Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL)

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and reduced health-related quality of life. Findings from clinical trials have demonstrated the effectiveness of dupilumab in CRSwNP, although real-world evidence is still limited. Methods This Phase IV real-life, observational, multicenter study assessed the effectiveness and safety of dupilumab in patients with severe uncontrolled CRSwNP (n = 648) over the first year of treatment. We collected data at baseline and after 1, 3, 6, 9, and 12 months of follow-up. We focused on nasal polyps score (NPS), symptoms, and olfactory function. We stratified outcomes by comorbidities, previous surgery, and adherence to intranasal corticosteroids, and examined the success rates based on current guidelines, as well as potential predictors of response at each timepoint. Results We observed a significant decrease in NPS from a median value of 6 (IQR 5–6) at baseline to 1.0 (IQR 0.0–2.0) at 12 months (p < .001), and a significant decrease in Sino-Nasal Outcomes Test-22 (SNOT-22) from a median score of 58 (IQR 49–70) at baseline to 11 (IQR 6–21; p < .001) at 12 months. Sniffin' Sticks scores showed a significant increase over 12 months (p < .001) compared to baseline. The results were unaffected by concomitant diseases, number of previous surgeries, and adherence to topical steroids, except for minor differences in rapidity of action. An excellent-moderate response was observed in 96.9% of patients at 12 months based on EPOS 2020 criteria. Conclusions Our findings from this large-scale real-life study support the effectiveness of dupilumab as an add-on therapy in patients with severe uncontrolled CRSwNP in reducing polyp size and improving the quality of life, severity of symptoms, nasal congestion, and smell

Fatality rate and predictors of mortality in an Italian cohort of hospitalized COVID-19 patients

Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among different countries and during different phases of the pandemia. Here, we aimed to evaluate the case fatality rate (CFR) and to identify predictors of mortality in a cohort of COVID-19 patients admitted to three hospitals of Northern Italy between March 1 and April 28, 2020. All these patients had a confirmed diagnosis of SARS-CoV-2 infection by molecular methods. During the study period 504/1697 patients died; thus, overall CFR was 29.7%. We looked for predictors of mortality in a subgroup of 486 patients (239 males, 59%; median age 71 years) for whom sufficient clinical data were available at data cut-off. Among the demographic and clinical variables considered, age, a diagnosis of cancer, obesity and current smoking independently predicted mortality. When laboratory data were added to the model in a further subgroup of patients, age, the diagnosis of cancer, and the baseline PaO2/FiO2 ratio were identified as independent predictors of mortality. In conclusion, the CFR of hospitalized patients in Northern Italy during the ascending phase of the COVID-19 pandemic approached 30%. The identification of mortality predictors might contribute to better stratification of individual patient risk

Liver Tumor Burden in Pancreatic Neuroendocrine Tumors: CT Features and Texture Analysis in the Prediction of Tumor Grade and 18F-FDG Uptake

Pancreatic neuroendocrine tumors (p-NETs) are a rare group of neoplasms that often present with liver metastases. Histological characteristics, metabolic behavior, and liver tumor burden (LTB) are important prognostic factors. In this study, the usefulness of texture analysis of liver metastases in evaluating the biological aggressiveness of p-NETs was assessed. Fifty-six patients with liver metastases from p-NET were retrospectively enrolled. Qualitative and quantitative CT features of LTB were evaluated. Histogram-derived parameters of liver metastases were calculated and correlated with the tumor grade (G) and 18F-fluorodeoxyglucose (18F-FDG) standardized uptake value (SUV). Arterial relative enhancement was inversely related with G (-0.37, p = 0.006). Different metastatic spread patterns of LTB were not associated with histological grade. Arterialentropy was significantly correlated to G (-0.368, p = 0.038) and to Ki67 percentage (-0.421, p = 0.018). The ROC curve for the Arterialentropy reported an area under the curve (AUC) of 0.736 (95% confidence interval 0.545-0.928, p = 0.035) in the identification of G1-2 tumors. Arterialuniformity values were correlated to G (0.346, p = 0.005) and Ki67 levels (0.383, p = 0.033). Arterialentropy values were directly correlated with the SUV (0.449, p = 0.047) which was inversely correlated with Arterialuniformity (-0.499, p = 0.025). Skewness and kurtosis reported no significant correlations. In conclusion, histogram-derived parameters may predict adverse histological features and metabolic behavior of p-NET liver metastases

Radiofrequency ablation of hepatocellular carcinoma: CT texture analysis of the ablated area to predict local recurrence

