Prospective phase II study of post-surgical adjuvant chemo-immunotherapy using autologous dendritic cells and activated killer cells from tissue culture of tumor draining lymph nodes in primary lung cancer patients

3048 Background: We conducted a phase II study to evaluate the efficacy and toxicity of adjuvant chemo-immunotherapy using dendritic cells and activated killer cells from tissue culture of tumor-draining lymph nodes (TDLN) in primary lung cancer patients. Methods: Pathological N2 lung cancer patients were selected for the post-surgical adjuvant chemo-immunotherapy. Activated killer cells and dendritic cells obtained from tissue cultures of TDLN or TDLN co-cultured with peripheral blood lymphocytes (TDLN-Pb) were used for the adoptive transfer of immunotherapy. Patients received 4 courses of post-surgical chemotherapy or chemotherapy along with immunotherapy (immunotherapy group) every 2 months for 2 years. Results: There were 57 N2 patients eligible for the study, 28 for immunotherapy and 29 for chemotherapy. For the 28 immunotherapy cases, a total of 313 courses of immunotherapy were administered. The main toxicities were fever (78.0%), chill (83.4%). The 5-year survival rates in the immunotherapy and chemotherapy groups were 56.5% and 12.5% respectively. Among the variables analyzed, immunotherapy was the most significant independent prognostic factor (p=0.0042.) Conclusions: Adoptive transfer of activated killer cells and dendritic cells from the tumor draining lymph nodes of primary lung cancer patients is safe and feasible, and a large-scale multi-institutional study is necessary for the evaluation of the efficacy of this treatment. No significant financial relationships to disclose.