Obstrução lacrimal pós-tratamento oncológico: revisão de literatura / Lacrimal drainage system obstruction after cancer treatment: a literature review

RESUMO A obstrução de via lacrimal é uma possível complicação decorrente de tratamentos oncológicos sistêmicos e locais. A epífora crônica gera grande impacto na qualidade de vida desses pacientes, e, como a fibrose terminal da via lacrimal pode necessitar de procedimentos complexos para sua resolução, é importante estarmos atentos a esse efeito adverso, com o objetivo de reconhecê-lo e tratá-lo precocemente, ou mesmo preveni-lo. Nesta revisão da literatura, os autores analisam todos os agentes quimioterápicos e radioterápicos associados à obstrução lacrimal e descrevem os mecanismos, a frequência, os tratamentos e a profilaxia. Os tratamentos oncológicos associados à obstrução lacrimal foram: radioterapia em cabeça e pescoço (dosagem acima de 45 a 75Gy), radioiodoterapia (dosagem acima de 150mCi) e quimioterapia com 5-FU, S-1, capecitabine e docetaxel. A obstrução lacrimal pode ser irreversível, e a intubação profilática das vias lacrimais é uma possibilidade descrita de tratamento profilático em casos de radioterapia e uso do 5-FU, S-1 e docetaxel. O tratamento cirúrgico de todos os casos é a dacriocistorrinostomia.

ABSTRACT Lacrimal duct obstruction can be a side effect of systemic and/or local cancer treatments. Chronic epiphora has a great impact on the quality of life of oncological patients. Since terminal fibrosis of the lacrimal system may require complex procedures, it is important to be aware of this adverse effect in order to recognize and treat it, or even prevent it. A literature review was performed to identify all types of systemic cancer treatment associated with lacrimal obstruction and to describe the mechanisms, frequency, treatment, and prophylaxis. The oncological treatments associated with lacrimal obstruction were head and neck radiotherapy (dosage above 45-75 Gy), radioiodine therapy (dosage above 150 mCi), and chemotherapy with 5-FU, S-1, Capecitabine and Docetaxel. Depending on the dose, this complication may be irreversible. Prophylactic intubation of the lacrimal system is an option for prophylaxis in cases of radiotherapy, use of 5-FU, S-1, and Docetaxel. Final surgical treatment is dacryocystorhinostomy.

Evaluación geriátrica guiada por G8 en la decisión del tratamiento de adultos mayores con cáncer: un estudio piloto / Geriatric evaluation guided by G8 in the decision to treat older adults with cancer: a pilot study / Avaliação geriátrica guiada pelo G8 na decisão de tratar idosos com câncer: um estudo piloto

Introducción: El cáncer es una enfermedad asociada al envejecimiento y tiene una alta prevalencia en los adultos mayores. La valoración geriátrica integral (VGI) mejora los cuidados de los adultos mayores (AM) con cáncer. En contextos sanitarios con recursos limitados, no todos los AM podrán ser evaluados por un geriatra. Un modelo en 2 pasos, incluyendo el test G8, en la consulta habitual del oncólogo, permite seleccionar aquellos pacientes que se beneficiarán de una VGI. Esta puede aportar en la toma de decisiones del tratamiento oncológico específico. Objetivo: Evaluar el beneficio del test G8 y la VGI en ≥ 70 años con cáncer candidatos a recibir quimioterapia. Material y Métodos: Estudio observacional, descriptivo, de corte transversal, de una muestra no probabilística de pacientes ≥ de 70 años con diagnóstico de cáncer y candidatos a recibir quimioterapia. Se aplicó el G8 por el oncólogo y se completó la VGI en los que presentaron alteración en algunas de las áreas evaluadas. Resultados: Se analizaron 32 pacientes. Se realizó G8 a todos, en 21 de ellos se completó la VGI. En estos, en reunión multidisciplinaria con oncólogo y geriatra se discutió el tratamiento. En el 38% de los pacientes se cambió la conducta oncológica tras contar con la valoración geriátrica integral. Conclusión: Creemos que la incorporación del G8 en la práctica clínica del oncólogo aporta una herramienta de cribado útil para identificar los pacientes ≥70 años que se benefician de una VGI previa al inicio de tratamiento oncoespecífico, optimizando de esta manera los recursos.

Introduction: Cancer is a disease associated with aging and has a high prevalence in older adults. Comprehensive geriatric assessment (CGA) improves the care of older adults (OA)with cancer. In healthcare settings with limited resources, not all OA may be evaluated by a geriatrician. A 2-step model, including the G8 test, in the usual oncologist consultation, allows selecting those patients who will benefit from CGA. This can contribute to decision-making regarding specific cancer treatment. Objective: To evaluate the benefit of the incorporation of the G8 test and CGA in the ≥ 70 years with cancer candidates for chemotherapy. Material and Methods: Observational, descriptive, cross-sectional study of a non-probability sample of patients ≥ 70 years of age with a diagnosis of cancer and candidates for chemotherapy. The G8 was applied by the oncologist and the CGA was completed in those who presented alteration in some of the evaluated areas. Results: 32 patients were analyzed. G8 was performed in all, in 21 of them the CGA was completed. In these, the treatment was discussed in a multidisciplinary meeting with an oncologist and a geriatrician. Oncological behavior was changed in 38% of patients after having a comprehensive geriatric evaluation. Conclusion: We believe that the incorporation of the G8 test in the clinical practice of the oncologist provides a useful screening tool to identify patients ≥70 years who benefit from CGA prior to the start of oncospecific treatment, thus optimizing resources.

Introdução: O câncer é uma doença associada ao envelhecimento e tem alta prevalência em idosos. A avaliação geriátrica ampla (AGA) melhora o atendimento a idosos com câncer. Em ambientes de saúde com recursos limitados, nem todos eles podem ser avaliadas por um geriatra. Um modelo de duas etapas, incluindo o teste G8, na consulta oncológica usual, permite selecionar os pacientes que serão beneficiados pela AGA. Isso pode contribuir para a tomada de decisões em relação ao tratamento específico do câncer. Objetivo: Avaliar o benefício da incorporação do teste G8 e AGA nos ≥ 70 anos com câncer, candidatos à quimioterapia. Material e Métodos: Estudo observacional, descritivo e transversal de uma amostra não probabilística de pacientes com idade ≥ 70 anos com diagnóstico de câncer e candidatos à quimioterapia. O G8 foi aplicado pelo oncologista e a AGA foi realizada naqueles que apresentaram alteração em algumas das áreas avaliadas. Resultados: 32 pacientes foram analisados. O G8 foi realizado em todos, em 21 deles a AGA foi aplicada. Nesses, o tratamento foi discutido em reunião multidisciplinar com oncologista e geriatra. O tratamento oncológico foi alterado em 38% dos pacientes após uma avaliação geriátrica amplia. Conclusão: Acreditamos que a incorporação do teste G8 na prática clínica do oncologista fornece uma ferramenta de triagem útil para identificar pacientes com idade ≥70 anos que se beneficiam da AGA antes do início do tratamento oncoespecífico, otimizando recursos.