Purpose: To investigate the role of CT-texture analysis of liver ablation area to predict local recurrence after HCC ablation. Methods: Patients treated with liver ablation were retrospectively enrolled. CT-texture analysis was performed on the core and borders of ablation area 1-2 months after procedure. Tumors were grouped according to the onset of local recurrence at follow-up (persistence, recurrence-free, short- or long-term recurrence). Differences in texture parameters and which parameters were predictive of recurrence risk were assessed using a Cox regression model. Results: 151 HCCs were treated in 98 patients (72 ± 9 years, 83 men). 68 HCCs reported no disease recurrence, 32 persistent disease, 19 short-term and 32 long-term recurrence. Median follow-up was 280 [IQR: 156-569] days. Venous phase (Ven)Skewness (HR 6.07, 1.29-28.6, p =.02) and VenKurtosis (HR 2.27, 1.23-4.21, p =.01) of the ablation core were predictive of short-term recurrence. VenHUmean (HR 0.30, 0.11-0.81, p =.02) and VenGLRLM_HGRE (HR 1.06, 1.01-1.11, p =.02) of the core were independent predictors of tumor recurrence (C-index 0.64, CI 0.52-0.76, p =.03). Arterial phase (Art)Entropy of ablation border predicted the recurrence risk (HR 3.15, 1.05-9.42, p =.04) and values higher than 3.71 reported an increased recurrence incidence (p =.05). ArtHUstd (HR 1.14, 1.04-1.24, p =.01), LateHUmean (HR 8.69, 1.11-68.23, p =.04), LateGLRLM_HGRE (HR 0.9, 0.82-0.99, p =.03), LateGLZLM_HGZE (HR 1.01, 1.00-1.02, p <.01) and LateGLZLM_SZHGE (HR 0.99, 0.99-1.00, p =.02) of ablation border were independent predictors of local recurrence risk (C-index 0.73, CI 0.61-0.86, p <.01). Conclusions: CT texture analysis of ablation area performed at 1-2 months follow-up could estimate the risk of local recurrence of hepatocellular carcinoma treated by radiofrequency ablation

CT Simplified Radiomic Approach to Assess the Metastatic Ductal Adenocarcinoma of the Pancreas

The aim of this study was to perform a simplified radiomic analysis of pancreatic ductal adenocarcinoma based on qualitative and quantitative tumor features and to compare the results between metastatic and non-metastatic patients. A search of our radiological, surgical, and pathological databases identified 1218 patients with a newly diagnosed pancreatic ductal adenocarcinoma who were referred to our Institution between January 2014 and December 2018. Computed Tomography (CT) examinations were reviewed analyzing qualitative and quantitative features. Two hundred eighty-eight patients fulfilled the inclusion criteria and were included in this study. Overall, metastases were present at diagnosis in 86/288 patients, while no metastases were identified in 202/288 patients. Ill-defined margins and a hypodense appearance on portal-phase images were significantly more common among patients with metastases compared to non-metastatic patients (p < 0.05). Metastatic tumors showed a significantly larger size and significantly lower arterial index, perfusion index, and permeability index compared to non-metastatic tumors (p < 0.05). In the management of pancreatic ductal adenocarcinoma, early detection and correct staging are key elements. The study of computerized tomography characteristics of pancreatic ductal adenocarcinoma showed substantial differences, both qualitative and quantitative, between metastatic and non-metastatic disease

Variation in Body Mass and Skeletal Muscle Indices in Head and Neck Cancer Patients Undergoing (Chemo)Radiotherapy and Nutritional Intervention

The aim of this study was to analyze variation in body mass index (BMI) and skeletal muscle index (SMI) in head and neck squamous cell carcinoma (HNSCC) patients who underwent exclusive radiotherapy (RT) or concurrent chemo-radiotherapy (RT-CHT). We enrolled 73 HNSCC pts treated with definitive or post-operative RT (14 pts) or RT-CHT (59 pts). At the time of diagnosis (t0) and 3 months after treatment completion (t3), CT scans were retrieved to measure skeletal muscle at the level of the C3 vertebra. Median follow-up was 16 months. Nine disease progressions with distant metastases and eleven local relapses were observed. Fifty-three pts were free from progression at 1 year. At t0, average BMI was 25.8 (SD 4.1), while at t3 it was 24.5, with no reduction in 54 pts. A BMI decrease of −1.3 (p-value 0 and t3 was found with the Wilcoxon signed-rank test. SMI was 57.1 and 59.2 at t0 and t3, respectively (p-value = 0.005). According to our analysis, SMI variation seems to reflect the effect of an appropriate nutritional intervention and may represent a reliable, simple tool for muscle mass analysis

Predictive and prognostic effect of computed tomography-derived body composition analysis during neoadjuvant chemotherapy for operable and locally advanced breast cancer

Excess adiposity is associated with several factors involved in carcinogenesis and breast cancer progression. Evidence supporting the role of body composition in breast cancer treatment is promising, but still scanty and mainly focused on adjuvant treatment. The aim of this study was to evaluate the changes in body composition during neoadjuvant chemotherapy and its association with pathologic complete response and survival outcome in patients treated for operable/locally advanced breast cancer