ABSTRACT
Introducción Actualmente se dispone de nuevos medicamentos que aumentan la supervivencia en pacientes con cáncer de próstata resistente a la castración. Entre ellos están la Enzalutamida y la Abiraterona. Actualmente no se dispone de experimentos clínicos comparativos. Este estudio tiene como objetivo identificar las diferencias entre la Enzalutamida y la Abiraterona, a través de un modelo de comparación indirecta de tratamientos en pacientes con cáncer de próstata metastásico resistente a la castración. Materiales y Métodos Se realizó una búsqueda sistemática de la literatura incluyendo ensayos clínicos aleatorizados, en pacientes con cáncer de próstata resistente a la castración que recibieron manejo con Enzalutamida y Abiraterona; tomando como desenlace la supervivencia global y libre de progresión radiológica. Se realizó una comparación de la información y un modelo de Bucher para datos indirectos. Resultados Se incluyeron 2 experimentos clínicos fase 3 de manejo pre quimioterapia y 2 en manejo postquimioterapia. Se involucraron 1418 pacientes en el grupo de estudio prequimioterapia y 1596 en el grupo de estudio postquimioterapia. Al comparar la Enzalutamida versus Abiraterona, no se encontraron diferencias estadísticamente significativas. En la prequimioterapia, la supervivencia global con HR 0,87 (95%IC 0,701,09) (p = 0,94), supervivencia libre de progresion radiológica con HR 0,35 (95% IC 0,280,44) (p = 0,81) y en postquimioterapia, supervivencia global con HR 0,85 (95% IC 0,671,06) (p = 0,82) y supervivencia libre de progresión radiológica con HR 0,60 (95% IC 0,490,74) (p = 0,82). Conclusiones No existe una diferencia estadísticamente significativa en la supervivencia global y libre de progresión radiológica entre los dos medicamentos.
Introduction and Objective From translational medicine, development of new drugs that increase survival in patients with castration-resistant prostate cancer is obtained. Among these are abiraterone and Enzalutamide, with different mechanisms of action, but with an aplication in the same clinical stage. Currently, there are no comparative clinical trials between these drugs. This study aims to identify the differences between Enzalutamide and Abiraterone through a model of indirect comparison of treatment in patients with castration resistant prostate cancer in pre and post chemotherapy stages. Materials and Methods A systematic search of the literature was conducted including randomized phase 3 clinical trials in patients with castration-resistant prostate cancer receiving management with Enzalutamide and Abiraterone compared with placebo or corticoid in pre and post chemotherapy stages, taking as outcome overall survival and radiologic progression-free survival. In addition to the demographic analysis, a comparison of information and a modified model of Bucher for indirect data was performed, with the statistical program Stata version 12 and ICT CADTH program. Results 2 Phase III clinical trials were included in the pre chemotherapy stage and 2 in postchemotherapy stage. 1418 patients in the study group prechemotherapy and 1596 in the post- chemotherapy group study were involved. Control groups involved 1387 and 796 cases respectively. When comparing Enzalutamide vs Abiraterone in the pre chemotherapy group, no statistically significant difference was noted in overall survival HR 0.87 (95% CI 0.70 - 1.09) (p = 0.94) and radiologic progression-free survival HR 0.35 (95 % CI 0.28 to 0.44) (p = 0.81). In post-chemotherapy group, overall survival HR 0.85 (95 % CI 0.67 - 1.06) (p = 0.82) and radiologic progression-free survival HR 0.60 (95 % CI 0.49 to 0.74 ) (p = 0.82) no statistically significant difference was noted. Conclusions There is no statistically significant difference in overall survival and radiologic progression-free survival between the two drugs. The indirect comparison of treatments offers a valid alternative in the absence of direct comparative clinical experiences.
Subject(s)
Humans , Male , Prostatic Neoplasms , Pharmaceutical Preparations , Castration , Drug Therapy , Therapeutics , Control Groups , Adrenal Cortex Hormones , Information Technology , Survivorship , Progression-Free SurvivalABSTRACT
OBJECTIVE: To describe the degree of introduction of new technologies in the medication use process in pharmacy services in Spain. METHOD: A descriptive study via a survey into the degree of introduction of computer systems for: management, computerized physician order entry (CPOE), automated unit dose drug dispensing, preparation of parenteral nutrition solutions, recording drug administration, pharmaceutical care and foreseen improvements. The survey was sent by electronic mail to the heads of the pharmacy services of 207 hospitals throughout Spain. RESULTS: Response index: 82 hospitals (38.6%). 29 hospitals (36.7%) have a modular management system, 24 (30.4%) an integrated one and 34 (44.9%) a modular-integrated one. CPOE is utilised in 17 (22.4%). According to the size of the hospital, between 17.9 and 26.7% of unit dose dispensing is done online with a management software; between 5.1 and 33.3% of unit dose dispensing is automated. Automation of unit dose dispensing centred in the pharmacy service varies between 10 and 33.3%. Between 13.2 and 35.7% of automated in-ward dispensing systems are utilised. Administration records are kept manually on a computerised sheet at 23 (31.5%) of the hospitals; at 4 (5.4%) on CPOE and 7 (9.5%) online on the integral management programme and 4 (5.4%) on specific nursing softwares. Sixty-three per cent foresee the implementation of improvements in the short to medium term. CONCLUSIONS: The introduction of new technologies is being developed in Spain aiming to improve the safety and management of drugs, and there is a trend towards increasing their deployment in the near future. It is hoped that their fomentation could help to bring about process reengineering within pharmacy services in order to increase the time available for devotion to pharmaceutical care.
