Efectividad y seguridad de la eribulina en la vida real en el tratamiento de cáncer de mama metastásico en un hospital general / Efficacy and safety of eribulin in real life in the treatment of metastasic breast cancer in a Spanish general center

Objetivo: analizar la eficacia y la seguridad de la eribulina en la vida real en el tratamiento del cáncer de mama metastásico refractario en un hospital terciario. Métodos: estudio observacional y retrospectivo que incluyó a pacientes con cáncer de mama metastásico (CMm) quienes recibieron eribulina entre el 01/04/2014 y el 31/10/2020. Se analizaron variables demográficas (sexo/edad), del tratamiento quimioterápico (duración, dosis, regímenes previos) y clínicas (sobreexpresión HER2, receptores hormonales, supervivencia libre de progresión [SLP], supervivencia global [SG], toxicidad). La progresión se analizó siguiendo los criterios de RECISTv1.1 y la toxicidad según CTCAE.5.0. Se realizó un análisis estadístico mediante Log-Rank test y regresión de Cox. Resultados: se incluyeron 38 pacientes de 57,6 años (± 11,85) con ECOG PS ≥ 2 (84,2%), sin sobreexpresión HER2 (86,8%) y expresión de receptores hormonales (84,2%). Todas habían fracasado a 2 líneas quimioterápicas. La duración del tratamiento fue de 4,35 meses (2,44–6). El 79% sufrieron retraso en la administración y 60% reducción de la dosis. Se presentaron un 15,8% de eventos de grado 3 y 10,5% grado 4. Fallecieron 32 pacientes con mediana SG 12,4 meses (8,3-16,5) y 37 progresaron con mediana SLP 6 meses (4,85-7,16). Se observaron diferencias significativas para SG en el subgrupo con hormonoterapia previa (tipos luminal A y B) (13,8 meses [9,9–17,6]; HR = 0,34 IC 95% [0,12–0-98]; p = 0,045 frente a 6,5 meses [6,1-6,9]. SLP superior y significativa en el subgrupo con ECOG PS > 2 (6,5 meses [3,65-9,34]; HR = 0,35 IC 95% [00,16-0,75]; p = 0,038 frente a 3,73 [0,09-7,38]). Conclusiones: la eficacia de la eribulina en nuestra práctica asistencial habitual es similar a la obtenida en ensayos clínicos, observándose una mayor SG en las pacientes pretratadas con hormonoterapia y mayor SLP en las pacientes ECOG PS > 2, con menor incidencia de toxicidades grado 3–4. (AU)

Objective: To assess efficacy (progression-free survival (PFS) and overall survival (OS)) and safety of eribulin in real clinical practice. Methods: Observational and retrospective study. Patients with metastatic breast cancer (mBC) treated with eribulin between 01/04/2014 and 31/10/2020 were included. Age, sex, ECOG performance status, HER-2, hormone receptor status, previous regimens for metastatic disease, previous ratio/hormone/surgical therapy, duration of treatment, toxicity and time to progression or death, were collected. Progression was evaluated by RECISTv1.1 criteria and toxicity by CTCAE.5.0 criteria. Statistical analysis was conducted by Log-Rank's test and Cox's Regression. Results: 38 patients were included, median age 57,6 years (±11,85), ECOG PS ≥ 2 (84,2%), negative HER2 overexpression (86,8%), hormone receptors expression (84,2%). All patients had already failed 2 chemotherapy regimens. Median duration was 4,35 months (IQR:2,44–6) and median cycles was 6 (IQR:4–8). Delays or reductions were 79% and 60,5%, respectively. Treatment was generally well tolerated, with 15.8% grade 3 and 10.5% grade 4 toxicities. 32 patients deceased, median OS 12,4 months (8,3-16,5). 37 had progressed, median PFS 6 moths (4,85-7,16). Log-Rank's test showed statistically significant difference in OS in patients with previous hormone therapy confirmed in Cox's regression [median 13,8 months (9.9–17.6); HR = 0,34 CI95%(0,12-0,98); p = 0,045 vs 6,5 months (6,1-6,9)]. ECOG PS > 2 showed better PFS in Log-Rank's Test and Cox's Regression [6,5 months (3,65-9,34); HR:0,35 CI95%(0,16-0,75); p = 0.038 vs 3,73 (0,09-7,38)]. Conclusions: Efficacy of eribulin in our real practice is similar to data from clinical essays observing statistically significant more OS in patients with previous hormone therapy and more PFS in ECOG's PS >2 subgroup and less incidence of grade 3/4-toxicity. (AU)

Regulación actual de los productos sanitarios: ¿es suficiente? / Current medical device regulation: Is that enough?

No disponible

¿Podemos hablar de la existencia de ‘productos sanitarios peligrosos’? / Can we talk about the existence of ‘hazardous medical devices’?

No disponible

Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios / Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS (AU)

Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS (AU)

[Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance]. / Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios.

OBJECTIVE: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. METHOD: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. RESULTS: SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. CONCLUSIONS: SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS.

