Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines

[EN] Trial Design: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix. 57.14% (12 out 21) had a positive response to second dose of Fendrix . 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix . No serious adverse event occurred. Conclusions: The use of Fendrix , is a viable vaccine alternative for NHS workers classified as ‘‘nonresponders”. Revaccination of healthy non-responders with Fendrix, resulted in very high proportions of responders without adverse events. Trial registration: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). Funding: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013–2016 and co-financed by and the European Regional Development Fund (ERDF)

Knowledge and attitudes towards clinical trials among women with ovarian cancer: results of the ACTO study

Background Despite several initiatives by research groups, regulatory authorities, and scientific associations to engage citizens/patients in clinical research, there are still obstacles to participation. Among the main discouraging aspects are incomplete understanding of the concepts related to a clinical trial, and the scant, sometimes confused, explanations given. This observational, cross-sectional multicenter study investigated knowledge, attitudes and trust in clinical research. We conducted a survey among women with ovarian cancer at their first follow-up visit or first therapy session, treated in centers belonging to the Mario Negri Gynecologic Oncology (MaNGO) and Multicenter Italian Trials in Ovarian Cancer (MITO) groups. A questionnaire on knowledge, attitudes and experience was assembled ad hoc after a literature review and a validation process involving patients of the Alliance against Ovarian Cancer (ACTO). Results From 25 centers 348 questionnaire were collected; 73.5% of responders were 56 years or older, 54.8% had a high level of education, more than 80% had no experience of trial participation. Among participants 59% knew what clinical trials were and 71% what informed consent was. However, more than half did not know the meaning of the term randomization. More than half (56%) were in favor of participating in a clinical trial, but 35% were not certain. Almost all responders acknowledged the doctor's importance in decision-making. Patients' associations were recognized as having a powerful role in the design and planning of clinical trials. Conclusions This study helps depict the knowledge and attitudes of women with ovarian cancer in relation to clinical trials, suggesting measures aimed at improving trial "culture", literacy and compliance, and fresh ways of communication between doctors and patients

Liver Metastases from Primary Rectal Cancer: A Multidisciplinary Reverse Approach

The article comment the multidisciplinary reverse approach for the treatment of primary rectal cancer presenting with liver metastases. This approach contmplated firstly the association of preoperative chemotherapy and Bevacizumab and then a two-stage surgery, having liver resection as first procedure

Ovarian endometrioid adenocarcinoma with a yolk sac tumor component in a postmenopausal woman: Case report and review of the literature

none7noYolk sac tumors (YSTs) of the ovary are rare and highly malignant germ cell tumors of utmost importance, occurring in children and young adults. They are characterized by endodermal differentiation. YSTs coexisting with a variety of histologic patterns have been described but those with an epithelial malignant component are extremely rare, especially in postmenopausal women. We describe a rare case of ovarian endometrioid adenocarcinoma (EOC) with a YST component occurring in a 73-years-old woman (pT1aN0M0) that was treated with a combination of paclitaxel and carboplatin for 6 cycles. At 22-months’ follow-up, the patient was free of recurrence. This is the longest diseasefree survival seen when compared with other reported cases in the literature. No conclusions could be drawn from this case report; we hope that other authors describe their experiences to define the most appropriate approach to this rare tumoropenGiuliani, Jacopo; Marzola, Marina; Pizzutilo, Pamela; Martinello, Ruby; Marzola, Andrea; Indelli, Monica; Frassoldati, AntonioGiuliani, Jacopo; Marzola, Marina; Pizzutilo, Pamela; Martinello, Ruby; Marzola, Andrea; Indelli, Monica; Frassoldati, Antoni

Gli standard oncologici nel Percorso Diagnostico Terapeutico Assistenziale del paziente con carcinoma del colon: Dati del biennio 2009-2010 presso l'UO di Oncologia Clinica dell'AOU di Ferrara

