Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy

Jong Yeup Kim,1 Dong Won Yang,1 Sangjae Kim,2 Jong Gwon Choi3 1Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon, Republic of Korea; 2Department of Research and Development, Teloid Inc., Los Angeles, CA, 90010, USA; 3Department of Oncology-Hematology, Konyang Uni...

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Main Authors: Kim JY, Yang DW, Kim S, Choi JG
Format: Article
Language:English
Published: Dove Medical Press 2023-12-01
Series:Breast Cancer: Targets and Therapy
Subjects:
Online Access:https://www.dovepress.com/retrospective-analysis-of-the-clinical-characteristics-of-patients-wit-peer-reviewed-fulltext-article-BCTT
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author Kim JY
Yang DW
Kim S
Choi JG
author_facet Kim JY
Yang DW
Kim S
Choi JG
author_sort Kim JY
collection DOAJ
description Jong Yeup Kim,1 Dong Won Yang,1 Sangjae Kim,2 Jong Gwon Choi3 1Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon, Republic of Korea; 2Department of Research and Development, Teloid Inc., Los Angeles, CA, 90010, USA; 3Department of Oncology-Hematology, Konyang University Hospital, Daejeon, Republic of KoreaCorrespondence: Jong Gwon Choi, Oncology-Hematology, Konyang University Hospital, 158 Gwanjeodong-Ro, Seo-Gu, Daejeon, Republic of Korea, Email jabuss@naver.comPurpose: 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.Keywords: telomerase, GV1001, quality of life, safety, breast cancer
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spelling doaj.art-393955e25db54ed4b47516043fb7d7ff2023-12-21T17:27:36ZengDove Medical PressBreast Cancer: Targets and Therapy1179-13142023-12-01Volume 1595596689214Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic ChemotherapyKim JYYang DWKim SChoi JGJong Yeup Kim,1 Dong Won Yang,1 Sangjae Kim,2 Jong Gwon Choi3 1Department of Biomedical Informatics, College of Medicine, Konyang University, Daejeon, Republic of Korea; 2Department of Research and Development, Teloid Inc., Los Angeles, CA, 90010, USA; 3Department of Oncology-Hematology, Konyang University Hospital, Daejeon, Republic of KoreaCorrespondence: Jong Gwon Choi, Oncology-Hematology, Konyang University Hospital, 158 Gwanjeodong-Ro, Seo-Gu, Daejeon, Republic of Korea, Email jabuss@naver.comPurpose: 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.Keywords: telomerase, GV1001, quality of life, safety, breast cancerhttps://www.dovepress.com/retrospective-analysis-of-the-clinical-characteristics-of-patients-wit-peer-reviewed-fulltext-article-BCTTtelomerasegv1001quality of lifesafetybreast cancer
spellingShingle Kim JY
Yang DW
Kim S
Choi JG
Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
Breast Cancer: Targets and Therapy
telomerase
gv1001
quality of life
safety
breast cancer
title Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
title_full Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
title_fullStr Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
title_full_unstemmed Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
title_short Retrospective Analysis of the Clinical Characteristics of Patients with Breast Cancer Treated with Telomerase Peptide Immunotherapy Combined with Cytotoxic Chemotherapy
title_sort retrospective analysis of the clinical characteristics of patients with breast cancer treated with telomerase peptide immunotherapy combined with cytotoxic chemotherapy
topic telomerase
gv1001
quality of life
safety
breast cancer
url https://www.dovepress.com/retrospective-analysis-of-the-clinical-characteristics-of-patients-wit-peer-reviewed-fulltext-article-BCTT
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