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.

High dose irradiation after pleurectomy/decortication or biopsy for pleural mesothelioma treatment.

PURPOSE: The role played by radiation therapy after pleurectomy/decortication or surgical biopsy in malignant pleural mesothelioma is uncertain. We treated patients with accelerated hypofractionated radiotherapy using helical tomotherapy and intensity-modulated arc therapy in an attempt to keep lung toxicity to a minimum. The present study reports the feasibility and toxicity of this approach. MATERIAL AND METHODS: Between 2008 and 2012, 36 patients with malignant pleural mesothelioma underwent accelerated hypofractionated radiotherapy to the hemithorax after pleurectomy/decortication (19 patients) or biopsy (17 patients). The prescription dose was 25Gy in five fractions over 5 consecutive days. RESULTS: We observed three patients with G3 pneumonitis, five cases of grade 2 dyspnea and six cases of grade 2 cough. The median follow-up was 37 months (range: 3-54 months). The median overall survival for patients who underwent pleurectomy/decortication followed by radiotherapy was 21.6 months [95% confidence interval (95% CI): 15.5-24.1] compared to 19.4 months for patients not submitted to surgery. CONCLUSION: Treatment of intact lung with pleural intensity-modulated arc irradiation in malignant pleural mesothelioma patients with malignant pleural mesothelioma proved safe and feasible, with an acceptable rate of pneumonitis. Survival rates were encouraging for both biopsy-only and pleurectomy/decortication groups. We are currently conducting a phase II dose escalation trial in a similar patient setting to prospectively evaluate the impact of radiotherapy on toxicity, disease-free survival and overall survival.

[Health promotion and obesity in the workplace among health care workers of a hospital in Catania (Italy)]. / Promozione della salute e obesità in operatori sanitari di una azienda ospedaliera della provincia di Catania.

BACKGROUND: Italian Legislative Decree No. 81/2008 foresees the involvement of a "specialised physician" in activities for the promotion of health at the workplace. OBJECTIVES: These activities are aimed at modifying erroneous lifestyles (such as smoking, drinking, bad diet, etc.) which are responsible for serious illnesses and also for repercussions on the assessment of fitness for a specific task. Obesity, as we know, represents the major risk factor in the onset of metabolic, neoplastic, cardiovascular and respiratory diseases and also in the increased incidence of accidents at the workplace and sick absence. METHODS: A specific questionnaire was administered to 700 health care workers of a Hospital in Catania to estimate the incidence of factors which favour the onset of these diseases: factors such as familiarity, endocrinal dysfunction problems (diabetes mellitus, hypothyroidism), shift work and little physical exercise. RESULTS AND CONCLUSION: Statistical processing of the data confirmed, partially, that little physical exercise, hypothyroidism, diabetes mellitus, familiarity in the > 36 age group were the major risk factors in the onset of obesity, as reported in the literature. However, contrary to the literature reports, shift work did not seem to be a risk factor in the sample under study. A programme of rehabilitation, on a voluntary basis, will be offered to those workers who are overweight/obese. This programme will involve professionals such as nutritionists, endocrinologists and psychologists, and it will aim at improving workers' health conditions as well as their work performance.

Transmission line matrix modelling of thermal injuries to skin.

A numerical model based on the transmission line matrix method is presented for the quantitative prediction of skin burn resulting from exposure of a specific region of human skin surface to a high temperature heat source. Transient temperatures were numerically estimated by Pennes' bioheat equation, and the damage function denoting the extent of burn was calculated using the Arrhenius assumptions for protein damage rate. A two-dimensional transmission line matrix model was used to predict the effects of exposure time and structure thicknesses on the transient temperature distribution and damage extent. Compared with other numerical sources the transmission line matrix results revealed good agreement, suggesting that this method may be an effective tool for the thermal diagnostic of burns.

[Silica carcinogenicity: description of a clinical case]. / Cancerogenicità da silice: descrizione di un caso clinico.

