cochrane Library were searched. Study quality was assessed by the Quality Assessment for Studies of Diagnostic Accuracy-2, and sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (dOR), and their corresponding 95% confidence intervals (CIs) were calculated using a bivariate random-effect meta-analysis model. Meta-regression and subgroup analyses were performed to assess heterogeneity. Eighty-four study units from 18 articles with 8368 subjects were included. The pooled sensitivity and specificity of salivary DNA methylation were 0.39 and 0.87, respectively, while PLR and NLR were 3.68 and 0.63, respectively. The overall area under the curve (AUC) was 0.81 and the dOR was 8.34. The combination of methylated genes showed higher diagnostic accuracy (AUC, 0.92 and dOR, 36.97) than individual gene analysis (AUC, 0.77 and dOR, 6.02). These findings provide evidence regarding the potential clinical application of salivary DNA methylation for HNC diagnosis.

Salivary DNA Methylation as an Epigenetic Biomarker for Head and Neck Cancer. Part II: A Cancer Risk Meta-Analysis.

Aberrant methylation of tumor suppressor genes has been reported as an important epigenetic silencer in head and neck cancer (HNC) pathogenesis. Here, we performed a comprehensive meta-analysis to evaluate the overall and specific impact of salivary gene promoter methylation on HNC risk. The methodological quality was assessed using the Newcastle-Ottawa scale (NOS). Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to evaluate the strength of the association and Egger's and Begg's tests were applied to detect publication bias. The frequency of salivary DNA promoter methylation was significantly higher in HNC patients than in healthy controls (OR: 8.34 (95% CI = 6.10-11.39; p < 0.01). The pooled ORs showed a significant association between specific tumor-related genes and HNC risk: p16 (3.75; 95% CI = 2.51-5.60), MGMT (5.72; 95% CI = 3.00-10.91), DAPK (5.34; 95% CI = 2.18-13.10), TIMP3 (3.42; 95% CI = 1.99-5.88), and RASSF1A (7.69; 95% CI = 3.88-15.23). Overall, our meta-analysis provides precise evidence on the association between salivary DNA promoter hypermethylation and HNC risk. Thus, detection of promoter DNA methylation in saliva is a potential biomarker for predicting HNC risk.

Detection of the Accessory Mental Foramina on Human Mandibles Using Cone-beam Computed Tomography: A Systematic Review and Meta-analysis.

INTRODUCTION: This study aimed to perform a systematic review and meta-analysis on accessory mental foramen (AMF) research using cone-beam computed tomographic (CBCT) imaging. METHODS: A systematic review was performed in PubMed, Embase, Thomas Reuter's Web of Science, Scopus, and ScienceDirect databases according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Articles focusing on AMF prevalence and location using CBCT imaging were selected without language restrictions. Studies reporting pooled results only or presenting any pathology in the area surrounding the mental foramen (MF) were excluded. A meta-analysis using random effects was performed. RESULTS: The present meta-analysis included a total of 46 articles involving 21,761 subjects. The overall pooled AMF prevalence was 7.87% (95% confidence interval [CI], 6.69-9.24) in subjects and 4.75% (95% CI, 3.79-5.95) in hemimandibles (n = 31,158). AMF presence was most commonly unilateral, reaching 90.15% (95% CI, 82.98-94.49). AMFs were significantly more frequent in right hemimandibles (χ2 = 5.20, P < .05) and were most commonly located posterior and inferior to the MF. However, AMFs superior to the MF were also observed in 47.43% (95% CI, 38.45-56.58) of cases. The studies conducted over the last 3 years showed significantly higher AMF prevalence levels (χ2 = 5.12, P < .05). CONCLUSIONS: Our meta-analysis demonstrates that AMF prevalence is considerable and should not be underestimated. AMFs are most frequently located in right hemimandibles. The presence of AMFs superior to the MF is frequent. Around 3% of people present superior AMFs. This fact puts those patients at greater risk for injury when performing periapical surgery in this area.

