title: A phase II study of a personalized peptide vaccination for chemotherapy-resistant advanced pancreatic cancer patients.
abstract: Pancreatic cancer is one of the most aggressive cancers with a median survival time (MST) of <6 months in chemotherapy-resistant patients. Therefore, the development of novel treatment modalities is needed. In the present study, a phase II study of personalized peptide vaccination (PPV) was conducted, in which vaccine antigens were selected and administered based on the pre-existing IgG responses to 31 different pooled peptides, for 41 chemotherapy-resistant advanced pancreatic cancer patients. No vaccine-related severe adverse events were observed. IgG responses specific to at least one of the vaccine peptides were augmented in 14 of 36 patients (39%) and in 18 of 19 patients (95%) tested after the 5th and 11th vaccination, respectively. MST from the first vaccination was 7.9 months with a 1-year survival rate of 26.8%. Higher serum amyloid A (SAA) and C-reactive protein (CRP) levels in pre-vaccination plasma were unfavorable factors for overall survival (OS). Due to the safety profile and the potential clinical efficacy, the conduction of additional clinical trials of PPV for chemotherapy-resistant advanced pancreatic cancer patients is warranted.
authors.affiliation: Department of Immunology and Immunotherapy, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Yutani
authors.forename: Nobukazu
authors.initials: N
authors.lastname: Komatsu
authors.forename: Munehiro
authors.initials: M
authors.lastname: Yoshitomi
authors.forename: Satoko
authors.initials: S
authors.lastname: Matsueda
authors.forename: Koji
authors.initials: K
authors.lastname: Yonemoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Mine
authors.forename: Masanori
authors.initials: M
authors.lastname: Noguchi
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishihara
authors.forename: Akira
authors.initials: A
authors.lastname: Yamada
authors.forename: Kyogo
authors.initials: K
authors.lastname: Itoh
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Sasada
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D006680:HLA Antigens / Q000276:immunology; D006801:Humans; D007136:Immunoglobulins / Q000032:analysis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000276:immunology / Q000627:therapeutic use*; D057285:Precision Medicine; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D014611:Vaccination; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D019496:Cancer Vaccines; D004338:Drug Combinations; D006680:HLA Antigens; D007136:Immunoglobulins; D010446:Peptide Fragments; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin; D000093542:Gemcitabine