| 黄 平,刘雅娟,陈占红.曲妥珠单抗一线治疗66例HER2阳性转移性乳腺癌的疗效和安全性分析[J].肿瘤学杂志,2017,23(6):517-522. |
| 曲妥珠单抗一线治疗66例HER2阳性转移性乳腺癌的疗效和安全性分析 |
| Efficacy and Safety of Trastuzumab in the First-line Treatment of 66 Patients with HER2-positive Metastatic Breast Cancer |
| 投稿时间：2017-03-31 |
| DOI：10.11735/j.issn.1671-170X.2017.06.B012 |
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| 中文关键词: 曲妥珠单抗 乳腺肿瘤 转移性肿瘤 疗效 安全性 |
| 英文关键词:trastuzumab breast neoplasms metastasis efficacy safety |
| 基金项目:浙江省重大科技专项计划项目（2012C13019-1） |
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| 中文摘要: |
| 摘 要：［目的］ 探讨曲妥珠单抗一线治疗人表皮生长因子受体2（HER2）阳性转移性乳腺癌患者的疗效和安全性。［方法］ 回顾性分析66例曲妥珠单抗联合化疗药物一线治疗HER2阳性转移性乳腺癌患者的临床疗效和不良反应。心脏功能的变化采用彩色超声心动图监测左心室射血分数（LVEF）。 ［结果］ 66例患者中，完全缓解（CR）3例（4.54%），部分缓解（PR）52例（78.79%），疾病稳定（SD）9例（13.64%），疾病进展（PD）2例（3.03%），客观有效率（ORR）为83.33%（55/66）。中位无进展生存期(mPFS)为12.0个月，中位总生存期（OS）为38.0个月，1、2、3、5、10年生存率为98.5%、80.3%、57.6%、30.3%和11.4%。单因素及多因素分析显示，转移灶的数量是影响PFS的独立因素（P＜0.05），转移灶的数量、曲妥珠单抗累积使用时间是影响OS的独立因素（均P＜0.05）。曲妥珠单抗治疗相关的不良反应主要表现为心脏功能的下降，最重为3级LVEF下降，发生率为1.5%（1例）。［结论］ 曲妥珠单抗一线治疗HER2阳性转移性乳腺癌患者疗效明显且安全。小负荷转移病灶及早并长期应用曲妥珠单抗治疗，能给患者带来生存获益。 |
| 英文摘要: |
| Abstract：［Objective］ To investigate the efficacy and safety of trastuzumab in the treatment of human epidermal growth factor receptor 2(HER2) positive metastatic breast cancer. ［Methods］ The clinical efficacy and side effects of trastuzumab plus chemotherapy in the first-line treatment of 66 patients with HER2-positive metastatic breast cancer were analyzed retrospectively. Cardiac function changes in left ventricular ejection fraction(LVEF) were monitored by color echocardiography.［Results］ Three patients had complete remission(CR)(4.54%)，52 patients had partial remission(PR)(78.79%)，9 patients had disease stable(SD)(13.64%)，and 2 patients had disease progression(PD)(3.03%). The objective response rate(ORR) was 83.33%(55/66). The median progression-free survival(mPFS) was 12.0 months. The median overall survival(OS)was 38.0 months. The 1-，2-，3-，5-，and 10-year survival rates were 98.5%，80.3%，57.6%，30.3% and 11.4%. Univariate and multivariate analyses showed that the number of metastatic lesions was an independent prognostic factor of PFS(P<0.05). The number of metastatic lesions and the cumulative use time of trastuzumab were independent prognostic factors of OS(P<0.05). The main trastuzumab-related adverse reaction was degression of cardiac function，and the most severe was grade 3 LVEF decline，and the incidence was 1.5%(n=1). ［Conclusion］ Trastuzumab as the first-line treatment in patients with HER2-positive metastatic breast cancer is effective and safe. Early long-term use of trastuzumab in patients with small load metastases can lead to survival benefit. |
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