Safety in radiation oncology: transposition of directive 2013/59/EURATOM in the Spanish Radiation Oncology Departments-recommendations for its adequate and effective application.

INTRODUCTION: The Official Journal of the European Union published on January 17, 2014 the Council Directive 2013/59/EURATOM of December 5, 2013, which establishes basic safety standards for the protection against the dangers derived from the exposure to ionizing radiation, and should have been transposed to the regulations of the member countries of the European Union. METHODS: We carried out and exhaustive review of the Directive, to highlight its aspects referred to radiotherapy, in order to issue recommendations for its adequate and effective application in Spain. RECOMMENDATIONS FOR ITS TRANSPOSITION: A series of recommendations are issued, from highest to lowest organizational level: Legislative, Scientific Societies, Healthcare Centers, Radiation Oncology Departments, Radiation Oncologists and Patients. CONCLUSIONS: The implementation of what the transposition of the Directive to our legal order implies, besides the implication of the professionals, Centers and Administration, a need and a consumption of resources. If not enough are allocated, there is a risk that the innovation and improvement that the transposition would imply in order to raise the level of patient safety and the quality of Radiation Oncology in Spain will remain a paper tiger and, as the Romans said, "Non progredi est regredi", that is, when it does not go forward, it goes backwards.

Patient safety in radiation oncology in Spain: a need to change.

PURPOSE: The Working Group on Patient Safety and Quality of the Spanish Society of Radiation Oncology, revised the most relevant national and international recommendations, selecting a series of important aspects for patient safety, evaluating whether they are included in Spanish legislation MATERIALS AND METHODS: We have considered a concept as relevant to the patient safety in radiotherapy if so defined in at least 8 of the 16 documents reviewed. RESULTS: 12 subjects were selected: training and qualification, human resources, protocols, safety culture, communication, peer review, accreditation: audits, checklists, areas without interruptions, maps of processes and risks, prospective risk analysis, notification, registration and incident learning, and quality control of the equipment. CONCLUSIONS: At the legislative level, as well as the professional organizations and the health center directorates, the implementation of safety culture must continue to be fostered. Only in this environment will the tools and measures to increase patient safety be effective. The current Spanish legislation must be revised and updated, in accordance with directive 2013/59/EURATOM and the Patient Safety Strategy 2015-2020 of the Spanish National Health System, introducing the obligation to perform risk analysis and incidents management. Audits and accreditations must be carried out, thus raising the general level of practice of the specialty. In this process, the Spanish Society of Radiation Oncology must continue playing its fundamental role, collaborating with the institutions and the rest of the scientific societies involved in the radiotherapy process, issuing recommendations on patient safety and disseminating the safety culture in our specialty.

Merkel cell carcinoma: what do we know about it and what should we do?

Merkel cell carcinoma (MCC) is a rare primary cutaneous carcinoma of the skin that is highly aggressive, and has a high risk of locoregional and distant spread, a mortality rate considerably higher than that of cutaneous melanoma and poor survival. Its incidence has increased during the past twenty years. The studies published since 2008 have introduced changes in the understanding of its epidemiology and pathogenesis, and consequently the therapeutic approach. Despite this, there is still controversy surrounding its optimal management, which requires clarification. This is the purpose of this review (AU)

Prophylaxis with a cream containing urea reduces the incidence and severity of radio-induced dermatitis

INTRODUCTION: Radio-induced dermatitis is one of the most frequent side effects of radiotherapy. Among the commercially available products for the care of irradiated skin is a hydrating lotion containing 3% urea, polidocanol and hyaluronic acid. Its effectiveness for preventing the appearance of radiodermatitis or reducing its severity has been studied on a number of occasions. OBJECTIVE: To evaluate the effectiveness of "intensive use" of the lotion containing 3% urea, polidocanol and hyaluronic acid for preventing the appearance of acute radiodermatitis and controlling its severity. MATERIAL AND METHODS: Prospective observational study in 98 patients with breast cancer with a 10-week follow-up period. Skin toxicity (RTOG/EORTC scale) was evaluated weekly. To study the effectiveness we compared incidence and grade of toxicity with a sample of 174 breast cancer patients (control sample) treated in our centre during 2006 who used skin-support measures at the start of the radiotherapy or the occurrence of radiodermatitis. RESULTS: The proportion of patients who did not develop radiodermatitis was significantly higher in the intensive use group (27.6% vs. 15.5%; p<0.05; OR: 2.07). Compared with the same lotion in standard conditions, the intensive use group showed lower incidence of radiodermatitis (p<0.01), lower grade of toxicity (p<0.001) and lower proportion of radiodermatitis grade 2 or higher (p<0.01). CONCLUSIONS: Intensive use of the lotion doubles the likelihood that breast cancer patients will not develop radiodermatitis during radiotherapy. Furthermore, compared with standard use, intensive use is more effective in reducing the incidence of skin toxicity and skin toxicity grade 2 or higher (AU)