Use of audiovisual media to enhance patients' knowledge regarding the oral adverse effects of oncology treatment / Uso de mídia audiovisual para aprimorar o conhecimento dos pacientes sobre os efeitos adversos orais do tratamento oncológico

Objetivo: o presente estudo teve como objetivo avaliar a eficácia de alternativas didáticas, como a mídia audiovisual, na transmissão de informações sobre os efeitos adversos orais do tratamento oncológico em pacientes com câncer. Métodos: pacientes oncológicos foram divididos aleatoriamente em dois grupos: grupo controle (n = 40) e grupo audiovisual (n = 36). O grupo controle recebeu informações verbais sobre os efeitos colaterais orais do tratamento do câncer. Por outro lado, o grupo audiovisual recebeu a mesma informação verbal, juntamente com uma apresentação ilustrativa de mídia audiovisual. Além disso, foram aplicados questionários sobre o assunto antes e após a intervenção da equipe odontológica. Resultados: o presente estudo empregou o teste exato de Fisher para análise estatística, e os resultados mostraram similaridade estatística entre os dois grupos (P > 0,05). Ambas as abordagens educacionais alcançaram o objetivo pretendido. Conclusão: um diálogo bem conduzido pode criar uma compreensão adequada entre pacientes com câncer, melhorando a sua adaptação. Opcionalmente, o uso de técnicas inovadoras, como recursos audiovisuais, pode ser uma alternativa acessível e eficiente, que também pode ser usada na educação desses pacientes. Dessa forma, vídeos educacionais podem ser usados para melhorar a compreensão dos pacientes, a adesão a esquemas terapêuticos e a qualidade de vida, além de contribuir para um melhor prognóstico.(AU)

Objective: the present study aimed to evaluate the efficacy of didactic alternatives, namely the audiovisual media, in conveying information regarding the oral adverse effects of oncology treatment in cancer patients. Methods: cancer patients were randomly divided into two groups: control group (n = 40) and audiovisual group (n = 36). The control group received verbal information regarding the oral side effects of cancer treatment. Conversely, the audiovisual group received the same verbal information, along with an illustrative audiovisual media presentation. Additionally, questionnaires on the subject were administered before and after the intervention by the dental team. Results: the current study employed Fisher's exact test for statistical analysis, and the results showed statistical similarity between the two groups (P > 0.05). Both educational approaches achieved the intended objective. Conclusion: a well-conducted dialogue can create adequate awareness among cancer patients and improve adaptation. Optionally, the use of innovative techniques, such as audiovisual resources, was observed to be an accessible and efficient alternative that can also be used in patient education. Therefore, educational videos can be used to improve patients' understanding, adherence to therapeutic regimens, and quality of life and contribute to a better prognosis.(AU)

Laser doppler flowmetry as a method of analysis for the evaluation of chemo - induced oral mucositis: a pilot study / Flujometría por láser doppler como método de análisis para la evaluación de la mucositis oral inducida por quimioterapia: un estudio piloto

Background: Oral mucositis (OM) is an inflammation of the oral mucosa due to cancer therapy that compromises the patient's quality of life. Laser Doppler flowmetry (LDF) is a non-invasive method to monitor microvascular blood flow (BF) in real-time. Purpose: Develop a method to evaluate BF in the genian region cheek in patients undergoing chemotherapy by LDF and compare the degrees of OM and pain with evaluation of BF. Material and methods: Evaluation of OM was performed using the World Health Organization (WHO) and Oral Mucositis Assessment Scale (OMAS) scales and the visual analog scale for pain evaluation. For flowmetry analysis, a laser Doppler flowmeter (moorVMSTM™, 780 nm wavelength and VP3 probe), fixed by an acrylic resin support was used; VP3 probe was positioned on the genian region and the patient's head was stabilized with a neck pillow for an accurate measurement. The Wilcoxon test was used to compare the flowmetry results at the studied times. The Pearson correlation coefficient was used to evaluate relationships between BF and the WHO, OMAS and visual analog scales. Results: Eleven patients of both sexes, aged between 30 and 78 years, with OM were included. An increase in cutaneous BF was observed at the initial times of OM, with progressive reduction during the chemotherapy cycle. There was a statistical difference (p<0.05) between time point T0 (first consultation) and time point T6 (last consultation). Conclusion: The method developed in this pilot study is effective, reliable, and reproducible, and allows the evaluation of BF dynamics in the genian region using LDF of patients undergoing chemotherapy at risk of developing OM.

Antecedentes: La mucositis oral (MO) es una inflamación de la mucosa oral debido a la terapia del cáncer, que compromete la calidad de vida del paciente. La flujometría láser Doppler (FLD) es un método no invasivo para monitorear el flujo sanguíneo microvascular (FS) en tiempo real. Objetivo: Desarrollar un método para evaluar la FS en la mejilla de la región geniana en pacientes sometidos a quimioterapia por FLD y comparar los grados de MO y dolor con la evaluación del FS. Material y Métodos: La evaluación de la MO se realizó utilizando las escalas de la Organización Mundial de la Salud (OMS) y la Escala de Evaluación de la Mucositis Oral (OMAS) y la escala analógica visual para la evaluación del dolor. Para el análisis de flujometría se utilizó un flujómetro láser Doppler (moorVMSTM™, longitud de onda de 780 nm y sonda VP3), fijado por un soporte de resina acrílica; La sonda VP3 se colocó en la región geniana y la cabeza del paciente se estabilizó con una almohada para el cuello para una medición precisa. Se utilizó la prueba de Wilcoxon para comparar los resultados de la flujometría en los tiempos estudiados. Se utilizó el coeficiente de correlación de Pearson para evaluar las relaciones entre FS y las escalas de la OMS, OMAS y analógicas visuales. Resultados: Se incluyeron 11 pacientes de ambos sexos, con edades comprendidas entre 30 y 78 años, con MO. Se observó un aumento del FS cutáneo en los momentos iniciales de la MO, con reducción progresiva durante el ciclo de quimioterapia. Hubo una diferencia estadística (p<0.05) entre el momento T0 (primera consulta) y el momento T6 (última consulta). Conclusión: El método desarrollado en este estudio piloto es efectivo, confiable y reproducible, y permite evaluar la dinámica del FS en la región geniana utilizando FLD de pacientes sometidos a quimioterapia con riesgo de desarrollar MO.