The aim of this study is to analyse the oncological quality indicators on our Colorectal Cancer Program, that are reflective of the scope of care, feasible to implement and supported by evidence. We compared two different populations during the same period: patients referring to our Clinical Oncology Unit coming from Regional Colorectal Cancer Screening Program and the other population that was not in any Colorectal Cancer Program. On the basis of our experience, we concluded for high-quality care for both population. Any critical point should be carefully analysed in order to implement quality of care

The management of skin toxicity during cetuximab treatment in advanced colorectal cancer: how much does it cost? A retrospecive economic assessment from a single-center experience

Skin rash is a predictable and manageable side effect of anti-EGFR therapy such as cetuximab. The aim of this study is to estimate the costs for the foreseeable management of skin toxicity in patients treated with cetuximab in our institute in order to assess the direct medical economic impact

Porous Si Microparticles Infiltrated with Magnetic Nanospheres

Porous silicon (pSi) microparticles obtained by porosification of crystalline silicon wafers have unique optical properties that, together with biodegradability, biocompatibility and absence of immunogenicity, are fundamental characteristics to candidate them as tracers in optical imaging techniques and as drug carriers. In this work, we focus on the possibility to track down the pSi microparticles also by MRI (magnetic resonance imaging), thus realizing a comprehensive tool for theranostic applications, i.e., the combination of therapy and diagnostics. We have developed and tested an easy, quick and low-cost protocol to infiltrate the COOH-functionalized pSi microparticles pores (tens of nanometers about) with magnetic nanospheres (SPIONs-Super Paramagnetic Iron Oxide Nanoparticles, about 5-7 nm) and allow an electrostatic interaction. The structural properties and the elemental composition were investigated by electron microscopy techniques coupled to elemental analysis to demonstrate the effective attachment of the SPIONs along the pores' surface of the pSi microparticles. The magnetic properties were investigated under an external magnetic field to determine the relaxivity properties of the material and resulting in an alteration of the relaxivity of water due to the SPIONs presence, clearly demonstrating the effectiveness of the easy functionalization protocol proposed

Gastrointestinal stromal tumors and other malignancies: A case series

Purpose: This paper aims to review the clinical and pathological features of gastrointestinal stromal tumors (GISTs) occurring with other malignancies. Methods: A retrospective analysis has been worked out considering all consecutive patients with GISTs referred to our institution between February 2002 and June 2010. We analyzed the relationship among clinical and biological characteristics of the disease and the occurrence of second cancer. Results: Twenty-four patients with GIST have been recorded: in eight cases (33.3%), a second cancer was diagnosed and was synchronous in six patients. In the subgroup of synchronous malignancy, GISTs (four of stomach and one of ileum) were discovered during surgery for other gastrointestinal cancers, whereas one case (arising in the duodenum) was diagnosed during the staging procedure for another primary cancer. In the subgroup of GISTs associated with a second cancer, median age at diagnosis was higher (69 vs 65 years), patients were more frequently male (62.5% vs 43.8%), GISTs were smaller (median size 3 vs 8 cm), and spindle cell histology was less frequent (25% vs 69.2%); all cases were CD117-positive. Other characteristics were similar in the two subgroups, with the exception of risk category, with low or very low cases higher (75% vs 20%), even if not statistically, in the subgroup of cases associated with other cancers. Conclusions: Because of the limited number of cases, we cannot exclude an incidental relationship, but this association should be considered, especially during disease staging or surgery for other gastrointestinal cancer, when lesions in other intestinal tracts are detected. Larger studies are needed. © 2012 Springer Science+Business Media, LLC

Is it possible a conservative approach after radiochemiotherapy in locally advanced rectal cancer (LARC). A systematic review of a literature and metanalysys

Locally advanced rectal cancer is usually treated with a preoperative approach with radiochemotherapy followed by surgery. Patients obtaining a pathologic complete response have a very favorable long-term prognosis. This study was intended to assess whether major surgery can reduce tumor recurrences and prolong survival of patients with a complete response after radiochemotherap