META-ANÁLISIS PARA EVALUAR LA SEGURIDAD DE LA VACUNA EGF EN PACIENTES CON CANCER DE PULMÓN AVANZADO

Abstract

Purpose: In this work we undertook a meta-analysis of pooled data from 6 Clinical Trials of vaccination with Epidermal Growth Factor (EGF) in patients with advanced non small cell lung cancer (NSCLC). We realize a meta-analysis with the objective to evaluate the safety of vaccine. Patients and methods: 221 patients with advanced disease were included in 6 Clinical Trials and vaccinated with the EGF Vaccine with the following distribution: Pilot I (12 patients), Pilot II (34 patients), Pilot III (25 patients), Pilot IV (42 patients) Pilot V (28 patients) and Phase II (80 patients). The trials were designed to evaluate the immunogenicity and safety of the vaccine using different adjutants (alum and Montanide ISA 51), cyclophosphamide pre-treatment or not so as different dosages of the Vaccine). To evaluate the safety of vaccine we analyzed the behavior of all hematological and hemochemical laboratory variables and the apparition of adverse events during the time of study. The majority of adverse event found was light and moderate and they weren’t always related with the product administered during the study. Conclusion: Vaccination with EGF is safe and influence in survival of advanced NSCLC patients, therefore it improves the quality of live in patient with advanced lung cance