Risk factors associated with antineoplastic chemotherapy-induced nausea and vomiting / Fatores de risco associados a náuseas e vômitos induzidos por quimioterapia antineoplásica

ABSTRACT OBJECTIVE: To estimate the incidence and to evaluate risk factors for antineoplastic nausea and vomiting with high and moderate emetogenic chemotherapy in adult patients in the first treatment cycle. METHODS: Prospective cohort study with follow-up of 269 adults during the first cycle of antineoplastic chemotherapy. The incidence of nausea and vomiting was evaluated in the acute phase (0-24 hours), in the late phase (24 hours-5th day) and in the total phase (0-5th day). RESULTS: In total, 152 patients underwent high emetogenic chemotherapy and 117 moderate emetogenic chemotherapy. The relative frequency of nausea was higher when compared with vomiting in the acute phase (p < 0.001) and in the late phase (p < 0.001). The risk factors identified were: age group ≤ 49 years (odds ratio = 0.47; 95%CI 0.23-0.95) and 50-64 years (odds ratio = 0.45; 95%CI 0.23-0.87), tobacco use (odds ratio = 0.35; 95%CI 0.14-0.88), and high emetogenic chemotherapy (odds ratio 0.55; 95%CI 0.31-0.95). CONCLUSION: The incidence of nausea was higher than that of vomiting, and adverse effects were more frequent in the late phase. The results suggest the risk factors for chemotherapy-induced nausea and vomiting are tobacco, age (young adults), and high emetogenic chemotherapy.

RESUMO OBJETIVO: Estimar a incidência e avaliar os fatores de risco para náuseas e vômitos induzidos por antineoplásicos com alto e moderado potencial emético em pacientes adultos, no primeiro ciclo de tratamento. MÉTODOS: Estudo de coorte prospectiva, com 269 adultos acompanhados durante o primeiro ciclo de quimioterapia antineoplásica. A incidência de náuseas e vômitos foi avaliada na fase aguda (0-24 horas), na fase tardia (24 horas-5° dia) e na fase total (0-5° dia). RESULTADOS: 152 pacientes foram submetidos a quimioterápico com alto potencial emético e 117 a moderado potencial emético. A frequência relativa de náuseas foi maior quando comparada à de vômitos na fase aguda (p < 0,001) e na fase tardia (p < 0,001). Os fatores de risco identificados foram: faixa etária ≤ 49 anos (odds ratio = 0,47; IC95% 0,23-0,95) e 50-64 anos (odds ratio = 0,45; IC95% 0,23-0,87), uso de tabaco (odds ratio = 0,35; IC95% 0,14-0,88) e alto potencial emético dos quimioterápicos (odds ratio 0,55; IC95% 0,31-0,95). CONCLUSÃO: A incidência de náuseas foi maior do que a de vômitos, e na fase tardia os efeitos adversos foram mais frequentes. Os resultados sugerem que os fatores de risco para náuseas e vômitos induzidos por quimioterapia são o tabaco, a idade (adultos jovens) e o alto potencial emético do quimioterápico.

Partição de Comprimidos Antineoplásicos Utilizados no Tratamento de Leucemias Agudas em Crianças e Adolescentes / Splitting of Antineoplastic Tablets Used in Acute Leukemias Treatment in Children and Adolescents / Partición de Comprimidos Antineoplásicos Empleados en el Tratamiento de Leucemias Agudas en Niños y Adolescentes

Introdução: A manipulação de antineoplásicos para ajuste de dose, como partição de comprimidos, é comum no tratamento de leucemias agudas de crianças e adolescentes. Objetivo: Identificar a frequência e descrever a prática da partição domiciliar de comprimidos antineoplásicos utilizados no tratamento oral de crianças e adolescentes com leucemias agudas na fase de manutenção. Método: Trata-se de um estudo transversal descritivo, realizado em um hospital pertencente à rede de saúde pública do Distrito Federal com assistência especializada em pediatria. Foram incluídos no estudo crianças e adolescentes entre 1 e 18 anos, diagnosticados com leucemias agudas e em fase de manutenção do tratamento no período de estudo. Foi aplicado um questionário semiestruturado ao responsável principal pela administração dos medicamentos quimioterápicos via oral, podendo ser o cuidador ou a própria criança/adolescente. Foram coletadas variáveis sociodemográficas dos pacientes e cuidadores e variáveis sobre a prática de partição de medicamentos antineoplásicos no domicílio. Resultados: Todos os 48 entrevistados no período do estudo relataram ter partido comprimidos antineoplásicos ao longo do tratamento de leucemias agudas, sendo estes mercaptopurina (n=45 [93,75%]) e tioguanina (n=3 [6,25%]). Conclusão: A partição de comprimidos antineoplásicos foi uma prática unânime em virtude da necessidade referida de ajuste de dose individual para o tratamento de leucemias agudas de crianças e adolescentes, considerando a indisponibilidade de formulações adequadas. Os resultados reforçam a necessidade de a partição ser uniformizada e realizada de maneira a minimizar os riscos e a garantir a segurança para as crianças e adolescentes e seus cuidadores.

Introduction: Antineoplastic drug manipulation for dose adjustment, such as tablet splitting, is standard in acute leukemia treatment for children and adolescents. Objective: To identify the frequency and describe the practice of household splitting of antineoplastic tablet for oral treatment of children and adolescents with acute leukemias in the maintenance phase. Method: Cross-sectional descriptive study performed in a public health system hospital from Distrito Federal (Brazil) with specialized pediatric assistance. Children and teenagers between 1 and 18 years old, diagnosed with acute leukemia and in treatment maintenance phase during the study period were included. A semi-structured questionnaire was applied to the main responsible for administering oral chemotherapy drugs, which could be the caregiver or the child/adolescent themselves. Sociodemographic variables of patients and caregivers and variables on the practice of splitting antineoplastic drugs at home were collected. Results: All 48 interviewees in the study period reported having split antineoplastic tablets during the treatment for acute leukemias, such as mercaptopurine (n = 45 [93.75%]) and thioguanine (n = 3 [6.25%]). Conclusion: The splitting of antineoplastic tablets was a unanimous practice due to the reported need to adjust the individual dose for acute leukemia treatment in children and adolescents, considering the unavailability of adequate formulations. The results reinforce the need for splitting to be standardized and performed in a way that minimizes risks and ensures safety for patients and their caregivers

