Epidermal growth factor vaccine in non-small-cell lung cancer.

After many years of uncertainty regarding the role of immunotherapy in cancer, we finally have vaccines approved for the treatment of some malignancies (e.g., prostate cancer and melanoma). In non-small-cell lung cancer, several vaccines are being studied in randomized Phase III clinical trials due to their promising results seen in the clinic, such as BLP-25 and melanoma-associated antigen A3. Traditionally, non-small-cell lung cancer has not been considered a good target for immunotherapy due to lack of immunogenicity and the strong presence of regulatory T cells, which do not allow an adequate immune response in the host. EGF vaccination is a novel area of immunotherapy for this disease. Thus far, there has been success in generating immune and clinical responses with this vaccine in several clinical trials, and we will review in depth the efficacy and toxicity of this novel agent.

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.