Eficacia y Seguridad del Ribociclib más Terapia Endocrina Frente a Terapia Endocrina sola en Pacientes Premenopáusicas y Posmenopáusicas con Cáncer de Mama Temprano y Metastásico HR+/HER2 -: Un Metaanálisis de Ensayos Clínicos Aleatorizados
Palabras clave:
ribociclib, metaanálisis, cáncer de mama, HR /HER2
Resumen
Introducción: El cáncer de mama es la neoplasia más común diagnosticada en mujeres. Este metaanálisis precisa la eficacia y perfil de seguridad de Ribociclib en cáncer de mama HR+/HER2-. Objetivo: Evaluar de manera cuantitativa la eficacia de Ribociclib más terapia endocrina, en comparación a terapia endocrina sola en pacientes premenopáusicas y posmenopaúsicas con cáncer de mama HR+/HER2- temprano y metastásico. Metodología: Se realizó una búsqueda bibliográfica exhaustiva en múltiples bases de datos PubMed, Science Direct, Google Scholar y ASCOPUBS. Los datos se agruparon y analizaron mediante modelo de efectos aleatorios. Se calcularon hazard ratio y risk ratio para eficacia y seguridad, respectivamente. Se evaluaron la heterogeneidad y riesgo de sesgo. Resultados y Discusión: Se incluyeron cinco ensayos clínicos aleatorizados. La eficacia demostró un HR=0,68 [IC del 95 %: 0.58 a 0.79]. El perfil de seguridad del fármaco mostró un Risk Ratio (RR) de 28,86 [IC del 95 %: 11.84 a 70.37] para neutropenia, un RR de de 2.08 [IC del 95 %: 1.00 a 4.33] para prolongación del intervalo QT y un RR de 2.01 [IC del 95 %: 0.83 a 4.84] para hepatotoxicidad. Conclusiones: El ribociclib sumado a la terapia endocrina en el manejo de cáncer de mama HR+/HER2- es efectivo con la necesidad de monitorización continua de valores hematológicos, electrocardiograma y función hepática.
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GRADEpro. (s. f.). Recuperado 3 de agosto de 2025, de https://www.gradepro.org/
Jerzak, K. J., Bouganim, N., Brezden-Masley, C., Edwards, S., Gelmon, K., Henning, J.-W., Hilton, J. F., & Sehdev, S. (2023). HR+/HER2– Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review. Current Oncology, 30(6), 5425-5447. https://doi.org/10.3390/curroncol30060411
Ji, Y., Schiller, H., Yang, S., Quinlan, M., Darstein, C., Huth, F., Winter, S., & Chakraborty, A. (2024). Use of Pharmacokinetic and Pharmacodynamic Data to Develop the CDK4/6 Inhibitor Ribociclib for Patients with Advanced Breast Cancer. Clinical Pharmacokinetics, 63(2), 155-170. https://doi.org/10.1007/s40262-023-01338-z
Kalinsky, K., Accordino, M. K., Chiuzan, C., Mundi, P. S., Sakach, E., Sathe, C., Ahn, H., Trivedi, M. S., Novik, Y., Tiersten, A., Raptis, G., Baer, L. N., Oh, S. Y., Zelnak, A. B., Wisinski, K. B., Andreopoulou, E., Gradishar, W. J., Stringer-Reasor, E., Reid, S. A., … Hershman, D. L. (2023). Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer: MAINTAIN Trial. Journal of Clinical Oncology, 41(24), 4004-4013. https://doi.org/10.1200/JCO.22.02392
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Lu, Y.-S., Im, S.-A., Colleoni, M., Franke, F., Bardia, A., Cardoso, F., Harbeck, N., Hurvitz, S., Chow, L., Sohn, J., Lee, K. S., Campos-Gomez, S., Villanueva Vazquez, R., Jung, K. H., Babu, K. G., Wheatley-Price, P., De Laurentiis, M., Im, Y.-H., Kuemmel, S., … Tripathy, D. (2022). Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2− Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clinical Cancer Research, 28(5), 851-859. https://doi.org/10.1158/1078-0432.CCR-21-3032
