PMID- 38146419 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231227 IS - 1179-1314 (Print) IS - 1179-1314 (Electronic) IS - 1179-1314 (Linking) VI - 15 DP - 2023 TI - Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy. PG - 955-966 LID - 10.2147/BCTT.S431333 [doi] AB - PURPOSE: Telomerase activation, a critical step in cancer progression, occurs in approximately 95% of breast cancer cases. Telomerase is an attractive therapeutic target for breast cancer owing to its unique expression pattern. GV1001, a telomerase-derived peptide, is loaded onto human leukocyte antigen (HLA) class II antigen-presenting cells and binds to CD4+ T cell activating immune responses. This study aimed to evaluate the effectiveness and safety of co-administration of GV1001 and cytotoxic chemotherapy in patients with heavily-treated metastatic breast cancer. PATIENTS AND METHODS: We analyzed 63 patients with breast cancer who received both GV1001 and cytotoxic chemotherapy. The GV 1001 administration methods involves 0.56 mg intradermal injection three times during the first week, one time at weeks 2, 3, 4, and 6, and then once every 28 days. The primary endpoint of this study was quality of life according to EORTC QLO-C30 and EQ-5D, while the secondary endpoint was the antitumor response according to RECIST 1.1, progression-free survival, overall survival, and toxicity profile. RESULTS: In 34 patients with HR+ breast cancer evaluable for tumor response, the disease control rate (DCR) and overall response rate (ORR) were 58.8% and 26.4%, respectively. The DCR and ORR were 66.6% and 28.5% in 21 patients with HER-2+ and 50% and 25% in patients with triple-negative breast cancer (TNBC), respectively. The median progression free survival was 10.4, 8.7, and 5.6 months in HR+, HER-2+, TNBC, respectively. The overall survival was 19.7, 13.2, and 9.4 months for patients with HR+, HER-2+, and TNBC, respectively. Most patients had an improved quality of life with statistically significant differences in some variables. The patients in this study experienced no additional toxicities other than the cytotoxic chemotherapy-associated side effects. CONCLUSION: GV1001 is a relatively safe anticancer vaccine for patients with heavily-treated breast cancer and can to improve the quality of life. CI - (c) 2023 Kim et al. FAU - Kim, Jong Yeup AU - Kim JY AUID- ORCID: 0000-0003-1230-9307 AD - Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon, Republic of Korea. FAU - Yang, Dong Won AU - Yang DW AUID- ORCID: 0009-0002-5307-8971 AD - Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon, Republic of Korea. FAU - Kim, Sangjae AU - Kim S AUID- ORCID: 0009-0003-8877-1060 AD - Department of Research and Development, Teloid Inc., Los Angeles, CA, 90010, USA. FAU - Choi, Jong Gwon AU - Choi JG AUID- ORCID: 0000-0002-5085-902X AD - Department of Oncology-Hematology, Konyang University Hospital, Daejeon, Republic of Korea. LA - eng PT - Journal Article DEP - 20231221 PL - New Zealand TA - Breast Cancer (Dove Med Press) JT - Breast cancer (Dove Medical Press) JID - 101591856 PMC - PMC10749539 OTO - NOTNLM OT - GV1001 OT - breast cancer OT - quality of life OT - safety OT - telomerase COIS- The authors report no conflicts of interest in this work. EDAT- 2023/12/26 06:41 MHDA- 2023/12/26 06:42 PMCR- 2023/12/21 CRDT- 2023/12/26 03:41 PHST- 2023/08/28 00:00 [received] PHST- 2023/12/08 00:00 [accepted] PHST- 2023/12/26 06:42 [medline] PHST- 2023/12/26 06:41 [pubmed] PHST- 2023/12/26 03:41 [entrez] PHST- 2023/12/21 00:00 [pmc-release] AID - 431333 [pii] AID - 10.2147/BCTT.S431333 [doi] PST - epublish SO - Breast Cancer (Dove Med Press). 2023 Dec 21;15:955-966. doi: 10.2147/BCTT.S431333. eCollection 2023.