Introducción: La manipulación de fármacos antineoplásicos para el ajuste de dosis, como las particiones de comprimidos, es frecuente en el tratamiento de las leucemias agudas en niños y jóvenes. Objetivo: Identificar la frecuencia y describir la práctica de la división domiciliaria de medicamentos antineoplásicos utilizados en el tratamiento oral de niños y adolescentes con leucemias agudas en la fase de mantenimiento. Método: Se trata de un estudio transversal descriptivo realizado en un hospital de la red de salud pública del Distrito Federal (Brasil) con asistencia especializada en pediatría. El estudio incluyó a niños y jóvenes de entre 1 y 18 años de edad diagnosticados con leucemia aguda y en fase de mantenimiento del tratamiento en el período del estudio. Se aplicó un cuestionario semiestructurado a la persona principal responsable de la administración de fármacos quimioterapéuticos por vía oral, que puede ser el cuidador o el propio niño/joven. Fueron colectadas variables sociodemográficas de los pacientes y cuidadores y variables sobre la práctica de la división de los medicamentos antineoplásicos en domicílios. Resultados: Los 48 entrevistados en el período de estudio informaron haber roto las pastillas antineoplásicas durante el tratamiento de la leucemia aguda, siendo éstas mercaptopurina (n=45 [93,75%]) y tioguanina (n=3 [6,25%]). Conclusión: La partición de comprimidos antineoplásicos fue una práctica unánime debido a la necesidad mencionada de ajustar la dosis individual para el tratamiento de las leucemias agudas de niños y adolescentes, considerando la falta de formulaciones apropiadas. Los resultados refuerzan la necesidad de estandarizar y realizar la partición para minimizar los riesgos y garantizar la seguridad de los niños, jóvenes y sus cuidadores.

Evaluation of the systemic and therapeutic repercussions caused by drug interactions in oncology patients

SUMMARY INTRODUCTION: Drug interaction is an important cause of global morbidity. It is of particular importance in cancer patients since they are often in use of polypharmacy, related to interactions between the drugs and the chemotherapeutics used. OBJECTIVE: To evaluate the drug interaction between chemotherapy and other drugs in cancer patients. METHODS: a cross-sectional study carried out in the outpatient oncology department of a public tertiary hospital. Two hundred thirty-five patients were included, and the drugs they were using were identified. Using the MedScape and Epocrates database, we evaluated the interactions between medications and chemotherapy by defining their frequency and dividing their severity from interaction into mild, close monitoring necessity and severe. RESULTS: 161 patients had some drug interaction. We identified 9 types of mild interactions, 23 types of interactions with close monitoring necessity, and 2 types of serious interactions. The most frequent interactions were between fluorouracil and leucovorin (32 cases) and cyclophosphamide and doxorubicin (19 cases). Serious interactions were between aspirin and pemetrexed; and leucovorin and Bactrim. CONCLUSION: In the present study, drug interactions were frequent, including serious interactions with a potential increase in morbidity and mortality. Thus, it is necessary for oncologists to draw up a therapeutic plan considering potential interactions between prescribed chemotherapy and current medications in use by patients.

RESUMO INTRODUÇÃO: Interação medicamentosa é uma importante causa de morbidade mundial. Apresenta especial importância em pacientes oncológicos, pois esses frequentemente estão em uso de polifarmácia, podendo haver interações entre os medicamentos e os quimioterápicos utilizados. OBJETIVO: Avaliar a interação medicamentosa entre a quimioterapia e outros medicamentos em pacientes oncológicos. MÉTODOS: Estudo transversal realizado em serviço ambulatorial de oncologia de um hospital público terciário. Foram incluídos 235 pacientes, identificando-se quais medicamentos eram utilizados por eles. Por meio do auxílio do banco de dados do MedScape e Epocrates, avaliaram-se as interações entre as medicações e os quimioterápicos, definindo sua frequência e dividindo sua gravidade da interação em leve, monitorização próxima e grave. RESULTADOS: Do total estudado, 161 pacientes apresentavam alguma interação medicamentosa, sendo nove tipos de interações leves, 23 tipos de interações com necessidade de monitorização próxima e dois tipos de interações graves. As interações mais frequentes foram entre fluoracil e leucovorin (32 casos) e ciclofosfamida e doxorrubicina (19 casos). As interações sérias foram entre aspirina e pemetrexed; e leucovorim e bactrim. CONCLUSÃO: No presente trabalho, interações medicamentosas foram frequentes, incluindo interações graves com potencial aumento de morbimortalidade. Assim, faz-se necessário que oncologistas tracem um plano terapêutico levando em consideração as possíveis interações medicamentosas entre a quimioterapia prescrita e demais medicações em uso pelos pacientes.

Left Ventricular Regional Wall Motion Abnormality is a Strong Predictor of Cardiotoxicity in Breast Cancer Patients Undergoing Chemotherapy / Alteração Contrátil Segmentar Ventricular Esquerda é Preditor Independente de Cardiotoxicidade em Pacientes com Câncer de Mama em Tratamento Quimioterápico

Abstract Background: Chemotherapeutic agents of anthracyclines class and humanized monoclonal antibodies are effective treatments for breast cancer, however, they present a potential risk of cardiotoxicity. Several predictors have been recognized as predictors in the development of cardiac toxicity, and the evaluation of left ventricular segmental wall motion abnormalities (LVSWMA) has not been studied. Objective: To analyze prospectively the role of LVSWMA among echocardiographic parameters in the prediction of development of cardiotoxicity in breast cancer patients undergoing treatment with chemotherapy. Methods: Prospective cohort of patients diagnosed with breast cancer and in chemotherapy treatment with potential cardiotoxicity medications including doxorubicin and trastuzumab. Transthoracic echocardiograms including speckle tracking strain echocardiography were performed at standard times before, during and after the treatment to assess the presence (or lack thereof) of cardiotoxicity. Cardiotoxicity was defined by a 10% decrease in the left ventricular ejection fraction, on at least one echocardiogram. Multivariate logistic regression models were used to verify the predictors related to the occurrence of cardiotoxicity over time. Results: Of the 112 patients selected (mean age 51,3 ± 12,9 years), 18 participants (16.1%) had cardiotoxicity. In the multivariate analysis using the logistic regression model, those with LVWMA (OR = 6.25 [CI 95%: 1.03; 37.95], p < 0,05), LV systolic dimension (1.34 [CI 95%: 1.01; 1.79], p < 0,05) and global longitudinal strain by speckle tracking (1.48 [CI 95%: 1.02; 2.12], p < 0,05) were strongly associated with cardiotoxicity. Conclusion: In the present study, we showed that LVWMA, in addition to global longitudinal strains, were strong predictors of cardiotoxicity and could be useful in the risk stratification of these patients.

