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This randomized phase  II  study investigated the immunological efficacy of herbal medicines ( HM ) using Hochu‐ekki‐to and Keishi‐bukuryo‐gan in combination with personalized peptide vaccination ( PPV ) for castration‐resistant prostate cancer ( CRPC ). Seventy patients with  CRPC  were assigned to two arms;  PPV  plus  HM  or  PPV  alone. Two to four peptides were chosen from 31 peptides derived from cancer antigens for a s.c. injection of  PPV  given eight times according to the patient's human leukocyte antigen type and levels of antigen‐specific IgG titer before  PPV  treatment. Peptide‐specific  CTL , IgG, regulatory T cells (Treg), monocytic myeloid‐derived suppressor cells (Mo‐ MDSC ), and interleukin‐6 ( IL ‐6) responses were measured before and at the eighth vaccination. Clinical outcomes were also analyzed. Combination therapy of  PPV  with  HM  was well tolerated without severe adverse events. There was no significant change in antigen‐specific IgG,  CTL , Treg or clinical outcomes. Combination therapy of  PPV  with  HM  stabilized the frequency of Mo‐ MDSC  (1.91%–1.92%,  P  = 0.96) and serum levels of  IL ‐6 (19.2 pg/ mL  to 16.1 pg/ mL ,  P  = 0.63) during the treatment. In contrast, the frequency of Mo‐ MDSC  and levels of  IL ‐6 in the  PPV ‐alone group were significantly increased (0.91%–1.49% for Mo‐ MDSC  and 9.2 pg/ mL  to 19.4 pg/ mL  for  IL ‐6, respectively). These results suggest that the combined use of  HM  has the potential to prevent the immunosuppression induced by Mo‐ MDSC  or  IL ‐6 during immunotherapy. More research is needed to validate the findings of the present study.

Immunological efficacy of herbal medicines in prostate cancer patients treated by personalized peptide vaccine