ABSTRACT
Background Palbociclib and ribociclib are novel oral agents in hormone receptor-positive metastatic breast cancer. Neutropenia is a common adverse event associated with these treatments and its clinical management often requires regimen changes, such as cycle delays and dose adjustments. Objective To provide a real-world experience of the effectiveness and toxicities associated with these drugs and to evaluate the impact of regimen changes in disease progression. Setting This study was performed at Hospital Universitario La Paz, in Spain. Methods Observational, retrospective study which included hormone receptor-positive metastatic breast cancer patients who initiated treatment with palbociclib or ribociclib between March 1st, 2018 and March 1st, 2019. Main outcome measure The primary effectiveness variable was progression-free survival. Safety evaluation was performed to determine neutropenia-incidence and severity, as well as its clinical management, including dose adjustments and treatment interruptions. Correlations between these regimen changes and effectiveness were also evaluated. Results Sixty-one patients were included, 33 treated with palbociclib and 28 with ribociclib. Palbociclib was mainly used as second line of treatment in the metastatic setting (81.8%) and ribociclib as first line (67.9%). The median progression-free survival was 12.76 months (95% CI 7.5 to not estimable) in palbociclib and not reached in ribociclib. After 12 months, the progression-free survival rate was 51.5% (95% CI 34-69) in palbociclib and 78.6% (95% CI 63-94.1) in ribociclib. Neutropenia was the most common adverse event with an incidence rate of 87.9% in palbociclib and 82.1% in ribociclib. Cycle delays were needed in more than half of the patients treated with palbociclib and ribociclib (63.6% and 64.3%). Dose adjustments were seen in 42.4% and 53.6% of the patients receiving palbociclib and ribociclib, respectively. Regimen changes did not involve statistically significant differences in 12-month PFS rates in the cohort investigated. Conclusion Palbociclib and ribociclib outcomes are comparable to those reached in the phase III trials, PALOMA-3 and MONALEESA-2, respectively, and cannot be compared as they were used in different treatment settings. The toxicity profile is favourable, being neutropenia the most common adverse event, easily managed with regimen changes. Further studies are needed to confirm the observed tendency of no detrimental impact on effectiveness of these regimen changes.
Subject(s)
Breast Neoplasms , Aminopyridines , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Female , Humans , Piperazines , Purines , Pyridines , Retrospective StudiesABSTRACT
OBJETIVO: Analizar el procedimiento de entrega a domicilio de medicación de dispensación hospitalaria instaurado en el Servicio de Farmacia Hospitalaria (SFH) durante la pandemia COVID-19. Conocer el perfil de pacientes que aceptan la dispensación domiciliaria, analizar por patología las dispensaciones a domicilio y evaluar el grado de satisfacción de los pacientes mediante una encuesta telefónica. MÉTODOS: Estudio observacional, retrospectivo y descriptivo. Se analizaron las entregas de medicación a domicilio desde el SFH en el periodo del 7 de abril al 7 de mayo. Las características clínicas y demográficas de los pacientes se obtuvieron a partir del programa informático de pacientes externos del SFH e historia clínica electrónica. El grado de satisfacción de los pacientes se evaluó mediante la realización de una encuesta telefónica posterior a la entrega a domicilio. RESULTADOS: Se realizaron 2.028 entregas de medicación a domicilio abarcando toda la Comunidad Autónoma de Madrid (CAM), con un grado de aceptación del 76,82%. La patología con mayor número de entregas fue VIH. Los pacientes con enfermedades inmunomediadas fueron los que mayor aceptación reportaron. El 99% de los pacientes se mostraron satisfechos con el servicio. CONCLUSIONES: El servicio de entrega de medicación a domicilio ha sido ampliamente aceptado por los pacientes, mostrando un alto grado de satisfacción con el mismo. Se han evitado desplazamientos al hospital, disminuyendo el riesgo de contagio. Los pacientes demandan la prolongación de este servicio fuera del periodo de pandemia y sugieren que se complemente con una consulta de atención farmacéutica por telefarmacia
OBJECTIVE: To analyze the home delivery process of hospital medication set up in a Hospital Pharmacy Department (HPD) during the COVID-19 pandemic. To asses the profile of patients who accept home delivering, to analyze home dispensations by pathology and to evaluate the patient satisfaction through a telephone survey. METHODS: Observational, retrospective and descriptive study. Medication home delivery from the HPD in the period from April 7 to May 7 was analyzed. Patients demographic and clinical characteristics were obtained from the outpatient software used at the HPD and the electronic medical record. The degree of patient satisfaction was assessed by conducting a telephone survey after home delivery. RESULTS: A total of 2,028 home deliveries were made to the entire Community of Madrid, with an acceptance rate of 76,82%, being HIV the pathology with the highest number of deliveries. Patients with immune-mediated diseases were the ones with the greater acceptance rate. Overall patient satisfaction with the service was 99%. CONCLUSIONS: Medication home delivery service has been widely accepted by patients, showing a high degree of satisfaction. Avoiding trips to the hospital has reduced the risk of contagion. Patients demand the continuation of this service after the pandemic and support Pharmaceutical Care by telepharmacy
