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1.
An. Facultad Med. (Univ. Repúb. Urug., En línea) ; 8(2): e201, dic. 2021. graf, tab
Article in Spanish | LILACS, BNUY, UY-BNMED | ID: biblio-1358026

ABSTRACT

Introducción: Existen pocas pautas para el tratamiento del cáncer de mama (CM) en pacientes añosas, lo que puede conducir al sub o sobre tratamiento. Objetivo: Conocer las características, manejo y la evolución del CM precoz en mujeres añosas. Material y métodos: Estudio observacional, descriptivo, transversal. Se recolectaron datos relacionados con las características clínico-patológicas y la evolución de pacientes de 70 años o más tratadas por CM en el período comprendido entre el 1/1/ 2011 y el 31/12/ 2018, asistidas en el Hospital de Clínicas. Se utilizaron herramientas de estadística descriptiva y para calcular la sobrevida global (SVG) se utilizó el método de Kaplan-Meier. Resultados: se incluyeron 31 pacientes; la edad mediana al diagnóstico fue 76,8 años; las características clínico-patológicas fueron: carcinoma ductal: 71%; GH 1-2: 74,2%; estadio I: 54,8 %; sin metástasis axilares: 80,6 %; HER2-RE/RP+ 80,6%; HER2+ 16,7%, y triple negativas 3,2%. El 29% de las pacientes fueron diagnosticadas mediante tamizaje poblacional y el 74,2% recibieron tratamiento según pautas vigentes, mientras que el 38,7% fueron subtratadas y el 16,1% sobretratadas. La mediana de SVG fue de 98,7 meses. Conclusiones: Una minoría de las pacientes fue diagnosticada mediante tamizaje poblacional, el tipo histológico más frecuente fue el ductal y la prevalencia de los tumores HER2-RE/RP+ fue mayor que en las pacientes más jóvenes. La mayoría de las pacientes recibió tratamiento estandar.


Introduction: There are few guidelines for the treatment of breast cancer (BC) in older patients, which can lead to under- or over-treatment. Objective: To understand the characteristics, management and evolution of early BC in older women. Material and methods: Observational, descriptive, cross-sectional study. Data were collected on the clinical-pathological characteristics and evolution of patients aged 70 years or older, treated for BC in the period from 1/1/ 2011 to 31/12/ 2018, at the Hospital de Clínicas. Descriptive statistical tools were used and the Kaplan-Meier method was applied to calculate the overall survival (OS) rate. Results: 31 patients were included; median age at diagnosis was 76.8 years old; the clinical-pathological characteristics were: ductal carcinoma: 71%; HG 1-2: 74.2%; stage I: 54.8%; no axillary metastases: 80.6%; HER2-ER/PR+ 80.6%; HER2+ 16.7%, and triple negative 3.2%. Of all the patients, 29% were diagnosed through screening and 74.2% were treated according to current guidelines, while 38.7% were under-treated and 16.1% over-treated. The median OS was 98.7 months. Conclusions: A minority of patients were diagnosed by screening, the most frequent histological type was ductal and the prevalence of HER2-RE/RP+ tumors was higher than in younger patients. Most patients received standard treatment.


Introdução: Existem poucas diretrizes para o tratamento do câncer de mama (CM) em pacientes idosos, o que pode levar ao sub ou excesso de tratamento. Objetivo: Conhecer as características, manejo e evolução do MC precoce em mulheres idosas. Material e métodos: estudo observacional, descritivo e transversal. Foram coletados dados relacionados às características clínico-patológicas e à evolução dos pacientes com 70 anos ou mais atendidos por CM no período de 01/01/2011 a 31/12/2018, atendidos no Hospital de Clínicas. Ferramentas de estatística descritiva foram usadas e o método de Kaplan-Meier foi usado para calcular a sobrevida global (SVG). Resultados: 31 pacientes foram incluídos; a mediana de idade ao diagnóstico foi de 76,8 anos; as características clínico-patológicas foram: carcinoma ductal: 71%; GH 1-2: 74,2%; estágio I: 54,8%; sem metástases axilares: 80,6%; HER2-RE / RP + 80,6%; HER2 + 16,7% e triplo negativo 3,2%. 29% dos pacientes foram diagnosticados por triagem populacional e 74,2% receberam tratamento de acordo com as diretrizes atuais, enquanto 38,7% foram subtratados e 16,1% supertratados. O SVG médio foi de 98,7 meses. Conclusões: A minoria dos pacientes foi diagnosticada por rastreamento populacional, o tipo histológico mais frequente foi ductal e a prevalência de tumores HER2-RE / RP + foi maior do que em pacientes mais jovens. A maioria dos pacientes recebeu tratamento padrão.


Subject(s)
Humans , Female , Aged , Aged, 80 and over , Breast Neoplasms/surgery , Breast Neoplasms/diagnosis , Breast Neoplasms/drug therapy , Epidemiology, Descriptive , Cross-Sectional Studies , Treatment Outcome , Chemotherapy, Adjuvant , Trastuzumab/therapeutic use
2.
Rev. colomb. gastroenterol ; 36(supl.1): 2-11, abr. 2021. graf
Article in Spanish | LILACS | ID: biblio-1251539

ABSTRACT

Resumen El cáncer gástrico avanzado es una entidad que incluye dos situaciones clínicas distintas: el cáncer gástrico localmente avanzado no resecable y la enfermedad metastásica, cuyo tratamiento estándar es la quimioterapia. La sobreexpresión del receptor 2 del factor de crecimiento epidérmico humano (HER2) se puede presentar en esta enfermedad de un 9 % a un 38 % y ha sido el primer biomarcador predictivo utilizado para el tratamiento dirigido con trastuzumab en pacientes con tumores gástricos y de la región gastroesofágica avanzados. Se presenta en este artículo el caso de un paciente con cáncer gástrico avanzado con HER2 positivo manejado con quimioterapia convencional más trastuzumab como terapia blanco con adecuada respuesta clínica.


