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We previously reported a phase I clinical trial of a peptide vaccine ring finger protein 43 ( RNF 43) and 34‐ kD a translocase of the outer mitochondrial membrane ( TOMM 34) combined with uracil‐tegafur ( UFT )/ LV  for patients with metastatic colorectal cancer ( CRC ), and demonstrated the safety and immunological responsiveness of this combination therapy. In this study, we evaluated vaccination‐induced immune responses to clarify the survival benefit of the combination therapy as adjuvant treatment. We enrolled 44 patients initially in an  HLA ‐masked fashion. After the disclosure of  HLA , 28 patients were in the  HLA ‐A*2402‐matched and 16 were in the unmatched group. In the  HLA ‐matched group, 14 patients had positive  CTL  responses specific for the  RNF 43 and/or  TOMM 34 peptides after 2 cycles of treatment and 9 had negative responses; in the  HLA ‐unmatched group, 10  CTL  responses were positive and 2 negative. In the  HLA ‐matched group, 3‐year relapse‐free survival ( RFS ) was significantly better in the positive  CTL  subgroup than in the negative‐response subgroup. Patients with negative vaccination‐induced  CTL  responses showed a significant trend towards shorter  RFS  than those with positive responses. Moreover, in the  HLA ‐unmatched group, the positive  CTL  response subgroup showed an equally good 3‐year  RFS  as in the  HLA ‐matched group. In conclusion, vaccination‐induced  CTL  response to peptide vaccination could predict survival in the adjuvant setting for stage  III CRC .

Cytotoxic T lymphocyte response to peptide vaccination predicts survival in stage III colorectal cancer