Effectiveness and safety of pembrolizumab monotherapy in patients with locally advanced or metastatic non-small-cell lung cancer.

INTRODUCTION: Immunotherapy has become a standard treatment for lung cancer; the objective of this study was to evaluate the effectiveness, safety of pembrolizumab monotherapy in patients with advanced or metastatic non-small-cell lung cancer used in real-world clinical practice. MATERIAL AND METHODS: Retrospective observational study of every patient treated with pembrolizumab in our centre from January 2017 to June 2019. Outcomes collected: sex, age, Eastern Cooperative Oncology Group, programmed death receptor 1 level, previous metastatic line therapies, adverse events and smoking status. RESULTS: A total of 62 patients were reviewed. The median age was 62.34 ± 10.62 years, 48 (77.41%) were men and 91.93% of patients had Eastern Cooperative Oncology Group 0. The median dose administered was 170.5 mg (108 - 240 mg) and the median follow-up was 3 months (range: 1 - 38). A median of four cycles of pembrolizumab (range: 1 - 56) were administered as monotherapy. The reason for treatment discontinuation was mainly due to disease progression in 38.70% of patients or death in 30.64%. As first-line pembrolizumab monotherapy, median progression-free survival was 7.7 months (95% CI: 3.66 - 11.73) (N = 33). With respect to patients who were treated in second-third-line treatment, median progression-free survival was 3.5 months (95% CI: 2.40 - 4.59) (N=29). As to overall survival, pembrolizumab-treated patients as first-line treatment reached 19 months median OG (95% CI: 13.36 - 24.63) (N = 33) and those treated in second-third-line treatment got 11 months (95% CI: 3.4 - 18.5). A total of 64.51% of patients presented some adverse events to pembrolizumab however, only, 9.38% of them were grade 3. CONCLUSION: Pembrolizumab represents an effective and feasible alternative in terms of progression-free survival. It is a well-tolerated treatment option.

Spanish Translation, Transcultural Adaptation, Validation and Clinical Applicability of Female Genital-Self Image Scale (FGSIS).

BACKGROUND: As female genital cosmetic surgeries have significantly increased, appropriate tools to evaluate self-esteem about women's own genitalia are necessary. AIM: to translate, culturally adapt to Spanish women and to evaluate the psychometric properties of the Female Genital Self-Image Scale (FGSIS). METHODS: FGSIS was forward and backward translated, culturally adapted into Spanish and its content evaluated through Delphi consensus. One item from the original scale was discarded after expert panel evaluation, developing the final Spanish scale (FGSIS-S) consisting of 6 items. Its psychometric properties were evaluated among 202 women attending gynecological consults through an online survey. The survey included socio-demographic data and FGSIS-S. MAIN OUTCOME MEASURE: Socio-demographic items, psychometric characteristics of the FGSIS-S (construct evaluation, internal consistency and test-retest reliability) were assessed. RESULTS: FGSIS-S proved to relate appropriately with the proposed construct (sum-content validity index 0.9, and significant inverse correlation with women concerned about their genital appearance or considering cosmetic surgery) with a 1-factor solution on exploratory factor analysis. The test proved good internal consistency (McDonald's omega 0.86) and test-retest reliability (intraclass correlation 0.86, P < .001). In 41.1% of cases, women referred concern about their genital's self-image and in 12.4% had considered undergoing cosmetic surgery. CLINICAL TRANSLATION: The validated version of FGSIS-S can help both professionals and patients, and its implementation can be easily made in gynecological consults. STRENGTHS AND LIMITATIONS: The main limitation is a self-selection bias in women attending gynecological consults, who may be more worried about their gynecological/sexual health. The sample is also a relatively homogeneous Caucasian population, with medium-high educational level, coming from gynecological consults. Strengths include the large sample size and the demographic survey that permitted evaluating the performance of FGSIS-S in the context of concern about genitals or consideration of cosmetic surgery. CONCLUSION: FGSIS-S is an adequate scale to measure women's genital image self-perception in Spanish-speaking population of Spain. Bartolomé A, Villalaín C, Bermejo R, et al. Spanish Translation, Transcultural Adaptation, Validation and Clinical Applicability of Female Genital-Self Image Scale (FGSIS). Sex Med 2022;10:100558.

Effectiveness and Safety of Palbociclib plus Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Real-World Results.

