Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study. / [Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24 h and 48 h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Guía de práctica clínica de melanoma de la Academia Española de Dermatología y Venereología / Clinical Practice Guideline on Melanoma From the Spanish Academy of Dermatology and Venereology (AEDV)

El diagnóstico y tratamiento del melanoma en atención especializada es un campo en el que se han producido numerosos cambios. El objetivo de esta guía es ofrecer a los dermatólogos españoles una referencia para resolver las dudas clínicas más frecuentes basándose en la evidencia actual. Para la realización de esta guía se escogió a miembros del Grupo Español de Dermato-Oncología y Cirugía con experiencia en el tratamiento de estos tumores y con interés en participar en la elaboración de la guía. Se hizo una adaptación de las guías de práctica clínica existentes mediante el método ADAPTE: inicialmente se resumió el proceso de atención y se elaboraron las preguntas clínicas relevantes. Se seleccionaron las guías mejor puntuadas mediante el instrumento AGREE II, realizando la búsqueda de las respuestas en dichas guías y elaborando las recomendaciones. Finalmente se sometió la guía a revisión externa. La guía se estructuró a partir de 21 preguntas clínicas que fueron seleccionadas por su relevancia, dado que se centran en aspectos que pueden plantear decisiones difíciles en el manejo del melanoma, y se han respondido empleando la evidencia obtenida de las mejores guías existentes. Entre las limitaciones de esta guía merece reseñarse que la evidencia es escasa para responder a algunas preguntas. En algunos aspectos el cambio es rápido y exige una actualización frecuente de la guía. Esta guía responde a preguntas habituales sobre el manejo del melanoma en la práctica clínica diaria, sirviendo a los dermatólogos como referencia en la toma de decisiones, siempre teniendo presente los recursos y preferencias del paciente

Specialist approaches to the diagnosis and treatment of melanoma have undergone many changes. This guideline aims to provide Spanish dermatologists with evidence-based information for resolving the most common doubts that arise in clinical practice. Members of the Spanish Oncologic Dermatology and Surgery Group (GEDOC) with experience treating melanoma were invited to participate in drafting the guideline. The group developed a new guideline on the basis of existing ones, using the ADAPTE collaboration process, first summarizing the care process and posing relevant clinical questions, then selecting guidelines with the best scores according to the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. Finally, the group searched the selected guidelines for answers to the clinical questions, drafted recommendations, and sent them for external review. The guideline is structured around 21 clinical questions chosen for their relevance to issues that make clinical decisions about the management of melanoma difficult. Evidence from existing guidelines was used to answer the questions. A limitation of this guide derives from the scarce evidence available for answering some questions. Moreover, some areas are changing rapidly, so recommendations must be updated often. The present guideline offers answers to clinical questions about the routine management of melanoma in clinical practice and provides dermatologists with a reference to guide decisions, taking into consideration the resources available and patient preferences

Clinical Practice Guideline on Melanoma From the Spanish Academy of Dermatology and Venereology (AEDV). / Guía de práctica clínica de melanoma de la Academia Española de Dermatología y Venereología.

Specialist approaches to the diagnosis and treatment of melanoma have undergone many changes. This guideline aims to provide Spanish dermatologists with evidence-based information for resolving the most common doubts that arise in clinical practice. Members of the Spanish Oncologic Dermatology and Surgery Group (GEDOC) with experience treating melanoma were invited to participate in drafting the guideline. The group developed a new guideline on the basis of existing ones, using the ADAPTE collaboration process, first summarizing the care process and posing relevant clinical questions, then selecting guidelines with the best scores according to the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. Finally, the group searched the selected guidelines for answers to the clinical questions, drafted recommendations, and sent them for external review. The guideline is structured around 21 clinical questions chosen for their relevance to issues that make clinical decisions about the management of melanoma difficult. Evidence from existing guidelines was used to answer the questions. A limitation of this guide derives from the scarce evidence available for answering some questions. Moreover, some areas are changing rapidly, so recommendations must be updated often. The present guideline offers answers to clinical questions about the routine management of melanoma in clinical practice and provides dermatologists with a reference to guide decisions, taking into consideration the resources available and patient preferences.

