Combination of recombinant human endostatin and neoadjuvant chemotherapy for breast cancer
OBJECTIVE: Recombinant human endostatin (rh-Endostatin), a protein modified by an additional nine-amino acid sequence to the N-terminal of endostatin, is a novel antiangiogenesis drug developed in China. The preclinical data suggested that it can inhibit proliferation and migration not only in endothelial cells, but also in some types of tumor cells. Theoretically, antiangiogenesis drugs should also be effective in the therapy of other solid tumors, including breast cancer. Here a prospective, randomized, controlled, phase II trial of combining rh-Endostatin and neoadjuvant chemotherapy was performed to evaluate its efficacy and safety profiles in patients with breast cancer.
METHODS: A total of 68 patients with pathologically confirmed breast cancer were randomly assigned to receive the neoadjuvant DE regimen (docetaxel: 75 mg/m(2), d1, epirubicin: 75 mg/m(2), d1) every 3 weeks with or without rh-Endostatin (7.5 mg/m(2), d1-d14). Surgical resection was performed after 3 cycles of neoadjuvant treatment. The primary end-points were objective response rate (ORR) and pathological complete response rate (PCRR) while the secondary end-points quality of life (QOL) and toxicity.
RESULTS: Among all of them, 64 were assessable for efficacy and 68 for toxicity. The ORRs were 90.9% (30/33) and 67.7% (21/31) in the combination and control groups respectively (P = 0.021). The stratification analysis showed that rh-Endostatin was more effective in the treatment of pre-menopausal and Eastern Cooperative Oncology Group (ECOG) = 0 patients (P < 0.05). The PCRRs were 15.2% (5/33) and 6.5% (2/31) in the combination and control groups respectively (P = 0.428). No significant difference was identified in QOL score and side effects (P > 0.05).
CONCLUSIONS: Compared with DE regimen alone, the combination of rh-Endostatin with DE chemotherapy may achieve a higher ORR with no increased toxicity in breast cancer patients. Thus it can be utilized safely and effectively in the neoadjuvant treatment of breast cancer.
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2012 |
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| Erschienen: |
2012 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:92 |
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| Enthalten in: |
Zhonghua yi xue za zhi - 92(2012), 10 vom: 13. März, Seite 668-71 |
| Sprache: |
Chinesisch |
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| Beteiligte Personen: |
Chen, Jiang-hao [VerfasserIn] |
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| Themen: |
Clinical Trial, Phase II |
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| Anmerkungen: |
Date Completed 20.03.2013 Date Revised 11.07.2012 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM21930937X |
|---|
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| 245 | 1 | 0 | |a Combination of recombinant human endostatin and neoadjuvant chemotherapy for breast cancer |
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| 500 | |a Date Revised 11.07.2012 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: Recombinant human endostatin (rh-Endostatin), a protein modified by an additional nine-amino acid sequence to the N-terminal of endostatin, is a novel antiangiogenesis drug developed in China. The preclinical data suggested that it can inhibit proliferation and migration not only in endothelial cells, but also in some types of tumor cells. Theoretically, antiangiogenesis drugs should also be effective in the therapy of other solid tumors, including breast cancer. Here a prospective, randomized, controlled, phase II trial of combining rh-Endostatin and neoadjuvant chemotherapy was performed to evaluate its efficacy and safety profiles in patients with breast cancer | ||
| 520 | |a METHODS: A total of 68 patients with pathologically confirmed breast cancer were randomly assigned to receive the neoadjuvant DE regimen (docetaxel: 75 mg/m(2), d1, epirubicin: 75 mg/m(2), d1) every 3 weeks with or without rh-Endostatin (7.5 mg/m(2), d1-d14). Surgical resection was performed after 3 cycles of neoadjuvant treatment. The primary end-points were objective response rate (ORR) and pathological complete response rate (PCRR) while the secondary end-points quality of life (QOL) and toxicity | ||
| 520 | |a RESULTS: Among all of them, 64 were assessable for efficacy and 68 for toxicity. The ORRs were 90.9% (30/33) and 67.7% (21/31) in the combination and control groups respectively (P = 0.021). The stratification analysis showed that rh-Endostatin was more effective in the treatment of pre-menopausal and Eastern Cooperative Oncology Group (ECOG) = 0 patients (P < 0.05). The PCRRs were 15.2% (5/33) and 6.5% (2/31) in the combination and control groups respectively (P = 0.428). No significant difference was identified in QOL score and side effects (P > 0.05) | ||
| 520 | |a CONCLUSIONS: Compared with DE regimen alone, the combination of rh-Endostatin with DE chemotherapy may achieve a higher ORR with no increased toxicity in breast cancer patients. Thus it can be utilized safely and effectively in the neoadjuvant treatment of breast cancer | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a English Abstract | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, U.S. Gov't, Non-P.H.S. | |
| 650 | 7 | |a Endostatins |2 NLM | |
| 650 | 7 | |a Recombinant Proteins |2 NLM | |
| 700 | 1 | |a Li, Dong |e verfasserin |4 aut | |
| 700 | 1 | |a Yao, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Ju-liang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Ting |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Ling |e verfasserin |4 aut | |
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