BACKGROUND: Real-world data are critical to demonstrate the reproducibility of evidence and the external generalizability of randomized clinical trials. Palbociclib is an oral small-molecule inhibitor of cyclin-dependent kinases 4/6 that has been shown to improve progression-free survival when combined with letrozole or fulvestrant in phase 3 clinical trials. OBJECTIVE: To evaluate real-world outcomes in patients with metastatic breast cancer who received palbociclib in combination with endocrine therapy in routine clinical practice. METHODS: In this retrospective observational multicentre study, data were evaluated for all women with metastatic breast cancer who were treated with palbociclib from April 2017 to September 2019. Treatment response was assessed through progression-free survival according to the Response Evaluation Criteria in Solid Tumors, version 1.1. RESULTS: Fifty-three patients were included in the study, with median age 57 years (range 31-87 years). For all patients treated with palbociclib, median progression-free survival by the end of the study period was 14.4 months (95% confidence interval [CI] 6.2-22.2 months). Twenty-three women who received palbociclib as a first-line treatment did not experience progression-free survival; for these patients, the median treatment duration was 12.1 months (95% CI 1.4-28.0 months). For the 23 patients who received palbociclib as second-line therapy for metastatic breast cancer, median progression-free survival was 13.3 months (95% CI 4.1-22.4 months). Among the 7 women who received palbociclib as third-line therapy, median progression-free survival was 6.0 months (95% CI 0.9-11.1 months). The most common adverse events were hematologic, with grade 3 or 4 neutropenia occurring in 20 (38%) of the 53 patients. CONCLUSIONS: This study provides data from a real-world setting that match the results of previous studies in terms of effectiveness (i.e., progression-free survival) when palbociclib plus endocrine therapy was used as second- or third-line treatment. Palbociclib had appropriate tolerability and a profile of easily manageable adverse effects, with none of the patients suspending their treatment because of toxic effects.

CONTEXTE: Les données du monde réel sont essentielles pour démontrer la reproductibilité des éléments probants et la « généralisabilité ¼ externe des essais cliniques randomisés. Il a été démontré qu'en association avec le létrozole ou le fulvestrant dans les essais cliniques de phase 3, le palbociclib (un inhibiteur oral à petite molécule des kinases dépendantes des cyclines 4/6) améliorait la survie sans progression. OBJECTIF: Évaluer les résultats réels des patientes atteintes d'un cancer du sein métastatique qui ont reçu du palbociclib en association avec un traitement endocrinien dans le cadre d'une pratique clinique de routine. MÉTHODES: Dans cette étude observationnelle rétrospective multicentrique, les données ont été évaluées pour toutes les femmes atteintes d'un cancer du sein métastatique et qui ont été traitées avec du palbociclib d'avril 2017 à septembre 2019. La réponse au traitement a été évaluée par la survie sans progression au moyen des critères RECIST d'évaluation de la réponse des tumeurs solides, version 1.1. RÉSULTATS: Cinquante-trois patientes (âge médian : 57 ans; extrêmes 31­87 ans) ont été incluses dans l'étude. Pour toutes les patientes traitées avec le palbociclib, la survie moyenne sans progression à la fin de la période d'étude était de 14,4 mois (intervalle de confiance à 95 % [IC] 6,2­22,2 mois). Vingt-trois femmes ayant reçu du palbociclib en guise de traitement de première ligne n'ont pas connu de survie sans progression; pour ces patientes, la durée moyenne du traitement était de 12,1 mois (IC à 95 % 1,4­28 mois). Pour les 23 patientes ayant reçu le palbociclib en guise de traitement de deuxième ligne pour le cancer du sein métastatique, la survie moyenne sans progression était de 13,3 mois (IC à 95 % 4,1­22,4 mois). Parmi les 7 femmes ayant reçu le palbociclib en guise de traitement de troisième ligne, la survie moyenne sans progression était de 6,0 mois (IC à 95 % 0,9­11,1 mois). Les effets indésirables les plus fréquents étaient d'ordre hématologique, avec une neutropénie de grade 3 ou 4 survenant chez 20 (38 %) des 53 patientes. CONCLUSIONS: Cette étude fournit des données provenant d'un contexte réel. Elles correspondent aux résultats d'études précédentes en termes d'efficacité (c'est-à-dire « survie sans progression ¼) lorsque le palbociclib, associé à un traitement endocrinien, était utilisé comme traitement de deuxième ou de troisième ligne. Le seuil de tolérance du palbociclib est approprié et son profil d'effets indésirables est facilement gérable : aucune des patientes n'a en effet suspendu son traitement en raison d'effets toxiques.