Carcinoma basocelular cutáneo: diagnóstico y tratamiento en atención especializada dermatológica. Guía de Práctica Clínica de la AEDV / Diagnosis and Treatment of Basal Cell Carcinoma in Specialized Dermatology Units: A Clinical Practice Guideline

ANTECEDENTES Y OBJETIVO: El carcinoma basocelular supone el cáncer de piel más frecuente en la población. Hay una gran variabilidad en su manejo y las diferentes guías extranjeras que existen son difícilmente aplicables en nuestro medio. El objetivo de la presente guía es servir de referencia a los dermatólogos españoles para mejorar el manejo de este tumor basándose en la evidencia actual. MATERIALES Y MÉTODOS: Se escogió a miembros del Grupo Español de Dermato-Oncología y Cirugía (GEDOC) con experiencia en el tratamiento de estos tumores y con interés en participar en la elaboración de la guía. Se hizo una adaptación de las guías de práctica clínica existentes mediante el método ADAPTE, se resumió el proceso de atención, y se elaboraron las preguntas clínicas relevantes. Se seleccionaron las guías mejor puntuadas mediante el instrumento AGREE II, realizando la búsqueda de las respuestas en dichas guías y elaborando posteriormente las recomendaciones. Finalmente se sometió la guía a revisión externa. RESULTADOS: Las guías con mejor puntuación fueron las de la British Association of Dermatologits (BAD), del National Comprehensive Cancer Network (NCCN), del European Dermatology Forum (EDF) y de la European Academy of Dermatology and Venereology (EADV). Se obtuvieron en total 11 preguntas clínicas, contestadas a partir de estas guías. CONCLUSIONES: Esta guía responde a preguntas habituales sobre el manejo del carcinoma basocelular en la práctica clínica diaria y sirve a los dermatólogos como referencia en la toma de decisiones, siempre teniendo en cuenta los recursos y las preferencias del paciente

BACKGROUND AND OBJECTIVE: Basal cell carcinoma (BCC) is the most common skin cancer in the general population. BCC is managed in a variety of ways, and available international guidelines are difficult to put into practice in Spain. This guideline aims to improve the management of BCC based on current evidence and provide a point of reference for Spanish dermatologists. MATERIAL AND METHODS: Members of the Spanish Oncologic Dermatology and Surgery Group (GEDOC) with experience treating BCC were invited to participate in drafting this guideline. The drafters used the ADAPTE collaboration process to develop the new guideline based on existing ones, first summarizing the care pathway and posing relevant clinical questions. They then searched for guidelines, assessed them with the AGREEII (Appraisal of Guidelines for Research and Evaluation) tool, and searched the selected guidelines for answers to the clinical questions. Finally, the recommendations were drafted and submitted for external review. RESULTS: The highest-scoring guidelines were from the Association of Dermatologists, the National Comprehensive Cancer Network, the European Dermatology Forum, and the European Academy of Dermatology and Venereology. A total of 11 clinical questions were answered. CONCLUSIONS: This new guideline answers the working group's clinical questions about the routine management of BCC in Spain. It provides dermatologists with a tool they can use for decision-making while taking into consideration the resources available and patient preferences

Diagnosis and Treatment of Basal Cell Carcinoma in Specialized Dermatology Units: A Clinical Practice Guideline. / Carcinoma basocelular cutáneo: diagnóstico y tratamiento en atención especializada dermatológica. Guía de Práctica Clínica de la AEDV.

BACKGROUND AND OBJECTIVE: Basal cell carcinoma (BCC) is the most common skin cancer in the general population. BCC is managed in a variety of ways, and available international guidelines are difficult to put into practice in Spain. This guideline aims to improve the management of BCC based on current evidence and provide a point of reference for Spanish dermatologists. MATERIAL AND METHODS: Members of the Spanish Oncologic Dermatology and Surgery Group (GEDOC) with experience treating BCC were invited to participate in drafting this guideline. The drafters used the ADAPTE collaboration process to develop the new guideline based on existing ones, first summarizing the care pathway and posing relevant clinical questions. They then searched for guidelines, assessed them with the AGREEII (Appraisal of Guidelines for Research and Evaluation) tool, and searched the selected guidelines for answers to the clinical questions. Finally, the recommendations were drafted and submitted for external review. RESULTS: The highest-scoring guidelines were from the Association of Dermatologists, the National Comprehensive Cancer Network, the European Dermatology Forum, and the European Academy of Dermatology and Venereology. A total of 11 clinical questions were answered. CONCLUSIONS: This new guideline answers the working group's clinical questions about the routine management of BCC in Spain. It provides dermatologists with a tool they can use for decision-making while taking into consideration the resources available and patient preferences.