Evaluación del riesgo nutricional e instauración de soporte nutricional en pacientes oncológicos, según el protocolo del grupo español de Nutrición y Cáncer / Nutricional risk evaluation and establishment of nutricional support in oncology patients according to the protocol of the spanish nutrition and cancer group

Introducción: El cáncer, los tratamientos que lo acompañan y los síntomas consecuentes que a su vez generan, aumentan en los pacientes el riesgo de sufrir malnutrición. La cual produce un gran deterioro del estado de salud, con el consecuente aumento de complicaciones, disminución de la tolerancia al tratamiento oncológico y una disminución de la calidad de vida del paciente. Por este motivo, un grupo de profesionales sanitarios de diferentes puntos de España se reunieron con el objetivo de mejorar la intervención nutricional en pacientes oncológicos, con el apoyo de la Sociedad Española de Nutrición Básica y Aplicada (SENBA). Metodología: Este grupo multidisciplinar de profesionales elaboró un documento de consenso basado en la literatura y en la experiencia personal, creando un protocolo de evaluación y de intervención nutricional en forma de algoritmos. Se clasifican los pacientes en tres pasos: 1. según el tipo de tratamiento oncológico que reciben, ya sea de tipo curativo o paliativo; 2. riesgo nutricional de la terapia antineoplásica (bajo, mediano, o alto riesgo), y 3. de acuerdo a la Valoración Global Subjetiva-Generada por el paciente (VGS-gp), que clasifica a los pacientes en: A. pacientes con adecuado estado nutricional, B. pacientes con malnutrición o a riesgo de malnutrición y C. pacientes con malnutrición severa. Durante un año el protocolo se puso en marcha en 226 pacientes mayores de 18 años de ambos sexos, escogidos al azar en las consultas externas de Radioterapia Oncológica y Oncología Médica. Resultados: Más de la mitad sufren malnutrición (64%), y este valor se incrementa llegando hasta un 81% en pacientes con tratamiento paliativo. La mayoría de los pacientes tienen tratamiento de intención curativa (83%) y reciben tratamiento oncológico de intensidad moderada o de alto riesgo nutricional (69%). Un 68% de los pacientes tienen algún tipo de dificultad en la alimentación. La media en el porcentaje de pérdida de peso es del 6,64% ± 0,87 (min 0, máx 33%). El 32% de la población presenta cifras de albúmina entre 3 y 3,5 g/dl, existiendo una correlación negativa entre ésta y las dificultades con la alimentación p = 0,001. El IMC no mostró ser un parámetro significativo para detectar malnutrición (sólo un 10% se encontraba por debajo de 19,9 kg/m2), pero tiene una tendencia lineal significativa con las dificultades en la alimentación, de forma tal que a medida que disminuye el IMC aumentan las dificultades p = 0,001. Más de la mitad de la población, requirió recomendaciones dietéticas específicas para el control de los síntomas que dificultaban la ingesta y una tercera parte de la población necesitó la indicación de suplementos nutricionales. Tras la intervención nutricional más de la mitad (60%) mantuvo su peso y una sexta parte lo aumentó. Conclusión: La aplicación de este protocolo es útil, sencillo y podría facilitar la detección de malnutrición en los pacientes oncológicos. Seleccionando a los pacientes que realmente se podrían beneficiar de una intervención nutricional específica, pero debería aplicarse al inicio coincidiendo si fuera posible con el diagnóstico de la enfermedad. El soporte nutricional resulta eficaz en la mayoría de los pacientes (AU)