Resumo Fundamento: Os agentes quimioterápicos da classe das antraciclinas e dos anticorpos monoclonais humanizados são tratamentos eficazes para o câncer de mama, entretanto, apresentam alto risco de cardiotoxicidade. Diversos parâmetros têm sido reconhecidos como preditores no desenvolvimento de toxicidade cardíaca, sendo que a avaliação da alteração contrátil segmentar ventricular esquerda (ACSVE) ainda não foi estudada. Objetivo: Analisar a associação entre o surgimento de ACSVE e o desenvolvimento de cardiotoxicidade em pacientes com câncer de mama em tratamento com quimioterapia. Métodos: Coorte prospectiva de pacientes diagnosticados com câncer de mama e em tratamento quimioterápico com doxorrubicina e/ou trastuzumab. Foram realizados ecocardiogramas transtorácicos antes, durante e depois do tratamento para avaliar a presença ou não de cardiotoxicidade. A cardiotoxicidade foi definida por um decréscimo de 10% na fração de ejeção do ventrículo esquerdo, em pelo menos um ecocardiograma. Modelos de regressão logística multivariada foram utilizados para verificar os fatores preditores na ocorrência de cardiotoxicidade ao longo do tempo. Resultados: Dos 112 pacientes selecionados (idade média = 51,3 ± 12,9 anos), 18 (16,1%) apresentaram cardiotoxicidade. Na análise multivariada os pacientes com ACSVE (OR = 6,25 [IC 95%: 1,03; 37,95], p < 0,05), diâmetro sistólico do VE (OR = 1,34 [IC 95%:1,01; 1,79], p < 0,05) e strain longitudinal global pela técnica de speckle tracking (OR = 1,48 [IC 95%: 1,02; 2,12], p < 0,05) foram preditores significativos e independentes na predição de cardiotoxidade. Conclusão: Mostramos que ACSVE, bem como a redução do strain longitudinal global foram preditores independentes para cardiotoxicidade, podendo ser úteis na estratificação de risco destes pacientes.

Rare complications of multikinase inhibitor treatment

ABSTRACT Objective: The advent of multikinase inhibitor (MKI) therapy has led to a radical change in the treatment of patients with advanced thyroid carcinoma. The aim of this manuscript is to communicate rare adverse events that occurred in less than 5% of patients in clinical trials in a subset of patients treated in our hospital. Subjects and methods: Out of 760 patients with thyroid cancer followed up with in our Division of Endocrinology, 29 (3.8%) received treatment with MKIs. The median age at diagnosis of these patients was 53 years (range 20-70), and 75.9% of them were women. Sorafenib was prescribed as first-line treatment to 23 patients with differentiated thyroid cancer and as second-line treatment to one patient with advanced medullary thyroid cancer (MTC). Vandetanib was indicated as first-line treatment in 6 patients with MTC and lenvatinib as second-line treatment in two patients with progressive disease under sorafenib treatment. Results: During the follow-up of treatment (mean 13.7 ± 7 months, median 12 months, range 6-32), 5/29 (17.2%) patients presented rare adverse events. These rare adverse effects were: heart failure, thrombocytopenia, and squamous cell carcinoma during sorafenib therapy and squamous cell carcinoma and oophoritis with intestinal perforation during vandetanib treatment. Conclusions: About 3 to 5 years after the approval of MKI therapy, we learned that MKIs usually lead to adverse effects in the majority of patients. Although most of them are manageable, we still need to be aware of potentially serious and rare or unreported adverse effects that can be life-threatening.

Relationship between food perceptions and health-related quality of life in a prospective study with breast cancer patients undergoing chemotherapy

OBJECTIVE: To correlate the perceptions related to dietary intake with the domains and subscales of health-related quality of life (HRQL) in women with breast neoplasms receiving chemotherapy. METHODS: In this prospective study, 55 women with breast cancer were followed up during chemotherapy at three different times (T0, T1, T2). Before chemotherapy, perceptions related to food consumption were evaluated. HRQL was analyzed with the EORTC QLQ-C30 and Br23 instruments 21 days after each investigated cycle. The differences (T2-T0) in the subscales and HRQL domains were correlated with the differences (T2-T0) in the appetite scores. Spearman's correlation was used to verify a possible correlation between differences in functional and overall HRQL domains (T2-T0) and differences in appetite scores for certain foods and between the differences in some subscales of EORTC QLQ-C30 and Br23 (T2-T0) and differences in appetite scores for certain food groups (T2-T0). RESULTS: Correlations between pain and appetite for bitter taste and between an increased appetite for juices and pain intensification or fatigue were identified, and pain was correlated with an appetite for starchy foods. An appetite for vegetables, legumes and meat/eggs was correlated with physical function. The only significant correlation with social functions occurred between the appetite for sweet foods and these functions. We found a correlation between overall health, emotional function, social function and physical function and the appetite for juices. CONCLUSION: Chemotherapy alters the individual's relationship with food and, consequently, the individual's HRQL.

Case-control study of oral disease indexes in individuals with head and neck cancer after antineoplastic therapy / Estudo caso-controle de índices de doenças bucais em indivíduos com câncer de cabeça e pescoço após terapia antineoplásica

ABSTRACT Objective To evaluate the oral health of patients with head and neck cancer after antineoplastic treatment, and to compare them with patients with no history of cancer. Methods A total of 75 patients, divided into Study Group, composed of individuals after antineoplastic treatment (n=30), and Control Group, with individuals with no history of cancer (n=45), aged 37 to 79 years. The oral health status was evaluated through the index of decayed, missing or filled permanent teeth (DMFT), community periodontal index and evaluation of the use and need of prosthesis. All of these items were evaluated according to the criteria recommended by the World Health Organization. The statistical analysis was descriptive and used the Pearson's χ2 test. Results The community periodontal index was higher in the Study Group when compared to the Control Group (p<0.0001). The need for an upper (p<0.001) and lower (p<0.0001) prostheses was higher in the Study Group. Also, the use of upper prosthesis was higher in the Study Group (p<0.002). The missing or filled permanent teeth index between the two groups (p>0.0506) and the use of lower prosthesis (p>0.214) did not present a relevant statistical difference. Conclusion Periodontal disease and edentulism are the most significant changes in individuals who received antineoplastic therapy for head and neck cancer as well as greater need for oral rehabilitation.

