Elderly breast cancer patients treated with Nab-paclitaxel: Results in real clinical practice / Cáncer de mama en pacientes ancianas: experiencia con Nab-paclitaxel en la práctica clínica real

Objective Clinical trials have shown that Nab-paclitaxel is more effective than paclitaxel in the treatment of metastatic breast cancer (MBC). Although the incidence of cancer increases with age, elderly patients are under-represented in clinical trials and tend to receive suboptimal treatment to avoid toxicity. The main aim of our study was to compare progression-free survival (PFS) among patients older and younger than 65 years treated with Nab-paclitaxel in real-world clinical practice. A secondary aim was to assess overall survival (OS) as well as the response rate and toxicity. Methods and patients This single-centre study retrospectively analyzed a cohort of 60 patients with MBC treated with Nab-paclitaxel monotherapy in Hospital Clínico Lozano Blesa de Zaragoza. Results The median PFS was 5.92 months (3.62–11.2) in patients<65 years and was 5.06 months (4.31–12.4) in those ≥65 years (p=0.868). The median OS was 26.9 months (18.6–30.7) in patients < 65 years and was 20.3 months (11.4–33.6) in those ≥65 years (p=0.138). Conclusions Although patients in the cohort studied had a median age of 60.45 years, which is higher than the median age in most clinical trials, PFS and OS in conditions of real-world clinical practice were similar to previously published data. The results of the use of Nab-paclitaxel in patients older than 65 years are similar to those in younger patients, with no additional toxicity problems. The results of our study agree with those of other notable studies. (AU)

Objetivo En los ensayos clínicos se ha demostrado que el Nab-paclitaxel es más eficaz que el paclitaxel en el tratamiento del cáncer de mama metastásico (CMM). Aunque la incidencia del cáncer aumenta con la edad, los pacientes ancianos están infrarrepresentados en los ensayos clínicos, y tienden a recibir un tratamiento subóptimo para evitar toxicidades. El objetivo principal de nuestro estudio es comparar la supervivencia libre de progresión (SLP) entre las mayores y menores de 65 años tratadas con Nab-paclitaxel en la práctica clínica real. El objetivo secundario es evaluar la supervivencia global (SG), así como la tasa de respuestas y la toxicidad. Métodos y pacientes Se ha analizado de forma unicéntrica y retrospectiva, una cohorte de 60 pacientes con CMM tratadas con Nab-paclitaxel en monoterapia en el Hospital Clínico Lozano Blesa de Zaragoza. Resultados Mediana SLP<65 años: 5,92 meses (3,62-11,2) y ≥65 años, mediana: 5,06 meses (4,31-12,4) (p=0,868). Mediana de SG en <65 años: 26,9 meses (18,6-30,7) y ≥65 años: 20,3 meses (11,4-33,6) (p=0,138). Conclusiones Aunque las pacientes de la cohorte estudiada tienen una mediana de edad de 60,45 años, que es superior a la mediana de edad de la mayoría de los ensayos clínicos, la SLP y la SG en condiciones de práctica clínica real son similares a los datos publicados anteriormente. En cuanto al uso de Nab-paclitaxel en pacientes de edad avanzada, se obtienen resultados similares a las de aquellas pacientes más jóvenes, sin observarse problemas de seguridad adicionales. Además, con los datos disponibles, los resultados son congruentes con los presentados en otros estudios de impacto. (AU)

Mini Nutritional Assessment - Short Form Is a Useful Malnutrition Screening Tool in Patients with Liver Cirrhosis, Using the Global Leadership Initiative for Malnutrition Criteria as the Gold Standard.

