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PURPOSE: To evaluate the efficacy and safety of lapatinib (L) and trastuzumab (T) combination in HER2-positive metastatic breast cancer (MBC) patients previously treated with T and/or L. MATERIALS AND METHODS: We conducted a retrospective, post-authorized, multicenter study including patients with HER2-positive MBC or locally advanced breast cancer (ABC) treated with the combination of L-T. Concomitant endocrine therapy, as well as brain metastasis and/or prior exposure to L, were allowed. RESULTS: One hundred and fifteen patients from 14 institutions were included. The median age was 59.8 years. The median number of prior T regimens in the advanced setting was 3 and 73 patients had received a prior L regimen. The clinical benefit rate (CBR) was 34.8% (95% CI 26.1-43.5). Among other efficacy endpoints, the overall response rate was 21.7%, and median progression-free survival (PFS) and overall survival were 3.9 and 21.6 months, respectively. Heavily pretreated and ≥ 3 metastatic organ patients showed lower CBR and PFS than patients with a low number of previous regimens and < 3 metastatic organs. Moreover, CBR did not significantly change in L-pretreated compared with L-naïve patients (31.5% versus 40.5% for L-pretreated versus L-naïve). Grade 3/4 adverse events were reported in 19 patients (16.5%). CONCLUSION: The combination of L-T is an effective and well-tolerated regimen in heavily pretreated patients and remains active among patients progressing on prior L-based therapy. Our study suggests that the L-T regimen is a safe and active chemotherapy-free option for MBC patients previously treated with T and/or L.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Lapatinib/uso terapêutico , Receptor ErbB-2/metabolismo , Trastuzumab/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Inibidores de Proteínas Quinases/uso terapêutico , Receptor ErbB-2/antagonistas & inibidores , Estudos Retrospectivos , Espanha , Resultado do TratamentoRESUMO
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RESUMO
PURPOSE: Elevated markers of host inflammation, a hallmark of cancer, have been associated with worse outcomes in several solid tumors. Here, we explore the prognostic role of the derived neutrophil-to-lymphocyte ratio (dNLR), across different tumor subtypes, in patients with early breast cancer. PATIENTS AND METHODS: This was a retrospective analysis of 1246 patients with lymph node-positive, operable early breast cancer enrolled in the GEICAM/9906 trial, a multicenter randomized phase 3 study evaluating adjuvant chemotherapy. dNLR was calculated as the ratio of neutrophils and the difference between total leukocytes and neutrophils in peripheral blood before chemotherapy. Disease-free survival (DFS) and overall survival were explored using a Cox proportional hazard analysis. RESULTS: The analysis comprised 1243 (99.8%) patients with dNLR data, with a median follow-up of 10 years. Data on intrinsic subtypes were available from 818 (66%) patients (luminal A 34%, luminal B 32%, HER2-enriched 21% and basal-like 9%). Median dNLR was 1.35 [interquartile range (IQR) 1.08-1.71]. In the whole population, dNLR was not prognostic after adjustment for clinico-pathological factors. However, dNLR ≥ 1.35 was independently associated with worse DFS in the hormone receptor-negative/HER2+ population (HR 2.86; p = 0.038) and in patients with one to three lymph node metastases (HR 1.32, p = 0.032). There was a non-significant association with worse DFS in non-luminal and in HER2-enriched tumors (HR 1.40, p = 0.085 and HR 1.53, p = 0.067). No significant interaction was observed between the treatment arm and dNLR. CONCLUSION: Elevated dNLR appears to be an adverse prognostic factor in hormone receptor-negative early breast cancer. TRIAL REGISTRATION: EudraCT: 2005-003108-12 (retrospectively registered 28/06/2005). ClinicalTrials.gov Identifier: NCT00129922 (retrospectively registered 10/08/2005). Results of this study were presented in part at the 2016 ESMO conference October 7-11, 2016, Copenhagen, Denmark (oral presentation).
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Biomarcadores Tumorais/imunologia , Neoplasias da Mama/imunologia , Contagem de Linfócitos , Neutrófilos , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biomarcadores Tumorais/sangue , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Quimioterapia Adjuvante , Ensaios Clínicos Fase III como Assunto , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Prognóstico , Modelos de Riscos Proporcionais , Estudos RetrospectivosRESUMO
INTRODUCTION: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. MATERIALS AND METHODS: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. RESULTS: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2- patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). CONCLUSIONS: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.
