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Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study

BACKGROUND: Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Previous experiments have shown that rh-endostatin can inhibit the proliferation and migration of endothelial cells and some types of tumor cells. In this study, we evaluated the efficacy an...

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Autores principales: Chen, Jianghao, Yao, Qing, Li, Dong, Zhang, Juliang, Wang, Ting, Yu, Ming, Zhou, Xiaodong, Huan, Yi, Wang, Jing, Wang, Ling
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664086/
https://www.ncbi.nlm.nih.gov/pubmed/23693018
http://dx.doi.org/10.1186/1471-2407-13-248
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author Chen, Jianghao
Yao, Qing
Li, Dong
Zhang, Juliang
Wang, Ting
Yu, Ming
Zhou, Xiaodong
Huan, Yi
Wang, Jing
Wang, Ling
author_facet Chen, Jianghao
Yao, Qing
Li, Dong
Zhang, Juliang
Wang, Ting
Yu, Ming
Zhou, Xiaodong
Huan, Yi
Wang, Jing
Wang, Ling
author_sort Chen, Jianghao
collection PubMed
description BACKGROUND: Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Previous experiments have shown that rh-endostatin can inhibit the proliferation and migration of endothelial cells and some types of tumor cells. In this study, we evaluated the efficacy and safety profiles of combination therapy of rh-endostatin and neoadjuvant chemotherapy for breast cancer patients in a prospective, randomized, controlled, phase II trial. METHODS: Sixty-eight patients with core-biopsy confirmed breast cancer were allocated randomly to two groups to receive 3 cycles of intravenous administration of either neoadjuvant DE (docetaxel: 75 mg/m(2), d1, epirubicin: 75 mg/m(2), d1, every 3 weeks), or neoadjuvant DE combined with rh-endostatin (7.5 mg/m(2), d1-d14, every 3 weeks). The primary end point was clinical response based upon Response Evaluation Criteria in Solid Tumors, and the secondary end point was safety and quality of life. RESULTS: All patients were assessable for toxicity and 64 (94.2%) were assessable for efficacy evaluation. The objective response rate was 67.7% for chemotherapy (n = 31) and 90.9% for rh-endostatin plus chemotherapy (n = 33) (P = 0.021). A retrospective subset analysis revealed that rh-endostatin was more effective in premenopausal patients and patients with ECOG score of zero (P = 0.002 and P = 0.049, respectively). Five patients in the rh-endostatin plus chemotherapy arm achieved pathologic complete response compared with 2 in the chemotherapy arm (P = 0.428). No significant difference was identified in quality of life score and side effects (P > 0.05). CONCLUSION: The combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT00604435
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spelling pubmed-36640862013-05-26 Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study Chen, Jianghao Yao, Qing Li, Dong Zhang, Juliang Wang, Ting Yu, Ming Zhou, Xiaodong Huan, Yi Wang, Jing Wang, Ling BMC Cancer Research Article BACKGROUND: Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Previous experiments have shown that rh-endostatin can inhibit the proliferation and migration of endothelial cells and some types of tumor cells. In this study, we evaluated the efficacy and safety profiles of combination therapy of rh-endostatin and neoadjuvant chemotherapy for breast cancer patients in a prospective, randomized, controlled, phase II trial. METHODS: Sixty-eight patients with core-biopsy confirmed breast cancer were allocated randomly to two groups to receive 3 cycles of intravenous administration of either neoadjuvant DE (docetaxel: 75 mg/m(2), d1, epirubicin: 75 mg/m(2), d1, every 3 weeks), or neoadjuvant DE combined with rh-endostatin (7.5 mg/m(2), d1-d14, every 3 weeks). The primary end point was clinical response based upon Response Evaluation Criteria in Solid Tumors, and the secondary end point was safety and quality of life. RESULTS: All patients were assessable for toxicity and 64 (94.2%) were assessable for efficacy evaluation. The objective response rate was 67.7% for chemotherapy (n = 31) and 90.9% for rh-endostatin plus chemotherapy (n = 33) (P = 0.021). A retrospective subset analysis revealed that rh-endostatin was more effective in premenopausal patients and patients with ECOG score of zero (P = 0.002 and P = 0.049, respectively). Five patients in the rh-endostatin plus chemotherapy arm achieved pathologic complete response compared with 2 in the chemotherapy arm (P = 0.428). No significant difference was identified in quality of life score and side effects (P > 0.05). CONCLUSION: The combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT00604435 BioMed Central 2013-05-21 /pmc/articles/PMC3664086/ /pubmed/23693018 http://dx.doi.org/10.1186/1471-2407-13-248 Text en Copyright © 2013 Chen et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Chen, Jianghao
Yao, Qing
Li, Dong
Zhang, Juliang
Wang, Ting
Yu, Ming
Zhou, Xiaodong
Huan, Yi
Wang, Jing
Wang, Ling
Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title_full Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title_fullStr Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title_full_unstemmed Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title_short Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study
title_sort neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase ii study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664086/
https://www.ncbi.nlm.nih.gov/pubmed/23693018
http://dx.doi.org/10.1186/1471-2407-13-248
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