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目的研究单药诺拉替尼(neratinib)和诺拉替尼联合曲妥珠单抗治疗表皮生长因子受体-2(HER-2)过表达难治性复发转移性乳腺癌的疗效和安全性。方法 17例HER-2过表达难治性复发转移性乳腺癌,其中10例为既往曲妥珠单抗治疗失败患者,4例为无症状脑转移患者。9例接受单药诺拉替尼治疗,8例接受诺拉替尼联合曲妥珠单抗治疗。诺拉替尼为口服240mg.d-1;曲妥珠单抗为首剂4 mg.kg-1静滴,维持剂量为2 mg.kg-1.周-1静滴。每4周为1周期,每2周期评价疗效同时记录不良事件。结果 17例患者可评价疗效,1例完全缓解,部分缓解8例,有效率52.9%(9/17)。单药诺拉替尼组有效率77.7%(7/9),诺拉替尼联合曲妥珠单抗组有效率25%(2/8)。2例脑转移患者颅内病灶明显好转,2例脑转移颅内病灶稳定。共17例患者261周期可评价毒性反应,其中腹泻是主要不良反应,Ⅱ～Ⅲ度占47.1%(8/17),预防性应用止泻药物后可以得到控制。结论单药诺拉替尼和诺拉替尼联合曲妥珠单抗是治疗HER-2过表达难治性复发转移性乳腺癌的有效方案,部分脑转移患者中显示出一定疗效。其最常见不良反应为腹泻,经过对症处理后总体不良反应能够耐受。
Objective To investigate the efficacy and safety of single-agent combination of neratinib and norabitinib combined with trastuzumab in the treatment of epidermal growth factor receptor-2 (HER-2) overexpressing refractory and relapsed metastatic breast cancer . Methods Seventeen patients with HER-2 overexpressing refractory and relapsed metastatic breast cancer, of whom 10 were previously treated with trastuzumab failure and 4 were asymptomatic patients with brain metastases. Nine received single-agent noradinib and eight received noradinib plus trastuzumab. Noradinib was orally administered 240mg.d-1; trastuzumab as the first dose of 4 mg.kg-1 intravenous infusion, maintenance dose of 2 mg.kg-1. Week -1 intravenous infusion. Every 4 weeks for 1 cycle, every 2 cycles evaluation of efficacy while recording adverse events. Results 17 patients could evaluate the curative effect, 1 complete remission, partial remission in 8 cases, the effective rate was 52.9% (9/17). The effective rate was 77.7% (7/9) in the noradinib group and 25% (2/8) in the noradinib group and the trastuzumab group. 2 cases of brain metastases in patients with intracranial lesions improved significantly, 2 cases of brain metastases intracranial lesions stable. Twenty-one patients (261 cycles) were evaluated for toxicity. Among them, diarrhea was the major adverse drug reaction, accounting for 47.1% (8/17) of Ⅱ ~ Ⅲ degree. Prophylaxis with antidiarrheal drugs could be controlled. Conclusion The single-drug noradinib and noradinib combined with trastuzumab is an effective treatment for HER-2 overexpressing refractory and relapsed metastatic breast cancer, and some patients with brain metastasis show some curative effect. The most common adverse reaction is diarrhea, after symptomatic treatment of overall adverse reactions can tolerate.