Moxetumomab pasudotox-tdfk for relapsed/refractory hairy cell leukemia: a review of clinical considerations.

PURPOSE: Hairy cell leukemia (HCL) is a rare mature B cell leukemia. Purine analogs are the mainstay of treatment of HCL, but relapse after purine analog therapy is common. Outcomes of treatment of relapsed/refractory HCL typically diminish with each successive line of therapy. Moxetumomab pasudotox-tdfk is a novel recombinant immunotoxin approved for the treatment of patients with relapsed/refractory HCL who have received at least two prior therapies, including a purine analog. This article reviews HCL treatment, focusing on moxetumomab pasudotox-tdfk, its place in therapy, considerations for preparation and administration, and strategies for prevention and management of toxicities. METHODS: A literature search was conducted in the PubMed database from inception to January 2019, using the following terms: moxetumomab, hairy cell leukemia, relapsed/refractory hairy cell leukemia, immunotoxin, and CD22. The package insert and available posters and abstracts were also reviewed. RESULTS: FDA approval of moxetumomab pasudotox-tdfk was based on a phase III single-arm, open-label trial in 80 patients. Treatment with moxetumomab pasudotox-tdfk yielded a durable complete response rate of 30% with a median duration of response that had not yet been reached at a median follow-up of 16.7 months. The objective response rate was 75% based on blinded independent central review. The most common adverse reactions were infusion-related reactions, edema, nausea, fatigue, headache, pyrexia and anemia. Serious adverse events include capillary leak syndrome and hemolytic uremic syndrome. CONCLUSIONS: Clinicians providing care for patients receiving moxetumomab pasudotox-tdfk should be aware of the strategies required for safe administration, including the management of serious adverse events.

O trabalho em rede nos casos de alta complexidade e de alta vulnerabilidade: a experiência de uma UBS / Health care networking in cases of high complexity and high vulnerability: the experience of an Health Center / El trabajo en redes en los casos de alta complejidad y alta vulnerabilidad: la experiencia de una Unidad Básica de Salud

Este estudo tem como objetivo apresentar e analisar os processos de formação de redes de atenção à saúde em torno de casos complexos e em contextos de alta vulnerabilidade, atendidos pela Estratégia Saúde da Família na UBS XXX, na região da Brasilândia, São Paulo. Tais processos foram desenvolvidos a partir de oficinas de escrita realizadas pelo Pró-Saúde-PUCSP em parceria com a Supervisão Técnica de Saúde da Freguesia do Ó/Brasilândia da Secretaria Municipal de Saúde de São Paulo. As oficinas se constituíram como forma de mobilizar o relato de experiências e a reflexão sobre a prática profissional. Partiu-se de três casos índices atendidos na Unidade Básica de Saúde que demandaram uma configuração de redes ampliadas de cuidado que se estenderam para além do atendimento multiprofissional da Unidade e do apoio do Núcleo de Apoio à Saúde da Família (NASF). Foram tecidas reflexões em torno dos diferentes modelos de assistência em saúde, da resolubilidade de tais casos e a da corresponsabilidade dos atores envolvidos no cuidado. Concluiu-se que a formação de rede aproxima os profissionais do território, explora a potencialidade de assistência e possibilita uma abordagem mais integrada, proporcionando um atendimento mais humanizado.

This study aims to present and analyze the health care network formation processes around cases of high complexity and high vulnerability served by the Family Health Strategy at UBS XXXX, in the region of Brasilândia, in São Paulo, Brazil. Such processes have been developed from writing workshops conducted by PUC-SP Pro-Health in partnership with Health Supervision Technical FÓ/Brasilândia SMS/ SP. The workshops were formed as a way to mobilize the narrative of experiences and reflection about the professional practices. The work was started from three index cases treated at UBS, which required a configuration of extended care networks that extended beyond the multidisciplinary care of the Unit and the support of NASF. Reflections were woven around the different health care models, of the possibility of resolving such cases and the responsibility of the actors involved in the care. It was concluded that the network formation approximates professionals of the territory, explores the assistance capability and makes it possible a more integrated approach, providing a more humanized care.

Este estudio tiene como objetivo presentar y analizar los procesos de formación de la red de atención de salud en torno de casos complejos y en contextos de alta vulnerabilidad, atendidos por la Estrategia Salud de la Familiar en la Unidad Básica de Salud (UBS) XXXX, en la región de Brasilândia, en Sao Paulo, Brasil. Tales procesos se han desarrollado a partir de talleres de escritura realizadas por ProSalud-PUC-SP en colaboración con la Supervisión Técnica de Salud de la "Freguesia do Ó"/ Brasilândia Secretaria Municipal de São Paulo. Los talleres se formaron como una forma de movilizar la narración de experiencias y la reflexión sobre las prácticas profesionales. El trabajo se inició a partir de tres casos índice tratados en la UBS, que requerían una configuración de redes ampliadas de atención que se extendieron más allá de la atención multidisciplinaria de la Unidad y del apoyo del Núcleo de Apoyo a la Salud (NASF). Reflexiones fueron tejidas en torno a los diferentes modelos de atención de la salud, a la posibilidad de resolver este tipo de casos y a la corresponsabilidad de los actores implicados en la atención. Se concluyó que la formación de la red aproxima a los profesionales del territorio, explora la capacidad de asistencia y hace posible un enfoque más integrado, proporcionando una atención más humanizada.

