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Aim Assess the effectiveness and safety of nivolumab versus cetuximab in patients with R/M HNSCC, as well as to analyze possible prognostic factors for response to treatment with nivolumab. Methods We conducted an observational, retrospective, descriptive study of patients with R/M HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in two periods of equivalent duration. Overall efficacy was measured in progression-free survival (PFS) and overall survival (OS); safety was evaluated using the CTCAE (Common Terminology Criteria for Adverse Events) classification version 5.0 of the National Cancer Institute (NCI). Results Median overall survival (OS) was 9.1 months with nivolumab (n=34) vs. 6.3 months with cetuximab (n=12)(HR=0.5; 95%CI: 0.24-1.03; p=0.058). Progression free survival (PFS) were 4.3 for nivolumab and 4.65 months for cetuximab (HR=0.59; 95%CI: 0.29-1.19; p=0.14). Any grade adverse events (AEs) were reported in 97% and 100% of the patients treated with nivolumab and cetuximab. Serious AEs were observed in 26% and 58% of the patients respectively. Elevated albumin values, lymphocytosis, neutropenia and elevated neutrophil/lymphocyte ratio values have positive prognostic value on the response to nivolumab in R/M CCECC. Conclusion Effectiveness of nivolumab in terms of OS remains superior to cetuximab. OS, PFS and severe or any grade AEs were superior in both arms of our study than in the clinical trials. The AEs profile of nivolumab differs in our study from the clinical trials’ observations. We have identified four positive statistically significant prognostic variables on the response to nivolumab in R/M HNSCC.

Aim Assess the effectiveness and safety of nivolumab versus cetuximab in patients with R/M HNSCC, as well as to analyze possible prognostic factors for response to treatment with nivolumab. Methods We conducted an observational, retrospective, descriptive study of patients with R/M HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in two periods of equivalent duration. Overall efficacy was measured in progression-free survival (PFS) and overall survival (OS); safety was evaluated using the CTCAE (Common Terminology Criteria for Adverse Events) classification version 5.0 of the National Cancer Institute (NCI). Results Median overall survival (OS) was 9.1 months with nivolumab (n=34) vs. 6.3 months with cetuximab (n=12)(HR=0.5; 95%CI: 0.24-1.03; p=0.058). Progression free survival (PFS) were 4.3 for nivolumab and 4.65 months for cetuximab (HR=0.59; 95%CI: 0.29-1.19; p=0.14). Any grade adverse events (AEs) were reported in 97% and 100% of the patients treated with nivolumab and cetuximab. Serious AEs were observed in 26% and 58% of the patients respectively. Elevated albumin values, lymphocytosis, neutropenia and elevated neutrophil/lymphocyte ratio values have positive prognostic value on the response to nivolumab in R/M CCECC. Conclusion Effectiveness of nivolumab in terms of OS remains superior to cetuximab. OS, PFS and severe or any grade AEs were superior in both arms of our study than in the clinical trials. The AEs profile of nivolumab differs in our study from the clinical trials’ observations. We have identified four positive statistically significant prognostic variables on the response to nivolumab in R/M HNSCC.

Aim and objectives Primary aim: to assess the correlation between the dose of isavuconazol administered and its plasma drug concentrations (IsaPlasmConc). Secondary aim: to analyse differences in IsaPlasm at different points in the ECMO circuit to study drug sequestration. Material and methods Prospective study in critically ill patients treated with intravenous isavuconazol and receiving ECMO in the intensive care unit (ICU) from August to October 2021. Isavuconazol area under the curve (AUCisa) was calculated using the trapezoidal method. Blood samples were drawn from an arterial catheter and from ECMO circuit pre-and post-oxygenator at 0 (predose) and 1 hour (end of infusion), and from an arterial catheter at 2, 4, 6 and 12 hours after isavuconazol infusion.A therapeutic goal of IsaPlasmConc 2.5-10 mg/mL was established. The analytical method used was high-pressure liquid chromatography. Differences greater than 10% on ECMO sites were considered as possible drug sequestration. Results Both patients received a loading dose of isavuconazole 200 mg/8 hours over 48 hours. No relevant drug interactions were identified.Patient 1: male, 61 years, 65 kg. Pulmonary aspergillosis treated with isavuconazole 200 mg/24 hours intravenously (IV). On day 4, IsaPlasmConc