BACKGROUND: Until the early 1980's there was a general consensus that no relationship existed between occupational silica exposure and lung cancer, in spite of a number of reports to the contrary. Confirmation arrived later from animal experiments and in 1997 the IARC modified its carcinogenic agents classification to include silica in group 1, human carcinogens. This fact brought about a change in insurance practice regarding occupational diseases due to silica, with greater attention dedicated to pneumoconiosis-related lung cancers. OBJECTIVE: To describe a clinical case of lung cancer due to occupational exposure to silica in a worker of a ceramics industry already receiving compensation for silicosis. METHODS: Diagnosis and recognition of the occupational origin of the disease were achieved via assessment of exposure to silica in the past and review of the medical examinations over the years. RESULTS: The pathogenesis and the causative relationship between pneumoconiosis and cancer is debated and lung cancer was recognized as an occupational disease. CONCLUSIONS: It is concluded that a causative relationship can exist more due to the presence of silicosis than due to occupational exposure to silica.

[Incidence of dysphonia in teaching staff of schools]. / Incidenza della disfonia nel personale docente della scuola.

Some categories of workers (actors, teachers, singers) use a particular working tool: their voice. In order to assess the spread of dysphonia and its possible causes across a specific class of workers--the teachers of some schools in the city of Catania--we have set up a ad hoc questionnaire. A special database has been subsequently arranged, aimed at the statistical analysis of the responses obtained. The analysis of the responses shows that the phenomenon is more present in female than male teachers, 48% versus 30%. The dysphonia occurs mainly at the end of the working day, lasts throughout the school year and improves in summer, demonstrating the importance of teaching activity in its pathogenesis. One aspect especially stands out: dysphonia occurs exclusively in those individuals suffering from diseases with possible alterations of the voice, such as allergopathies, tireopathies and gastropathies. Therefore, work activity alone does not seem able to cause a chronic dysphonia, whereas the presence of diseases causing disability of vocal cords appears to play an important role.

[Occupational hazards in management of an experimental constructed wetlands]. / Rischi professionali nella gestione di un impianto sperimentale di fitodepurazione.

The sewage from urban settlements is an important cause of water pollution. Recent Italian legislation offers new possibilities for intervention in the purification of wastewater. The "Decreto Legislativo" 152 of April 3, 2006, indicating "Environmental Standards", recommends the possible use of constructed wetlands considered particularly suitable for small and medium communities according to low operating costs, lack of energy, and manageability. The Authors, after describing the characteristics of these facility, analyze the occupational risks associated with the control and maintenance of a experimental subsurface constructed wetland (H-SSF, SubSurface Horizontal Flow) coming to the conclusion that the management of this type of facility has a low risk of exposure to biological agents.

[Radiation protection issues in brachytherapic treatment of prostatic cancer]. / Problematiche radioprotezionistiche nel trattamento brachiterapico del cancro della prostata.

Brachytherapy is an effective radiotherapeutic treatment for localized prostatic cancer. The permanent brachytherapy is a particular kind of radiotherapy which, US guided, uses permanently implanted seeds containing radioactive sources (Pd103 or I 125). The procedure is minimally invasive and allows to obtain high percentage of success which is comparable to surgery. The possibility to confine permanent radioactive implants in a well delimitated area doesn't exclude the exposition of both the medical staff and family's members of implanted patients. The radiation exposure involves the medical physicists, the radiotherapists, the Medical Radiology Technician, the anaesthetists, the surgeons, the professional nurses but also, after the brachytherapy treatment, public and family members, comforters and cares. It's necessary to consider radiation safety aspects of brachytherapy in order to reduce the risks of exposition. At the end, several studies showed that cremation of bodies could be a possible radiation source that remains in the patient's ashes, potentially inhaled by crematorium staff or members of the public.

Environmental radioactivity at Stromboli (Aeolian Islands).

HPGe gamma spectrometry, thermoluminescence dosimetry, X-ray diffractometry and fluorescence techniques have been used to analyze the natural radionuclides content of soil and rock samples, air kerma and geochemical features on the island of Stromboli, belonging to the Aeolian Islands, in the Mediterranean Sea. The 214Bi, 238Ac, and 40K contents obtained are in agreement with the magmatic evolution of the rock formation, as shown by the correlations between radionuclide and chemical elements abundacies, depending on the various magmatic differentiation mechanisms. Correlations between radiometric, lithological and geochemical data have been assessed in order to obtain some hints on the geochronology of the magmatic products.