Seguridad de un catéter multiperforado implantado en la herida quirúrgica para la infusión continua de anestésicos locales en la analgesia post-operatoria / Safety of a multiperforated catheter implanted in the surgical wound for the continuous infusion of local anaesthetics in post-operative analgesia

Objetivo Evaluar la incidencia de infección del sitio quirúrgico en pacientes en los que se implanta un catéter multiperforado para infusión continua de un anestésico local a este nivel con intención analgésica. Pacientes y método Estudio observacional, descriptivo, y prospectivo, de un mes de duración. Se incluyeron 50 pacientes sometidos a laparotomía programada en los que se implantó el catéter pre-peritoneal multiperforado con intención analgésica (Painfusor®. Baxter). Se excluyeron del estudio los pacientes con una incisión quirúrgica inferior a 15cm y/o ASA>III. Resultados El catéter se retiró en todos los pacientes a las 48 horas. El 6% de los pacientes a los que se les implantó el catéter presentó una infección del sitio quirúrgico, con una incidencia similar a la del centro para cirugías limpias-contaminadas (5,5%; IC95%: 3,4-8,7%). En dos pacientes se observó colonización del catéter, presentando solo uno infección del sitio quirúrgico. Conclusiones La utilización del catéter en posición pre-peritoneal para analgesia post-quirúrgica no incrementa el riesgo de infección del sitio quirúrgico (AU)

Objective To evaluate the incidence of infection at the surgical site in patients who have a multiperforated catheter implant for continuous infusion of a local anaesthetic as a local analgesic. Patients and method An observational, descriptive and prospective study, of one month duration. It included 50 patients subjected to selective laparotomy in whom a multiperforated pre-peritoneal catheter was implanted for analgesia purposes (Painfusor®. Baxter). Patients with a surgical incision of less than 15cm and/or ASA>III, were excluded from the study. Results The catheter was removed from all patients at 48hours. An infection at the surgical site was present in 6% of the patients who had the catheter implanted, which was similar to the incidence in clean-contaminated surgery (5.5%; 95% CI: 3.4-8.7%). Colonisation of the catheter was observed in two patients, causing only one infection of the surgical site. Conclusions The use of an in-situ pre-peritoneal catheter for post-surgical anaesthesia does not increase the risk of surgical site infection (AU)

[Safety of a multiperforated catheter implanted in the surgical wound for the continuous infusion of local anaesthetics in post-operative analgesia]. / Seguridad de un catéter multiperforado implantado en la herida quirúrgica para la infusión continua de anestésicos locales en la analgesia post-operatoria.

OBJECTIVE: To evaluate the incidence of infection at the surgical site in patients who have a multiperforated catheter implant for continuous infusion of a local anaesthetic as a local analgesic. PATIENTS AND METHOD: An observational, descriptive and prospective study, of one month duration. It included 50 patients subjected to selective laparotomy in whom a multiperforated pre-peritoneal catheter was implanted for analgesia purposes (Painfusor®. Baxter). Patients with a surgical incision of less than 15 cm and/or ASA>III, were excluded from the study. RESULTS: The catheter was removed from all patients at 48 hours. An infection at the surgical site was present in 6% of the patients who had the catheter implanted, which was similar to the incidence in clean-contaminated surgery (5.5%; 95% CI: 3.4-8.7%). Colonisation of the catheter was observed in two patients, causing only one infection of the surgical site. CONCLUSIONS: The use of an in-situ pre-peritoneal catheter for post-surgical anaesthesia does not increase the risk of surgical site infection.

[Effectiveness of peginterferon alpha-2a or -2b plus ribavirin in naïve patients with hepatitis C infection]. / Efectividad del tratamiento de la hepatitis C con peginterferón alfa (2a o 2b) más ribavirina en pacientes naïve.

INTRODUCTION: Treatment of hepatitis C is based on the combination of peginterferon alfa-2a or -2b plus ribavirin; the more effective peginterferon for this purpose has not been established. The aim of this study is to compare the effectiveness of hepatitis C treatment according to the type of peginterferon used. METHODS: A prospective cohort study was performed from November 2002 to May 2004, with up to 12 months of follow-up in all patients after completion of treatment. The study included naïve monoinfected patients, divided into two groups: Group A: peginterferon alfa-2a plus ribavirin and Group B: peginterferon alfa-2b plus ribavirin. The main variables studied were plasma glutamate pyruvate transferase levels (biochemical response), viral load (virologic response), and treatment effectiveness (biochemical and virologic response). RESULTS: A total of 202 patients were studied (Group A: 87; Group B: 115), there were no significant differences in baseline characteristics between the two groups. Sustained biochemical response: 75.8% vs. 76.2% (P = .908); Sustained virological response: 71.3% vs. 64.3% (P = .293); Effectiveness of treatment: 64.2% vs. 60.87% (P = .628). CONCLUSION: No differences in the sustained virological or biochemical response were found between groups receiving peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin, suggesting that the two types of peginterferon alfa are similarly effective for treating hepatitis C in monoinfected patients.