Drug testing in biological samples vs. maternal surveys for the detection of substance use during whole pregnancy.

BACKGROUND: Early diagnosis of nicotine, ethanol and drug use during pregnancy is critical in order to provide adequate care. Current screening procedures show limitations in terms of reliability and short windows of detection. OBJECTIVES: To investigate the prevalence and identify biomarkers of substance use and changes in substance use during pregnancy. To compare drug testing results in different types of biological samples (maternal hair, meconium, placenta, umbilical-cord) with self-reported data. PARTICIPANTS AND SETTING: Prospective cohort study using data from pregnant women and their newborns. METHODS: Biological matrices were collected at birth and analyzed by liquid chromatography tandem mass spectrometry. A paper survey was provided to determine substance use habits. RESULTS: 867 mother-newborn pairs were included. According to the analysis of biological samples, 29.1% cases were positive for one or more substances (13.6% nicotine, 8.4% ethanol, 8.3% cocaine, 6.4% cannabis, 5.7% opioids). The profile of the substance-using mother was a single woman, <28 years-old, with no higher education and unemployed. Segmental maternal hair analysis showed a decrease in tobacco, cannabis and cocaine use throughout pregnancy (p < 0.001). The level of concordance between results from interviews and from biological analyses was weak for opioids, cocaine, and cannabis (kappa coefficient < 0.40). Maternal hair detected the highest number of cases, followed by meconium and by placenta and/or umbilical-cord. CONCLUSIONS: Maternal survey was not a reliable screening technique. Analysis of maternal hair detected the highest number of cases with the broadest detection window (whole pregnancy).

Association of Salivary Human Papillomavirus Infection and Oral and Oropharyngeal Cancer: A Meta-Analysis.

BACKGROUND: Human papillomavirus (HPV) infection has been recognized as an important risk factor in cancer. The purpose of this systematic review and meta-analysis was to determine the prevalence and effect size of association between salivary HPV DNA and the risk of developing oral and oropharyngeal cancer. METHODS: A systematic literature search of PubMed, EMBASE, Web of Science, LILACS, Scopus and the Cochrane Library was performed, without language restrictions or specified start date. Pooled data were analyzed by calculating odds ratios (ORs) and 95% confidence intervals (CIs). Quality assessment was performed using the Newcastle-Ottawa Scale (NOS). RESULTS: A total of 1672 studies were screened and 14 met inclusion criteria for the meta-analysis. The overall prevalence of salivary HPV DNA for oral and oropharyngeal carcinoma was 43.2%, and the prevalence of salivary HPV16 genotype was 27.5%. Pooled results showed a significant association between salivary HPV and oral and oropharyngeal cancer (OR = 4.94; 2.82-8.67), oral cancer (OR = 2.58; 1.67-3.99) and oropharyngeal cancer (OR = 17.71; 6.42-48.84). Significant associations were also found between salivary HPV16 and oral and oropharyngeal cancer (OR = 10.07; 3.65-27.82), oral cancer (OR = 2.95; 1.23-7.08) and oropharyngeal cancer (OR = 38.50; 22.43-66.07). CONCLUSIONS: Our meta-analysis demonstrated the association between salivary HPV infection and the incidence of oral and oropharyngeal cancer indicating its value as a predictive indicator.

Salivary biomarkers for cancer diagnosis: a meta-analysis.