RESUMO Objetivo Avaliar a saúde bucal de pacientes com câncer de cabeça e pescoço após tratamento antineoplásico, e compará-los com pacientes sem histórico de câncer. Métodos Foram avaliados 75 pacientes, divididos em Grupo de Estudo de indivíduos após tratamento antineoplásico (n=30) e Grupo de Controle de indivíduos sem histórico de câncer (n=45), com faixa etária de 35 a 79 anos. A condição de saúde oral foi avaliada pelo índice de dentes permanentes cariados, perdidos e obturados (CPOD), pelo índice periodontal comunitário e por uma avaliação de uso e necessidade de prótese, conforme critérios preconizados pela Organização Mundial da Saúde. A análise estatística foi descritiva e realizada por meio do teste do χ2 de Pearson. Resultados O índice periodontal comunitário foi maior no Grupo de Estudo quando comparado ao controle (p<0,0001). A necessidade de prótese superior (p<0,001) e inferior (p<0,0001) foi maior no Grupo de Estudo. O uso de prótese superior foi maior no Grupo de Estudo (p<0,002). O índice de dentes permanentes cariados, perdidos e obturados entre os dois grupos (p>0,0506) e o uso de prótese inferior (p>0,214) não apresentaram diferença estatística relevante. Conclusão A doença periodontal e o edentulismo são as alterações mais significativas em indivíduos que receberam terapia antineoplásica de câncer de cabeça e pescoço, assim como maior necessidade de reabilitação oral.

Intrahepatic, Perihilar and Distal Cholangiocarcinoma: Management and Outcomes

Abstract: Introduction and aims. Cholangiocarcinomas are a heterogeneous group of tumors that can be classified into three clinically distinct types of cancers, intrahepatic, perihilar and distal cholangiocarcinoma. The inconsistent use of nomenclature for these cancers has obscured a true knowledge of the epidemiology, natural history and response to therapy of these cancers. Our aims were to define demographic characteristics, management and outcomes of these three distinct cancer types. Materials and methods. A retrospective study of patients enrolled in an institutional cancer registry from 1992 to 2010. Median survival was compared between different treatment modalities over three time periods for the three types of cholangiocarcinoma at different stages of the disease using Kaplan Meyer analysis. Results. 242 patients were identified. All cases were reviewed and classified into intrahepatic (90 patients), distal (48 patients) or perihilar (104 patients) cholangiocarcinomas. These cancers differed in median age of onset, gender distribution, median survival and stage. 13.8% of patients presented with stage I, 5.8% with stage II, 9.6% with stage III, 28% with stage IV, with 41.8% having unknown stage. The overall median survival was 15.8 months, and was 23, 25, 14, and 4.5 months for stages I, II, III, and IV respectively. Surgery improved survival in both early and advanced stages. Multimodality therapies further improved outcomes, particularly for perihilar cholangiocarcinoma. Conclusion. Perihilar, distal and intrahepatic cholangiocarcinoma vary in their presentation, natural history and therapeutic approach to management. A consistently applied classification is essential for meaningful interpretation of studies of these cancers.

Analysis of the costs and quality of cardiovascular care in oncological monitoring / Análise dos custos e da qualidade da assistência cardiovascular no seguimento oncológico

Summary Objective: To analyze the health care costs specifically related to cardiovascular diseases, which were spent by patients of a private healthcare provider in southern Brazil, after their diagnosis of cancer. Method: We developed an observational, cross-sectional, retrospective study, with a qualitative-quantitative strategy, through the activity of analytical internal audit of medical accounts. Results: 860 accounts from 2012 to 2015 were analyzed, 73% referred to female users, with average age of 62.38 years, and a total direct cost of BRL 241,103.72. There was prevalence of 37% of breast cancer, 15% of prostate cancer and 9% of colon cancer. In relation to the cardiovascular care, 44% were consultations, 44% were complementary exams, 10% were emergency care, and 3% were hospitalizations. Regarding the health care costs with cardiovascular services, higher costs were in hospitalizations (51%), followed by complementary exams (37%), consultations (8%) and emergency care (4%). Conclusion: The cancer survivors commonly use health care in other specialties such as cardiology, and the main cost refers to hospitalization. It is recommended to invest in prevention (consultation and complementary exam) as well as in programs of chronic disease management to reduce costs and improve the quality of health care.

Resumo Objetivo: analisar os custos assistenciais com afecções cardiovasculares utilizados por usuários sobreviventes do câncer de uma operadora de saúde suplementar na região Sul do Brasil. Método: foi desenvolvido um estudo observacional, transversal, retrospectivo, com estratégia quali-quantitativa, através de atividade de auditoria interna analítica de contas médico-hospitalares. Resultados: foram analisadas 860 contas, de 2012 a 2015, com 73% de usuários femininos e uma média etária de 62,38 anos, somando um custo total direto de R$ 241.103,72. Houve predomínio de 37% de neoplasias de mamas, 15% de próstata e 9% de cólon. Com relação à assistência cardiovascular, 44% foram consultas, 44% foram exames complementares, 10% foram atendimentos de emergência e 3% foram hospitalizações. Os custos em assistência cardiovascular foram maiores nas hospitalizações (51%), seguidos pelos exames complementares (37%), pelas consultas (8%) e pelos atendimentos emergenciais (4%). Conclusão: os sobreviventes de câncer habitualmente utilizam a assistência à saúde em outras especialidades, como a cardiologia, e o principal custo é em hospitalização. Recomenda-se investir em prevenção (consultas e exames), assim como em programas de gestão de casos crônicos para reduzir os custos e melhorar a qualidade da assistência à saúde.

Longitudinal assessment of nutritional risk in patients under chemo or radiotherapy / Avaliação longitudinal do risco nutricional em pacientes sob quimio ou radioterapia

Summary Objective: To compare nutritional risk in adult patients undergoing chemotherapy and radiotherapy in the beginning, middle, and end of oncologic treatment. Method: This prospective, comparative study included 83 adult patients, 44 undergoing chemotherapy (CT group) and 39 undergoing radiotherapy (RT group) at an oncology treatment center. Nutritional risk was determined by NRS-2002 in the beginning, middle, and end of therapy. Statistical analysis was performed using Statistica 8.0 software. Results: No differences in food intake or body mass index were observed between the CT (24.6±4.8 kg/m²) and RT groups (25.0±5.9 kg/m², p=0.75). Weight loss in the preceding 3 months was detected in 56.8% of CT group and 38.5% of RT group (p=0.09). The weight loss percentage compared with the usual weight within 3 months was greater (p<0.001) in the CT (11.4±6.5%) than in the RT group (3.9±6.8%). In the beginning of treatment, we observed high percentages of patients at moderate (18.2 vs. 15.4%, p=0.73) and high nutritional risk (61.4 vs. 48.7%, p=0.25), with no statistical difference between the CT and RT groups, respectively. During therapy, the nutritional risk remained unaltered in both groups. In the end of therapy, the majority of patients were at moderate (18.2 vs. 12.8%, p=0.50) or severe nutritional risk (50.0 vs. 51.3%, p=0.91), in the CT and RT groups, respectively, regardless of the type of oncologic treatment. Conclusion: The high prevalence of patients at moderate or high nutritional risk in the beginning of treatment indicates the need for an early and continuous follow-up of the nutritional status of patients undergoing oncologic treatment.