Conciliación de la medicación al ingreso en el servicio de cirugía ortopédica y traumatológica / Medication reconciliation at admission to The Orthopaedic Surgery and Traumatology Department

INTRODUCCIÓN: Identificar las discrepancias existentes entre la medicación prescrita al ingreso en el servicio de traumatología y la medicación habitual de los pacientes, determinar la prevalencia de errores de conciliación y analizar el grado de aceptación de las intervenciones farmacéuticas realizadas para su resolución. MÉTODO: Estudio prospectivo de dos años de duración en un hospital comarcal público de España donde se seleccionaron los pacientes ingresados en traumatología con algún medicación domiciliario prescrito. Tras 24-48 horas del ingreso, el farmacéutico realizó la conciliación de la medicación, comparando la orden médica prescrita al ingreso con el tratamiento domiciliario. Se identificaron las discrepancias comunicándose al médico y se analizó el grado de aceptación de las recomendaciones. RESULTADOS: Se incluyeron 756 pacientes, con un total de 834 episodios de hospitalización; 66,1% mujeres, edad media: 72 ± 12,3 años, media de medicamentos domiciliarios por paciente: 8,1 ± 4,3. Se analizaron 8422 prescripciones, identificándose un 57,5% de discrepancias. La mayoría de las discrepancias no justificadas se debieron a omisión de medicamento (75%) seguido de la modificación de la posología o vía de un medicamento (19,1%). En el 87,4% de los episodios se encontró al menos una discrepancia. Las recomendaciones propuestas por el farmacéutico fueron aceptadas en el 69,9% de los casos. CONCLUSIONES: Existe un alta prevalencia de errores de conciliación al ingreso en el servicio de traumatología. Esta metodología ha permitido la coordinación del farmacéutico con el resto de profesionales implicados en la conciliación de la medicación, con el fin de detectar y resolver las discrepancias de medicación y reducir así los errores

INTRODUCTION: We aim to describe a method that would ensure continuity of patient care as regards drug therapy at admission to the orthopaedic surgery and traumatology department, identify the reconciliation discrepancies, determine the prevalence of reconciliation errors and analyse the acceptance of the pharmacist interventions. METHODS: Prospective observational study was conducted for two years in a regional public hospital in Spain. The study included patients hospitalized in the Orthopaedic Surgery and Traumatology Department with chronic medi¬cation prescribed. At 24-48 hours after hospital admission, the pharmacist compared the pre-admission pharmaco¬logical treatment of patients with the medication received in hospital to identify and reconciliation discrepancies. They were communicated and we analysed the acceptance of the pharmacist interventions. RESULTS: The study included 756 patients, with a total of 834 hospitalization episodes, 66,1% of whom were women, mean age: 72±12,3 years and a mean of 8,1±4,3 drugs. We analysed 8422 prescriptions, 57,5% reconciliation discrep¬ancies. The most frequent unjustified discrepancies were drug omission (75,2%), following by modification of the dose or route of administration (19,1%). There was at least one medication reconciliation discrepancy in 87,4% of hospitalization episodes. Pharmacist recommendations were accepted in 69,9% of cases. CONCLUSIONS: There was a high prevalence of reconciliation errors among patients admitted to the Orthopaedic Surgery and Traumatology Department. This methodology has allowed a workflow to be established that facilitates coordination between the pharmacist and others healthcare providers, to identify and resolve medication discrepancies to reduce medication errors

Effectiveness of 12 week ledipasvir/sofosbuvir and predictors of treatment failure in patients with hepatitis C / Efectividad de ledipasvir/sofosbuvir durante 12 semanas de tratamiento y factores predictivos de fracaso del tratamiento en pacientes con hepatitis C

INTRODUCTION: The efficacy of ledipasvir/sofosbuvir (LDV/SOF) have been demonstrated in randomized controlled trials, however,there is an unmet need for real-world effectiveness data. It is important to gather data regarding potential predictors of treatment failure with (LDV/SOF). Predictors of sustained virologic response (SVR) to all-oral HCV regimens can inform nuanced treatment decisions. The objectives of this study were to evaluate the effectiveness of LDV/SOF, SVR12 as main endpoint and SVR24 as second endpoint, and identify predictors of treatment failure. MATERIAL AND METHODS: Retrospective and observational study carried out from April 2015 to January 2016. Inclusion criteria: patients with HCV infection treated with LDV/SOF for 12 weeks during study period. The patients that were treated during 24 weeks were excluded as well as those treated with peg-interferon. Binary logistic regression was used to predict what variable was associated with treatment failure. RESULTS: A total of 122 patients were analyzed achieving SVR12 91.80% (112/122) of them. The patients with HCV genotype (GT) 1a or GT1b or GT4 achieved SVR12. Only one pre-treated non-cirrhotic HCV GT1 patients relapsed to treatment. The lowest SVR12 were obtained for GT3, 43.75%, (7/16). Everybody that got SVR12 achieved SVR24. None of the variables analyzed significantly influenced the SVR12, except GT (p = 0.001). Almost all the relapses occurred in GT3. CONCLUSION: LDV/SOF combination has been very effective to treat GT1 and GT4 infected patients, however, has constituted a suboptimal therapeutic option for those patients infected with GT3, regardless of the rest of the variables analyzed

