title: [Development of Peptide Vaccines for Triple-Negative Breast Cancer Treatment].
abstract: Our previous phase II clinical trial showed that therapeutically selected personalized peptide vaccines(PPVs)were effective at boosting anticancer immunity; the immune response after PPV was associated with a clinical outcome as a prognostic factor for metastatic breast cancer(mBC). We conducted an early phase II study to evaluate the safety and efficacy of a new regimen using multiple peptide vaccines(KRM-19)for patients with metastatictriple -negative breast cancer. KRM-19 consisted of 19 mixed peptides chosen from the previously reported 31 PPVs according to their anti-tumor immunologiceffec ts and safety profiles for patients with mBC. All patients had histologically confirmed measurable ER-PgR-HER2- mBC and their human leukocyte antigen(HLA) / -A molecules were A2, A3, A11, A24, A26, A31, or A33. KRM-19(19mg/mL)was administrated subcutaneously every week for a total of 6 doses. Concurrent conventional chemo- and/or endocrine therapy were not permitted during treatment. This was an open-label, early phase II study. The primary endpoint was safety and anti-tumor immunologic effect, while the secondary endpoints were clinical responses and progression-free survival(PFS). The estimated enrollment was 10-15 and 8 patients were enrolled(Clinical trial registry number: UMIN000014616). Measurement of peptide-specific cytotoxic T lymphocyte and IgG responses were conducted before and after vaccination. The correlation between PFS and the increased IgG response and/or CTL levels were investigated.
authors.affiliation: Dept. of Surgery Kurume University School of Medicine.
authors.forename: Uhi
authors.initials: U
authors.lastname: Toh
authors.forename: Shuko
authors.initials: S
authors.lastname: Saku
authors.forename: Mina
authors.initials: M
authors.lastname: Okabe
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Iwakuma
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kimitsuki
authors.forename: Momoko
authors.initials: M
authors.lastname: Akashi
authors.forename: Etsuyo
authors.initials: E
authors.lastname: Ogo
authors.forename: Akira
authors.initials: A
authors.lastname: Yamada
authors.forename: Shigeki
authors.initials: S
authors.lastname: Shichijo
authors.forename: Kyogo
authors.initials: K
authors.lastname: Itoh
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Akagi
mesh_terms: D019496:Cancer Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000276:immunology; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
chemical_list: D019496:Cancer Vaccines; D022223:Vaccines, Subunit