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Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Lobular/tratamento farmacológico , Resistencia a Medicamentos Antineoplásicos , Estradiol/análogos & derivados , Pós-Menopausa , Idoso , Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/metabolismo , Carcinoma Ductal de Mama/secundário , Carcinoma Lobular/metabolismo , Carcinoma Lobular/secundário , Estradiol/uso terapêutico , Feminino , Seguimentos , Fulvestranto , Humanos , Metástase Linfática , Pessoa de Meia-Idade , Prognóstico , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Estudos RetrospectivosRESUMO
OBJECTIVE: To determine the prevalence of psychological distress and its relationship with academic engagement (absorption, dedication and vigor), sex and degree among students from four public universities. METHOD: A non-experimental,comparative correlational, quantitative investigation without intervention. STUDY POPULATION: 1840 nursing and physical therapy students. The data collection tool used was a questionnaire. RESULTS: A 32.2% prevalence of psychological distress was found in the subjects; a correlation between vigor and psychological distress was found for all of the subjects and also for women. High absorption and dedication scores and low psychological distress scores predicted higher vigor scores. CONCLUSION: The risk of psychological distress is high, especially for women. Women seem to have a higher level of psychological distress than men. Vigor, energy and mental resilience positively influence psychological distress and can be a vehicle for better results during the learning and studying process.
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Aspirações Psicológicas , Impulso (Psicologia) , Estresse Psicológico/epidemiologia , Estudantes de Ciências da Saúde/psicologia , Feminino , Humanos , Masculino , Prevalência , Adulto JovemRESUMO
INTRODUCTION: The randomised controlled trial BCIRG001 has recently demonstrated that docetaxel in combination with doxorubicin and cyclophosphamide (TAC) has better efficacy than the standard treatment (FAC, i.e., 5-fluorouracil, doxorubicin and cyclophosphamide) in the adjuvant treatment of patients with node-positive breast cancer. The cost-effectiveness of TAC vs. FAC in the Spanish setting is analysed. PATIENTS AND METHODS: Clinical outcomes from trial BCIRG001 were combined with Spanish costs and longterm efficacy of FAC and TAC extrapolated up to 5 years by means of a Markov model. Results are shown as cost per life year gained (C/LYG) and cost per quality-adjusted life year (C/QALY). Costs and effects were discounted at a rate of 3%. RESULTS: Mean survival was 17.8 and 16.5 years for TAC and FAC, with total costs of euro14,611 and euro11,586, respectively. The results of the cost-effectiveness analysis showed that TAC achieves a C/LYG and a C/QALY of only euro2345 and euro2631, respectively. Sensitivity analysis confirmed the robustness of the results. CONCLUSIONS: Combined therapy based on docetaxel (TAC) is not only an effective option, but also presents a favourable cost-effectiveness ratio, clearly below the Spanish efficiency threshold in all the scenarios considered.
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Protocolos de Quimioterapia Combinada Antineoplásica/economia , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/economia , Fluoruracila/economia , Taxoides/economia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/mortalidade , Análise Custo-Benefício , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Docetaxel , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Feminino , Fluoruracila/efeitos adversos , Fluoruracila/uso terapêutico , Humanos , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Taxoides/administração & dosagem , Taxoides/efeitos adversosRESUMO
La hepatitis viral B continúa siendo una de las patologías hepáticas más frecuentes; en ese sentido, sólo en el continente americano se estima que hay cerca de 7 millones de personas infectadas. Esta situación se ve agravada por las condiciones socio-sanitarias de los países en desarrollo, así como por las deficiencias en los programas de prevención, tales como la vacunación universal en niños menores de un año y en poblaciones en alto riesgo. El propósito del presente trabajo fue el de inmunizar contra la hepatitis viral B a una población de niños en alto riesgo, en edades entre un 1 mes a 10 años, con una vacuna recombinante ya aprobada en Venezuela. Para tal fin, se elaboró un protocolo abierto, multicéntrico, donde se incluyeron 244 niños (138 varones y 106 hembras), aparentemente sanos, seronegativos para la hepatitis viral B (HBsAg y Core Total), no vacunados previamente contra la hepatitis viral B, provenientes de "hogares" del Instituto Nacional del Menor. A los niños se les tomó una muestra de sangre (3,0 ml) de la vena
