Evaluación de la Eficacia y la Seguridad del preparado vacunal NGlicolilGM3/VSSP en el tratamiento de pacientes con cáncer de mama metastásico
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Fecha
2010-06-25
Autores
Alfonso García, Yamila
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Universidad Central "Marta Abreu" de las Villas
Resumen
El cáncer de mama representa la tercera causa entre las enfermedades malignas a nivel mundial y la más común de las afecciones oncológicas que padece la mujer en todo el mundo. Debido a que aún no existe en el mercado el tratamiento ideal la industria farmacéutica se esfuerza por introducir nuevos productos dirigidos a las pacientes que fallan los tratamientos oncoespecíficos. El Centro de Inmunología Molecular ha desarrollado una vacuna para pacientes con cáncer de mama avanzado que se administra desde hace algunos años en el servicio de oncología de Villa Clara. El objetivo del presente trabajo es evaluar la eficacia y seguridad del preparado vacunal NGlicolilGM3/VSSP en el tratamiento de pacientes con cáncer de mama avanzado. Con este fin se realizó un estudio retrospectivo que estudió el comportamiento de la supervivencia, el tiempo libre a la progresión y la respuesta objetiva antitumoral en las pacientes con cáncer de mama avanzado tratadas con el producto en investigación. Además se evaluó la seguridad del producto mediante el seguimiento de los eventos adversos que se presentaron en las pacientes. Se observaron ventajas de supervivencia en las pacientes tratadas, especialmente en las pacientes con metástasis no viscerales, las pacientes vacunadas mostraron mejores tiempos a la progresión que los reportados en la literatura y en su mayoría mostraron al menos estabilización de la enfermedad durante el tratamiento. El producto resultó seguro siendo los eventos adversos que se presentaron en su mayoría no relacionados con el producto y los relacionados clasificados de intensidad leve y moderada.
Breast cáncer is the third most fatal malignant disease and the most common oncological affectation in women in the world. Given that there is no ideal treatment in the world, the pharmaceutical industry works so hard to introduce new products for pacients iin whom oncospecifif treatment fails. In the molecular immunology centre has developed some vaccines which has been administered to patients with advanced breast cancer over the years in oncology service in the province of Villa Clara. In this project, the efficiency and security of the NGlicolilGM3/VSSP vaccine is evaluated in the treatment of advanced breast cancer. A retrospective method was used to study the survival, progression time and the objective antitumoral response in patients who were treated with the vaccine under investigation. Product security is also evaluated through the follow up of adverse effects that the patients manifested. Patients who were treated were advantaged when survival was evaluated, especially those with non visceral metastasis. Their progression time was even better than what is reported in literature and the majority showed stability of the disease during treatment. The product resulted secure given that the majority of the adverse effects manifested by patients were not related to the product and those related to the product had moderate or low intensity.
Breast cáncer is the third most fatal malignant disease and the most common oncological affectation in women in the world. Given that there is no ideal treatment in the world, the pharmaceutical industry works so hard to introduce new products for pacients iin whom oncospecifif treatment fails. In the molecular immunology centre has developed some vaccines which has been administered to patients with advanced breast cancer over the years in oncology service in the province of Villa Clara. In this project, the efficiency and security of the NGlicolilGM3/VSSP vaccine is evaluated in the treatment of advanced breast cancer. A retrospective method was used to study the survival, progression time and the objective antitumoral response in patients who were treated with the vaccine under investigation. Product security is also evaluated through the follow up of adverse effects that the patients manifested. Patients who were treated were advantaged when survival was evaluated, especially those with non visceral metastasis. Their progression time was even better than what is reported in literature and the majority showed stability of the disease during treatment. The product resulted secure given that the majority of the adverse effects manifested by patients were not related to the product and those related to the product had moderate or low intensity.
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Neoplasias de la Mama, Breast Neoplasms, Servicio de Oncología en Hospital, Oncology Service, Hospital, Villa Clara, Inmunoterapia Activa, Immunotherapy, Active, NGlicolilGM3/VSSP