Abstract Advanced gastric cancer (AGC) is an entity that encompasses two distinct clinical situations: locally advanced unresectable gastric cancer and metastatic disease, with chemotherapy as the standard treatment. HER2 overexpression can occur in 9% to 38% of the cases with this disease and has been the first predictive biomarker used for trastuzumab-targeted therapy in patients with advanced gastric and gastroesophageal tumors. This article presents a patient with AGC and positive HER2 treated with conventional chemotherapy plus trastuzumab as targeted therapy with adequate clinical response.


Subject(s)
Humans , Male , Aged , Stomach Neoplasms , Determination , Epidermal Growth Factor , Therapeutics , Drug Therapy , Trastuzumab
3.
Oncol. (Guayaquil) ; 30(3): 237-249, Diciembre 30, 2020.
Article in Spanish | LILACS | ID: biblio-1145729

ABSTRACT

Introducción: El tratamiento neodyuvante del cáncer de mama HER2 positivo ha ido evolucionando a través del tiempo, con la implementación de nuevas estrategias de manejo terapéutico. Es de esta manera como el trastuzumab, un anticuerpo monoclonal anti-HER2sigue siendo el tratamiento estándar en este subtipo de cáncer, los primeros estudios en los que se evidencia su eficacia son el realizado por el Dr. Buzdar y el estudio NOAH en los cuales las pacientes alcanzaron mayores tasas de respuesta patológica completa en comparación con quimioterapia sola, así como también un mayor número de cirugías conservadoras de mama en lugar de mastectomía.Con el paso de los años se han ido desarrollando nuevas estrategias de manejo terapéutico, así tenemos el doble bloqueo anti-HER2 con los anticuerpos monoclonales trastuzumab y pertuzumab que han mejorado las tasas de respuesta patológica completa. Además se ha incluido al lapatinib un inhibidor de tirosina quinasa como parte de las terapias dirigidas. Se ha dilucidado si las antraciclinas confieren un beneficio adicional al tratamiento neoadyuvante y los estudios demuestran que el beneficio es el mismo queotros esquemas de quimioterapia. Es en realidad la quimioterapia indispensable en la neoadyuvancia, el estudio PHERGain demuestra que existen pacientes que pueden alcanzar respuesta patológica completa solo con el doble bloqueo anti-her2 (trastuzumab y pertuzumab) lo que evitaría la toxicidad innecesaria por quimioterapia, y se podrían desarrollar estrategias para el manejo de aquellas pacientes que no alcanzaron una respuestapatológica completa posterior al doble bloqueo. Aún queda un campo amplio por explorar y con estudios en curso al momento. Palabras claves:DsCS:Receptor ErbB-2, Trastuzumab, Neoplasias de la Mama, Quimioterapia Adyuvante, Ado-Trastuzumab Emtansina


Introduction:The neodyuvanttreatment of HER2 positive breast cancer has evolved over time, with the implementation of new therapeutic management strategies. It is in this way that trastuzumab, an anti-HER2 monoclonal antibody continues to be the standard treatment in this subtype of cancer, the first studies in which its efficacy is evidenced are the one carried out by Dr. Buzdar and the NOAH study in which patients achieved higher rates of complete pathological response compared to chemotherapy alone, as well as a higher number of breast-conserving surgeries rather than mastectomy.Over the years, new therapeutic management strategies have been developed, thus we have the double anti-HER2 blockade with the monoclonal antibodies trastuzumab and pertuzumab that have improved the ratesof complete pathological response. In addition, lapatinib, a tyrosine kinase inhibitor, has been included as part of targeted therapies. It has been elucidated whether anthracyclines confer an additional benefit to neoadjuvant treatment and studies show that the benefit is the same as other chemotherapy regimens.It is actually the essential chemotherapy in neoadjuvant therapy, the PHERGain study shows that there are patients who can achieve a complete pathological response only with the double anti-her2 blockade (trastuzumab and pertuzumab), which would avoid unnecessary toxicity due to chemotherapy, and strategies could be developed for the management of those patients who did not achieve a complete pathological response after double blockade. There is still a wide field to explore and with studies underway at the moment. Keywords:MESH:Receptor, ErbB-2;Trastuzumab; Breast Neoplasms; Chemotherapy, Adjuvant; Ado-Trastuzumab Emtansine


Subject(s)
Humans , Breast Neoplasms , Receptor, ErbB-2 , Trastuzumab , Chemotherapy, Adjuvant , Ado-Trastuzumab Emtansine
4.
Oncol. (Guayaquil) ; 30(3): 249-279, Diciembre 30, 2020.
Article in Spanish | LILACS | ID: biblio-1222453

ABSTRACT

Introducción: Los tumores gliales, dentro de las lesiones neuroepiteliales, son las neoplásicas intraaxiales más comunes. Representan alrededor del 45% de todos los tumores primarios del sistema nervioso central (SNC) y el 77% de todos los tumores primarios malignos del SNC. El promedio de supervivencia media de los pacientes con glioblastoma multiforme (GBM) cuando se utiliza el tratamiento multimodal es de 15-18 meses y de 2 a 5 años con gliomas anaplásicos. Los tratamientos convencionales de los tumores cerebrales incluyen cirugía, radioterapia y quimioterapia. El tratamiento quirúrgico representa la primera aproximación para la gran mayoría de tumores cerebrales, sin embargo, la resección total no siempre es alcanzable en relación con la localización del tumor, de vital importancia para preservar estructuras nerviosas o vasculares. Modalidades de tratamiento agresivas han extendido la supervivencia media, pero la supervivencia a menudo se asocia con un deterioro significativo en la calidad de vida. La eficacia de quimioterapia sistémica está limitada por la presencia de la barrera hemato encefálica (BHE), la que limita el paso de una amplia variedad de agentes anti cancerígenos, la acción de los agentes alquilantes, está limitado por la activación de metil-guanina-metil-transferasa. El advenimiento de los estudios moleculares permite una nueva evaluación de la biología de los gliomas con, un nivel de precisión que promete interesantes avances hacia el desarrollo de terapias específicas eficaces. Las terapias dirigidas bloquean la activación de vías oncogénicas, ya sea a nivel de la interacción ligando-receptor o mediante la inhibición vías de transducción de señales, corriente abajo, inhibiendo así el crecimiento y la progresión del cáncer. El objetivo del presente trabajo fue realizar una revisión bibliográfica acerca de los aspectos relacionados con la patogénesis molecular en la progresión de estos tumores en los adultos, y sus potenciales blancos terapéuticos.


