Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer.

PURPOSE: We show the result of a randomized phase II clinical trial with an epidermal growth factor (EGF)-based cancer vaccine in advanced non-small-cell lung cancer (NSCLC) patients, evaluating immunogenicity, safety, and effect on survival. PATIENTS AND METHODS: Eighty patients with stage IIIB/IV NSCLC after finishing first-line chemotherapy were randomly assigned to receive best supportive care or EGF vaccinations. RESULTS: Vaccination was safe. Adverse events were observed in less than 25% of cases and were grade 1 or 2 according to National Cancer Institute Common Toxicity Criteria. Good anti-EGF antibody response (GAR) was obtained in 51.3% of vaccinated patients and in none of the control group. Serum EGF concentration showed a major decrease in 64.3% of vaccinated patients. GAR patients survived significantly more than those with poor antibody response (PAR). Also, patients whose serum EGF dropped below 168 pg/mL survived significantly more than the rest. There was a trend to an increased survival for vaccinated patients compared with controls. The survival advantage for vaccinated patients compared with controls was statistically significant in the subgroup of patients with age younger than 60 years. CONCLUSION: Vaccination with EGF was safe and provoked an increase in anti-EGF antibody titers and a decrease in serum EGF. There was a direct correlation between antibody response and survival. There was a direct correlation between decrease in serum EGF and survival. In patients younger than 60 years, vaccination was associated with increased survival.

Treatment of NSCLC Patients with an EGF-Based Cancer Vaccine

Epidermal Growth Factor (EGF) promotes tumor cell proliferation and survival uponbinding to its receptor. We have developed a new active specific immunotherapy based on EGF deprivation. In the present paper, we show the results of a Phase I trial in 43patients with advanced non-small cell lung cancer (NSCLC) who received the EGF vaccine. Patients who had already received first line therapy were randomized to receive a singleor double dose of the EGF vaccine, weekly for four weeks and monthly thereafter. No significant toxicity was seen after vaccination. Adverse events consisted primarily of fever,chills, nausea, vomiting and flushing. Fifteen patients (39percent) developed a good antibody response (GAR) against EGF. The geometric mean of the antibody titer was higher in thedouble dose group. EGF concentration was quantified in serum. An inverse correlation between anti-EGF antibody titers and EGF concentration was seen after immunization. Vaccinated patients achieved median survival times of 8.23 months from randomization. Patients who received the double dose of treatment showed a trend toward increased survival in comparison with patients who received the single dose. GAR and patients in whom the serum EGF decreased below the 168 pg/ml cut-off point had a significantly better survival when compared to poor responders or patients in which the EGF levels were not considerably reduced. Our results confirm the immunogenicity of the EGF vaccine in the treatment of patients with advanced stage NSCLC. Antibody titers and serum EGF levels appear to correlate with patient survival(AU)

Factor de Crecimiento Epidérmico (FEAG) promueve la proliferación celular tumoral y la supervivencia a unión a su receptor. Hemos desarrollado un nuevo principio activo basado en la inmunoterapia específica sobre la privación FEAG. En el presente trabajo, mostramos los resultados de un ensayo fase I en 43 pacientes con avanzado de células no pequeñas de cáncer de pulmón (CPNM) que recibieron la vacuna contra el FEAG. Los pacientes que ya habían recibido terapia de primera línea fueron asignados aleatoriamente a recibir un solo o doble dosis de la vacuna contra el FEAG, la semana durante cuatro semanas y mes. No toxicidad significativa fue visto después de la vacunación. Los eventos adversos se componía fundamentalmente de fiebre, escalofríos, náuseas, vómitos y enrojecimiento. Quince pacientes (39 por ciento) desarrollaron un buen anticuerpo respuesta (GAR) contra FEAG. La media geométrica de los anticuerpos fue mayor en el dosis doble grupo. FEAG se cuantificó la concentración en el suero. Una correlación inversa entre la lucha contra la FEAG los títulos de anticuerpos y FEAG concentración fue visto después de la vacunación. Pacientes vacunados alcanzado los tiempos medios de supervivencia de 8,23 meses desde la aleatorización. Los pacientes que recibieron la dosis doble de tratamiento mostraron una tendencia hacia un mayor la supervivencia en comparación con los pacientes que recibieron la dosis única. GAR y los pacientes en los cuales el suero FEAG disminuyó por debajo de los 168 pg / ml punto de corte tenía una significativa una mejor supervivencia en comparación con los pobres o los pacientes con respuesta en la que el FEAG niveles no se redujo considerablemente. Nuestros resultados confirman la inmunogenicidad de la vacuna contra el FEAG en el tratamiento de pacientes con CPNM avanzado. Los títulos de anticuerpos en suero y FEAG niveles parecen correlacionarse con la supervivencia de los pacientes

Análisis del cáncer broncopulmonar en el Instituto Nacional de Oncología y Radiobiología según las necropsias revisadas durante un período de 11 años (1972-1983) / Analysis of bronchopulmonary cancer at the National Institute of Oncology and Radiobiology, according to necropsies, during an 11 year period (1972-1983)

Por la importancia que tiene el cáncer del pulmón y su elevada morbimortalidad se revisaron 343 necropsias con el propósito de analizar los distintos factores presuntos. Se realizaron conclusiones

Análisis del cáncer broncopulmonar en el Instituto Nacional de Oncología y Radiobiología según las necropsias revisadas durante un período de 11 años (1972-1983) / Analysis of bronchopulonary cancer at the National Institute of Oncology and Radiobiology, according to necropsies, during an 11 year period (1972-1983)

Por la importancia que tiene el cáncer del pulmón y su elevada morbimortalidad se revisaron 343 necropsias con el propósito de analizar los distintos factores presuntos. Se realizaron conclusiones