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Humanos , Criança , Hepatite B , Pediatria , Vacinação , Vacinas Sintéticas/uso terapêutico , VenezuelaRESUMO
La estimación de la edad gestacional de un neonato es de vital importancia para establecer los riesgos postnatales. Para su cálculo, se han empleado la fecha obstétrica (última regla) y el ecosonograma, pero para el pediatra y el neonatólogo es esencial la estimación de la edad gestacional mediante el examen físico. Para ello, se han delineado varios métodos, entre ellos, el descrito por Dubowtz, Ucher, Ballard y Capurro. Este estudio trata de establecer la validez del método de Capurro, comparándolo con la fecha de última regla y el ecosonograma obstétrico. Se incluye un total de 140 neonatos con un peso promedio de 3105 (ñ395) gramos y una talla promedio de 50,01 (ñ2,88) cms. La edad materna promedio fue de 25,71 (ñ6,43) años, con un 34 por ciento de primigestas y el 64 por ciento se realizó por lo menos un ecosonograma. La edad gestacional promedio calculada por la fecha de última regla fue de 39,59 (ñ1,44) semanas, por el método postnatal de Capurro, 39,17 (ñ1,32) semanas y por ecosonografía, 38,74 (ñ1,68) semanas. Se encontró una baja correlación (r0,32), entre la fecha de la última regla y el método de Capurro, siendo aun menor, cuando se compara con la ecosonografía (r0,16). Si se calcula la diferencia promedio entre la edad gestacional por Capurro y fecha de última regla, se obtiene que es de 1,49 semanas a las 36 semanas y de 1,24 a las 37. Es de 0,46,-0,47 y 0,85 a las 38,39 y 40 semanas respectivamente, en tanto que a las 41 semanas es 2,09 semanas y de -2,20 en la semana 42. En conclusión, obtuvimos: 1) que la edad gestacional calculada por el método de Capurro no se correlaciona con la fecha última regla ni con el ecosonograma obstétrico y sugerimos, ademas, que esta falta de correlación se puede deber a la validez externa del método y 2) que la estimación de la edad gestacional por el método de Capurro tiende a sobreevaluar la edad de los prematuros y subevaluar la de los postérmino
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Humanos , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Idade Gestacional , Menstruação/fisiologia , Ciclo Menstrual/fisiologia , Ultrassonografia Pré-Natal/métodosRESUMO
En este trabajo, después de hacer algunas consideraciones teórico-metodológicas en ralación com la onda P300, son estudiados 30 pacientes con epilepsia: 15 con psicosis crónica interictal y 15 sin psicosis asociada, procedentes de la consulta externa de epilepsia, que funciona en el Departamento de Tratamientos Especializados (DTE). El diagnóstico de epilepsia fue formulado conforme con los criterios de la Liga Internacional contra la Epilepsia (ILAE), y el de psicosis interictal según los conceptos de trimble y del Manuel de Diagnóstico y Estadística (DSM-III-R). A los pacientes incluidos en la muestra, e les hizo el registro de la onda P300 por estimulación visual en un equipo MEDICID-)3M, los resultados fueron comparados estadísticamente mediante el uso de métodos paramétricos (análisis de varianza, t - Student) y no paramétricos (Mann Whitney, Kruskal Wallis y Wald Waldfowitz). Observamos que los pacientes con psicosis crónicas interictal presentaban latencias más prolongadas de la onda P300 y la amplitud promedio se encontró disminuida en los dos grupos
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Epilepsia/diagnóstico , Estimulação Luminosa , Transtornos Psicóticos/diagnósticoRESUMO
En este trabajo, despues de hacer algunas consideraciones teorico-metodologicas en relacion con la onda P300, son estudiados 30 pacientes con epilepsia: 15 con psicosis cronica interictal y 15 sin psicosis asociada, procedentes de la consulta externa de epilepsia, que funciona en el Departamento de Tratamientos Especializados (DTE). El diagnostico de epilepsia fue formulado conforme con los criterios de la Liga Internacional contra la Epilepsia (ILAE), y el de psicosis interictal segun los conceptos de Trimble y del Manuel de Diagnostico y Estadistica (DSM-III-R). A los pacientes incluidos en la nuestra, se les hizo el registro de la onda P300 por estimulacion visual en un equipo MEDICID-03M, los resultados fueron comparados estadisticamente mediante el uso de metodos parametricos (analise de varianza, t - Student) y no parametricos (Mam Whitney Kruskal Wallis y Wald Waldfowitz). Observamos que los pacientes con psicosis cronicas interictal presentaban latencias mas prolongadas de la P300 y la amplitud promedio se encontro disminuida en los dos grupos.
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Estimulação Luminosa , Epilepsia , Diagnóstico , Epilepsia , Transtornos Psicóticos , DiagnósticoRESUMO
A brief exposition of the elements that support the importance of the psychiatric chronic patient rehabilitation all over the world is done. The main elements of the model of psychiatric rehabilitation developed by the Havana Psychiatric Hospital are presented.