Introduction:Glial tumors, within neuroepithelial lesions, are the most common intraaxial neoplastic. They represent about 45% of all primary central nervous system (CNS) tumors and 77% of all malignant primary CNS tumors. The median median survival of patients with glioblastoma multiforme (GBM) when multimodal treatment is used is 15-18 months and 2-5 years with anaplastic gliomas. Conventional treatments for brain tumors include surgery, radiation therapy, and chemotherapy. Surgical treatment represents the first approach for the vast majority of brain tumors; however, total resection is not always achievable in relation to the location of the tumor, which is vitally important to preserve nerve or vascular structures.Aggressive treatment modalities have extended median survival, but survival is often associated with a significant deterioration in quality of life. The efficacy of systemic chemotherapy is limited by the presence of the blood-brain barrier (BBB), which limits the passage of a wide variety of anticancer agents, the action of alkylating agents, is limited by the activation of methyl-guanine-methyltransferase. The advent of molecular studies allows a new evaluation of the biology of gliomas with, a level of precision that promises interesting advances towards the development of effective specific therapies. Targeted therapies block the activation of oncogenic pathways, either at the level of ligand-receptor interaction or by inhibiting downstream signal transduction pathways, thus inhibiting cancer growth and progression.The objective of the present work was to carry out a bibliographic review about the aspects related to the molecular pathogenesis in the progression of these tumors in adults, and their potential therapeutic targets.


Subject(s)
Breast Neoplasms , Receptor, ErbB-2 , Trastuzumab , Chemotherapy, Adjuvant , Ado-Trastuzumab Emtansine
5.
Rev. costarric. cardiol ; 21(1): 7-13, ene.-jun. 2019. tab
Article in Spanish | LILACS | ID: biblio-1042858

ABSTRACT

Resumen La Cardio-oncología es una nueva disciplina que busca enfocarse en el tamizaje, monitoreo y tratamiento de los pacientes con cáncer que presentan enfermedad cardiaca durante o después de recibir tratamiento. Esto debido a que el efecto cardiotóxico asociado a los quimioterapéuticos es ampliamente conocido y respaldado por abundantes estudios clínicos. Sin embargo, no es hasta épocas recientes que en Costa Rica se desarrollaron por primera vez Unidades Cardio-oncológicas, los cuales actualmente se ubican en diversos centros médicos de nuestro sistema de salud público. A continuación, se presenta un resumen de las manifestaciones clínicas de las diversas terapias oncológicas diferentes a las antraciclinas que tenemos a disposición en la Caja Costarricense del Seguro Social (CCSS).


Abstract Cardio-oncology is a new discipline that looks to focus on the screening, monitoring and treatment of patients withcancer that show up with heart disease during and after their treatment. This is due to the fact that the cardiotoxic effectsassociated to chemotherapeutics is widely known and backed up with abundant clinical trials. Nevertheless, it is not untilrecently that in Costa Rica the Cardio-oncologic Units were created for the first time, which now can be found in multiplemedical centers of our public health system. Up next, we present a summary of the clinical manifestations of the diversenon-anthracycline oncologic therapies that are available in the "Caja Costarricense del Seguro Social".


Subject(s)
Humans , Abnormalities, Radiation-Induced , Doxorubicin , Anthracyclines , Costa Rica , Cyclophosphamide , Drug Therapy , Cardiotoxicity , Trastuzumab , Sorafenib , Antibiotics, Antineoplastic , Antineoplastic Agents
6.
Acta méd. costarric ; 61(1): 31-36, ene.-mar. 2019. tab
Article in Spanish | LILACS | ID: biblio-983716

ABSTRACT

Resumen Objetivo: dado que en este momento está disponible a nivel de la Seguridad Social Costarricense tanto trastuzumab para administración intravenosa como para administración subcutánea, y que la presentación para administración subcutánea ha documentado ser no inferior a la intravenosa, resulta pertinente contar con un estudio de minimización de costes que permita documentar cuál de las formulaciones resulta más conveniente mantener en el sistema público de salud, con base en criterios de eficiencia de la intervención. Métodos: se desarrolló un estudio que evaluó desde la perspectiva financiera de la Seguridad Social de Costa Rica, dos opciones diferentes de aplicación del trastuzumab en pacientes con cáncer de mama. Los procedimientos relacionados fueron identificados y documentados para los dos tipos de aplicación del tratamiento intravenosa y subcutánea. Ambas opciones de tratamiento se basaron en esquemas de diecisiete dosis, con la estimación de los suministros y el tiempo del profesional sanitario para cada posibilidad. El análisis incluyó la evaluación desde la perspectiva del paciente. Resultados: la evaluación económica del procedimiento de administración para ambas alternativas evidenció que la opción subcutánea tenía un costo de aplicación de $ 78,6 y $ 467,34 para la opción intravenosa. Desde la perspectiva financiera, la opción subcutánea constituye la alternativa con un costo menor: $ 4000,00 por tratamiento por paciente, y desde la perspectiva de este, implica un 45,0 % menos de tiempo por sesión de tratamiento por paciente, que en la opción intravenosa. Conclusiones: la formulación de trastuzumab subcutánea evidenció una reducción sustancial de tiempo y costo en comparación con la presentación intravenosa en el sistema de Seguridad Social Costarricense.


