ABSTRACT
Objetivos: Realizar una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con cáncer de próstata no metastásico resistente a la castración (CPRCnm) con alto riesgo de progresión a enfermedad metastásica. Material y métodos: Tras realizar una búsqueda bibliográfica se llevó a cabo una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica siguiendo el método de Bucher et al. Como variables se seleccionaron la supervivencia libre de metástasis (SLM) y la tasa de respuesta al PSA (TRPSA). Resultados: No se observaron diferencias estadísticamente significativas para las variables evaluadas entre enzalutamida y apalutamida. Para la comparación enzalutamida + TDA vs. Apalutamida + TDA: SLM obtuvo un HR (IC95%) = 1,036 (0,781-1,373) y TRPSA obtuvo un RR (IC95%) = 0,81 (0,339-1,938). Conclusiones: La comparación indirecta ajustada realizada en este estudio muestra que no existen diferencias estadísticamente significativas en términos de eficacia, a nivel de SLM y TRPSA, entre enzalutamida + TDA y apalutamida + TDA en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica. Sin embargo, se debería diseñar un ensayo independiente en el que se comparasen directamente ambos fármacos para confirmar estos resultados
Objectives: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. Material and methods: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). Results: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide + ADT vs. apalutamide + ADT: MFS a HR (95% CI) = 1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI) = 0.81 (0.339-1.938) was obtained. Conclusions: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide + ADT and apalutamide + ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required
Subject(s)
Humans , Male , Prostatic Neoplasms, Castration-Resistant/drug therapy , Androgen Antagonists/administration & dosage , Disease-Free Survival , Clinical Trials as Topic , Time FactorsABSTRACT
OBJECTIVES: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. MATERIAL AND METHODS: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). RESULTS: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide+ADT vs. apalutamide+ADT: MFS a HR (95% CI)=1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI)=0.81 (0.339-1.938) was obtained. CONCLUSIONS: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide+ADT and apalutamide+ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required.
Subject(s)
Phenylthiohydantoin/analogs & derivatives , Prostatic Neoplasms, Castration-Resistant/drug therapy , Thiohydantoins/therapeutic use , Aged , Benzamides , Disease Progression , Humans , Male , Neoplasm Metastasis , Nitriles , Phenylthiohydantoin/therapeutic use , Prostatic Neoplasms, Castration-Resistant/pathology , Risk Assessment , Treatment OutcomeABSTRACT
WHAT IS KNOWN AND OBJECTIVE: Melanoma causes the majority of skin cancer-related deaths. The outcome of melanoma depends on its stage at diagnosis. Currently, for patients with advanced melanoma, two MEK inhibitors (trametinib and cobimetinib) have been authorized by the European Medicines Agency. The main objective of this study was to compare the relative efficacy of trametinib-dabrafenib and cobimetinib-vemurafenib in patients with advanced melanoma through adjusted indirect treatment comparisons (ITCs). METHODS: A search was made up to the 3rd of November 2015. Databases consulted were MEDLINE, the Cochrane Library and the Centre for Reviews and Dissemination. Randomized controlled trials (RCTs) which compared the efficacy of trametinib-dabrafenib or cobimetinib-vemurafenib versus a common treatment comparator, in which outcomes of overall survival, progression-free survival (PFS) and overall response rate (ORR) were considered. ITCs were carried out using the method proposed by Bucher et al. RESULTS AND DISCUSSION: Two RCTs were included (one for each drugs combination). The results of the adjusted ITCs showed that there were no statistically significant differences between the two combinations in terms of PFS and ORR. WHAT IS NEW AND CONCLUSION: The ITCs indicate no difference in efficacy between both treatments. However, there should be an independent, head-to-head trial of both combinations to confirm the results.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Melanoma/drug therapy , Skin Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/pharmacology , Azetidines/administration & dosage , Disease-Free Survival , Humans , Imidazoles/administration & dosage , Indoles/administration & dosage , Melanoma/pathology , Neoplasm Staging , Oximes/administration & dosage , Piperidines/administration & dosage , Pyridones/administration & dosage , Pyrimidinones/administration & dosage , Randomized Controlled Trials as Topic , Skin Neoplasms/pathology , Sulfonamides/administration & dosage , Survival Rate , Treatment Outcome , VemurafenibABSTRACT
