Abstract
We conducted two types of phase I clinical studies using 1) tailor-made type of cancer vaccines (TM-type), namely peptides showing higher immune responses (a maximum of four peptides), or 2) peptides derived from colorectal cancer (CR-type) by using cDNA microarray profiling in combination with oral chemotherapy of UFT and LV for patients with metastatic colorectal cancer who had failed to respond to the standard therapy. Fourteen patients with TM-type and 20 patients with CR-type were enrolled. All adverse events were grade 1 or 2, and both protocols were well tolerated in all patients enrolled. Although no patients showed either complete of partial response in both protocols, stable disease (SD) was observed in 46-83% of them. Interestingly, overall survival was well correlated with increased levels of peptide-specific responses in both protocols. The longest survivor survived more than 1,000 days in both protocols. The cancer vaccine therapy with oral chemotherapy demonstrated satisfactory safety and good immunogenicity as well as promising disease control rate, and therefore warrants further clinical studies.