[Intraoperative electron radiotherapy (IOERT) in the QUART sequence: a phase I study]. / Radioterapia intraoperatoria con elettroni (IOERT) nella sequenza QUART: studio di fase I.

We evaluated the tolerance of a single dose of 800-1500 cGy, delivered with an electron beam from an IOERT-dedicated linear accelerator to the tumour bed in patients with breast cancer undergoing conservative treatment, instead of the traditional boost. We enrolled 27 patients (cT1-2, cN0). The first 6 received a dose of 800 cGy, 6 1000 cGy, 10 1200 cGy and 5 1500 cGy. External beam radiation therapy (EBRT) with a conventional schedule, 4000 cGy total dose, was performed after wound healing. The median gap between IOERT and EBRT was 8 weeks. Three patients with adverse prognostic factors undergoing chemotherapy, including doxorubicin or taxanes, received EBRT after completion of chemotherapy. One patient with a prosthesis implant had yielding of the surgical scar 8 months after IOERT (after 4 cycles of doxorubicin and 4 cycles of CMF complicated by frequent mastitis). Another patient with a large serum collection in the axilla manifested delayed scar formation. In the others no significant increase in healing time or surgery-related morbidity was observed. Another 4 patients developed mastitis. The cosmetic outcome was good in 26/27 patients. This treatment is well tolerated at all IOERT doses delivered. In the follow-up, to date, there have been no local relapses.

Gamma activity and geochemical features of building materials: estimation of gamma dose rate and indoor radon levels in Sicily.

A high-purity germanium detector has been used to measure the abundance of radium (Ra), thorium (Th) and potassium (K) in building materials used in Sicilian dwellings. The measurements were performed to evaluate which material was suitable for the construction of an enclosure, which would have a low background emission. The materials examined in this work showed concentrations of 226Ra, 232Th and 40K dramatically variable depending on the lithologies, particularly in the case of blocks, sands and aggregates commonly used in building materials in Sicily. The results are discussed and a criterion is indicated to reduce the radiation dose to humans. Since radon inlet is a major health problem, all the radiometric data and the geochemical features have been used to determine the radon exhalation, which arises from the disintegration of 226Ra in soils and walls of houses. From our experimental data it can be seen out that one of the geochemical parameters, Total Alkali (TA), may be an appropriate index to select materials of low radiological risk.

Seasonal variation of air kerma in the "Vulcano Porto" area (Aeolian Islands, Italy).

Air kerma was measured in the "Vulcano Porto" area of the Vulcano Island, belonging to the Aeolian Islands, in the Mediterranean Sea. Measurements were carried out using thermoluminescence dosimeters. The relationship between observed dose values and source lithology has been assessed. Data show a seasonal variation due to weather conditions but also probably related to features of the soils, making the variation more evident.

Neolithic ceramic findings from western Sicily. Chemical-physical and mineralogical characterization.

This paper presents the results of a study that is part of a wider research program regarding the knowledge of the initial living phases of Sicilian agricultural and pastoral societies. Three ceramic samples attributed to the medium initial Neolithic (NEO1 and NEO2) and to the first neolithic (NEO3), recovered in two different archaeological sites of the western Sicily, have been analysed. Chemical, mineralogical and spectroscopic data point out a similarity between NEO1 and NEO3 samples; compositional and morphological differences instead have been observed in the NEO2 sample. The firing temperatures of the samples have been estimated by Mössbauer spectroscopy; they are lower than 500 degrees C for the samples NEO1 and NEO3, and about 700 degrees C for NEO2.

Environmental gamma radiation measurements on the island of Pantelleria.

The population exposure to those living on the island of Pantelleria, Italy, was estimated by measuring the natural gamma background. Gamma spectra of natural rocks and measurements of absorbed dose in air were taken. A correlation was found between the mean gamma exposure rate and the mean values of natural radionuclide concentrations in the investigated rocks.