Objective Measure the degree of compliance of prescriptions given to Chronic Obstructive Pulmonary Disorder (COPD) patients upon hospital discharge by comparing them to international recommendations. Identify factors that influence the degree of compliance. Evaluate the effect of that degree of compliance on the number of COPD exacerbations. Method Retrospective observational study. We selected all episodes identified as COPD in a tertiary hospital during 2006. By consulting the clinical history database, we accessed the hospital discharge report and calculated the treatment's degree of proximity to the recommendations issued in the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For each episode, we calculated the number of exacerbations in the six following months. Descriptive, bivariate statistical analysis. Results We obtained 365 episodes. The mean degree of compliance was 82% (SD=15.9). The patient's age and the severity of the disease did not influence the degree of compliance. We observed an inverse correlation between the hospital stay and the degree of compliance (p=0.026). Discharge reports issued by the Pneumonology Department had a significantly higher degree of compliance (p<0.001). No statistically significant relationship was found between the degree of compliance and the number of exacerbations. Conclusions The degree of compliance is high according to the GOLD recommendations. The Pneumology Department had the highest degree of compliance, and a higher degree of compliance was related to a shorter hospital stay. The treatment compliance had no effect on the number of exacerbations of the disease (AU)
Objetivo Cuantificar el grado de adecuación de la prescripción al alta hospitalaria a las recomendaciones internacionales en pacientes con EPOC. Identificar los factores que influyen sobre el grado de adecuación. Evaluar la influencia del grado de adecuación sobre el número de reagudizaciones de la EPOC. Método Estudio observacional retrospectivo. Se seleccionaron todos los episodios del año 2006 con diagnóstico principal codificado como EPOC en un hospital terciario. A través de la consulta de la historia clínica digital, se accedió al informe de alta hospitalaria y se calculó el grado de adecuación a las recomendaciones de Global Initiative for Chronic Obstructive Lung Disease; se contabilizó para cada episodio el número de reagudizaciones en los 6 meses posteriores. Análisis estadístico descriptivo y bivariante. Resultados Se obtuvieron 365 episodios. El grado de adecuación medio fue del 82% (SD=15,9). La edad del paciente y la gravedad de la enfermedad no influyeron sobre el grado de adecuación. Se observó relación inversa entre estancia hospitalaria y grado de adecuación (p=0,026). Los informes de alta hospitalaria a cargo del servicio de neumología presentaron significativamente mayor grado de adecuación (p<0,001). No se halló relación estadísticamente significativa entre grado de adecuación y número de exacerbaciones. Conclusiones El grado de adecuación a las recomendaciones de Global Initiative for Chronic Obstructive Lung Disease es elevado. Se detecta mayor adecuación en el servicio de neumología y un mayor grado de adecuación se relaciona con una menor estancia hospitalaria. El grado de adecuación no influye sobre el número de reagudizaciones de la enfermedad (AU)
Subject(s)
Humans , Guideline Adherence/statistics & numerical data , Patient Discharge , Pulmonary Disease, Chronic Obstructive/drug therapy , Disease Progression , Emergency Service, Hospital , Hospital Departments , Hospital Records , Practice Guidelines as Topic , Pulmonary Disease, Chronic Obstructive , Retrospective Studies , SpainABSTRACT
OBJECTIVE: Measure the degree of compliance of prescriptions given to Chronic Obstructive Pulmonary Disorder (COPD) patients upon hospital discharge by comparing them to international recommendations. Identify factors that influence the degree of compliance. Evaluate the effect of that degree of compliance on the number of COPD exacerbations. METHOD: Retrospective observational study. We selected all episodes identified as COPD in a tertiary hospital during 2006. By consulting the clinical history database, we accessed the hospital discharge report and calculated the treatment's degree of proximity to the recommendations issued in the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For each episode, we calculated the number of exacerbations in the six following months. Descriptive, bivariate statistical analysis. RESULTS: We obtained 365 episodes. The mean degree of compliance was 82% (SD=15.9). The patient's age and the severity of the disease did not influence the degree of compliance. We observed an inverse correlation between the hospital stay and the degree of compliance (p=0.026). Discharge reports issued by the Pneumonology Department had a significantly higher degree of compliance (p<0.001). No statistically significant relationship was found between the degree of compliance and the number of exacerbations. CONCLUSIONS: The degree of compliance is high according to the GOLD recommendations. The Pneumology Department had the highest degree of compliance, and a higher degree of compliance was related to a shorter hospital stay. The treatment compliance had no effect on the number of exacerbations of the disease.
