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).

Visual evoked potentials to emotional slides presented for 2 sec. were investigated in 13 subjects. 73 emotional slides (pleasant, unpleasant, and neutral) were selected from a standardized set of photographic slides, the 1988 International Affective Picture System of Lang, Ohman, and Vaitl Visual evoked potentials were recorded from three head locations, frontal, central and parietal (Fz, Cz, and Pz). Analyses were performed in the two latency ranges: 300-400 msec. and 400-500 msec. Analyses showed an arousal effect, as indicated by a quadratic trend, indicating that emotional slides (both pleasant and unpleasant) gave higher cortical positivity than neutral ones, for all components. In addition, in the two latency epochs, larger positivities were found at Pz, compared to Fz and Cz, whereas Fz and Cz did not differ from each other.

Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.

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The diagnosis of pancreatic cancer is usually made in the advanced stages of the disease when the prognosis is poor. We compared the behavior of CA19.9, CEA and the newly proposed mucin CA242 in a consecutive series of 42 pancreatic carcinomas. A control group was recruited of 21 patients with benign pancreatic diseases. With the recommended cutoffs (37 U/ml for CA19.9, 20 U/ml for CA242 and 8 ng/ml for CEA) we obtained a specificity of 90% for CA19.9 and of 85% for CA242 and CEA. The sensitivity was 85.7% for CA19.9, 73.8% for CA242 and 26.2% for CEA. CA19.9 and CA242 showed identical behavior in various TNM stages of cancer and in stages III and IV of the Hermreck classification. Moreover, CA19.9 and CA242 showed identical behavior in 10 patients monitored during the survival period who developed recurrence of disease. ROC curve evaluation demonstrated that CA242 and CA19.9 were very similar. The results of CA242 were better than those of CA19.9 in the false positive range under 10%, whereas CA19.9 had a better performance in the true positive range over 70%. CA242 could be used instead of CA19.9 for diagnosing pancreatic carcinoma.