Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No.17, Panjiayuan Nanli, Chaoyang District, Beijing, 100021, People's Republic of China.
Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, People's Republic of China.
Breast Cancer Res Treat. 2021 Jul;188(2):441-447. doi: 10.1007/s10549-021-06216-5. Epub 2021 Apr 25.
We conducted a single-arm prospective phase II trial to evaluate the efficacy and safety of oral metronomic vinorelbine combined with trastuzumab (mNH) in human epidermal growth factor receptor 2-positive (HER2-positive) metastatic breast cancer (MBC) patients.
HER2-positive MBC patients received oral vinorelbine 40 mg thrice a week and trastuzumab (loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoints were objective response rate (ORR), clinical benefit rate (CBR; CR + PR + SD for ≥ 24 weeks). The secondary endpoints were progression-free survival (PFS), tolerability, and overall survival (OS).
Twenty patients with HER2-positive MBC were enrolled, with a median of 1 prior chemotherapy regimens for MBC. Median age was 61.5 years (95% Confidence Interval (CI) 48.6-63.1). Visceral involvements presented in 14 patients (70.0%). ORR was 20.0%, and CBR was 75% with 4 PR (20.0%) and 11 SD (55.0%). The median PFS (mPFS) and median OS (mOS) were 7.4 months (95% CI 3.2-11.5) and 45.8 months (95%CI: not reached), respectively. The mPFS was 17.7 months (95%CI not reached) and 5.8 months (95%CI 5.6-5.9) in mNH as first-line and ≥ second-line therapy (log rank p = 0.03), respectively. The most common grade 1 adverse events (AEs) included nausea (15%), leukopenia (15%), ALT/AST elevation (15%), diarrhea (10%), and peripheral neuropathy (10%). Grade 2 adverse events included leukopenia (5%) and neutropenia (10%). No grade 3/4 AEs were observed.
Oral metronomic vinorelbine combined with trastuzumab is a well-tolerated and effective anti-tumor regimen for HER2-positive MBC.
我们进行了一项单臂、前瞻性的 II 期试验，以评估口服节拍式长春瑞滨联合曲妥珠单抗（mNH）在人表皮生长因子受体 2 阳性（HER2 阳性）转移性乳腺癌（MBC）患者中的疗效和安全性。
HER2 阳性 MBC 患者接受口服长春瑞滨 40mg，每周 3 次，曲妥珠单抗（负荷剂量 8mg/kg，随后每 3 周 6mg/kg），直至疾病进展、无法耐受或患者撤回同意。主要终点为客观缓解率（ORR）、临床获益率（CBR；CR+PR+SD 持续时间≥24 周）。次要终点为无进展生存期（PFS）、耐受性和总生存期（OS）。
共纳入 20 例 HER2 阳性 MBC 患者，中位既往 MBC 化疗方案数为 1 个。中位年龄为 61.5 岁（95%置信区间 [CI] 48.6-63.1）。14 例患者（70.0%）存在内脏转移。ORR 为 20.0%，CBR 为 75.0%，其中 4 例 PR（20.0%）和 11 例 SD（55.0%）。中位 PFS（mPFS）和中位 OS（mOS）分别为 7.4 个月（95%CI 3.2-11.5）和 45.8 个月（95%CI：未达到）。mNH 作为一线和≥二线治疗时，mPFS 分别为 17.7 个月（95%CI 未达到）和 5.8 个月（95%CI 5.6-5.9）（对数秩检验，p=0.03）。最常见的 1 级不良事件（AE）包括恶心（15%）、白细胞减少（15%）、ALT/AST 升高（15%）、腹泻（10%）和周围神经病（10%）。2 级不良事件包括白细胞减少（5%）和中性粒细胞减少（10%）。未观察到 3/4 级 AE。
口服节拍式长春瑞滨联合曲妥珠单抗是一种耐受性良好且有效的抗 HER2 阳性 MBC 治疗方案。
