新辅助安洛替尼/辛替单抗联合化疗治疗三阴性乳腺癌(NeoSACT): 2期试验。

IF 11.7 1区 医学 Q1 CELL BIOLOGY
Cell Reports Medicine Pub Date : 2025-07-15 Epub Date: 2025-06-19 DOI:10.1016/j.xcrm.2025.102193
Liulu Zhang, Lu Yang, Yan Ge, Zhaowen Zhu, Bo Chen, Ciqiu Yang, Hongfei Gao, Mei Yang, Teng Zhu, Kun Wang
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引用次数: 0

摘要

肿瘤血管生成有助于免疫逃避,血管正常化通过重塑肿瘤微环境增强免疫治疗反应。这项2期试验评估了新辅助anlotinib(抗血管生成)、sintilimab(程序性细胞死亡蛋白1 [PD-1]抑制剂)和化疗在29例II-III期三阴性乳腺癌(TNBC)患者中的疗效。主要终点病理完全缓解(pCR)达到69.0%(95%可信区间[CI]: 49.0%-85.0%),最小残留疾病(残余癌症负担[RCB] 0 + 1)率为86.2%。值得注意的是,程序性死亡配体1 (PD-L1)阴性患者的pCR率为75.0%,与PD-L1阳性患者(64.7%)相当。2年无事件生存率(EFS)为92.4%,pCR患者的EFS为100%。31.0%的患者发生3/4级不良事件,主要是皮疹和血液毒性。这些结果表明,抗血管生成治疗联合免疫治疗和化疗可提高治疗效果,有可能克服PD-L1的局限性,并支持在高危TNBC中的进一步研究。该试验已在ClinicalTrials.gov注册(NCT04877821)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Neoadjuvant anlotinib/sintilimab plus chemotherapy in triple-negative breast cancer (NeoSACT): Phase 2 trial.

Tumor angiogenesis contributes to immune evasion, and vascular normalization enhances immunotherapy response by reshaping the tumor microenvironment. This phase 2 trial evaluates neoadjuvant anlotinib (antiangiogenic), sintilimab (programmed cell death protein 1 [PD-1] inhibitor), and chemotherapy in 29 patients with stage II-III triple-negative breast cancer (TNBC). The primary endpoint, pathological complete response (pCR), is achieved in 69.0% (95% confidence interval [CI]: 49.0%-85.0%), with an 86.2% minimal residual disease (residual cancer burden [RCB] 0 + 1) rate. Notably, programmed death-ligand 1 (PD-L1)-negative patients achieve a 75.0% pCR rate, comparable to PD-L1-positive patients (64.7%). The 2-year event-free survival (EFS) is 92.4%, with 100% EFS in pCR patients. Grade 3/4 adverse events occur in 31.0% of patients, primarily rash and hematologic toxicities. These results demonstrate that combining antiangiogenic therapy with immunotherapy and chemotherapy enhances treatment efficacy, potentially overcoming PD-L1 limitations, and supports further investigation in high-risk TNBC. This trial was registered at ClinicalTrials.gov (NCT04877821).

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来源期刊
Cell Reports Medicine
Cell Reports Medicine Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)
CiteScore
15.00
自引率
1.40%
发文量
231
审稿时长
40 days
期刊介绍: Cell Reports Medicine is an esteemed open-access journal by Cell Press that publishes groundbreaking research in translational and clinical biomedical sciences, influencing human health and medicine. Our journal ensures wide visibility and accessibility, reaching scientists and clinicians across various medical disciplines. We publish original research that spans from intriguing human biology concepts to all aspects of clinical work. We encourage submissions that introduce innovative ideas, forging new paths in clinical research and practice. We also welcome studies that provide vital information, enhancing our understanding of current standards of care in diagnosis, treatment, and prognosis. This encompasses translational studies, clinical trials (including long-term follow-ups), genomics, biomarker discovery, and technological advancements that contribute to diagnostics, treatment, and healthcare. Additionally, studies based on vertebrate model organisms are within the scope of the journal, as long as they directly relate to human health and disease.
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