Experiencia clínica inicial con ribociclib en cáncer de mama avanzado RH+/HER2− en Uruguay.

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Title: Experiencia clínica inicial con ribociclib en cáncer de mama avanzado RH+/HER2− en Uruguay.
Alternate Title: Initial clinical experience with ribociclib in advanced HR+/HER2− breast cancer in Uruguay.
Authors: Camejo-Martínez, Natalia1 ncam3@yahoo.com, Strazzarino-Peluffo, Noelia1, Amarillo-Hernández, Dahiana1, Castillo-Leska, Cecilia1, Krygier-Waltier, Gabriel1
Source: Revista Medica del IMSS. may/jun2026, Vol. 64 Issue 3, p1-7. 7p.
Subjects: CYCLIN-dependent kinase inhibitors, HORMONE receptor positive breast cancer, TREATMENT effectiveness, METASTATIC breast cancer, ADVERSE health care events, HORMONE therapy, SAFETY
Geographic Terms: URUGUAY
Abstract (English): Background: Ribociclib improves progression-free and overall survival (PFS and OS) in women with advanced HR+/HER2− breast cancer (BC), but real-world evidence in Uruguay is limited. Objective: To describe the clinical characteristics, outcomes, and safety profile of women with advanced HR+/ HER2− breast cancer treated with ribociclib plus hormone therapy in Uruguay. Materials and methods: Observational, retrospective study. Demographic and clinical variables, type of hormone therapy, treatment duration, and adverse events were analyzed. Results: A total of 54 patients from public and private institutions were included, with a median age of 60 years. 67% relapsed after adjuvant treatment. Bone was the most common metastatic site (72%). Ribociclib was administered as first-line treatment in 81% of cases, and combined with aromatase inhibitors in 63%. The mean OS was 41.6 months and the mean PFS was 30 months; medians were not reached. Neutropenia was the most frequent adverse event (66%), followed by gastrointestinal toxicity (nausea 33%, diarrhea 28%) and skin toxicity (16%). One death due to pulmonary embolism was recorded, and QTc prolongation was documented in 5.6% of patients. Dose reduction was required in 20%, and one patient discontinued treatment due to skin toxicity. Conclusion: Ribociclib was well tolerated, with a safety profile consistent with the literature. This study provides relevant local evidence and supports its use in real-world settings. Longer follow-up is needed to more accurately assess OS and PFS outcomes. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Introducción: el ribociclib mejora la supervivencia libre de progresión y global (SVLP y SVG) en mujeres con cáncer de mama (CM) avanzado RH+/HER2−, pero la evidencia en la vida real es limitada en Uruguay. Objetivo: describir las características clínicas, evolución y perfil de seguridad de mujeres con CM avanzado RH+/ HER2− tratadas con ribociclib más hormonoterapia en Uruguay. Material y métodos: estudio observacional y retrospectivo. Se analizaron variables demográficas, clínicas, tipo de hormonoterapia, duración del tratamiento y eventos adversos (EA). Resultados: se incluyeron 54 pacientes de instituciones públicas y privadas, con una mediana de edad de 60 años. El 67% recayó tras tratamiento adyuvante. El sitio metastásico más común fue el óseo (72%). El ribociclib se administró en primera línea en 81% de los casos, y en combinación con inhibidores de aromatasa en 63%. La media de SVG fue de 41.6 meses y la de SVLP de 30 meses, sin alcanzarse la mediana en ninguno de los casos. La neutropenia fue el EA más frecuente (66%), seguida de toxicidad digestiva (náuseas 33%, diarrea 28%) y cutánea (16%). Se registró una muerte por tromboembolismo pulmonar y prolongación del QTc en el 5.6%. El 20% requirió reducción de dosis y una paciente suspendió el tratamiento por toxicidad cutánea. Conclusión: el ribociclib fue bien tolerado, con un perfil de toxicidad acorde a la literatura. Este estudio aporta evidencia local relevante y respalda su uso en escenarios reales. Se requiere seguimiento más prolongado para evaluar SVG y SVLP con mayor precisión. [ABSTRACT FROM AUTHOR]
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Database: MedicLatina
Description
Abstract:Background: Ribociclib improves progression-free and overall survival (PFS and OS) in women with advanced HR+/HER2− breast cancer (BC), but real-world evidence in Uruguay is limited. Objective: To describe the clinical characteristics, outcomes, and safety profile of women with advanced HR+/ HER2− breast cancer treated with ribociclib plus hormone therapy in Uruguay. Materials and methods: Observational, retrospective study. Demographic and clinical variables, type of hormone therapy, treatment duration, and adverse events were analyzed. Results: A total of 54 patients from public and private institutions were included, with a median age of 60 years. 67% relapsed after adjuvant treatment. Bone was the most common metastatic site (72%). Ribociclib was administered as first-line treatment in 81% of cases, and combined with aromatase inhibitors in 63%. The mean OS was 41.6 months and the mean PFS was 30 months; medians were not reached. Neutropenia was the most frequent adverse event (66%), followed by gastrointestinal toxicity (nausea 33%, diarrhea 28%) and skin toxicity (16%). One death due to pulmonary embolism was recorded, and QTc prolongation was documented in 5.6% of patients. Dose reduction was required in 20%, and one patient discontinued treatment due to skin toxicity. Conclusion: Ribociclib was well tolerated, with a safety profile consistent with the literature. This study provides relevant local evidence and supports its use in real-world settings. Longer follow-up is needed to more accurately assess OS and PFS outcomes. [ABSTRACT FROM AUTHOR]
ISSN:04435117
DOI:10.5281/zenodo.18715279