Background: Saliva represents a promising non-invasive source of novel biomarkers for diagnosis and prognosis cancer. This meta-analysis evaluates the diagnostic value of salivary biomarkers for detection of malignant non-oral tumours to better define the value of saliva as an alternative liquid biopsy.Materials and methods: We performed a systematic review and meta-analysis. PubMed, Embase, LILACS and the Cochrane Library were searched to identify articles that examined the potential of salivary biomarkers for the diagnosis of malignant non-oral tumours. To assess the overall accuracy, we calculated the diagnostic odds ratio (DOR), area under hierarchical summary receiver operating characteristic (AUC) curve, sensitivity, specificity, positive likelihood ratio (PLR) and negative likelihood ratio (NLR) using a random- or fixed-effects model. Heterogeneity and publication bias were assessed. Statistical tests were two-sided.Results: One hundred fifty-five study units from 29 articles with 11,153 subjects were included. The pooled sensitivity, specificity, PLR, NLR, DOR and AUC were 0.76 (95% confidence intervals (CI), 0.74-0.77), 0.76 (95% CI, 0.75-0.77), 3.22 (95% CI, 2.92-3.55), 0.31 (95% CI, 0.28-0.34), 13.42 (95% CI, 12.28-15.96) and 0.85 (95% CI, 0.84-0.87), respectively.Conclusion: Salivary biomarkers may be potentially used for non-invasive diagnosis of malignant non-oral tumours.Key messagesThis meta-analysis evaluates the diagnostic value of salivary biomarkers for detection of malignant non-oral tumours to better define the role of saliva as an alternative liquid biopsy.Salivary biomarkers showed 85% accuracy for cancer distant to the oral cavity.Saliva represents a promising non-invasive source of novel biomarkers in cancer.

Efficacy of baths with mineral-medicinal water in patients with fibromyalgia: a randomized clinical trial.

The layout of this study, designed as a randomized crossover clinical trial, is to evaluate the efficacy of an intervention with mineral-medicinal water from As Burgas (Ourense) in patients suffering from fibromyalgia. This sample was randomly divided into two groups: group A and group B. In phase 1, group A had 14 baths in thermal water for a month and standard pharmacological treatment; group B, standard pharmacological treatment. Washout period is 3 months. In phase 2, group A had standard treatment and group B had 14 baths in thermal water for a month plus standard treatment. The Fibromyalgia Impact Questionnaire (FIQ) was used; this grades the impact of the illness from 1 (minimum) to 10 (maximum), which was measured in both phases. Twenty-five patients were included in each group and the study was concluded with 20 patients in group A and 20 in group B. The intervention group obtained, once the baths finished, a mean score of 60.3 (± 11.8) and the control group of 70.8 (± 13.0) (p < 0.001). Three months later, the intervention group presented a mean score of 64.4 (± 10.6) and the control group of 5.0 (± 11.3) (p < 0.001). We can therefore conclude that the simple baths with mineral-medicinal water from As Burgas can make an improvement on the impact caused by fibromyalgia.

Assessing the performance of the PRECISE-DAPT and PARIS risk scores for predicting one-year out-of-hospital bleeding in acute coronary syndrome patients.

AIMS: The PRECISE-DAPT and PARIS risk scores (RSs) were recently developed for bleeding risk assessment in percutaneous coronary intervention (PCI) patients treated with dual antiplatelet therapy (DAPT). We aimed to assess the performance of these RSs for predicting out-of-hospital bleeding in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: Retrospectively, we studied 1,926 consecutive ACS patients treated with PCI and DAPT. The performance of RSs for predicting one-year BARC type 2, 3 or 5 bleeding and BARC type 3 or 5 bleeding was assessed and compared. Both RSs were effective for the prediction of bleeding events. For BARC type 2, 3 or 5 bleeding, the c-statistic values for PRECISE-DAPT and PARIS were 0.61 and 0.63 (p=0.29), respectively. The two scores displayed equal c-statistics of 0.73 for predicting BARC type 3 or 5 bleeding. PARIS significantly outperformed PRECISE-DAPT in terms of indices of categoryless net reclassification improvement and integrated discrimination. Decision curve analyses also favoured PARIS. CONCLUSIONS: Within our cohort, PARIS and PRECISE-DAPT were fairly to moderately effective for the prediction of bleeding. Their predictiveness varies according to the bleeding severity. PARIS-derived bleeding risk assessment was associated with a higher net benefit compared to PRECISE-DAPT-based bleeding risk assessment.