Sacituzumab govitecan 治疗 HR HER2 转移性乳腺癌:随机 3 期 EVER-132-002 试验。
Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial.
发表日期:2024 Oct 01
作者:
Binghe Xu, Shusen Wang, Min Yan, Joohyuk Sohn, Wei Li, Jinhai Tang, Xiaojia Wang, Ying Wang, Seock-Ah Im, Dongdong Jiang, Theresa Valdez, Anandaroop Dasgupta, Yiran Zhang, Yilin Yan, Kimberly M Komatsubara, Wei-Pang Chung, Fei Ma, Ming-Shen Dai
来源:
NATURE MEDICINE
摘要:
在全球 TROPiCS 中,与化疗相比,Sacituzumab govitecan (SG) 显着改善了激素受体阳性人表皮生长因子受体 2 阴性 (HR HER2-) 转移性乳腺癌 (mBC) 的无进展生存期 (PFS) 和总生存期 (OS) -02学习。 TROPiCS-02 招募了少数亚洲患者。在此,我们报告了 EVER-132-002 研究中 HR HER2-mBC 亚洲患者的 SG 结果。患者被随机分配接受 SG (n = 166) 或化疗 (n = 165)。主要终点得到满足:SG 与化疗相比,PFS 得到改善(风险比为 0.67,95% 置信区间为 0.52-0.87;P = 0.0028;中位数为 4.3 个月与 4.2 个月)。与化疗相比,SG 的 OS 也有所改善(风险比为 0.64,95% 置信区间为 0.47-0.88;P = 0.0061;中位数为 21.0 个月与 15.3 个月)。最常见的≥3级治疗引起的不良事件是中性粒细胞减少症、白细胞减少症和贫血。与化疗相比,SG 在 PFS 和 OS 方面表现出显着且具有临床意义的改善,其安全性可控,与之前的研究一致。 SG 代表了亚洲 HR HER2-mBC 患者的一种有前景的治疗选择(ClinicalTrials.gov 标识符号 NCT04639986)。© 2024。作者。
Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2-) metastatic breast cancer (mBC) in the global TROPiCS-02 study. TROPiCS-02 enrolled few Asian patients. Here we report results of SG in Asian patients with HR+HER2- mBC from the EVER-132-002 study. Patients were randomized to SG (n = 166) or chemotherapy (n = 165). The primary endpoint was met: PFS was improved with SG versus chemotherapy (hazard ratio of 0.67, 95% confidence interval 0.52-0.87; P = 0.0028; median 4.3 versus 4.2 months). OS also improved with SG versus chemotherapy (hazard ratio of 0.64, 95% confidence interval 0.47-0.88; P = 0.0061; median 21.0 versus 15.3 months). The most common grade ≥3 treatment-emergent adverse events were neutropenia, leukopenia and anemia. SG demonstrated significant and clinically meaningful improvement in PFS and OS versus chemotherapy, with a manageable safety profile consistent with prior studies. SG represents a promising treatment option for Asian patients with HR+HER2- mBC (ClinicalTrials.gov identifier no. NCT04639986 ).© 2024. The Author(s).