Cancer vaccine is proceeding to a promising therapy against cancer since 1990 when expression cloning method of tumor associated antigens was reported. Clinical trials showed immunological therapies contribute to prolonged survival in patients with cancers, such as prostate cancer and melanoma, so that FDA approved a dendritic cell vaccine in USA, and peptide vaccines are developing energetically in recent years in Japan. Peptide vaccines have advantages immunologically and economically as a cancer vaccine spreads all over the world, because CTL epitope peptides of tumor associate antigen has a highly antigen-specificity, and can be synthesized uniformly in large quantities for easy handing agents. However it has weak points, such as limited effectiveness in clinical responses due to cancer cells escaped from cancer immunity and possibility of unfavorable immune responses. For development of cancer peptide vaccines, biomarkers related with clinical effects and methods to measure favorable and unfavorable immune responses are necessary about vaccine alone and combination with multidisciplinary modalities in large scale phase III studies.

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