PMID- 27760950 OWN - NLM STAT- MEDLINE DCOM- 20170127 LR - 20170127 IS - 0385-0684 (Print) IS - 0385-0684 (Linking) VI - 43 IP - 10 DP - 2016 Oct TI - [Development of Peptide Vaccines for Triple-Negative Breast Cancer Treatment]. PG - 1249-1251 AB - 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. FAU - Toh, Uhi AU - Toh U AD - Dept. of Surgery Kurume University School of Medicine. FAU - Saku, Shuko AU - Saku S FAU - Okabe, Mina AU - Okabe M FAU - Iwakuma, Nobutaka AU - Iwakuma N FAU - Kimitsuki, Yuko AU - Kimitsuki Y FAU - Akashi, Momoko AU - Akashi M FAU - Ogo, Etsuyo AU - Ogo E FAU - Yamada, Akira AU - Yamada A FAU - Shichijo, Shigeki AU - Shichijo S FAU - Itoh, Kyogo AU - Itoh K FAU - Akagi, Yoshito AU - Akagi Y LA - jpn PT - Journal Article PL - Japan TA - Gan To Kagaku Ryoho JT - Gan to kagaku ryoho. Cancer & chemotherapy JID - 7810034 RN - 0 (Cancer Vaccines) RN - 0 (Vaccines, Subunit) SB - IM MH - Cancer Vaccines/adverse effects/immunology/*therapeutic use MH - Clinical Trials as Topic MH - Humans MH - Triple Negative Breast Neoplasms/*drug therapy/immunology MH - Vaccines, Subunit/adverse effects/immunology/therapeutic use EDAT- 2016/10/21 06:00 MHDA- 2017/01/28 06:00 CRDT- 2016/10/21 06:00 PHST- 2016/10/21 06:00 [pubmed] PHST- 2017/01/28 06:00 [medline] PHST- 2016/10/21 06:00 [entrez] PST - ppublish SO - Gan To Kagaku Ryoho. 2016 Oct;43(10):1249-1251.