Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).
We found a specifically subset of patients where the combination of prognostic factors, in particular, negative surgical margins R0, tumour size ≤ 30 mm and the absence of lymph node metastasis independently reduced the mortality indicating that earlier tumour detection and histologically curative resection are important factors contributing to long term survival and healing of ductal adenocarcinoma of the head of the pancreas.
BackgroundAngiodysplasia of the gastrointestinal tract is an uncommon, but not rare, cause of bleeding and severe anemia in elderly. Different treatments exist for this kind of pathology.MethodsThe aim of this work was to study 40 patients treated for intestinal angiodysplasia with two different kind of endoscopic treatments: argon plasma coagulation (APC) and bipolar electrocoagulation (BEC).ResultsAge of patients was similar in both groups (76,2 ± 10.8 years vs 74,8 ± 8,7 years, P = 0,005). Angiodysplasia treated were located in small bowel, right colon, left colon, transverse colon and cecum. We analysed number of treatment, recurrence, hospital discharge, needs of blood transfusions before and after endoscopic treatment. Number of treatment was the same in both groups (1,2 ± 0,2 vs 1,1 ± 0,1, P < 0,001). We had more recurrence in patients treated with BEC (4/20 vs 2/20, P < 0,001). Hospital discharge was comparable in both groups (5,3 ± 3,1 days vs 5,4 ± 2,8 years, P < 0.001)ConclusionsTreatment of angiodysplasia in elderly is not easy. Different kinds of treatment could be adopted. APC and BEC are both safe and effective. The choice of a treatment should consider several factors: age, comorbidity, source of bleeding. In conclusion we think that treatment of bleeding for angiodysplasia in elder population should be a tailored treatment.
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