Resumo Objetivo: comparar o risco nutricional de pacientes adultos submetidos a quimio e radioterapia no início, no meio e ao término do tratamento oncológico. Método: estudo prospectivo e comparativo conduzido com 83 pacientes adultos de um centro de tratamento oncológico, sendo 44 sujeitos sob quimioterapia (grupo QTx) e 39 sob radioterapia (grupo RTx). O risco nutricional foi determinado pelo questionário NRS-2002 no início, ao meio e ao término da terapia. A análise estatística foi feita com o software Statistica 8.0. Resultados: não houve diferença no padrão de ingestão alimentar e no IMC (24,6±4,8 vs. 25±5,9 kg/m²; p=0,75) nos grupos QTx e RTx, respectivamente. Perda de peso nos 3 meses precedentes ocorreu em 56,8% dos pacientes sob quimioterapia e em 38,5% daqueles sob radioterapia (p=0,09). Os pacientes do grupo QTx apresentaram maior porcentagem de perda de peso em relação ao habitual em 3 meses (11,4±6,5 vs. 3,9±6,8%; p<0,001). No início do tratamento, houve alta taxa de risco nutricional moderado (18,2 vs. 15,4%; p=0,73) e grave (61,4 vs. 48,7%; p=0,25), sem diferença estatística entre os grupos QTx e RTx, respectivamente. No meio do tratamento, o risco nutricional foi mantido em ambos os grupos. Ao término da terapia, mais da metade dos pacientes apresentava risco nutricional moderado (18,2 vs. 12,8%; p=0,50) ou grave (50 vs. 51,3%; p=0,91), independentemente da modalidade de tratamento oncológico. Conclusão: a alta prevalência de risco nutricional moderado ou grave no início do tratamento aponta para a necessidade de abordagem nutricional precoce e permanente durante a terapia oncológica.

Chemotherapy for advanced non-small cell lung cancer in the elderly population

ABSTRACT BACKGROUND: Approximately 50% of patients with newly diagnosed non-small cell lung cancer (NSCLC) are over 70 years of age at diagnosis. Despite this fact, these patients are underrepresented in randomized controlled trials (RCTs). As a consequence, the most appropriate regimens for these patients are controversial, and the role of single-agent or combination therapy is unclear. In this setting, a critical systematic review of RCTs in this group of patients is warranted. OBJECTIVES: To assess the effectiveness and safety of different cytotoxic chemotherapy regimens for previously untreated elderly patients with advanced (stage IIIB and IV) NSCLC. To also assess the impact of cytotoxic chemotherapy on quality of life. METHODS: Search methods: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to 31 October 2014), EMBASE (1974 to 31 October 2014), and Latin American Caribbean Health Sciences Literature (LILACS) (1982 to 31 October 2014). In addition, we handsearched the proceedings of major conferences, reference lists from relevant resources, and the ClinicalTrial.gov database. Selection criteria: We included only RCTs that compared non-platinum single-agent therapy versus non-platinum combination therapy, or non-platinum therapy versus platinum combination therapy in patients over 70 years of age with advanced NSCLC. We allowed inclusion of RCTs specifically designed for the elderly population and those designed for elderly subgroup analyses. Data collection and analysis: Two review authors independently assessed search results, and a third review author resolved disagreements. We analyzed the following endpoints: overall survival (OS), one-year survival rate (1yOS), progression-free survival (PFS), objective response rate (ORR), major adverse events, and quality of life (QoL). MAIN RESULTS: We included 51 trials in the review: non-platinum single-agent therapy versus non-platinum combination therapy (seven trials) and non-platinum combination therapy versus platinum combination therapy (44 trials). Non-platinum single-agent versus non-platinum combination therapy Low-quality evidence suggests that these treatments have similar effects on overall survival (hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.72 to 1.17; participants = 1062; five RCTs), 1yOS (risk ratio (RR) 0.88, 95% CI 0.73 to 1.07; participants = 992; four RCTs), and PFS (HR 0.94, 95% CI 0.83 to 1.07; participants = 942; four RCTs). Non-platinum combination therapy may better improve ORR compared with non-platinum single-agent therapy (RR 1.79, 95% CI 1.41 to 2.26; participants = 1014; five RCTs; low-quality evidence). Differences in effects on major adverse events between treatment groups were as follows: anemia: RR 1.10, 95% 0.53 to 2.31; participants = 983; four RCTs; very low-quality evidence; neutropenia: RR 1.26, 95% CI 0.96 to 1.65; participants = 983; four RCTs; low-quality evidence; and thrombocytopenia: RR 1.45, 95% CI 0.73 to 2.89; participants = 914; three RCTs; very low-quality evidence. Only two RCTs assessed quality of life; however, we were unable to perform a meta-analysis because of the paucity of available data. Non-platinum therapy versus platinum combination therapy Platinum combination therapy probably improves OS (HR 0.76, 95% CI 0.69 to 0.85; participants = 1705; 13 RCTs; moderate-quality evidence), 1yOS (RR 0.89, 95% CI 0.82 to 0.96; participants = 813; 13 RCTs; moderate-quality evidence), and ORR (RR 1.57, 95% CI 1.32 to 1.85; participants = 1432; 11 RCTs; moderate-quality evidence) compared with non-platinum therapies. Platinum combination therapy may also improve PFS, although our confidence in this finding is limited because the quality of evidence was low (HR 0.76, 95% CI 0.61 to 0.93; participants = 1273; nine RCTs). Effects on major adverse events between treatment groups were as follows: anemia: RR 2.53, 95% CI 1.70 to 3.76; participants = 1437; 11 RCTs; low-quality evidence; thrombocytopenia: RR 3.59, 95% CI 2.22 to 5.82; participants = 1260; nine RCTs; low-quality evidence; fatigue: RR 1.56, 95% CI 1.02 to 2.38; participants = 1150; seven RCTs; emesis: RR 3.64, 95% CI 1.82 to 7.29; participants = 1193; eight RCTs; and peripheral neuropathy: RR 7.02, 95% CI 2.42 to 20.41; participants = 776; five RCTs; low-quality evidence. Only five RCTs assessed QoL; however, we were unable to perform a meta-analysis because of the paucity of available data. AUTHORS' CONCLUSIONS: In people over the age of 70 with advanced NSCLC who do not have significant co-morbidities, increased survival with platinum combination therapy needs to be balanced against higher risk of major adverse events when compared with non-platinum therapy. For people who are not suitable candidates for platinum treatment, we have found low-quality evidence suggesting that non-platinum combination and single-agent therapy regimens have similar effects on survival. We are uncertain as to the comparability of their adverse event profiles. Additional evidence on quality of life gathered from additional studies is needed to help inform decision making

Sunitinib treatment in patients with advanced renal cell cancer: the Brazilian National Cancer Institute (INCA) experience

