在未经治疗的,高级的三阴性乳腺癌中,Sacituzumab Govitecan
Javier Cortés1,2,3,4,5,6, Kevin Punie7, Carlos Barrios8
1International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona.
The New England journal of medicine
|October 22, 2025
概括
萨西图祖马布可显著改善无进展的存活在先进的三阴性乳腺癌患者不符合PD-1/PD-L1抑制剂. 副作用与化疗相似,尽管很常见.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 临床试验 临床试验
背景情况:
- 对于那些患有晚期,不可切除或转移的三阴性乳腺癌 (TNBC) 患者,他们不能接受编程细胞死亡蛋白1 (PD-1) 或编程死亡配体1 (PD-L1) 抑制剂,存在有限的治疗选择.
- 这种患者群体通常包括那些先前接触过免疫疗法或特定的并存疾病,阻止使用PD-1/PD-L1抑制剂的患者.
研究的目的:
- 为了评估sacituzumab govitecan与标准化疗相比的疗效和安全性,先前未接受过治疗的PD-1/PD-L1抑制剂不合格的高级TNBC患者.
主要方法:
- 一项国际,第三期,开放标签,随机试验招募了558名晚期TNBC患者.
- 患者被随机分为1:1接受萨基图祖马布戈维特干或化疗 (帕克利塔克塞尔,纳布-帕克利塔克塞尔或格姆西塔宾/卡博普拉丁).
- 主要终点是无进展生存 (PFS),次要终点包括整体生存,客观反应率,反应持续时间和安全.
主要成果:
- 与化疗相比,sacituzumab govitecan的无进展生存时间中位数显著长 (9.7个月与6.9个月) (HR,0.62;P<0.001).
- 客观响应率相似 (48%vs. 46%),但响应持续时间较长的sacituzumab govitecan (12.2个月vs. 7.2个月).
- 3级或更高的不良事件是频繁的,并且在两组之间可比较 (66%的萨基图祖马布戈维特肯vs. 62%的化疗),中性质衰竭是最常见的.
结论:
- 萨西图祖马布戈维特康 (Sacituzumab govitecan) 对那些无法接受PD-1/PD-L1抑制剂的晚期TNBC患者来说,比化疗更有显著的生存益处.
- 虽然有效,但sacituzumab govitecan与化学疗法的严重不良事件发生率相似,需要仔细监测.
- 这项研究强调了sacituzumab govitecan作为这种特定患者亚组的有价值的治疗选择.
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