ABSTRACT
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Subject(s)
Humans , Female , Middle Aged , Peripheral Vascular Diseases/drug therapy , Skin Ulcer/drug therapy , Biopsy , Anticoagulants/therapeutic use , Wound Healing , Skin Ulcer/complications , Microcirculation , Lower Extremity/injuries , Rivaroxaban/therapeutic useABSTRACT
Purpose. To evaluate the effectiveness of safeguards introduced in the process of using cytostatic agents for increasing the safety of oncology patients. Methods. Prospective hospital study conducted in two stages, before and after the implementation of safeguards: staff training, standardized procedures, computerized prescription, pharmaceutical validation, implementation of bar codes, and a new manual on drug interactions. Medication errors (MEs) were actively recorded during the process of administering chemotherapy in the Medical Oncology Department. The study classified MEs by the stage of the medication process in which they occurred and assessed their severity. Results. 500 patients, 250 before implementing safeguards and 250 afterward, were included in this study . Out of all patients included before, 43.1% had at least 1 error, compared to 27% of those included later. The number of MEs detected before and after was 144 vs. 95: 125 vs. 55 prescription errors, 2 vs. 5 validation errors, 14 vs. 4 preparation errors, 3 vs. 1 dispensation errors and 0 vs. 30 administration errors. The number of MEs that reached the patient before and after safeguard implementation was 16.7% vs. 6.3%. After the safeguards were introduced, all MEs that could have caused harm or required monitoring of some kind were prevented. Conclusions. Implementing safeguards in the hospitals cytostatic treatment cycle is useful for preventing MEs. Computerized prescription, pharmaceutical validation, and the creation/dissemination of proper work procedures are effective barriers that keep MEs from reaching the patient. Administering chemotherapy with a bar-code system facilitates detection error detection at this stage of the cycle and prevents them from reaching the patient (AU)
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Subject(s)
Humans , Patient Safety , Cytostatic Agents/administration & dosage , Cytostatic Agents/therapeutic use , Medication Errors/adverse effects , Medication Errors/prevention & control , Drug-Related Side Effects and Adverse Reactions , Antineoplastic Agents/adverse effects , Evaluation of the Efficacy-Effectiveness of Interventions , Prospective Studies , Clinical Protocols , Drug Therapy/methodsABSTRACT
Objetivo: Evaluar la respuesta a cetuximab en términos detiempo hasta progresión y supervivencia global en pacientes concáncer colorrectal (CCR) con determinación del receptor del factorde crecimiento epidérmico (EGFR) indetectable.Método: Se seleccionaron nueve pacientes con cetuximabEGFR negativo, confirmado mediante estudio inmunohistoquímico.Variables recogidas: datos demográficos, diagnóstico, tratamientosprevios, tiempo desde la primera metástasis hasta iniciocon cetuximab, reacciones adversas y marcadores tumorales. Larespuesta se monitorizó mediante marcadores tumorales y progresiónde la enfermedad. La evaluación de la calidad de vidamediante estado funcional de Karnofsky (KPS) o Eastern CooperativeOncology Group (ECOG).Resultados: 22% hombres (2/9) con una mediana de edadde 48 años (rango 31-63). La mediana de tiempo desde el diagnósticode enfermedad metastásica hasta inicio de tratamientocon cetuximab fue 19 meses (rango 12-48). Todos los pacienteshabían fracasado a un esquema que incluyó irinotecán, el 77,77%(7/9) también a uno con oxaliplatino. La mediana de ciclos concetuximab fue de 14 (rango 6-32). El principal efecto adverso fuela aparición de una erupción cutánea acneiforme presente en el100% de los casos. La mediana de tiempo hasta progresión fue 7(rango 3-16) meses y la supervivencia global 10,2 meses (rango 4-24). Los resultados en calidad de vida mostraron KPS entre 80-100% y ECOG < 2. Los resultados obtenidos en nuestro estudioen supervivencia global y tiempo hasta progresión son superioresa los del estudio pivotal, 10,2 vs. 8,6 meses y 7 vs. 4,1 meses respectivamente.Conclusiones: Con los resultados obtenidos se puede cuestionarla utilidad de la determinación de la expresión del EGFR, almenos mediante la técnica de inmuhistoquímica, como predictorde respuesta al tratamiento con cetuximab. Esto sugiere que laselección de los pacientes mediante la determinación rutinaria deeste receptor pudiera ser inapropiada, ya que excluye a pacientesque potencialmente pueden beneficiarse del tratamiento. No obstante,se requieren más ensayos clínicos en este ámbito que corroborenestas conclusiones
Objective: To evaluate the response to cetuximab, in terms oftime passed until disease progression and overall survival, inpatients with colorectal cancer (CRC) in which the epidermalgrowth factor receptor (EGFR) is undetectable.Method: Nine EGFR-negative patients (confirmed by animmunohistochemistry study), who were being treated with cetuximab,were selected. Variables collected: demographic data, diagnosis,previous treatments, time since first metastasis to start oftreatment with cetuximab, adverse events and tumour markers.The response was monitored using tumour markers and diseaseprogression. Well-being was assessed using the Karnofsky performancestatus (KPS) or that of the Eastern Cooperative OncologyGroup (ECOG).Results: 22% men (2/9) with a median age of 48 (31-63).The median time from being diagnosed with the metastatic diseaseto the start of treatment with cetuximab was 19 months (12-48). All patients had failed an irinotecan-based regime, 77.77%(7/9) had also failed one which included oxaliplatin. The mediannumber of cycles with cetuximab was 14 (6-32). The mainadverse event was the appearance of an acneiform rash in 100%of the cases. The median time until disease progression was 7months (3-16) and 10.2 months (4-24) for overall survival. Theresults for well-being showed a KPS of between 80-100% and anECOG of < 2. The results obtained in the present study for overallsurvival and time until disease progression are higher than thosein the pivotal study (10.2 compared to 8.6 months and 7 comparedto 4.1 months respectively). Conclusions: According to the results obtained, the use ofassessing the EGFR expression (by the immunohistochemistrytechnique at least), as a means of predicting response to treatmentwith cetuximab may be questioned. This suggests that selectingpatients using the routine assessment of this receptor is inappropriate,since it excludes patients who may potentially benefit fromthe treatment. However, more clinical trials are required in thisarea in order to confirm these conclusions