Abstract Objective: Given that at this time is available at the Costa Rican Social security both trastuzumab for intravenous as for subcutaneous administration, and that the presentation for subcutaneous administration has documented to be not inferior to the intravenous. It is relevant to have a study of cost minimization to investigate what formulation is more convenient to maintain in the public health system, based on criteria of efficiency of the intervention. Methods: A study was developed to evaluate, from the financial perspective of the Social Security of Costa Rica, two different options of application of trastuzumab in patients with breast cancer. The related procedures were identified and documented for the two types treatment application. Both treatment options were based on seventeen dose schemes, with the estimate of supplies and the time of the health professional for each possibility. The analysis also included the evaluation from the patient's perspective. Results: The economic evaluation of the application procedure for both alternatives evidenced that the subcutaneous option had an application cost of $78.6 and $467.34 for the intravenous option. From the financial perspective the subcutaneous option constitutes the alternative with lower cost, with a cost around $4000.0 by treatment per patient, and from the patient perspective implies a 45.0% less time for session than then intravenous option. Conclusions: Trastuzumab subcutaneous formulation evidenced a substantial time and cost reduction in comparison with the intravenous formulation in the Costa Rican Social Security System.


Subject(s)
Humans , Breast Neoplasms/drug therapy , Trastuzumab/administration & dosage , Costa Rica
8.
Arq. bras. cardiol ; 112(1): 50-56, Jan. 2019. tab, graf
Article in English | LILACS | ID: biblio-973832

ABSTRACT

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.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Breast Neoplasms/drug therapy , Ventricular Dysfunction, Left/chemically induced , Antineoplastic Agents/adverse effects , Stroke Volume/drug effects , Echocardiography/methods , Doxorubicin/adverse effects , Logistic Models , Prospective Studies , Risk Factors , ROC Curve , Anthracyclines/adverse effects , Cardiotoxicity/etiology , Trastuzumab/adverse effects
9.
Rev. bras. cancerol ; 65(3)19/09/2019.
Article in Portuguese | LILACS | ID: biblio-1048395

ABSTRACT

Introdução: O câncer de mama é o mais comum entre as mulheres em todo o mundo, representando quase 25% de todos os casos de câncer. Alguns fármacos possuem características peculiares relacionadas à cardiotoxicidade. Objetivo: Analisar a incidência, as características clínicas e os fatores de risco associados à ocorrência de cardiotoxicidade em pacientes submetidas ao protocolo doxorrubicina e ciclofosfamida seguido ou não de taxanos e naquelas que realizaram o mesmo protocolo associado ao trastuzumabe. Método: Trata-se de um estudo de coorte realizado em um hospital público do Rio de Janeiro. Foram incluídas 153 pacientes que iniciaram tratamento entre os meses de setembro e novembro de 2012. A cardiotoxicidade foi definida com base nos critérios do Cardiac Review and Evaluation Committee e da Sociedade Brasileira de Cardiologia. Foi calculado o risco relativo (RR), utilizando-se um intervalo de confiança (IC) de 95%. Resultados: A incidência de cardiotoxicidade foi de 17%. Observou-se queda da fração de ejeção do ventrículo esquerdo em 31,3% e 52,2% das pacientes nos grupos human epidermal growth factor receptor-type 2 (HER-2) negativo e positivo, respectivamente. Foram identificados três casos de insuficiência cardíaca, sendo dois em pacientes HER-2 positivas. As pacientes que utilizaram trastuzumabe apresentaram maior risco de desenvolver cardiotoxicidade (RR=3,53; IC 95%: 1,84-6,79) em comparação com as mulheres do grupo HER-2 negativo. Conclusão:Foi possível verificar a ocorrência de casos de cardiotoxicidade em ambos os grupos com maior incidência para o grupo HER-2 positivo.


Introduction: Breast cancer is the most common among women worldwide, accounting for almost 25% of all cancer cases. Some drugs have a peculiar characteristic related to cardiotoxicity. Objective: Analyze the incidence, clinical characteristics and risk factors associated with cardiotoxicity in patients undergoing protocol doxorubicin and cyclophosphamide followed or not by taxanes and in those who underwent the same protocol associated with trastuzumab. Method: Cohort study conducted in a public hospital in Rio de Janeiro. 153 patients were included between September and November 2012. Cardiotoxicity was defined based on the criteria of the Cardiac Review and Evaluation Committee and the Brazilian Society of Cardiology. The relative risk (RR) was calculated using a 95% confidence interval (CI). Results: The incidence of cardiotoxicity was 17%. Left ventricular ejection fraction decreased in 31.3% and 52.2% of the patients in the negative and positive human epidermal growth factor receptor-type 2 (HER-2) groups, respectively. Three cases of heart failure were identified, two in HER-2 positive patients. Patients using trastuzumab had a higher risk of developing cardiotoxicity (RR=3.53; CI 95%: 1.84-6.79) compared to women in the HER-2 negative group. Conclusion: It was possible to verify the occurrence of cases of cardiotoxicity in both groups with higher incidence for the HER-2 positive group.


