First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)

The objective of this pilot clinical study was to assess the safety, technical feasibility, pharmacokinetic (PK) profile and tumour response of DC Bead™ with irinotecan (DEBIRI™) delivered by intra-arterial embolisation for the treatment of metastatic colorectal cancer. Eleven patients with unresectable liver metastases from CRC, tumour burden <30% of liver volume, adequate haematological, liver and renal function, performance status of <2 were included in this study. Patients received up to 4 sessions of TACE with DEBIRI at 3-week intervals. Feasibility of the procedure, safety and tumour response were assessed after each cycle. PK was measured after the first cycle. Patients were followed up to 24 weeks. Only mild to moderate adverse events were observed. DEBIRI is a technically feasibile procedure; no technical complications were observed. Average Cmax for irinotecan and SN-38 was 194 ng/ml and 16.7 ng/ml, respectively, with average t½ of 4.6 h and 12.4 h following administration of DEBIRI. Best overall response during the study showed disease control in 9 patients (2 patients with partial response and 7 with stable disease, overall response rate of 18%). Our study shows that transarterial chemoembolisation with irinotecan-loaded DC beads (DEBIRI) is safe, technically feasible and effective with a good PK profile

COVID-19 lockdown: The relationship between trait impulsivity and addictive behaviors in a large representative sample of Italian adults

open9noBackground: The importance of trait impulsivity in development, continuation and escalation of addictive behaviors has long been recognized. Methods: A cross-sectional population-based survey was conducted during the COVID-19 lockdown on 6003 Italian adults aged 18–74 years, representative of the Italian general population, to investigate the relationship between impulsivity (Barratt Impulsiveness Scale – BIS) and selected addictive behaviors (gambling habits, smoking status, cannabis use, average alcohol daily use). Results: A statistically significant relationship was found between motor impulsivity and starting/increasing drinking and increasing gambling (high vs. low motor impulsivity: multivariate odds ratio, OR=3.12; 95% confidence interval, CI: 1.45–6.74; p for trend=0.004 for start and OR=1.53; 95% CI: 1.26–1.86; p for trend&lt;0.001 for increase drinking, respectively; OR=2.09; 95% CI: 1.41–3.12; p for trend&lt;0.001 for increasing gambling). Limitations: Potential information and recall bias. The necessity to limit the length of the questionnaire not to reduce the quality of the answers of study participants. Conclusions: The multifaceted nature of impulsivity, potentially either cause or effect, hampers the understanding of its proper role in addictive behaviors. If confirmed by future longitudinal studies, our findings might support the planning, implementation and monitoring of evidence-based preventive interventions, to reduce addictive behaviors during public health emergencies.openAmerio A.; Stival C.; Lugo A.; Fanucchi T.; Gorini G.; Pacifici R.; Odone A.; Serafini G.; Gallus S.Amerio, A.; Stival, C.; Lugo, A.; Fanucchi, T.; Gorini, G.; Pacifici, R.; Odone, A.; Serafini, G.; Gallus, S

Secondhand smoke presence in outdoor areas in 12 European countries

Introduction: Secondhand smoke (SHS) causes morbidity and mortality among non-smokers. Objectives: To investigate SHS presence in outdoor areas from 12 European countries and its association with country-level characteristics. Methods: Cross-sectional study performed in 2017-2018 within the TackSHS project. We conducted a face-to-face survey on a representative sample of the population aged 15 years and older from 12 European countries: Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain. Out of 11,902 participants, 8,562 were non-smokers. SHS presence was assessed in selected outdoor areas and defined as respondents viewing someone smoking the last time they visited each setting within the last 6 months. A ranking score for outdoor SHS presence was assigned to each country based on the SHS presence in each setting. We used Spearman's correlation (r) and the Chi-squared tests to assess the relationship between SHS presence and country-level characteristics. Results: Except for children's playgrounds (39.5%; 95% confidence interval, CI: 37.6%-41.3%), more than half of non-smokers reported SHS presence in outdoor areas: schools (52.0%; 95%CI: 50.2%-53.7%), stadia (57.4%; 95%CI: 55.4%-59.4%), parks (67.3%; 95%CI: 66.0%-68.5%), hospitals (67.3%; 95%CI: 65.8%-68.7%), public transport stops (69.9%; 95%CI: 68.6%-71.2%), bar/restaurant terraces (71.4%; 95%CI: 70.2%-72.6%), and beaches (72.8%; 95%CI: 71.4%-74.1%). Residents in Latvia showed the highest overall outdoor SHS presence rank, followed by Greece, and Portugal. Outdoor SHS presence was directly correlated to the country's smoking prevalence (r = 0.64), and inversely correlated to the Tobacco Control Scale 2016 overall score (r = -0.62), the socio-demographic index 2017 (r = -0.56), and Gross Domestic Product per capita 2018 (r = -0.47) (p < 0.001). Conclusions: SHS presence is high in most outdoor areas in Europe, especially in countries with higher smoking prevalence and lower tobacco control performance. To address outdoor SHS exposure, our findings require considering smoking bans along with other strategies to reduce smoking prevalence