Alcohol attitudes and behaviors among faculty at U.S. schools and colleges of pharmacy / Actitudes y comportamientos sobre el alcohol entre académicos de las escuelas y facultades de farmacia en Estados Unidos

Despite attempts to control college-aged drinking, binge and underage drinking continues at colleges and universities. Although often underutilized, faculty have the potential to influence students’ behaviors and attitudes towards drinking. Little information is available pertaining to college faculty drinking patterns, views on drinking, or their influence on college drinking. What little information is available predates the economic crisis, mandates for increased alcohol education, and the American Pharmacists Association’s call for increased alcohol awareness in pharmacists. Objectives: This study was designed to determine alcohol use patterns and viewpoints among faculty at U.S. colleges of pharmacy, in particular, to identify alcohol practices among faculty, use of alcohol with their students, mentioning alcohol in classroom as a social norm, and perceived drinking norms within their colleagues. Methods: Following Institution Review Board approval, 2809 invitations were emailed to U.S. pharmacy faculty for this survey-based study. The survey consisted of demographic questions, the World Health Organization Alcohol Use Disorders Identification Test (AUDIT), and questions pertaining to personal and institution attitudes on drinking and on drinking with students. Results: More than 96% of 753 respondents had a total AUDIT score <8. Males and preceptors were more likely to have higher AUDIT scores. More than 75% of faculty reported never drinking with students. Conclusion: In order to help pharmacy students address the extent of their alcohol use and misuse, pharmacy faculty must address their own use, along with their own and their institutions attitudes and behaviors towards alcohol use (AU)

A pesar de los intentos de control de la ingesta de alcohol en las facultades, la juerga y la bebida entre menores continúa en facultades y universidades. Aunque a menudo infrautilizados, los académicos tienen la posibilidad de influenciar las actitudes y comportamientos de los estudiantes sobre la bebida. Hay poca información disponible sobre los hábitos de bebida de los académicos, visión de la bebida, o su influencia sobre la bebida en las facultades. La poca información disponible anterior a la crisis económica recomienda aumentar la educación sobre el alcohol y la Asociación de Americana de Farmacéuticos pide un aumento de la concienciación sobre el alcohol entre los farmacéuticos. Objetivos: Este estudio fue diseñado para determinar los patrones de uso de alcohol y los puntos de vista de los académicos en las facultades de farmacia de Estados Unidos, en particular, identificar las prácticas con el alcohol entre académicos, el uso de alcohol con sus estudiantes, menciones al alcohol en clases como hábito social, y hábitos percibidos sobre el alcohol con sus colegas. Métodos: Después de la aprobación del Comité de Investigación de la Institución, se enviaron por correo 2809 invitaciones a académicos de farmacia de Estados Unidos para esta encuesta. El cuestionario comprendía preguntas demográficas, el World Health Organization Alcohol Use Disorders Identification Test (AUDIT) y preguntas relativas a actitudes personales y de la institución sobre el beber y el beber con estudiantes. Resultados: Más del 96% de los 753 respondentes tenían una puntuación total en el AUDIT de <8. Los hombres y los preceptores tenían puntuaciones AUDIT mayores. Más del 75% de los académicos reportaron no beber nunca con estudiantes. Conclusión: Para ayudar a los estudiantes de farmacia a afrontar el extendido uso y abuso del alcohol, los académicos de farmacia deben afrontar su propio uso, así como sus actitudes y comportamientos y las de sus instituciones sobre el consumo de alcohol (AU)

Alcohol attitudes and behaviors among faculty at U.S. schools and colleges of pharmacy.

UNLABELLED: Despite attempts to control college-aged drinking, binge and underage drinking continues at colleges and universities. Although often underutilized, faculty have the potential to influence students' behaviors and attitudes towards drinking. Little information is available pertaining to college faculty drinking patterns, views on drinking, or their influence on college drinking. What little information is available predates the economic crisis, mandates for increased alcohol education, and the American Pharmacists Association's call for increased alcohol awareness in pharmacists. OBJECTIVE: This study was designed to determine alcohol use patterns and viewpoints among faculty at U.S. colleges of pharmacy, in particular, to identify alcohol practices among faculty, use of alcohol with their students, mentioning alcohol in classroom as a social norm, and perceived drinking norms within their colleagues. METHODS: Following Institution Review Board approval, 2809 invitations were emailed to U.S. pharmacy faculty for this survey-based study. The survey consisted of demographic questions, the World Health Organization Alcohol Use Disorders Identification Test (AUDIT), and questions pertaining to personal and institution attitudes on drinking and on drinking with students. RESULTS: More than 96% of 753 respondents had a total AUDIT score <8. Males and preceptors were more likely to have higher AUDIT scores. More than 75% of faculty reported never drinking with students. CONCLUSIONS: In order to help pharmacy students address the extent of their alcohol use and misuse, pharmacy faculty must address their own use, along with their own and their institutions attitudes and behaviors towards alcohol use.