Carcinoma de células de Merkel: diagnóstico y tratamiento en atención especializada dermatológica. Guía de práctica clínica de la Academia Española de Dermatología y Venerología / Diagnosis and Treatment of Merkel Cell Carcinoma in Specialized Dermatology Units: A Clinical Practice Guideline of the Spanish Academy of Dermatology and Venereology

Antecedentes y objetivo: El carcinoma de células de Merkel es un tipo de cáncer de piel infrecuente y agresivo. Hay una gran variación en su manejo y las diferentes guías extranjeras que existen cubren parcialmente los problemas identificados como principales. El objetivo de la presente guía es servir de referencia a los dermatólogos españoles para mejorar aspectos controvertidos del diagnóstico, estadificación y tratamiento del carcinoma de células de Merkel. Materiales y métodos: Se empleó el método ADAPTE: se escogió a miembros del Grupo Español de Dermato-Oncología y Cirugía (GEDOC) con experiencia en el tratamiento de estos tumores y con interés en participar en la elaboración de la guía. Tras resumir el proceso de atención y elaborar las preguntas clínicas relevantes, se hizo una búsqueda de guías, que se seleccionaron según su puntuación mediante el instrumento Appraisal of Guidelines for Research and Evaluation (AGREE II). Tras la búsqueda de las respuestas en dichas guías, se elaboraron posteriormente las recomendaciones. Por último, se sometió la guía a revisión externa. Resultados: Las guías con mejor puntuación fueron las de National Comprehensive Cancer Network, la European consensus-based interdisciplinary guideline, Alberta Healthservices Clinical practice guideline, American Cancer Society y Cutaneous Oncology Group of the French Society of Dermatology. Se obtuvieron en total 9 preguntas clínicas, contestadas a partir de estas guías. Conclusiones: Esta guía responde a preguntas habituales en la práctica clínica diaria y sirve a los dermatólogos como referencia en la toma de decisiones, siempre teniendo presentes los recursos y preferencias del paciente

Background and objective: Merkel cell carcinoma is a rare, aggressive skin cancer that is managed in a great variety of ways. However, international clinical practice guidelines give only partial coverage to issues considered major problems.The recommendations presented here aim to provide Spanish dermatologists with a guide to improving disputed aspects of diagnosis, staging, and treatment of localized Merkel cell carcinomas. Material and methods: The ADAPTE process was used. Members of the Spanish Group of Oncologic Dermatology and Surgery (GEDOC) with experience in treating Merkel cell carcinoma and interest in drafting these guidelines were selected. The group described the care process and listed the most important clinical questions. They then searched for guidelines and assessed them with the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. After consulting the guidelines for answers to their clinical questions, the group drafted the present statementand sent it for external review. Results: The guidelines that scored highest in the AGREE II assessment step were the consensus-based interdisciplinary guideline of the European Association of Dermato-Oncology and the European Organization of Research and Treatment of Cancer, and those of the Comprehensive Cancer Network, the Alberta Health Services in Canada, the American Cancer Society, and the Cutaneous Oncology Group of the French Society of Dermatology. A total of 9 clinical questions were answered based on these guidelines. Conclusions: The guidelines presented here answer clinical questions that arise in routine practice. They can provide dermatologists with a starting point for decision-making, although available resources and patient preferences must always be borne in mind

Diagnosis and Treatment of Merkel Cell Carcinoma in Specialized Dermatology Units: A Clinical Practice Guideline of the Spanish Academy of Dermatology and Venereology. / Carcinoma de células de Merkel: diagnóstico y tratamiento en atención especializada dermatológica. Guía de práctica clínica de la Academia Española de Dermatología y Venerología.

