三阴性乳腺癌（TNBC）患者的临床结果相对较差。免疫检查点抑制剂（ICI）派姆单抗联合化疗是目前 II 期和 III 期 TNBC 患者的标准治疗方法。鉴于转移试验中的不利结果，尚未对 TNBC 患者的新辅助治疗中的 ICI 单一疗法进行全面评估。然而，ICIs 已在手术或基于标准化疗的新辅助治疗之前的机会窗口 (WOO) 进行了测试。 WOO 设计非常适合单独评估 ICI 或与其他 ICI、靶向治疗、放疗或冷冻疗法联合评估，并测量其在未经治疗的人群中的药效和临床效果。在 WOO 研究中，一些患者对 ICI 表现出良好的反应。肿瘤浸润淋巴细胞、程序性死亡配体-1 和干扰素-γ 特征等生物标志物可以预测活性，并可以识别可能从 ICI 中受益的患者。此外，在 WOO 环境中施用 ICI 后，肿瘤浸润淋巴细胞的增加、程序性死亡配体 1 的表达或 T 细胞受体的扩增可能会提示免疫治疗的益处，从而允许调整进一步的治疗。本文回顾了评估早期 TNBC 人群免疫治疗的 WOO 试验，以及如何将这些结果转化为测试新辅助化疗和免疫治疗的降级策略而不影响患者的预后。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Patients with triple-negative breast cancer (TNBC) have a relatively poor clinical outcome. The immune checkpoint inhibitor (ICI) pembrolizumab combined with chemotherapy is the current standard of care in TNBC patients with stage II and III. Monotherapy with ICIs has not been comprehensively assessed in the neoadjuvant setting in TNBC patients, given unfavorable results in metastatic trials. ICIs, however, have been tested in the window of opportunity (WOO) before surgery or standard chemotherapy-based neoadjuvant treatment. The WOO design is well suited to assess an ICI alone or in combination with other ICIs, targeted therapy, radiotherapy or cryotherapy, and measure their pharmacodynamic and clinical effect in this treatment-naive population. Some patients show a good response to ICIs in WOO studies. Biomarkers like tumor-infiltrating lymphocytes, programmed death ligand-1, and interferon-γ signature may predict activity and may identify patients likely to benefit from ICIs. Moreover, an increase in tumor-infiltrating lymphocytes, programmed death ligand-1 expression or T cell receptor expansion following administration of ICIs in the WOO setting could potentially inform of immunotherapy benefit, which would allow tailoring further treatment. This article reviews WOO trials that assessed immunotherapy in the early-stage TNBC population, and how these results could be translated to test de-escalation strategies of neoadjuvant chemotherapy and immunotherapy without compromising a patient's prognosis.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.