Abstract
BackgroundRecombinant 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.MethodsSixty-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/m2, d1, epirubicin: 75 mg/m2, d1, every 3 weeks), or neoadjuvant DE combined with rh-endostatin (7.5 mg/m2, 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.ResultsAll 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).ConclusionThe combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients.Trial registrationClinicalTrials.gov Identifier, NCT00604435
Highlights
Recombinant human endostatin is a novel antiangiogenesis drug developed in China
Antiangiogenic therapy for cancer has attracted considerable attention. The rationale behind it is that tumor growth is dependent on angiogenesis [2], which was proposed by Dr Folkman and has been confirmed by basic and clinical research
Rh-endostatin increased tumor response rate, and significantly improved the overall survival (OS) without increasing the adverse effects. In another multicenter, randomized, double-blind, placebo-controlled study published in 2011, treatment with paclitaxel and carboplatin (TC) plus rhendostatin improved objective response rate (ORR) in patients with advanced non-small cell lung cancer (NSCLC) and exhibited a good safety profile, the differences in progression free survival (PFS) or OS were not statistically significant from Paclitaxel and carboplatin (TC) alone [6]. All these findings suggest that rh-endostatin may be effective as well in the treatment of other solid tumors, including breast cancer
Summary
Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Antiangiogenic therapy for cancer has attracted considerable attention. The rationale behind it is that tumor growth is dependent on angiogenesis [2], which was proposed by Dr Folkman and has been confirmed by basic and clinical research. Endostatin can directly target capillary endothelial cells around the tumor without detectable toxicity in normal cells. It may inhibit cell migration, induce cell apoptosis, and play a multitargeted antiangiogenic role by regulating expression of vascular endothelial growth factor (VEGF) and activity of proteolytic enzymes, indirectly leading to the quiescence or reduction of tumors [4]
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