Introducción: El cáncer de mama es el más común entre las mujeres en todo el mundo, y representa casi el 25% de todos los casos de cáncer. Algunos medicamentos tienen característica peculiar relacionada con la cardiotoxicidad. Objetivo: Analizar la incidencia, las características clínicas y los factores de riesgo asociados con la cardiotoxicidad en pacientes sometidos al protocolo doxorrubicina y ciclofosfamida seguidos o no por taxanos y en aquellos que se sometieron al mismo protocolo asociado con trastuzumab. Método: Este es un estudio de cohorte realizado en un hospital público en Río de Janeiro. Se incluyeron 153 pacientes que comenzaron el tratamiento entre septiembre y noviembre de 2012. La cardiotoxicidad se definió según los criterios del Comité de Revisión y Evaluación Cardíaca y la Sociedad Brasileña de Cardiología. El riesgo relativo (RR) se calculó utilizando un intervalo de confianza (IC) del 95%. Resultados: La incidencia de cardiotoxicidad fue del 17%. La fracción de eyección del ventrículo izquierdo disminuyó en el 31,3% y el 52,2% de los pacientes en los grupos human epidermal growth factor receptor-type 2 (HER-2) negativo y positivo, respectivamente. Se identificaron tres casos de insuficiencia cardíaca, dos en pacientes con HER-2 positivo. Los pacientes que usaban trastuzumab tenían un mayor riesgo de desarrollar cardiotoxicidad (RR=3,53; IC 95%: 1,84-6,79) en comparación con las mujeres en el grupo negativo HER-2. Conclusión: Fue posible verificar la aparición de casos de cardiotoxicidad en ambos grupos con mayor incidencia para el grupo HER-2 positivo.


Subject(s)
Humans , Female , Breast Neoplasms/drug therapy , Cardiotoxicity/epidemiology , Doxorubicin/adverse effects , Neoadjuvant Therapy , Cyclophosphamide/adverse effects , Epidemiological Monitoring , Trastuzumab/drug effects
10.
Rev. bras. cancerol ; 65(3)19/09/2019.
Article in Portuguese | LILACS | ID: biblio-1047725

ABSTRACT

Introdução: O câncer de mama representa a neoplasia mais frequente entre as mulheres, com elevada morbimortalidade. Com o advento de novos medicamentos, houve um aumento na sobrevida global; entretanto, o trastuzumabe, um anticorpo monoclonal utilizado no tratamento, pode promover cardiotoxicidade, que deve ser avaliada e monitorada durante o tratamento. O objetivo deste artigo é descrever um relato de caso de paciente que apresentou cardiotoxicidade associada ao uso de trastuzumabe e a importância do monitoramento e da identificação precoce da cardiotoxicidade por meio do monitoramento pelo ecocardiograma (ECO). Relato do caso: Paciente, sexo feminino, 63 anos, hipertensa, obesa, com câncer de mama, apresentou cardiotoxicidade associada ao uso de trastuzumabe, com redução da fração de ejeção do ventrículo esquerdo (FEVE) e desenvolveu diabetes após o tratamento. A paciente fez acompanhamento regular pelo ECO durante o tratamento, tendo sido esse processo fundamental para a detecção precoce e o manejo adequado da cardiotoxicidade associada ao uso do trastuzumabe. Foi utilizado um algoritmo na determinação da causalidade. Conclusão: Este estudo mostra a importância do acompanhamento da FEVE pelo ECO em pacientes submetidas à quimioterapia cardiotóxica e do monitoramento de possíveis alterações metabólicas após o tratamento oncológico.


Introduction: Breast cancer represents the most common neoplasm among women, with elevated morbimortality. With the appearance of new drugs, there has been an increase of global survival; however, trastuzumab, a monoclonal antibody used in the treatment, may promote cardiotoxicity that should be evaluated and monitored during treatment. The aim of this article is to describe a case report of a patient presenting trastuzumab-associated cardiotoxicity and the importance of monitoring and early identification of cardiotoxicity through echocardiography (ECHO). Case report: A 63-year-old female patient, hypertensive, obese, with breast cancer, presented trastuzumab-associated cardiotoxicity, reduced left ventricular ejection fraction (LVEF), who developed diabetes after the treatment. The patient underwent regular echocardiography follow-up during treatment and this process was essential for early detection and appropriate management of trastuzumab-associated cardiotoxicity. An algorithm was used to determine the causality. Conclusion: This study shows the importance of LVEF follow-up with ECHO in patients undergoing cardiotoxic chemotherapy, and the monitoring of possible metabolic changes after oncologic treatment.


Introducción: El cáncer de mama representa el cáncer más común entre las mujeres, con alta morbilidad y mortalidad. Con el advenimiento de nuevos medicamentos, ha habido un aumento en la supervivencia general, sin embargo, trastuzumab, un anticuerpo monoclonal utilizado en el tratamiento, puede promover la cardiotoxicidad, que debe evaluarse y monitorearse durante el tratamiento. El objetivo de este trabajo es describir un informe de caso de un paciente que presenta cardiotoxicidad asociada con el uso de trastuzumab y la importancia del monitoreo y la identificación temprana de la cardiotoxicidad a través del monitoreo ecocardiográfico (ECHO). Relato del caso: Una paciente de 63 años, hipertensa, obesa, con cáncer de mama, tenía cardiotoxicidad asociada con trastuzumab, fracción de eyección ventricular izquierda (FEVI) reducida y diabetes después del tratamiento. El paciente se sometió a un seguimiento ecocardiográfico regular durante el tratamiento y fue el proceso fundamental para la detección temprana y el manejo adecuado de la cardiotoxicidad asociada con el uso de trastuzumab. Se utilizó un algoritmo para determinar la causalidad. Conclusión: Este estudio muestra la importancia del seguimiento ECHO de la FEVI en pacientes sometidos a quimioterapia cardiotóxica, y el monitoreo de posibles cambios metabólicos después del tratamiento del cáncer.