BACKGROUND AND OBJECTIVE: Merkel cell carcinoma is a rare, aggressive skin cancer that is managed in a great variety of ways. However, international clinical practice guidelines give only partial coverage to issues considered major problems.The recommendations presented here aim to provide Spanish dermatologists with a guide to improving disputed aspects of diagnosis, staging, and treatment of localized Merkel cell carcinomas. MATERIAL AND METHODS: The ADAPTE process was used. Members of the Spanish Group of Oncologic Dermatology and Surgery (GEDOC) with experience in treating Merkel cell carcinoma and interest in drafting these guidelines were selected. The group described the care process and listed the most important clinical questions. They then searched for guidelines and assessed them with the AGREE II (Appraisal of Guidelines for Research and Evaluation) tool. After consulting the guidelines for answers to their clinical questions, the group drafted the present statementand sent it for external review. RESULTS: The guidelines that scored highest in the AGREE II assessment step were the consensus-based interdisciplinary guideline of the European Association of Dermato-Oncology and the European Organization of Research and Treatment of Cancer, and those of the Comprehensive Cancer Network, the Alberta Health Services in Canada, the American Cancer Society, and the Cutaneous Oncology Group of the French Society of Dermatology. A total of 9 clinical questions were answered based on these guidelines. CONCLUSIONS: The guidelines presented here answer clinical questions that arise in routine practice. They can provide dermatologists with a starting point for decision-making, although available resources and patient preferences must always be borne in mind.

Evaluación de indicadores de estructura en la atención al paciente con cáncer de piel en los servicios de dermatología / Evaluation of Structure Indicators for Assessing Skin Cancer Quality of Care in Dermatology Departments

INTRODUCCIÓN Y OBJETIVOS: Recientemente se han consensuado unos indicadores de calidad de la atención del cáncer de piel no melanoma y melanoma promovidos por la Fundación Piel Sana AEDV. El objetivo de este estudio es conocer la adherencia a estos criterios de calidad asistencial. MATERIAL Y MÉTODOS: En noviembre de 2016 se realizó una encuesta anónima que constaba de 32 preguntas, dirigida a los responsables de los servicios de dermatología y venereología españoles incluidos en la base de datos de la AEDV. Las preguntas de la encuesta hacían referencia a los diferentes indicadores consensuados previamente. RESULTADOS: Fueron respondidas 104 de las 150 encuestas enviadas (69,3% de porcentaje de respuesta). El menor porcentaje conseguido de respuesta a una pregunta fue del 56% (n=84). Más del 85% de los encuestados contestaron a 29 (91%) o más preguntas. Los indicadores con mayor implantación fueron la disponibilidad de TAC o RMN para el estudio de carcinoma espinocelular (98%), seguidos de la existencia de un modelo estandarizado para la realización del informe anatomopatológico de melanoma (90%). Los indicadores con menor implantación se relacionaron con el acceso a electroquimioterapia (25%) y el acceso a otras terapias invasivas para el melanoma locorregionalmente avanzado (20%). CONCLUSIONES: Se ha encontrado variabilidad en la adherencia de estos criterios en los diferentes centros. Con los datos obtenidos se pueden identificar posibilidades de mejora en los centros. Futuras investigaciones deberían centrarse en la medición de indicadores de proceso y resultado

INTRODUCTION AND OBJECTIVES: A series of quality indicators for melanoma and nonmelanoma skin cancer were recently approved within a project promoted by the Healthy Skin Foundation of the Spanish AEDV. The aim of this study was to evaluate adherence to these indicators. MATERIAL AND METHODS: In November 2016, an anonymous questionnaire consisting of 32 items was sent to the heads of Spanish dermatology and venereology departments listed in the AEDV's database. The questions referred to the above-mentioned quality of care indicators. RESULTS: The questionnaire was completed by 104 of the 150 people contacted (response rate, 69.3%). The lowest response rate for any given question was 56% (84 respondents). Over 85% of respondents answered 29 questions or more (91%). The most widely used indicators were those related to the use of computed tomography or magnetic resonance imaging for squamous cell carcinoma (98%), followed by the availability of a standardized melanoma pathology report (90%). The least widely used indicators were related to availability of electrochemotherapy (25%) and other invasive therapies for locoregionally advanced melanoma (20%). CONCLUSIONS: Adherence to quality of cancer care criteria at the different hospitals evaluated varied. Our findings could be useful for identifying areas for improvement at different hospitals. Future studies should focus on measuring both process and outcome indicators

Evaluation of Structure Indicators for Assessing Skin Cancer Quality of Care in Dermatology Departments. / Evaluación de indicadores de estructura en la atención al paciente con cáncer de piel en los servicios de dermatología.

