A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors.

This first-in-human (FIH), phase I, multicenter, open-label study was conducted to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy, and to establish the MTD/recommended dose for expansion (RDE) of PCA062 in patients with solid tumors. Adult patients with any solid tumor type and having a documented P-cadherin-positive tumor were enrolled; exceptions to P-cadherin positivity requirement were head and neck squamous cell carcinomas (HNSCC) and esophageal squamous cell carcinoma (ESCC). Dose escalation was guided by an adaptive Bayesian logistic regression model with escalation with overdose control to determine the MTD/RDE. Forty-seven patients were treated at 10 different dose levels of PCA062, ranging from 0.4 to 5.0 mg/kg every 2 weeks administered as a 1-hour intravenous infusion. All enrolled patients discontinued the treatment; primary reason for discontinuation was progressive disease (78.7%). All 47 patients experienced at least one AE, of which 32 patients had a grade ≥3 AE and 37 patients experienced AEs suspected to be study drug related. The MTD of PCA062 was 3.6 mg/kg every 2 weeks and thrombocytopenia was reported as a DLT that was attributed to the known toxicities of the DM1 payload with no P-cadherin-related toxicities. Pharmacokinetics was proportional, and no patients developed antidrug antibodies, suggesting adequate exposure at the doses tested. One patient of 47 achieved a partial response and there was no correlation between tumor P-cadherin expression and clinical efficacy. Because of limited antitumor activity at the MTD level, Novartis has terminated clinical development of PCA062 (NCT02375958).

Pré-natal masculino: desafios na prática de enfermagem na atenção básica à saúde / Male prenatal care: challenges in nursing practice in primary health care

Objetivo: descrever os desafios existentes na prática de Enfermagem quanto à implementação do pré-natal masculino. Método: Estudo descritivo, qualitativo, realizado com dez enfermeiras que atuam na Atenção Básica à Saúde, em Unidades de Saúde da Família, no município de Feira de Santana, Bahia, Brasil. Realizou-se entrevista individual, semiestruturada, analisadas pelo método do Discurso do Sujeito Coletivo. Resultados: Há desafios relacionados com as dimensões da formação acadêmica e profissional, tal como da captação e adesão masculina e no fazer técnico, atitudinal e assistencial direcionado à saúde de homens, e consequentemente a inserção masculina no pré-natal, que se encontra direcionada ao atendimento da lógica da produção das demandas, e focalizada na perspectiva cisheteronormativa. Conclusão: A presença dos desafios na implementação do pré-natal masculino, implica na ausência da produção do cuidado de Enfermagem direcionado a este contexto, com relação direta às construções de gênero, tal qual da organização do processo de formação acadêmica e da organização das práticas em saúde no sistema.

Objective: To describe the challenges in nursing practice regarding the implementation of male prenatal care. Method: Descriptive, qualitative study, conducted with ten nurses who work in Primary Health Care, in Family Health Units, in the municipality of Feira de Santana, Bahia, Brazil. An individual semi-structured interview was conducted, analyzed by the Collective Subject Discourse method. Results: There are challenges related to the dimensions of academic and vocational training, such as male uptake and adherence and technical, attitudinal and care delivery directed to men's health, and consequently male insertion in prenatal care, which is directed to meeting the logic of the production of demands, and focused on the cisheteronormative perspective. Conclusion: The presence of challenges in the implementation of male prenatal care implies the absence of nursing care production directed to this context, with direct relation to gender constructions, such as the organization of the academic formation process and the organization of practices. in health in the system.

Angioplastia coronária em pacientes com infarto do miocárdio e púrpura trombocitopênica idiopática / Coronary angioplasty in a patient with myocardial infarction and idiopathic thrombocytopenic purpura

A púrpura trombocitopênica idiopática (PTI) é um distúrbio autoimune, caracterizado clinicamente por plaquetopenia e sangramentos mucocutâneos. Trata-se de doença rara na população geral e a ocorrência de infarto agudo do miocárdio (IAM) em pacientes com PTI é ainda menos frequente. Neste artigo os autores descrevem um caso com PTI no qual foi praticada angioplastia coronária tranbsluminal na fase evolutiva do IAM.

Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by the presence of thrombocytopenia and mucocutaneous bleeding. It is a rare condition and the occurrence of an acute myocardial infarction (AMI) in patients with ITP is even less common. In the present manuscript the authors report a patient with ITP who underwent percutaneous transluminal coronary angioplasty in the follow-up phase of an AMI.

A participação da enfermagem e do alunato nos grupos com pacientes / psicóticos: um encontro fundamental

Pequenos recortes ilustram a participação conjunta, da enfermagem e dos estagiários de graduação em psicologia e enfermagem, nos grupos com pacientes psicóticos numa enfermaria de agudos. Essa experiência aponta para a sua importância fundamental no construir da formação e da reciclagem, incentivando o respeito aos diferentes saberes e às singularidades, o que leva conseqüentemente a uma prática assistencial mais humana e qualificada(AU)