ABSTRACT Purpose: The aim of this study was to assess the impact of sunitinib treatment in a non-screened group of patients with metastatic renal cell cancer (mRCC) treated by the Brazilian Unified Health System (SUS) at a single reference institution. Material and Methods: Retrospective cohort study, which evaluated patients with mRCC who received sunitinib between May 2010 and December 2013. Results: Fifty-eight patients were eligible. Most patients were male 41 (71%), with a median age of 58 years. Nephrectomy was performed in 41 (71%) patients with a median interval of 16 months between the surgery and initiation of sunitinib. The most prevalent histological subtype was clear cell carcinoma, present in 52 (91.2%) patients. In 50 patients (86%), sunitinib was the first line of systemic treatment. The main adverse effects were fatigue (57%), hypothyroidism (43%), mucositis (33%) and diarrhea (29%). Grade 3 and 4 adverse effects were infrequent: fatigue (12%), hypertension (12%), thrombocytopenia (7%), neutropenia (5%) and hand-foot syndrome (5%). Forty percent of patients achieved a partial response and 35% stable disease, with a disease control rate of 75%. Median progression free survival was 7.6 months and median overall survival was 14.1 months. Conclusion: Sunitinib treatment was active in the majority of patients, especially those with low and intermediate risk by MSKCC score, with manageable toxicity. Survival rates were inferior in this non-screened population with mRCC treated in the SUS.

A Prospective Cohort Study on Cardiotoxicity of Adjuvant Trastuzumab Therapy in Breast Cancer Patients / Estudo Prospectivo de Coorte sobre Cardiotoxicidade na Terapia Adjuvante com Trastuzumabe em Pacientes com Câncer de Mama

Abstract Background: Cardiotoxicity is an important side effect of trastuzumab therapy and cardiac surveillance is recommended. Objectives: The aim of our study was to prospectively assess baseline patients' characteristics, level of N-terminal pro-brain natriuretic peptide (NT-proBNP) and echocardiographic parameters as possible predictors of trastuzumab-related cardiac dysfunction. Methods: In a prospective cohort study, clinical, echocardiographic and neurohumoral assessment was performed at baseline, after 4, 8 and 12 months in breast cancer patients undergoing post-anthracycline (3-4 cycles) adjuvant therapy with trastuzumab. Trastuzumab-related cardiac dysfunction was defined as a decline of ≥ 10% in left ventricular ejection fraction (LVEF). Results: 92 patients (mean age, 53.6 ± 9.0 years) were included. Patients who developed trastuzumab-related LVEF decline ≥ 10% (20.6%) during treatment had significantly higher baseline LVEF (70.7 ± 4.4%) than those without (64.8 ± 5.5%) (p = 0.0035). All other measured baseline parameters (age, body mass index, arterial hypertension, level of NT-proBNP and other echocardiographic parameters) were not identified as significant. Conclusions: Our findings suggest that baseline patient' characteristics, level of NT-proBNP and echocardiographic parameters, as long as they are within normal range, are not a reliable tool to predict early trastuzumab-related cardiac dysfunction in patients undergoing post-low dose anthracycline adjuvant trastuzumab therapy. A LVEF decline in patients with high-normal baseline level although statistically significant is not clinically relevant.

Resumo Fundamento: Cardiotoxicidade é um importante efeito colateral da terapia com trastuzumabe, recomendando-se vigilância cardíaca. Objetivos: Avaliar prospectivamente as características basais de pacientes, nível de fração N-terminal do pró-peptídeo natriurético cerebral (NT-proBNP) e parâmetros ecocardiográficos como possíveis preditores de disfunção cardíaca relacionada ao trastuzumabe. Métodos: Em um estudo clínico prospectivo de coorte, realizou-se avaliação ecocardiográfica e neuro-humoral basal, aos 4, 8 e 12 meses em pacientes com câncer de mama submetidas a terapia adjuvante com trastuzumabe após antraciclina (3-4 ciclos). Definiu-se disfunção cardíaca relacionada ao trastuzumabe como uma redução na fração de ejeção ventricular esquerda (FEVE) ≥ 10%. Resultados: Este estudo incluiu 92 pacientes (idade média, 53,6 ± 9,0 anos). Pacientes que desenvolveram redução na FEVE ≥ 10% (20,6%) relacionada ao trastuzumabe durante tratamento tinham FEVE basal significativamente maior (70,7 ± 4,4%) do que aqueles sem (64,8 ± 5,5%) (p = 0,0035). Todos os demais parâmetros basais medidos (idade, índice de massa corporal, hipertensão arterial, nível de NT-proBNP e outros parâmetros ecocardiográficos) não foram identificados como significativos. Conclusões: Nossos achados sugerem que as características basais das pacientes, nível de NT-proBNP e parâmetros ecocardiográficos, contanto que dentro da variação normal, não são ferramentas confiáveis para predição precoce de disfunção cardíaca relacionada ao trastuzumabe em pacientes submetidas a terapia adjuvante com trastuzumabe após baixa dose de antraciclina. Uma redução na FEVE em pacientes com FEVE basal alta-normal, ainda que estatisticamente significativa, não é clinicamente relevante.

Pharmacovigilance of patients with multiple myeloma being treated with bortezomib and/or thalidomide

In order to evaluate the main adverse effects of drug protocols using bortezomib and/or thalidomide for the treatment of multiple myeloma, we conducted a prospective study. Data were collected through interviews, clinical observation, and from hospital records. A total of 59 patients were included. There was a predominance of females, 36 (61%) vs 23 (39%) males, and of whites, 49 (83.1%) vs 10 (16.9%) blacks. Age ranged from 40 to 94 years, with a median of 65 years (SD=11.6). Regarding staging at diagnosis, 27 (45.7%) patients were in stage III-A, with 12 (20.3%) patients having serum creatinine ≥2 mg/dL. The main adverse effects in the bortezomib treatment group (n=40) were: neutropenia (42.5%), diarrhea (47.5%), and peripheral neuropathy in 60% of cases, with no difference between the iv (n=26) and sc (n=14) administration routes (P=0.343). In the group treated with thalidomide (n=19), 31.6% had neutropenia, 47.4% constipation, and 68.4% peripheral neuropathy. Neutropenia was associated with the use of alkylating agents (P=0.038). Of the 3 patients who received bortezomib in combination with thalidomide, only 1 presented peripheral neuropathy (33.3%). Peripheral neuropathy was the main adverse effect of the protocols that used bortezomib or thalidomide, with a higher risk of neutropenia in those using alkylating agents. Improving the identification of adverse effects is critical in multiple myeloma patient care, as the patient shows improvements during treatment, and requires a rational and safe use of medicines.