INTRODUCTION AND OBJECTIVES: A series of quality indicators for melanoma and nonmelanoma skin cancer were recently approved within a project promoted by the Healthy Skin Foundation of the Spanish AEDV. The aim of this study was to evaluate adherence to these indicators. MATERIAL AND METHODS: In November 2016, an anonymous questionnaire consisting of 32 items was sent to the heads of Spanish dermatology and venereology departments listed in the AEDV's database. The questions referred to the above-mentioned quality of care indicators. RESULTS: The questionnaire was completed by 104 of the 150 people contacted (response rate, 69.3%). The lowest response rate for any given question was 56% (84 respondents). Over 85% of respondents answered 29 questions or more (91%). The most widely used indicators were those related to the use of computed tomography or magnetic resonance imaging for squamous cell carcinoma (98%), followed by the availability of a standardized melanoma pathology report (90%). The least widely used indicators were related to availability of electrochemotherapy (25%) and other invasive therapies for locoregionally advanced melanoma (20%). CONCLUSIONS: Adherence to quality of cancer care criteria at the different hospitals evaluated varied. Our findings could be useful for identifying areas for improvement at different hospitals. Future studies should focus on measuring both process and outcome indicators.

Posicionamiento de la Academia Española de Dermatología y Venereología sobre la teledermatología / Position Statement of the Spanish Academy of Dermatology and Venereology on Teledermatology

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El libro blanco del cáncer de piel de la AEDV / The White Book of Skin Cancer of the Spanish Academy of Dermatology and Venereology (AEDV)

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Benefits of plasma rich in growth factors (PRGF) in skin photodamage: clinical response and histological assessment.

Skin ageing is characterized by small and fine wrinkles, roughness, laxity, and pigmentation as a result of epidermal thinning, collagen degradation, dermal atrophy, and fewer fibroblasts. Plasma rich in growth factors (PRGF) is an autologous plasma preparation enriched in proteins obtained from patient's own blood aimed at accelerating tissue repair and regeneration. To evaluate the benefits of PRGF in skin photodamage, 10 healthy volunteers were treated with three consecutive intradermal injections of PRGF in the facial area. Clinical outcomes and histological analysis were performed. A statistically significant increase in the epidermis and papillary dermis thickness was seen after PRGF treatment (p < 0.001). Skin thickening was observed in all patients studied, being more intense in the group of patients with photodamage (p < 0.001). After PRGF treatment, a reduction of the average area fraction of solar elastosis was observed in patients with clinical and histological signs of skin photodamage (p < 0.05).No changeswere observed in the number of CD31, XIIIa factor, cKit, CD10, nor p53-positive cells. The improvement score after PRGF use was 0.75 (9/12) for the group of patients with signs of skin photodamage. Intradermal PRGF infiltration appears to be an effective treatment for the photodamaged skin.

Autocontrol fotográfico mediante smartphones para mejorar el diagnóstico precoz del melanoma / Skin Self-examination Using Smartphone Photography to Improve the Early Diagnosis of Melanoma

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Dynamic skin changes of acute radiation dermatitis revealed by in vivo reflectance confocal microscopy.

BACKGROUND: A better knowledge of the dynamic biological changes that the skin undergoes in response to ionizing radiation is advisable to improve the management of radiation dermatitis, allowing selection of patients needing treatment or close monitoring. OBJECTIVE: To describe the evolution of the skin in response to ionizing radiation through the reflectance confocal microscopy (RCM) features of acute radiation dermatitis. METHODS: In this prospective descriptive study, six women (median age, 55 years; range, 45-80 years) diagnosed with breast cancer in stages IA-IB undergoing adjuvant radiotherapy were included in the study through consecutive sampling. Clinical, dermoscopic and RCM evaluation of the skin were performed prior to treatment and on days 1, 15, 30 and 45 after radiotherapy. RESULTS: While clinical features of radiation dermatitis emerged after 30 days on average, histopathological changes were detectable by RCM after a mean time of 15 days. The main RCM features included initial appearance of spongiosis, exocytosis and inflammatory cells followed by the presence of dendritic-shaped cells, 'streaming-like figures', 'broken geographic papillae', epidermal architectural disarray, effacement of rete ridges, melanophages and, finally, hyperpigmentation of the basal layer. CONCLUSIONS: RCM may safely detect the dynamic biological changes that the skin undergoes in response to ionizing radiation, even before than clinical onset of acute radiation dermatitis. Therefore, RCM may be useful to make an early and non-invasive diagnosis of radiation dermatitis during radiotherapy, allowing an early selection of patients needing treatment or close monitoring and avoiding skin biopsies.