Subject(s)
Humans , Female , Middle Aged , Breast Neoplasms/drug therapy , Cardiotoxicity/diagnosis , Trastuzumab/adverse effects
11.
Article in English | WPRIM | ID: wpr-786493

ABSTRACT

Breast cancer (BC) is themost common cancer among females withmore than 2 million new cases diagnosed worldwide in 2018. Although the prognosis in the majority of cases in the early stages combined with appropriate treatment is positive, there are still about 30% of patients who will develop locoregional diseases and distant metastases. Molecular imaging is very important in the diagnosis, staging, follow-up, and radiotherapy planning. Additionally, it is useful in characterizing lesions, prognosis, and therapy response in BC patients. Nuclear medicine imaging modalities (SPECT and PET) are of indispensable importance in diagnosis (positron emission mammography), staging (sentinel lymph node detection), and follow-up with ¹⁸F-FDG and tumor characterization. Among many available PET tracers, the most commonly used are ¹⁸F-FLT, ¹⁸F-FES, ¹⁸F-FDHT, ⁶⁴Cu DOTA trastuzumab (bevacizumab), ⁶⁸Ga-PSMA, ⁶⁸Ga-RM2 (gastrin-releasing peptide receptor), ¹⁸F-fluorooctreotide (SSTR), and ⁶⁸Ga-TRAP (RGD)-3αvβ3-integrin. Molecular imaging helps in evaluation of tumor heterogeneity, allowing a shift from one-size-fits-all-approach to era of personalized medicine and precision oncology.


Subject(s)
Breast Neoplasms , Breast , Diagnosis , Female , Follow-Up Studies , Humans , Lymph Nodes , Molecular Imaging , Neoplasm Metastasis , Nuclear Medicine , Population Characteristics , Positron-Emission Tomography , Precision Medicine , Prognosis , Radiotherapy , Trastuzumab
12.
Cancer Research and Treatment ; : 1527-1539, 2019.
Article in English | WPRIM | ID: wpr-763208

ABSTRACT

PURPOSE: BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. MATERIALS AND METHODS: Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored. RESULTS: p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib. CONCLUSION: The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.


Subject(s)
Asian Continental Ancestry Group , Biomarkers , Biopsy , Breast Neoplasms , Breast , Diagnosis , Disease-Free Survival , Female , Humans , Neoplasm Metastasis , Prevalence , RNA, Messenger , Trastuzumab
13.
Article in English | WPRIM | ID: wpr-763123

ABSTRACT

PURPOSE: While concerns regarding trastuzumab-related cardiac dysfunction (TRCD) in patients with breast cancer are increasing, there is a lack of evidence supporting the current recommendations for TRCD monitoring. We aimed to investigate the clinical predictors of TRCD in the adjuvant setting of human epidermal growth factor receptor 2–positive breast cancer patients. MATERIALS AND METHODS: From August 2003 to April 2016, consecutive 998 patients who were treated with adjuvant trastuzumab for breast cancer were retrospectively evaluated. TRCD was defined as a decrease ≥10% in left ventricular ejection fraction (LVEF), with a decline below the normal limit or symptomatic heart failure. RESULTS: Among 787 eligible patients who had complete data sets consisting of both baseline and follow-up assessment of left ventricular systolic function by echocardiography (mean age, 49.9±9.5 years), 58 (7.4%) developed TRCD. TRCD patients had lower baseline LVEF (63% [59–66] vs. 65% [61–68], p=0.016) and more frequently administered Adriamycin (98% vs. 89%, p=0.022) than those without TRCD. On follow-up echocardiography, a drop in LVEF ≥5% within the first 3 months was more frequent in TRCD patients (78.3% vs. 38.4%, p<0.001). Regardless of baseline LVEF and Adriamycin treatment, a drop in LVEF ≥5% within the first 3 months of trastuzumab administration was strongly associated with the development of TRCD (adjusted hazard ratio, 45.1[17.0–127.6], p<0.001). CONCLUSION: The overall incidence of TRCD was 7.4% in Asian breast cancer patients treated with adjuvant trastuzumab. A decline in LVEF ≥5% within the first 3 months of trastuzumab initiation was strongly associated with TRCD development in patients with breast cancer.


Subject(s)
Asian Continental Ancestry Group , Breast Neoplasms , Breast , Cardiotoxicity , Dataset , Doxorubicin , Echocardiography , Follow-Up Studies , Heart Failure , Humans , Incidence , ErbB Receptors , Retrospective Studies , Stroke Volume , Trastuzumab
14.
Journal of Gastric Cancer ; : 148-156, 2019.
Article in English | WPRIM | ID: wpr-764492

ABSTRACT

Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.


Subject(s)
Combined Modality Therapy , Drug Therapy , Esophageal Neoplasms , Esophagogastric Junction , Humans , Incidence , Trastuzumab
15.
Journal of Breast Cancer ; : 260-273, 2019.
Article in English | WPRIM | ID: wpr-764264

ABSTRACT

PURPOSE: The American Joint Committee on Cancer 8th edition (AJCC8) prognostic stage (PS) was implemented January 1, 2018, but it is complex due to multiple permutations. A North American group proposed a simpler system using the anatomic stage with a risk score system (RSS) of 1 point each for grade 3 tumor and human epithelial growth factor receptor 2 (HER2) and estrogen receptor (ER) negativity. Here we aimed to evaluate this risk score system with our database of Asian breast cancer patients and compare it against the AJCC8 PS. METHODS: Patients diagnosed with breast cancer stage I–IV in 2006–2012 were identified in the SingHealth Joint Breast Cancer Registry. Five-year breast cancer-specific survival (CSS) and overall survival (OS) were calculated for each anatomic stage according to the risk score and compared with the AJCC8 PS. RESULTS: A total of 6,656 patients were analyzed. The median follow-up was 61 (interquartile range, 37–90) months. There was a high receipt of endocrine therapy (84.6% of ER+ patients), chemotherapy (84.3% of node-positive patients), and trastuzumab (86.0% of HER2+ patients). Within each anatomic stage, there were significant differences in survival in all sub-stages except IIIB. On multivariate analysis, the hazard ratio for negative ER was 1.74 (1.48–2.06), for negative HER2 was 1.49 (1.26–1.74), and for grade 3 was 1.84 (1.55–2.19). On multivariate analysis controlled for age, ethnicity, and receipt of chemotherapy, the RSS (Akaike information criterion [AIC] = 10,649.45; Harrell's Concordance Index [C] = 0.85) was not inferior to the AJCC8 PS (AIC = 10,726.65; C = 0.84) for CSS, nor was the RSS (AIC = 14,714.4; C = 0.82) inferior to the AJCC8 PS (AIC = 14,784.69; C = 0.81) for OS. CONCLUSION: The RSS is comparable to the AJCC8 PS for a patient population receiving chemotherapy as well as endocrine- and HER2-targeted therapy and further stratifies stage IV patients.