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Rugo, H. S., Bardia, A., Gradishar, W. J., Hamilton, E. P., Hurvitz, S. A., Jhaveri, K., Mahtani, R., & Tolaney, S. M. (2025). Expert consensus on treating HR+/HER2- metastatic breast cancer based on real-world practice patterns observed in the RETRACT survey of US oncologists. The Breast : Official Journal of the European Society of Mastology, 82, 104485. https://doi.org/10.1016/j.breast.2025.104485
Shao, Z., Tong, Z., Liu, Q., Li, W., Cai, L., Shen, K., Li, H., Wang, C., Yang, J., Song, Z., Wang, S., Luo, T., Zhao, W., Wang, H., Pan, Y., Nie, J., Zeng, X., Bai, Y., Chiang, W., … Xu, B. (2024). Initial ribociclib plus endocrine therapy for HR+/HER2− advanced breast cancer in pre- and postmenopausal Chinese women: Primary results from a phase 2 randomized study. Cancer Medicine, 13(15), e7408. https://doi.org/10.1002/cam4.7408
Slamon, D. J., Neven, P., Chia, S., Jerusalem, G., Laurentiis, M. D., Im, S., Petrakova, K., Bianchi, G. V., Martín, M., Nusch, A., Sonke, G. S., Cruz-Merino, L. D. la, Beck, J. T., Ji, Y., Wang, C., Deore, U., Chakravartty, A., Zarate, J. P., Taran, T., & Fasching, P. A. (2021). Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: Updated overall survival. Annals of Oncology, 32(8), 1015-1024. https://doi.org/10.1016/j.annonc.2021.05.353
Slamon, D., Lipatov, O., Nowecki, Z., McAndrew, N., Kukielka-Budny, B., Stroyakovskiy, D., Yardley, D. A., Huang, C.-S., Fasching, P. A., Crown, J., Bardia, A., Chia, S., Im, S.-A., Ruiz-Borrego, M., Loi, S., Xu, B., Hurvitz, S., Barrios, C., Untch, M., … Hortobagyi, G. (2024). Ribociclib plus Endocrine Therapy in Early Breast Cancer. New England Journal of Medicine, 390(12), 1080-1091. https://doi.org/10.1056/NEJMoa2305488
Wekking, D., Lambertini, M., Dessì, M., Denaro, N., Bardanzellu, F., Garrone, O., Scartozzi, M., & Solinas, C. (2023). CDK4/6 inhibitors in the treatment of metastatic breast cancer: Focus on toxicity and safety. Seminars in Oncology, 50(6), 131-139. https://doi.org/10.1053/j.seminoncol.2024.01.002
Xiong, X., Zheng, L.-W., Ding, Y., Chen, Y.-F., Cai, Y.-W., Wang, L.-P., Huang, L., Liu, C.-C., Shao, Z.-M., & Yu, K.-D. (2025). Breast cancer: Pathogenesis and treatments. Signal Transduction and Targeted Therapy, 10, 49. https://doi.org/10.1038/s41392-024-02108-4
Publicado
2025-12-15
Cómo citar
Carrasco Morales, M. H., Logacho Vega , K. Y., Artos Jácome, G. A., Pérez Oñate, C. V., Gavilanez Jiménez, M. V., Gualotuña Berrones, J. D., & Curillo Aguirre, C. A. (2025). Eficacia y Seguridad del Ribociclib más Terapia Endocrina Frente a Terapia Endocrina sola en Pacientes Premenopáusicas y Posmenopáusicas con Cáncer de Mama Temprano y Metastásico HR+/HER2 -: Un Metaanálisis de Ensayos Clínicos Aleatorizados. Ciencia Latina Revista Científica Multidisciplinar, 9(5), 17636-17657. https://doi.org/10.37811/cl_rcm.v9i5.21279
Número
Sección
Ciencias de la Salud
Derechos de autor 2025 Mario Hernán Carrasco Morales, Karina Yessenia Logacho Vega , Gary Andrés Artos Jácome, Cindy Vanessa Pérez Oñate, Melanie Victoria Gavilanez Jiménez, Jennifer Daniela Gualotuña Berrones, César Adrián Curillo Aguirre
Esta obra está bajo licencia internacional Creative Commons Reconocimiento 4.0.
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