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1.
Farm. hosp ; 42(1): 5-9, ene.-feb. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-169906

RESUMO

Objetivo: Analizar la efectividad y seguridad de los antineoplásicos orales (ANEO) autorizados en situaciones especiales en un hospital de tercer nivel y comparar los resultados obtenidos con los de la evidencia disponible empleada para autorizar el uso de estos fármacos. Método: Estudio descriptivo observacional y retrospectivo. Se incluyeron todos los pacientes adultos que iniciaron tratamiento con ANEO en situaciones especiales durante el año 2016. Se recogieron variables demográficas, relacionadas con el tratamiento, y clínicas (supervivencia global (SG), supervivencia libre de progresión (SLP)). Se recogieron reacciones adversas e interacciones detectadas. Se realizó una comparación no ajustada entre los resultados de la evidencia disponible y los de los pacientes del estudio. Resultados: Treinta y cuatro pacientes recibieron tratamiento, el 50% eran hombres, la mediana de edad fue de 58 años (38-80), y presentaron ECOG 1 el 64,7%. La mayoría de los pacientes tratados presentaban diagnóstico de cáncer colorrectal avanzado, tratados con trifluridina-tipiracil, seguidos de palbociclib en cáncer de mama, obteniendo resultados similares a los de la evidencia. La mediana de SLP fue de 2,8 meses (IC 95% 0,8-4,8) y la SG de 8 meses (IC 95% 3,4-12,5) para todos los pacientes. El 26% de los pacientes requirieron una reducción de la dosis debido a la toxicidad del tratamiento. Se encontraron 13 interacciones, que afectaron a 15 pacientes; solo dos de categoría X. Conclusiones: La efectividad de los ANEO en situaciones especiales en nuestro centro es similar al de la evidencia disponible. El impacto en la supervivencia es bajo y los efectos adversos son comunes (AU)


Objective: To analyse the effectiveness and safety of oral antineoplastic drugs (ANEOs) that are authorized in special situations in a third-level hospital and to compare the results obtained with the clinical evidence used for this authorization. Method: Descriptive observational and retrospective study. We included all adult patients who started treatment with ANEO in special situations during the year 2016. We collected demographic, treatment-related and clinical variables (overall survival (OS), progression-free survival (PFS)). Adverse reactions and detected interactions were collected. An unadjusted comparison was made between the results of the available evidence and those of the study patients. Results: 34 patients were treated, 50% were men, the median age was 58 years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated patients were diagnosed with advanced colorectal cancer, treated with trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8-4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients required dose reduction because of treatment toxicity. We found 13 interactions, which affected 15 patients, only two of category X. Conclusions: The effectiveness of ANEO in special situations in our center is similar to that of available evidence. The impact on survival is low and adverse effects are common (AU)


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Antineoplásicos/uso terapêutico , Avaliação de Eficácia-Efetividade de Intervenções , Neoplasias Colorretais/tratamento farmacológico , Trifluridina/uso terapêutico , Antineoplásicos/efeitos adversos , Estudos Retrospectivos
2.
Clin. transl. oncol. (Print) ; 19(2): 227-235, feb. 2017. tab, ilus, graf
Artigo em Inglês | IBECS | ID: ibc-159456

RESUMO

Purpose. TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer (mCRC) refractory or intolerant to standard therapies were evaluated in the phase 3 RECOURSE trial. Results of RECOURSE demonstrated significant improvement in overall survival (OS) and progression-free survival (PFS) with TAS-102 versus placebo [hazard ratio (HR) = 0.68 and 0.48 for OS and PFS, respectively; both P < 0.001]. The current analysis evaluates efficacy and safety of TAS-102 in the RECOURSE Spanish subgroup. Methods. Primary and key secondary endpoints were evaluated in a post hoc analysis of the RECOURSE Spanish subgroup, using univariate and multivariate analyses. Safety and tolerability were reported with descriptive statistics. Results. The RECOURSE Spanish subgroup included 112 patients (mean age 61 years, 62 % male). Median OS was 6.8 months in the TAS-102 group (n = 80) versus 4.6 months in the placebo group (n = 32) [HR = 0.47; 95 % confidence interval (CI): 0.28-0.78; P = 0.0032). Median PFS was 2.0 months in the TAS-102 group and 1.7 months in the placebo group (HR = 0.47; 95 % CI: 0.30-0.74; P = 0.001). Eighty (100 %) TAS-102 versus 31 (96.9 %) placebo patients had adverse events (AEs). The most common drug-related ≥Grade 3 AE was neutropenia (40 % TAS-102 versus 0 % placebo). There was 1 (1.3 %) case of febrile neutropenia in the TAS-102 group versus none in the placebo group. Conclusions. In the RECOURSE Spanish subgroup, TAS-102 was associated with significantly improved OS and PFS versus placebo, consistent with the overall RECOURSE population. No new safety signals were identified (AU)


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Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Resultado do Tratamento , Trifluridina/uso terapêutico , Placebos/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Metástase Neoplásica/tratamento farmacológico , Metástase Neoplásica/patologia , Metástase Neoplásica , Ensaios Clínicos Fase III como Assunto/instrumentação , Ensaios Clínicos Fase III como Assunto/métodos , Timidina Fosforilase/uso terapêutico , Avaliação de Eficácia-Efetividade de Intervenções , Declaração de Helsinki
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