Subject(s)
Asian Continental Ancestry Group , Biomarkers , Breast Neoplasms , Breast , Drug Therapy , Estrogens , Follow-Up Studies , Humans , Joints , Multivariate Analysis , Trastuzumab
16.
Journal of Breast Cancer ; : 336-340, 2019.
Article in English | WPRIM | ID: wpr-764258

ABSTRACT

Mucinous carcinoma (MC) is a rare subtype of breast cancer, which is composed of tumor cells floating in the abundant extracellular mucin. This form of cancer is usually estrogen receptor/progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative. Here, we present a case of HER2-positive MC with an unusual signet ring cell differentiation. It is very rare that a breast tumor consists entirely of signet ring cells. The tumor showed pathologic complete response (pCR) after neoadjuvant chemotherapy with trastuzumab and pertuzumab. pCR of HER2-positive MC has rarely been described in literature. It is important to consider the biological heterogeneity of MCs for effective management.


Subject(s)
Adenocarcinoma, Mucinous , Breast Neoplasms , Carcinoma, Signet Ring Cell , Cell Differentiation , Drug Therapy , Epidermal Growth Factor , Estrogens , Humans , Mucins , Neoadjuvant Therapy , Polymerase Chain Reaction , Population Characteristics , ErbB Receptors , Receptor, ErbB-2 , Trastuzumab
17.
Yonsei Medical Journal ; : 158-162, 2019.
Article in English | WPRIM | ID: wpr-742523

ABSTRACT

PURPOSE: Trastuzumab is an effective treatment for human epidermal growth factor receptor 2 (HER2)-amplified breast cancers. We sought to develop a simple protocol for HER2 image analysis of breast cancer specimens. MATERIALS AND METHODS: In a preliminary test, we found that at least 1000 tumor cells need to be examined in the most strongly stained areas. Next, we evaluated the clinical usefulness of this established protocol of image analysis in 555 breast cancer patients. Results of the HER2 immunohistochemical (IHC) staining were compared between manual scoring and image analysis. RESULTS: The HER2 IHC results obtained by the image analysis method correlated well with those obtained by the manual scoring method (Cohen's kappa=0.830). Using the HER2 silver in situ hybridization (SISH) results as a gold standard, sensitivity values were 72.1% for manual scoring and 74.0% for image analysis; specificity values were 96.2% for manual scoring and 94.7% for image analysis; and accuracy values were 91.7% for manual scoring and 90.8% for image analysis. McNemar's test was applied to the results, and there were no statistically significant differences in sensitivity and specificity between the positive (p=0.688) and negative (p=0.118) SISH groups. CONCLUSION: HER2 image analysis results were similar to those obtained via the manual scoring method, indicating that the use of image analysis can reduce assessment time and effort. We suggest that image analysis-based evaluation of 1000 tumor cells in the most strongly IHC-stained area, regardless of stroma content, is sufficient for determining HER2 expression levels in breast cancer specimens.


Subject(s)
Breast Neoplasms , Breast , Humans , Immunohistochemistry , In Situ Hybridization , Methods , ErbB Receptors , Research Design , Sensitivity and Specificity , Silver , Trastuzumab
18.
Journal of Breast Cancer ; : 120-130, 2019.
Article in English | WPRIM | ID: wpr-738410

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the risk of central nervous system (CNS) failure in Korean patients with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer treated with surgery followed by postoperative radiotherapy (RT). METHODS: A total of 749 patients from eight institutions were enrolled in this study. All of them underwent surgery followed by postoperative RT from 2003 to 2011; 246 (32.8%) received neoadjuvant chemotherapy and 649 (81.7%) received adjuvant chemotherapy. Adjuvant trastuzumab was administered to 386 patients (48.6%). RESULTS: The median follow-up duration was 84 (range, 8–171) months. The 7-year disease-free and overall survival rates were 79.0% and 84.2%, respectively. On multivariate analysis, mastectomy, nodal involvement, and presence of lymphatic invasion were correlated with poor overall survival (p = 0.004, 0.022, and 0.011, respectively), whereas T stage and lymphatic invasion were associated with disease-free survival (p = 0.018 and 0.005, respectively). Regarding CNS failures, 30 brain metastases, 2 leptomeningeal metastases, and 8 brain and leptomeningeal metastases were noted. The 7-year CNS relapse-free survival rates in patients receiving and not receiving trastuzumab were 91.2% and 96.9%, respectively (p = 0.005). On multivariate analysis, the administration of adjuvant trastuzumab was the only prognostic factor in predicting a higher CNS failure rate (hazard ratio, 2.260; 95% confidence interval, 1.076–4.746; p = 0.031). CONCLUSION: Adjuvant trastuzumab was associated with higher CNS failure rate in Korean patients with HER2-enriched breast cancer. Close monitoring and reasonable approaches such as CNS penetrating HER2 blockades combined with the current standard therapy could contribute to improving intracranial tumor control and quality of life in patients with CNS metastasis from HER2-enriched breast cancer.