BACKGROUND: The use of nutrition-screening tools in cirrhotic patients is not systematized. Recently, specific tools have been proposed for patients with cirrhosis, but their diagnostic capabilities have been scarcely studied. METHODS: This was a prospective study that includes outpatients with liver cirrhosis undergoing follow-up in the hepatology consultations of a tertiary-care university hospital. A trained gastroenterologist applied the screening tools: Liver Disease Universal Screening Tool (LDUST), Royal Free Hospital-Nutrition Prioritizing Tool (RFH-NPT), and Mini Nutritional Assessment-Short Form (MNA-SF). Subsequently, the diagnosis of malnutrition was made according to Global Leadership Initiative for Malnutrition (GLIM) criteria by an endocrinologist, who was blind to the results of the screening tools. RESULTS: Sixty-three patients (38.1% women, mean age 63.1 ± 9.9 years) with cirrhosis (60.3% Child-Pugh A, 34.9% Child-Pugh B, and 4.8% Child-Pugh C) were evaluated. The prevalence of malnutrition was 38.1% (15.9% moderate, 22.2% severe). Advanced stages of cirrhosis were associated with a higher prevalence of malnutrition (P = .021). MNA-SF was the most accurate screening tool, being superior to RFH-NPT and LDUST. It presented better sensitivity than RFH-NPT (88% [0.68-0.97] vs 67% [0.45-0.84], P = .031) and better specificity than both LDUST (97% [0.87-0.99] vs 62% [0.45-0.77], P < .001) and RFH-NPT (97% [0.87-0.99] vs 82% [0.67-0.93], P = .016). CONCLUSIONS: According to the GLIM criteria, malnutrition affected 38.1% of patients with cirrhosis, being severe in 22% of the patients. MNA-SF is the most accurate screening test, superior even to tools specifically designed for cirrhotic patients (LDUST).

Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF / Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

INTRODUCCIÓN: Ustekinumab, anticuerpo monoclonal que bloquea las interleucinas 12/23, ha demostrado en ensayos clínicos su eficacia para inducir y mantener la remisión clínica en la enfermedad de Crohn (EC). Su efectividad y su seguridad en la práctica clínica real es menos conocida y podría diferir respecto a los ensayos. OBJETIVO: Evaluar en la práctica clínica su efectividad y seguridad (pauta de inducción intravenosa esencialmente), como inducción y a largo plazo, en pacientes con EC refractarios a tratamiento biológico. MATERIAL Y MÉTODOS: Análisis retrospectivo multicéntrico (6 hospitales aragoneses), que incluye a todos los pacientes (N=69) con EC en tratamiento con ustekinumab (fuese con inducción intravenosa o subcutánea) que hubiesen alcanzado al menos 16 semanas de seguimiento. La respuesta o remisión clínica se ha evaluado en las semanas 16, 24, 32 y 48 mediante el índice de Harvey-Bradshaw. RESULTADOS: Se han incluido un total de 69 pacientes, edad media 42 años, 54% hombres. Un 89,86% (IC 95% [0,805, 0,949]) de los pacientes ha presentado mejoría clínica en la semana 16 (15,95% remisión, 73,92% respuesta). En el seguimiento posterior dicha respuesta se ha mantenido. Se han identificado mediante un modelo de regresión ordinal la edad (OR 0,95, p = 0.028) y el hábito tabáquico (OR 0,19, p = 0,027) como predictores de mala respuesta al tratamiento, mientras que la necesidad de cambio de biológico por efecto adverso (OR 96, p = 0,00017) y por pérdida de respuesta secundaria (OR 7,07, p = 0,034) han sido factores predictores de buena respuesta. No se han reportado efectos adversos graves que obligasen a interrumpir el tratamiento con ustekinumab. CONCLUSIÓN: Ustekinumab es efectivo y seguro en la práctica clínica real para lograr la inducción y el mantenimiento de la respuesta en pacientes con EC refractaria. El tabaco y la edad han mostrado ser predictores de mala respuesta, mientras que la indicación por efecto adverso a biológico previo y por pérdida de respuesta secundaria han mostrado ser predictores de buena respuesta

INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response

Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort. / Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF.

INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.