Incidence and risk factors for gallstones in patients with inflammatory bowel disease: a large case-control study

The risk for gallstones (GD) in inflammatory bowel diseases and the factors responsible for this complication have not been well established. We studied the incidence of GD in a cohort of Crohn's disease (CD) and ulcerative colitis (UC) patients and investigated the related risk factors. A case-controlled study was carried out. The study population included 634 inflammatory bowel disease (IBD) patients (429 CD, 205 UC) and 634 age-matched, sex-matched, and body mass index (BMI)-matched controls free of GD at enrollment, who were followed for a mean of 7.2 years (range, 5-11 years).The incidence of GD was calculated by dividing the number of events per person-years of follow-up. Multivariate analysis was used to discriminate among the impact of different variables on the risk of developing GD. The incidence rates of GD were 14.35/1,000 persons/year in CD as compared with 7.75 in matched controls (P=0.012) and 7.48/1000 persons/year in UC patients as compared with 6.06 in matched-controls (P=0.38). Ileo-colonic CD location (OR, 2.14), disease duration&gt;15 years (OR, 4.26), &gt;3 clinical recurrences (OR, 8.07), ileal resection&gt;30 cm (OR, 7.03), &gt;3 hospitalizations (OR, 20.7), multiple TPN treatments (OR, 8.07), and long hospital stay (OR, 24.8) were significantly related to GD in CD patients. CONCLUSION: Only CD patients have a significantly higher risk of developing GD than well-matched hospital controls. Site of disease at diagnosis, lifetime surgery, extent of ileal resections, number of clinical recurrences, TPN, and the frequency and duration of hospitalizations are independently associated with GD

Impact of Scottish smoke-free legislation on smoking quit attempts and prevalence

&lt;p&gt;&lt;b&gt;Objectives:&lt;/b&gt; In Scotland, legislation was implemented in March 2006 prohibiting smoking in all wholly or partially enclosed public spaces. We investigated the impact on attempts to quit smoking and smoking prevalence.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Methods:&lt;/b&gt; We performed time series models using Box-Jenkins autoregressive integrated moving averages (ARIMA) on monthly data on the gross ingredient cost of all nicotine replacement therapy (NRT) prescribed in Scotland in 2003–2009, and quarterly data on self-reported smoking prevalence between January 1999 and September 2010 from the Scottish Household Survey.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Results:&lt;/b&gt; NRT prescription costs were significantly higher than expected over the three months prior to implementation of the legislation. Prescription costs peaked at £1.3 million in March 2006; £292,005.9 (95% CI £260,402.3, £323,609, p&#60;0.001) higher than the monthly norm. Following implementation of the legislation, costs fell exponentially by around 26% per month (95% CI 17%, 35%, p&#60;0.001). Twelve months following implementation, the costs were not significantly different to monthly norms. Smoking prevalence fell by 8.0% overall, from 31.3% in January 1999 to 23.7% in July–September 2010. In the quarter prior to implementation of the legislation, smoking prevalence fell by 1.7% (95% CI 2.4%, 1.0%, p&#60;0.001) more than expected from the underlying trend.&lt;/p&gt; &lt;p&gt;&lt;b&gt;Conclusions:&lt;/b&gt; Quit attempts increased in the three months leading up to Scotland's smoke-free legislation, resulting in a fall in smoking prevalence. However, neither has been sustained suggesting the need for additional tobacco control measures and ongoing support.&lt;/p&gt