Subject(s)
Brain , Breast Neoplasms , Breast , Central Nervous System Neoplasms , Central Nervous System , Chemotherapy, Adjuvant , Disease-Free Survival , Drug Therapy , Follow-Up Studies , Humans , Mastectomy , Multivariate Analysis , Neoplasm Metastasis , Quality of Life , Radiation Oncology , Radiotherapy , ErbB Receptors , Retrospective Studies , Survival Rate , Trastuzumab
19.
Rev. méd. Chile ; 146(10): 1095-1101, dic. 2018. tab, graf
Article in Spanish | LILACS | ID: biblio-978744

ABSTRACT

Background: HER2+ breast cancer (BC) subtype overexpresses the Human Epidermal growth factor Receptor type-2 (HER2) and is characterized by its aggressiveness and its high sensitivity to monoclonal antibody-based HER2-targeted therapies. Aim: To assess the prognosis and evaluate the impact of novel anti-HER2 therapies on advanced HER2+ BC patients treated at our institution over the last decades. Material and Methods: Analysis of the patient database at a cancer center of a university hospital. Information about the subtype of cancer was obtained in 2,149 of 2,724 patients in the database. Eighteen percent of the latter were HER2+. We analyzed data of 83 of these patients with advanced disease. Results: Median overall survival (OS) was 24 months. For patients treated between 1997-2006 median OS was 17 months and for those treated in the period 2007-2017 median OS was 32 months (p = 0.09). Conclusions: A non-significant trend towards better survival in the last decade was observed. HER2+ BC overall survival has improved in our center. This can be probably attributed to the use of novel more effective anti-HER2 therapies.


Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Breast Neoplasms/mortality , Breast Neoplasms/chemistry , Receptor, ErbB-2/analysis , Time Factors , Breast Neoplasms/pathology , Breast Neoplasms/drug therapy , Immunohistochemistry , Chile/epidemiology , Retrospective Studies , Receptor, ErbB-2/antagonists & inhibitors , Kaplan-Meier Estimate , Trastuzumab/therapeutic use , Lapatinib/therapeutic use , Neoplasm Recurrence, Local , Antineoplastic Agents/therapeutic use
20.
J. bras. econ. saúde (Impr.) ; 10(3): 269-277, dez. 2018.
Article in Portuguese | LILACS, ECOS | ID: biblio-988170

ABSTRACT

OBJETIVO: Estimar o impacto orçamentário do trastuzumabe subcutâneo, comparado com o in-travenoso, no Sistema de Saúde Suplementar (SSS) para o tratamento do câncer de mama inicial e metastático HER-2 positivo. MÉTODOS: Foi realizada uma análise de impacto orçamentário na perspectiva do SSS. Os tratamentos de câncer de mama inicial foram trastuzumabe em monoterapia e trastuzumabe com paclitaxel ou docetaxel. No câncer de mama metastático, considerou-se trastu-zumabe associado com docetaxel ou paclitaxel na primeira linha e em monoterapia na segunda linha. Para ambos, comparou-se a substituição do trastuzumabe intravenoso pelo subcutâneo. Uma pesquisa com 28 operadoras mapeou taxas, preços e tabelas de referência usadas para o reembolso de medicamentos, materiais e procedimentos. Uma equipe multidisciplinar estimou o uso de recur-sos. Custos médicos diretos foram incluídos e os preços foram obtidos de fontes públicas. O horizon-te temporal foi cinco anos e considerou-se a incorporação progressiva de trastuzumabe subcutâneo com 20% no primeiro ano até atingir 100%. RESULTADOS: Estimaram-se 31.589 pacientes com câncer de mama no SSS em cinco anos. O uso progressivo de trastuzumabe subcutâneo em comparação com o intravenoso levou a uma economia de 962,7 mBRL, 14,5 mBRL, 1,5 mBRL e 0,2 mBRL no SSS, para operadoras de saúde de grande, médio e pequeno porte, respectivamente. Materiais e procedimentos de suporte com taxas médicas foram os parâmetros mais sensíveis. CONCLUSÃO: O trastuzumabe subcutâneo em comparação com o intravenoso pode levar a uma economia de até 962,7 mBRL no tratamento do câncer de mama no SSS.


Objective: To estimate the budgetary impact of subcutaneous trastuzumab, compared with intravenous trastuzumab, in the Brazilian Private Healthcare System (PHS), to treat early and metastatic HER-2 positive breast cancer. Methods: Budgetary impact analysis was performed in PHS perspective. For early breast cancer, treatment options were trastuzumab monotherapy, and trastuzumab plus paclitaxel or docetaxel, after adjuvant chemotherapy. For metastatic breast cancer, trastuzumab was combined with docetaxel or paclitaxel in the first line, and it was given in monotherapy in the second line. For both, a comparison of switching from intravenous to subcutaneous therapy was made. A survey was performed with 28 health maintenance organizations to map fees and sources used for reimbursement of drugs, materials and procedures. Direct medical costs were included. Time horizon was 5 years and market share of subcutaneous trastuzumab vary from 20% to 100%. Results were presented according to size of health maintenance organizations and a deterministic sensitivity analysis was conducted to analyze model robustness. Results: In 5 years, 31,589 breast cancer patients were estimated for the PHS, 284 patients for big, 30 patients for medium, and 6 patients for small HMOs. The progressive uptake of subcutaneous trastuzumab, compared with in-travenous formulation, can save up to 962,7 mBRL, 14,5 mBRL, 1,5 mBRL and 0,2 mBRL, respectively. Materials and support procedures along with medical fees were the most sensitive parameters. Con-clusion: Compared with the intravenous administration, subcutaneous trastuzumab can save up to 962,7 mBRL costs in the breast cancer treatment in the Brazilian PHS


Subject(s)
Humans , Health Care Economics and Organizations , Breast Neoplasms , Supplemental Health , Trastuzumab
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