Initial Safety and Tumor Control Results From a "First-in-Human" Multicenter Prospective Trial Evaluating a Novel Alpha-Emitting Radionuclide for the Treatment of Locally Advanced Recurrent Squamous Cell Carcinomas of the Skin and Head and Neck.

Purpose Our purpose was to report the feasibility and safety of diffusing alpha-emitter radiation therapy (DaRT), which entails the interstitial implantation of a novel alpha-emitting brachytherapy source, for the treatment of locally advanced and recurrent squamous cancers of the skin and head and neck. Methods and Materials This prospective first-in-human, multicenter clinical study evaluated 31 lesions in 28 patients. The primary objective was to determine the feasibility and safety of this approach, and the secondary objectives were to evaluate the initial tumor response and local progression-free survival. Eligibility criteria included all patients with biopsy-proven squamous cancers of the skin and head and neck with either primary tumors or recurrent/previously treated disease by either surgery or prior external beam radiation therapy; 13 of 31 lesions (42%) had received prior radiation therapy. Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events version 4.03. Tumor response was assessed at 30 to 45 days at a follow-up visit using the Response Evaluation Criteria in Solid Tumors, version 1.1. Median follow-up time was 6.7 months. Results Acute toxicity included mostly local pain and erythema at the implantation site followed by swelling and mild skin ulceration. For pain and grade 2 skin ulcerations, 90% of patients had resolution within 3 to 5 weeks. Complete response to the Ra-224 DaRT treatment was observed in 22 lesions (22/28; 78.6%); 6 lesions (6/28, 21.4%) manifested a partial response (>30% tumor reduction). Among the 22 lesions with a complete response, 5 (22%) developed a subsequent local relapse at the site of DaRT implantation at a median time of 4.9 months (range, 2.43-5.52 months). The 1-year local progression-free survival probability at the implanted site was 44% overall (confidence interval [CI], 20.3%-64.3%) and 60% (95% CI, 28.61%-81.35%) for complete responders. Overall survival rates at 12 months post-DaRT implantation were 75% (95% CI, 46.14%-89.99%) among all patients and 93% (95% CI, 59.08%-98.96%) among complete responders. Conclusions Alpha-emitter brachytherapy using DaRT achieved significant tumor responses without grade 3 or higher toxicities observed. Longer follow-up observations and larger studies are underway to validate these findings

Entrepreneurial artisan products as regional tourism competitiveness

Purpose – The purpose of this paper is to explore and analyse the role of entrepreneurial artisan products in regional tourism competitiveness. Design/methodology/approach – This study applies secondary data from different sources (Regional Directorate of Statistics of Madeira, the Madeira Institute of Wine, Embroideries and Handicrafts) covering a temporal period spanning the last 15 years (2001-2015). This deployed quantitative data analysis through an econometric approach with recourse to regression models and the Pearson’s correlation technique. Findings – According to the results, it is suggested that in terms of external support and funding, there should be a greater role and a boost in the number of projects carried out not only under the auspices of the European Union but also under the Autonomous Region of Madeira. Thus, participant companies may invest in greater business efficiency and entrepreneurship, in innovation, promotion and the internationalisation of their products, and thereby obtain greater overall regional competitiveness. Research limitations/implications – The generalisation of results remains to a certain extent limited, given the findings stem from only one particular region. The exclusive utilisation of secondary data may also undermine the robustness of the results obtained. Originality/value – The study provides empirical evidence that helps in identifying the role of artisan products within the capacity for regional tourism sector entrepreneurship and competitiveness. Furthermore, this also contributes to the knowledge of the scientific community particularly interested in artisan and cultural entrepreneurship and regional competitiveness in the tourism sector.info:eu-repo/semantics/publishedVersio

Human health risk assessment for aluminium, aluminium oxide, and aluminium hydroxide.

International audienc