Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Thorac Cancer. 2023 Aug;14(23):2259-2268. doi: 10.1111/1759-7714.15011. Epub 2023 Jul 4.
This single-arm prospective phase II trial was performed to assess the efficacy and safety of the dual oral metronomic vinorelbine and capecitabine (mNC) regimen in women with HER2-negative metastatic breast cancer (MBC) in China.
The mNC regimen was administered to the enrolled cases, including oral vinorelbine (VNR) 40 mg three times weekly (on days 1, 3 and 5 every week) and capecitabine (CAP) 500 mg three times a day, until disease progression or intolerable toxicity. The primary endpoint was the 1-year progression-free survival (PFS) rate. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and treatment-related adverse events (TRAEs). Stratified factors included treatment lines and hormone receptor (HR) status.
Between June 2018 and March 2023, 29 patients were enrolled into the study. The median follow-up time was 25.4 months (range, 2.0-53.8). In the entire group, the 1-year PFS rate was 54.1%. ORR, DCR and CBR were 31.0%, 96.6% and 62.1%, respectively. The mPFS was 12.5 months (range, 1.1-28.1). Subgroup analysis revealed that ORRs were 29.4% and 33.3% in first- and ≥second-line chemotherapy, respectively. ORRs were 29.2% (7/24) and 40.0% (2/5) for HR-positive MBC and metastatic triple-negative breast cancer (mTNBC), respectively. Grade 3/4 TRAEs were neutropenia (10.3%) and nausea/vomiting (6.9%).
The dual oral mNC regimen showed very good safety features and improved compliance without loss of efficacy in both first- and second-line treatments. The regimen also reached an excellent ORR in the mTNBC subgroup.
本单臂前瞻性 II 期试验旨在评估在我国人表皮生长因子受体 2（HER2）阴性转移性乳腺癌（MBC）女性中，双口服节拍型长春瑞滨和卡培他滨（mNC）方案的疗效和安全性。
纳入的病例接受 mNC 方案治疗，包括长春瑞滨（VNR）40mg 每周 3 次（每周 1、3、5 天）和卡培他滨（CAP）500mg 每日 3 次，直至疾病进展或不可耐受的毒性。主要终点为 1 年无进展生存期（PFS）率。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、临床获益率（CBR）和治疗相关不良事件（TRAEs）。分层因素包括治疗线数和激素受体（HR）状态。
2018 年 6 月至 2023 年 3 月，共纳入 29 例患者。中位随访时间为 25.4 个月（范围，2.0-53.8）。在整个队列中，1 年 PFS 率为 54.1%。ORR、DCR 和 CBR 分别为 31.0%、96.6%和 62.1%。mPFS 为 12.5 个月（范围，1.1-28.1）。亚组分析显示，一线和≥二线化疗的 ORR 分别为 29.4%和 33.3%。HR 阳性 MBC 和转移性三阴性乳腺癌（mTNBC）的 ORR 分别为 29.2%（7/24）和 40.0%（2/5）。3/4 级 TRAE 为中性粒细胞减少（10.3%）和恶心/呕吐（6.9%）。
双口服 mNC 方案在一线和二线治疗中均显示出非常好的安全性特征和改善的依从性，同时不影响疗效。该方案在 mTNBC 亚组中也达到了极好的 ORR。
