CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
与新辅助免疫治疗乳腺癌病理完全缓解相关的临床病理学和分子特征
英文原题：Clinicopathological and molecular characteristics associated with pathological complete response in neoadjuvant immunotherapy for breast cancer.
查看英文原题
Clinicopathological and molecular characteristics associated with pathological complete response in neoadjuvant immunotherapy for breast cancer.
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研究概要
新辅助免疫治疗与乳腺癌的良好结局相关。然而，对于 HER2+、淋巴结阴性或 sTIL 低密度的肿瘤患者，临床医生需要仔细权衡疗效、安全性和患者偏好，以提供个体化治疗。需要进一步开展具有长期结局的随机试验，以确认这些生物标志物的预测价值。
研究思路结论见上方概要
在乳腺癌中，基于免疫检查点抑制剂（ICI）的新辅助治疗自2021年起已获批用于临床实践。然而，常规收集的临床病理和分子特征在新辅助免疫治疗中的预测价值仍不清楚。
我们检索了EMBASE和MEDLINE数据库，寻找比较基于ICI的新辅助治疗与传统治疗的随机对照试验（RCT）。主要结局是病理完全缓解（pCR）。计算了比值比（OR）及其95%置信区间（CI）。本meta分析已在PROSPERO注册（CRD420261307112）。
在这项纳入12项RCTs、5674例患者的研究中，我们发现基于ICI的新辅助治疗与pCRs显著增加相关（OR，1.59；95% CI，1.32-1.90；P < 0.001）。值得注意的是，新辅助免疫治疗在HER2+肿瘤患者中未显示出pCRs的统计学显著改善（OR，1.17；95% CI，0.92-1.49；P = 0.23）。此外，基于ICI的新辅助治疗与淋巴结状态（P Interaction < 0.001）或间质TIL（肿瘤浸润淋巴细胞）（sTIL，P Interaction = 0.05）之间的交互作用具有统计学意义。在淋巴结阳性（OR，1.89；95% CI，1.56-2.28；P < 0.001）或高密度sTIL肿瘤（OR，2.89；95% CI，1.49-5.61；P < 0.001）患者中观察到更多pCRs，但在淋巴结阴性（OR，1.05；95% CI，0.80-1.39；P = 0.71）或低密度sTIL肿瘤（OR，1.26；95% CI，0.73-2.17；P = 0.41）女性中则未观察到。尚无足够证据支持其他特征，包括种族、年龄、PD-L1表达、临床分期、激素受体（HR）状态、绝经状态、美国东部肿瘤协作组（ECOG）体能状态和T分期，作为指导乳腺癌新辅助免疫治疗患者选择的预测性生物标志物。
展开英文摘要原文
In breast cancer, immune checkpoint inhibitor (ICI)-based neoadjuvant therapy has been approved for clinical practice since 2021. Nonetheless, the predictive values of routinely collected clinicopathological and molecular characteristics in neoadjuvant immunotherapy remain unknown.
We searched EMBASE and MEDLINE databases for randomized controlled trials (RCTs) comparing ICI-based neoadjuvant therapy with conventional treatment. The primary outcome was pathological complete response (pCR). The odds ratio (OR) and its 95% confidence intervals (CIs) were calculated. This meta-analysis was registered in PROSPERO (CRD420261307112).
Here, with 5674 patients enrolled in 12 RCTs, our study revealed ICI-based neoadjuvant therapy was associated with significantly increased pCRs (OR, 1.59; 95% CI, 1.32-1.90; P < 0.001). Notably, neoadjuvant immunotherapy did not demonstrate a statistically significant improvement of pCRs in patients with HER2+ tumors (OR, 1.17; 95% CI, 0.92-1.49; P = 0.23). Moreover, the interactions between ICI-based neoadjuvant therapy and nodal status ( P Interaction < 0.001) or stromal tumor-infiltrating lymphocyte (sTIL, P Interaction = 0.05) were statistically meaningful. More pCRs were observed in patients with nodal-positive (OR, 1.89; 95% CI, 1.56-2.28; P < 0.001) or high-density sTIL tumors (OR, 2.89; 95% CI, 1.49-5.61; P < 0.001), but not in women with nodal-negative (OR, 1.05; 95% CI, 0.80-1.39; P = 0.71) or low-density sTIL tumors (OR, 1.26; 95% CI, 0.73-2.17; P = 0.41). There was insufficient evidence to support other characteristics, including race, age, PD-L1 expression, clinical stage, hormone receptor (HR) status, menopausal status, Eastern Cooperative Oncology Group (ECOG) performance status, and T stage, as predictive biomarkers to guide patient selection for neoadjuvant immunotherapy in breast cancer.
Neoadjuvant immunotherapy was associated with favorable outcomes in breast cancer. However, for patients with HER2+, nodal-negative, or low-density sTIL tumors, clinicians need to carefully balance efficacy, safety, and patient preferences to deliver individualized treatment. Further randomized trials with long-term outcomes are needed to confirm the predictive values of these biomarkers. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261307112, identifier PROSPERO CRD420261307112.
论文信息
- 作者
- Zhang B、Chen Z、Mao R、Zhu J、Cai W、Zhao B
- 单位
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.China
- 文献类型
- 荟萃分析
- 期刊
- Frontiers in immunology2026
- 原文标识
- PubMed 41972153 · DOI 10.3389/fimmu.2026.1771228
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