Efectividad del tratamiento de la hepatitis C con peginterferón alfa (2a o 2b) más ribavirina en pacientes naïve / Effectiveness of peginterferon alpha-2a or -2b plus ribavirin in naïve patients with hepatitis C infection

Introducción. El tratamiento de la hepatitis C se basa en la combinación de peginterferón (PEG-INF) alfa (2a o 2b) más ribavirina, sin establecerse qué peginterferón es más eficaz. El objetivo principal de este trabajo es comparar la efectividad del tratamiento de la hepatitis C en función del tipo de peginterferón. Material y métodos. Estudio de cohortes, prospectivo, de noviembre 2002 a mayo 2004 con seguimiento de hasta 12 meses tras finalizar el tratamiento a todos los pacientes. Se incluyeron pacientes naïve monoinfectados. Grupo A: peginterferón alfa-2a más ribavirina; grupo B: peginterferón alfa-2b más ribavirina. Variables principales: Respuesta bioquímica, respuesta viral sostenida y efectividad del tratamiento (respuesta bioquímica y virológica). Resultados. Se incluyeron 202 pacientes (grupo A: 87; grupo B: 115), sin diferencias significativas en las características basales de ambos grupos de pacientes. Respuesta viral sostenida: el 71,3 frente al 64,3% (p 5 0,293); respuesta bioquímica sostenida: el 75,2 frente al 75,7% (p 5 0,934); efectividad: el 64,2 frente al 60,87% (p 5 0,628). Conclusión. No hay diferencias en la obtención de respuesta viral sostenida, bioquímica sostenida y efectividad del tratamiento entre ambos grupos de pacientes, por lo que se pueden considerar ambos peginterferones igual de efectivos para el tratamiento de la hepatitis C en pacientes monoinfectados (AU)

Introduction. Treatment of hepatitis C is based on the combination of peginterferon alfa-2a or -2b plus ribavirin; the more effective peginterferon for this purpose has not been established. The aim of this study is to compare the effectiveness of hepatitis C treatment according to the type of peginterferon used. Methods. A prospective cohort study was performed from November 2002 to May 2004, with up to 12 months of follow-up in all patients after completion of treatment. The study included naïve monoinfected patients, divided into two groups: Group A: peginterferon alfa-2a plus ribavirin and Group B: peginterferon alfa-2b plus ribavirin. The main variables studied were plasma glutamate pyruvate transferase levels (biochemical response), viral load (virologic response), and treatment effectiveness (biochemical and virologic response). Results. A total of 202 patients were studied (Group A: 87; Group B: 115), there were no significant differences in baseline characteristics between the two groups. Sustained biochemical response: 75.8% vs. 76.2% (P 5 .908); Sustained virological response: 71.3% vs. 64.3% (P 5 .293); Effectiveness of treatment: 64.2% vs. 60.87% (P 5 .628). Conclusion. No differences in the sustained virological or biochemical response were found between groups receiving peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin, suggesting that the two types of peginterferon alfa are similarly effective for treating hepatitis C in monoinfected patients (AU)

[Toxicity of the treatment of chronic hepatitis C with peginterferon alpha (2a or 2b) plus ribavirin in patients not previously treated]. / Toxicidad del tratamiento de la hepatitis C crónica con peginterferón alpha (2a o 2b) y ribavirina en pacientes no tratados anteriormente.

BACKGROUND AND OBJECTIVE: The adverse reactions (ADR) derived from the treatment of hepatitis C with peginterferon alpha and ribavirin causes dose reductions and discontinuations of the treatment that compromise its efectiveness. The aims of this study are to determine the ADR that the patients have presented according to the type of peginterferon alpha, and the effect of these in treatment duration and accumulated dose. PATIENTS AND METHOD: Cohort, prospective and longitudinal study (from November 2002 to April 2006), with monoinfected patients not previously treated (group A: peginterferon alpha-2a plus ribavirin; group B: peginterferon alpha-2b plus ribavirin). RESULTS: Group A: 93 patients; group B: 115. Hematologyc ADR: neutropenia, 24% vs. 26.90%; anemia: 12.50% vs. 9.60%. Not hematologyc ADR: fatigue, 73.10% vs 74.80%; fever (> 38 degrees C), 81.70% vs 86.10%. Permanency in treatment < 80%: 18.3% in group A patients vs. 9.5% in group B patients. Accumulated dose of peginterferon < 80%: 13.9% in group A patients vs. 11.3% in group B patients. CONCLUSIONS: We haven't found differences in the safety profile of both peginterferons, though the patients treated with peginterferon alpha-2b shows a higher permanency in the treatment and a percentage of total received doses > 80% of the theoretical ones.

Toxicidad del tratamiento de la hepatitis C crónica con peginterferón a (2a o 2b) y ribavirina en pacientes no tratados anteriormente / Toxicity of the treatment of chronic hepatitis C with peginterferon a (2a or 2b) plus ribavirin in patients not previously treated

No disponible