During a spontaneous and autonomous study, we assessed the ultrasound finding of lymphadenopathy after BNT162b2 Pfizer vaccine. We enrolled 18 patients with 58 lymphadenopathies: in 10 patients, they were in the laterocervical side, while in 8 patients in the axillar site. The largest diameter was 14 mm with a range from 7 to 16 mm (median value = 10 mm). In the same patient, we found different ultrasound nodal findings. A total of 25 nodes showed eccentric cortical thickening with wide echogenic hilum and oval shape. In total, 19 nodes showed asymmetric eccentric cortical thickening with wide echogenic hilum and oval shape. Overall, 10 nodes showed concentric cortical thickening with reduction in the width of the echogenic hilum and oval shape. A total of four nodes showed huge reduction and displacement of the echogenic hilum and round or oval shape. No anomaly was found at the Doppler echocolor study. In conclusion, eccentric cortical thickening with wide echogenic hilum and oval shape, asymmetric eccentric cortical thickening with wide echogenic hilum and oval shape, concentric cortical thickening with reduction in the width of the echogenic hilum and oval shape, and a huge reduction and displacement of the echogenic hilum and round shape are the features that we found in post BNT162b2 Covid-19 Vaccine lymphadenopathies.
BackgroundRecurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) has a poor prognosis and the combination of cisplatin and cetuximab, with or without 5-fluorouracil, is the gold standard treatment in this stage. Thus, the concomitant use of novel compounds represents a critical strategy to improve treatment results. Histone deacetylase inhibitors (HDACi) enhance the activity of several anticancer drugs including cisplatin and anti-Epidermal Growth Factor Receptor (anti-EGFR) compounds. Preclinical studies in models have shown that vorinostat is able to down regulate Epidermal Growth Factor Receptor (EGFR) expression and to revert epithelial to mesenchimal transition (EMT). Due to its histone deacetylase (HDAC) inhibiting activity and its safe use as a chronic therapy for epileptic disorders, valproic acid (VPA) has been considered a good candidate for anticancer therapy. A reasonable option may be to employ the combination of cisplatin, cetuximab and VPA in recurrent/metastatic SCCHN taking advantage of the possible positive interaction between histone deacetylase inhibitors, cisplatin and/or anti-EGFR.Method/DesignV-CHANCE is a phase 2 clinical trial evaluating, in patients with recurrent/metastatic squamous cell carcinoma of the head and neck never treated with first-line chemotherapy, the concomitant standard administration of cisplatin (on day 1, every 3 weeks) and cetuximab (on day 1, weekly), in combination with oral VPA given daily from day −14 with a titration strategy in each patient (target serum level of 50–100 μg/ml). Primary end point is the objective response rate measured according to Response Evaluation Criteria in Solid Tumors (RECIST). Sample size, calculated according to Simon 2 stage minimax design will include 21 patients in the first stage with upper limit for rejection being 8 responses, and 39 patients in the second stage, with upper limit for rejection being 18 responses. Secondary endpoints are time to progression, duration of response, overall survival, safety.Objectives of the translational study are the evaluation on tumor samples of markers of treatment efficacy/resistance (i.e. γH2AX, p21/WAF, RAD51, XRCC1, EGFR, p-EGFR, Ki-67) and specific markers of VPA HDAC inhibitory activity (histones and proteins acetylation, Histone deacetylase isoforms) as well as valproate test, histones and proteins acetylation of peripheral blood mononuclear cell, tested on blood samples at baseline and at different time points during treatment.DiscussionOverall, this study could provide a less toxic and more effective first-line chemotherapy regimen in patients with recurrent/metastatic squamous cell carcinoma of the head and neck by demonstrating the feasibility and efficacy of cisplatin/cetuximab plus valproic acid. Moreover, correlative studies could help to identify responder patients, and will add insights in the mechanism of the synergistic interaction between these agents.EudraCT Number2014-001523-69Trial registrationClinicalTrials.gov number, NCT02624128
Animal models of experimental liver carcinogenesis and epidemiological studies in humans suggest a relationship between sex hormones and hepatocellular carcinoma (HCC). In 1997, a systematic review of the existing, small randomized trials evaluating the antiestrogen tamoxifen yielded a positive result, but the large randomized CLIP-1 trial showed no survival advantage from the addition of tamoxifen to best supportive care. A possible explanation for the negative results is the lack of patient selection, but the expression of estrogen (ER) and progesterone (PgR) receptors in HCC does not clearly affect the survival outcome of the patients treated with tamoxifen. In the last years, it has been proposed that negative results might be due to the fact that tamoxifen in HCC could act via an ER-independent pathway, which requires much higher doses than those usually administered, but a double-blind Asian randomized trial conducted to assess possible dose-response effect showed no efficacy for tamoxifen, with an inversely negative impact with increasing dose. According to the results of large trials and of the Cochrane systematic review, neither further trials are warranted with tamoxifen in HCC, nor should any use in clinical practice be considered. Interesting results have been obtained when the type of hormonal treatment (tamoxifen or megestrol) has been chosen according to the presence of wild-type or variant ER, but these results should be confirmed in large randomized trials. Negative results have been obtained with antiandrogen therapy. In conclusion, hormonal treatment should not be a part of the current management of HCC patients.
Background and aimsSeveral neuromotor disorders share exclusive, although often overlooked, nutritional problems. The objective of this study is therefore to delineate the frequency of malnutrition, evaluate the effectiveness of nutritional care, and identify issues needing to be possibly strengthened when caring for these patients into a general pediatrics department.Patients and methodsThe study included 30 patients, 21 males and 9 females, aged between 2 and 15 years, affected by cerebral palsy, epileptic encephalopathy, and severe psychomotor developmental delay.Nutritional status was assessed by a dietary questionnaire administered to parents to investigate feeding difficulties; 3 days food diary to quantify daily calorie intake; anthropometrical (weight, height/length, body mass index percentiles, plicometry, specific body segments measurement) and blood (blood count, serum iron, albumin, transferrin, calcium, phosphorus) parameters.ResultsMore than 44% individuals of the study population was at risk of malnutrition, according to feeding difficulties, progressive depletion of weight, reduced daily calorie intake, reduced albumin and transferrin levels. This occurred despite a massive caregivers commitment, as documented by almost universal parental constant assistance during their long-duration meals.ConclusionsOur results individuate the nutritional aspect being still a problem in the care of children with severe neuromotor disability.
The epidemics of overweight and obesity has resulted in a significant increase of non alcoholic fatty liver disease (NAFLD), a potentially progressive condition. Currently, obesity related hepatopathy represents therefore the main cause of pediatric chronic liver disease. The first choice treatment at all ages is weight loss and/or lifestyle changes, however compliance is very poor and a pharmacological approach has become necessary. In the present article we present a systematic literature review focusing on established pediatric NALFD drugs (ursodeoxycholic acid, insulin sensitizers, and antioxidants) and on innovative therapeutic options as well.Regarding the former ones, a pediatric pilot study highlighted that ursodeoxycholic acid is not efficient on transaminases levels and bright liver. Similarly, a recent large scale, multicenter randomized clinical trial (TONIC study) showed that also insulin sensitizers and antioxidant vitamin E have scarce effects on serum transaminase levels. Among a large series of novel therapeutic approaches acting on recently proposed different pathomechanisms, probiotics seem hitherto the most interesting and reasonable option for their safety and tolerability. Toll-like receptors modifiers, Pentoxifylline, and Farnesoid X receptors agonists have been still poorly investigated, and will need further studies before becoming possible promising innovative therapeutic strategies.
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