INTRODUCCIÓN: La eficacia de ledipasvir/sofosbuvir (LDV/SOF) se ha demostrado en ensayos clínicos, sin embargo, son necesarios más estudios sobre su eficacia en la práctica clínica. Además es importante estudiar los posibles factores predictivos de fracaso de tratamiento con LDV/SOF. Los factores predictivos de respuesta viral sostenida (RVS) a antivirales de acción directa pueden informar sobre decisiones de tratamiento. Los objetivos de este estudio fueron evaluar la efectividad de LDV/SOF, RVS12 como variable principal y RVS24 como secundaria, e identificar los factores predictivos de fracaso del tratamiento. MATERIAL Y MÉTODOS: Estudio retrospectivo y observacional realizado desde abril de 2015 a enero de 2016. Criterios de inclusión: pacientes con infección por VHC tratados con LDV/SOF durante 12 semanas. Se excluyeron los pacientes tratados durante 24 semanas y los tratados con peg-interferón. Aplicamos el método estadístico denominado regresión logística binaria para predecir qué variable estaba relacionada con el fracaso del tratamiento. RESULTADOS: Se analizaron 122 pacientes logrando el 91,80% (112/122) RVS12. Los pacientes infectados con genotipo (GT) 1a o GT1b o GT4 lograron RVS12. Solo un paciente, no cirrótico y previamente tratado, infectado con GT1 no alcanzó RVS12. Las tasas más bajas de RVS12 se obtuvieron para GT3, 43.75%, (7/16). Todos los pacientes que obtuvieron RVS12 lograron RVS24. Ninguna de las variables analizadas influyó significativamente en la RVS12, excepto GT (p = 0.001). Casi todas las recaídas ocurrieron en GT3. CONCLUSIONES: La combinación LDV/SOF ha sido muy efectiva para tratar a los pacientes infectados con GT1 y GT4, sin embargo, ha constituido una opción terapéutica subóptima para los infectados con GT3, independientemente del resto de las variables analizadas

Vedolizumab en Enfermedad de Crohn; Informe de evaluación GENESIS-SEFH / Vedolizumab in Crohn Disease genesis-sefh drug evaluation report

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Adult severe haemophilia A patients under long-term prophylaxis with factor VIII in routine clinical practice.

There is no clear consensus on the best practice for long-term prophylaxis in adults with severe haemophilia A. This is a single-centre prospective case series study. We describe here the demographic data, type and reason of prophylaxis in adult patients (>18 years old) with severe (<1%) haemophilia A, treated in our centre from 2006 to 2013. Prophylaxis was tailored according to pharmacokinetic studies and posterior factor VIII (FVIII) trough level adjustment. We analysed FVIII consumption, bleeding rate, adherence and adverse events in this group of patients. In adult patients who initiated long-term prophylaxis during this period, we compared FVIII consumption and bleeding rate with the previous on-demand period. We analysed data from 18 patients. Median annual FVIII consumption was 2374.2 IU/kg/year. Among the patients receiving tertiary prophylaxis, initiated from 2006 onwards, the annual FVIII consumption was 2557.8 vs. 1696.8 IU/kg per year during the on-demand period (P = 0.312). In this group of patients, there was a decrease in annual bleeding events of 88.3% during prophylaxis compared with the on-demand therapy (P < 0.0001). A high adherence to prophylaxis was observed (84%). No cases of anaphylaxis or symptomatic thromboembolic events were recorded. In adult severe haemophilia A patients, the type of and reason to indicate long-term prophylaxis are diverse nowadays. FVIII consumption varies depending on the justification of prophylaxis. The observations reported provide further support for the efficacy of long-term prophylaxis in adult haemophilia A patients.