ABSTRACT
Introduction: Real-world data are critical to demonstrate the reproducibility of evidence and external generalizability of randomized clinical trials. The purpose of this study was to assess real-world security profile and management of adverse events (AEs) presented with ribociclib for the treatment of HR + /HER2- metastatic breast cancer (MBC). Our secondary objective was to provide real-world effectiveness of this treatment (measured with progression-free survival (PFS)) and to confirm the hypothesis that dose reductions are not related with disease progression. Material and methods: Observational retrospective study evaluating all females with MBC treated with ribociclib. Study period: January 2017 to September 2019. Follow-up was done until November 2021. Response was assessed through the PFS according to RECIST1.1 and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) was used to classify AEs. Results: The most common AE was any grade neutropenia, documented in 37 of 53 patients (69.8%) during the course of treatment. By the end of the follow-up period, overall median PFS with ribociclib therapy was 27.3 months (95% confidence interval (CI) 20.8-71.8 months). In total, 50 patients (94.4%) initiated ribociclib at 600 mg dose, 28 patients (58%) required dose reductions. PFS of patients receiving ribociclib as first-line treatment was 28 (95% CI 15-41 months). Conclusions: Our results from patients treated in real-world clinical settings indicate that ribociclib is safe and their AEs are manageable with active monitoring, temporal suspension of treatment and dose reduction. Furthermore, our results indicate that dose reduction of ribociclib is not associated with a loss of efficacy.
Subject(s)
Breast Neoplasms , Female , Humans , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Retrospective Studies , Reproducibility of Results , Aminopyridines/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Receptor, ErbB-2ABSTRACT
INTRODUCCIÓN: El objetivo del presente trabajo es describir el perfil de los pacientes VIH que ingresan en un hospital de tercer nivel así como analizar las causas de ingreso hospitalario y de mortalidad durante el mismo. MATERIAL Y MÉTODOS: Estudio observacional, retrospectivo llevado a cabo en un Hospital de tercer nivel. Criterios de inclusión: Pacientes ≥18 años con prescripción de tratamiento antirretroviral (TAR) y diagnóstico de VIH conocido o descubierto durante el ingreso.como motivo de ingreso hospitalario se utilizó el diagnóstico al alta de cada paciente. Se recogieron variables clínicas, analíticas así como las causas de exitus. RESULTADOS: En el periodo de estudio ingresaron un total de 162 pacientes VIH. Cumplieron los criterios de inclusión 128, de los cuales 8 fueron diagnosticados como VIH de novo. Un 79,7% fueron varones; edad 50,29+/-9,81 años. El principal diagnóstico al alta (38,3%) fueron ciertas enfermedades infecciosas y parasitarias (Clasificación CIE-10) y dentro de esta clasificación, las infecciones directamente relacionadas con el VIH fueron las mayoritarias (24,1%). Las tasas de mortalidad de los pacientes VIH ≥18 años que ingresaron en el Hospital (años 2016 y 2017) fue del 13,52%. Las causas de muerte más frecuentes fueron ciertas enfermedades infecciosas y parasitarias seguidas de neoplasias. CONCLUSIONES: Nuestros resultados enfatizan la necesidad de seguir reforzando el diagnóstico precoz de VIH así como la profilaxis primaria de Pneumocysitis jirovecii en los pacientes VIH. Insistir en la adherencia al TAR desde las consultas de seguimiento de especialista en enfermedades infecciosas y en las consultas de atención farmacéutica, concienciar a los clínicos en la prescripción del TAR durante el ingreso hospitalario así como solicitar analíticas de CV y linfocitos CD4 a todos los pacientes VIH ingresados en el Hospital
INTRODUCTION: The aim of this study is to describe the HIV population admitted to a tertiary level hospital and analyze hospital admission and mortality causes during hospitalization. MATERIAL AND METHODS: Observational, retrospective study carried out in a third level Hospital. Inclusion criteria: Patients ≥18 years with a prescription of ART and diagnosis of HIV known or discovered during admission. It was accepted hospital ward discharge diagnose as hospitalization causes. Clinical, analytical outcomes as well as causes of mortality were collected. RESULTS: Among 162 hospitalized HIV infected, 128 met the inclusion criteria, 8 of those were diagnosed as naive HIV patients.79.7% were male; Age 50.29 +/- 9.81 years. The main reasons for hospital admissions (38.3%) were certain infectious and parasitic diseases (ICD-10 Classification) and more specifically human immunodeficiency virus [HIV] disease represented 24,1% of whole hospitalizations. Mortality rates of ≥18 years HIV patients that were admitted to hospital during 2016-2017 were the 13.52%. The main causes of death were certain infectious and parasitic diseases followed by malignancies. CONCLUSIONS: Our results emphasize the need of intensifying the HIV early diagnosis as well as Pneumocystis jirovecii primary prophylaxis. Insist on ART adherence from infectology follow-up appointment and pharmacy care consultations, educate clinics on ART treatment prescription during hospital admission as well as requesting viral and CD4 lymphocytes loads to every HIV admitted patients
