Objective: To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer. Methods: Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS). Results: A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks (HR=0.24; 95%CI, 0.16-0.36; P<0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% (P<0.000 1) and DCR was 79.72% vs 45.63% (P<0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity. Conclusion: The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.
目的： 评价注射用重组抗人表皮生长因子受体2（HER2）人源化单克隆抗体（赛普汀）联合长春瑞滨用于HER2阳性转移性乳腺癌的临床疗效和安全性。 方法： 受试者按2∶1比例随机至试验组和对照组，试验组接受赛普汀（首剂4 mg/kg，维持剂量每周2 mg/kg，静脉滴注）联合长春瑞滨（25 mg/m(2)，第1，8，15天/28天，静脉滴注）治疗；对照组接受长春瑞滨（25 mg/m(2)，第1，8，15天/28天，静脉滴注）化疗。主要研究终点为无进展生存期（PFS)。 结果： 2009年1月至2013年1月期间共纳入受试者315例（试验组212例，对照组103例）。试验组较对照组中位PFS显著延长，为39.1周比14.0周（HR=0.24;95%CI,0.16~0.36;P<0.000 1)。试验组客观缓解率（ORR）和疾病控制率（DCR）较对照组均显著提高，ORR为46.7%比18.45%(P<0.000 1)，DCR为79.72%比45.63%(P<0.000 1)。中性粒细胞减少、白细胞减少和红细胞减少在两组发生率均较高，但组间差异无统计学意义。与赛普汀相关的不良反应最常见的为输注反应。共5例受试者治疗中心脏左室射血分数降低至低于50%，均可恢复，未出现严重心脏毒性。 结论： 赛普汀联合长春瑞滨具有显著疗效和良好安全性，是用于紫杉类治疗后的HER2阳性晚期乳腺癌的优选方案，为中国HER2阳性乳腺癌患者提供了更多靶向治疗机会。.
Keywords: Breast cancer; Cipterbin; Receptor,epidermal growth factor; Recombinant anti-HER2 humanized monoclonal antibody; Vinorelbine.