Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study.
Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study.
复制标题
新辅助重组人血管内皮抑素、多西紫杉醇和表柔比星治疗乳腺癌：前瞻性、随机、II 期研究的疗效和安全性
DOI：
10.1186/1471-2407-13-248
复制
发表时间：
2013-05-21
期刊：
影响因子：
3.8
通讯作者：
Wang L
中科院分区：
文献类型：
--
作者：
Chen J;Yao Q;Li D;Zhang J;Wang T;Yu M;Zhou X;Huan Y;Wang J;Wang L
重组人内皮抑素（rh-endostatin）是我国开发的一种新型抗血管生成药物。已有实验表明，重组人内皮抑素能抑制内皮细胞和某些肿瘤细胞的增殖和迁移。在这项研究中，我们评估了联合治疗的疗效和安全性的rh-endostatin和新辅助化疗乳腺癌患者在一个前瞻性，随机，对照，II期试验。将68例经组织芯活检证实的乳腺癌患者随机分为两组，接受3个周期的新辅助DE静脉给药（多西他赛：75 mg/m2，d1，表阿霉素：75 mg/m2，d1，每3周一次）或新辅助DE联合rh-endostatin（7.5 mg/m2，d1-d14，每3周一次）。主要终点是基于实体瘤疗效评价标准的临床疗效，次要终点是安全性和生活质量。所有患者均可进行毒性评估，64例（94.2%）可进行疗效评估。化疗组的客观有效率为67.7%（n = 31），rh-endostatin+化疗组的客观有效率为90.9%（n = 33）（P = 0.021）。回顾性亚组分析显示，rh-endostatin在绝经前患者和ECOG评分为0的患者中更有效（分别为P = 0.002和P = 0.049）。rh-endostatin联合化疗组中5例患者达到病理完全缓解，而化疗组中2例患者达到病理完全缓解（P = 0.428）。两组患者生活质量评分及不良反应差异无统计学意义（P > 0.05）。rh-endostatin联合化疗在乳腺癌患者中产生了更高的肿瘤缓解率，而不会增加毒性。ClinicalTrials.gov标识符，NCT 00604435
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. 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/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. 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). The combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. ClinicalTrials.gov Identifier, NCT00604435
登录
查看更多内容
影响因子：
45.3
作者：
SMITH, IE;WALSH, G;BAUM, M
通讯作者：
BAUM, M
影响因子：
16
作者：
Abdollahi, A;Hahnfeldt, P;Huber, PE
通讯作者：
Huber, PE
影响因子：
50.5
作者：
Apolone, G;Filiberti, A;Mosconi, P
通讯作者：
Mosconi, P
影响因子：
2.8
作者：
Jia, Yitao;Liu, Min;Huang, Wangang;Wang, Zhenbao;He, Yutong;Wu, Jianhua;Ren, Shuguang;Ju, Yingchao;Geng, Ruichao;Li, Zhongxin
通讯作者：
Li, Zhongxin
影响因子：
20.4
作者：
Han, Baohui;Xiu, Qingyu;Jin, Xianqiao
通讯作者：
Jin, Xianqiao