Introduction: Cancer and its oncological treatment cause symptoms which increase the patients risk to suffer from malnutrition. This affects the patients health status negatively by increasing the number of complications, reducing the tolerance to the oncology treatment and a decrease of the patients quality of life. Motivated by this, a group of health professionals from several spanish regions met with the backing of the Sociedad Española de Nutrición Básica y Aplicada (SENBA) to address strategies to improve the quality of nutritional intervention in cancer patients. Methods: This multidisciplinary group developed a protocol describing nutritional assessment and intervention in form of algorithms based on literature and personal experience. The patients are classified in a three step process: 1. type of their oncology treatment (curative or palliative); 2. nutritional risk of the antineoplastic therapy (low, medium or high risk) and 3. depending on the Subjective Global Assessment patient-generated (SGApg). The patients are classified as: A. patients with adequate nutritional state, B. patients with malnutrition or risk of malnutrition and C. patients suffering from severe malnutrition. During one year, the protocol has been used for 226 randomly chosen female and male patients older than 18 years. They were treated by the Medical and Radiotherapy Oncology outpatient clinic. Results: More than a half of the patients were suffering from malnutrition (64%) increasing up to 81% for patients undergoing palliative treatment. Most of them were treated curatively (83%) and received oncology treatment with moderate or high nutritional risk (69%). 68% of patients were affected by some feeding difficulty. The mean percentage of weight loss has been 6.64% ± 0.87 (min 0%, max 33%). Albumin values of 32% of the patients were between 3 and 3.5 g/dl and negatively correlated with feeding difficulties (p = 0.001). The body mass index (BMI) has not found to be a significant parameter for detecting malnutrition (only in 10% of the patients, the value was below 19.9 kg/m2). But a significant linear tendency when compared to feeding problems could be shown, such that in patients with less feeding problems a higher BMI has been found (p = 0.001). More than a half of the patients required nutritional counselling to control symptoms which made food intake difficult. One third of the patients needed oral nutritional supplementation. Following the nutritional intervention the weight of about 60% of the patients could be maintained and of one sixth it could be increased. Conclusion: The application of this protocol is useful, easy and could help detecting malnutrition in oncology patients. It provides the possibility to select those patients who can benefit from a specific nutritional intervention. If possible, the application of the protocol should be started immediatly after cancer is diagnosed. Nutritional support proves efficient for most of the patients (AU)

[Nutritional risk evaluation and establishment of nutritional support in oncology patients according to the protocol of the Spanish Nutrition and Cancer Group]. / Evaluación del riesgo nutricional e instauración de soporte nutricional en pacientes oncológicos, según el protocolo del grupo Español de Nutrición y Cáncer.

INTRODUCTION: Cancer and its oncological treatment cause symptoms which increase the patients risk to suffer from malnutrition. This affects the patients health status negatively by increasing the number of complications, reducing the tolerance to the oncology treatment and a decrease of the patients quality of life. Motivated by this, a group of health professionals from several spanish regions met with the backing of the Sociedad Española de Nutrición Básica y Aplicada (SENBA) to address strategies to improve the quality of nutritional intervention in cancer patients. METHODS: This multidisciplinary group developed a protocol describing nutritional assessment and intervention in form of algorithms based on literature and personal experience. The patients are classified in a three step process: 1. type of their oncology treatment (curative or palliative); 2. nutritional risk of the antineoplastic therapy (low, medium or high risk) and 3. depending on the Subjective Global Assessment patient-generated (SGA-pg). The patients are classified as: A. patients with adequate nutritional state, B. patients with malnutrition or risk of malnutrition and C. patients suffering from severe malnutrition. During one year, the protocol has been used for 226 randomly chosen female and male patients older than 18 years. They were treated by the Medical and Radiotherapy Oncology outpatient clinic. RESULTS: More than a half of the patients were suffering from malnutrition (64%) increasing up to 81% for patients undergoing palliative treatment. Most of them were treated curatively (83%) and received oncology treatment with moderate or high nutritional risk (69%). 68% of patients were affected by some feeding difficulty. The mean percentage of weight loss has been 6.64% +/- 0.87 (min 0%, max 33%). Albumin values of 32% of the patients were between 3 and 3.5 g/dl and negatively correlated with feeding difficulties (p = 0.001). The body mass index (BMI) has not found to be a significant parameter for detecting malnutrition (only in 10% of the patients, the value was below 19.9 kg/m2). But a significant linear tendency when compared to feeding problems could be shown, such that in patients with less feeding problems a higher BMI has been found (p = 0.001). More than a half of the patients required nutritional counselling to control symptoms which made food intake difficult. One third of the patients needed oral nutritional supplementation. Following the nutritional intervention the weight of about 60% of the patients could be maintained and of one sixth it could be increased. CONCLUSION: The application of this protocol is useful, easy and could help detecting malnutrition in oncology patients. It provides the possibility to select those patients who can benefit from a specific nutritional intervention. If possible, the application of the protocol should be started immediatly after cancer is diagnosed. Nutritional support proves efficient for most of the patients.

Introduccion

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Nutrición en el paciente con radioterapia / No disponible

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[Unexpected accumulation of 111In-antimyosin in the chest in an area corresponding to the radiation field of a squamous cell lung carcinoma]. / Acumulación inesperada de 111 In-antimiosina a nivel torácico en un área que se correspondía con el campo de irradiación de un carcinoma escamoso pulmonar.

We report a patient with squamous cell lung carcinoma treated with radiation therapy who suffered two clinical episodes suggestive of myocarditis, one before radiation therapy was administered and the other three months after ending treatment. In both episodes, 111In-antimyosin scintigraphies were performed, finding an unexpected antimyosin uptake in the irradiated area was in the second episode. After analyzing the possible etiologies of the image mentioned, we reached the conclusion that the most likely mechanism of antimyosin uptake could also be attribute to myosin released by myocardial and endothelial cells damage by ionizing radiation.