Chen Jiang-hao, Li Dong, Yao Qing, Zhang Ju-liang, Wang Ting, Wang Ling
Department of Vascular & Endocrine Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.
Zhonghua Yi Xue Za Zhi. 2012 Mar 13;92(10):668-71.
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.
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.
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).
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.
重组人内皮抑素（rh-Endostatin）是一种在中国研发的新型抗血管生成药物，其在内皮抑素的N端额外添加了一个九氨基酸序列。临床前数据表明，它不仅可以抑制内皮细胞的增殖和迁移，还可以抑制某些类型肿瘤细胞的增殖和迁移。理论上，抗血管生成药物在包括乳腺癌在内的其他实体瘤治疗中也应有效。在此进行了一项前瞻性、随机、对照、II期试验，以评估rh-Endostatin联合新辅助化疗在乳腺癌患者中的疗效和安全性。
总共68例经病理确诊的乳腺癌患者被随机分配，每3周接受新辅助DE方案（多西他赛：75mg/m²，第1天；表柔比星：75mg/m²，第1天），联合或不联合rh-Endostatin（7.5mg/m²，第1 - 14天）。新辅助治疗3个周期后进行手术切除。主要终点是客观缓解率（ORR）和病理完全缓解率（PCRR），次要终点是生活质量（QOL）和毒性。
其中，64例可评估疗效，68例可评估毒性。联合组和对照组的ORR分别为90.9%（30/33）和67.7%（21/31）（P = 0.021）。分层分析表明，rh-Endostatin在绝经前和东部肿瘤协作组（ECOG）= 0的患者治疗中更有效（P < 0.05）。联合组和对照组的PCRR分别为15.2%（5/33）和6.5%（2/31）（P = 0.428）。QOL评分和副作用方面未发现显著差异（P > 0.05）。
与单纯DE方案相比，rh-Endostatin联合DE化疗在乳腺癌患者中可能实现更高的ORR，且毒性不增加。因此，它可以安全有效地用于乳腺癌的新辅助治疗。
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