Seguridad de la vacuna anti-idiotípica 1E10 en pacientes con tumores de diversas localizaciones

Abstract

Cancer is a leading cause of death in Cuba and the world. Lung cancer is the leading cause of death, breast cancer is the second leading cause of death and colorectal cancer is the third leading cause of death. The 1E10 anti-idiotype vaccine is a new immunotherapeutic agent, registered for lung cancer by the Center for Molecular Immunology (CIM). You want to evaluate the safety of this vaccine in the treatment of various cancer sites. To determine the safety adverse events occurred in six clinical trials (one stage I lung, 3 phase II in breast, colon and lung, 1 phase II-III and program expanded use, both in lung) were evaluated. 656 patients were studied. Demographic variables, the characteristics of the disease and adverse events were measured. The studies were balanced with respect to baseline characteristics. The most common adverse events were local reactions associated with 1E10 anti-idiotype vaccine and systemic reactions of mild or moderate intensity that were not related to the administration of the vaccine under study. The 1E10 anti-idiotype vaccine is safe for the low frequency and intensity of adverse events reported.