目的    探讨早期三阴性乳腺癌（TNBC）程序性死亡配体-1综合阳性评分（CPS）及肿瘤浸润淋巴细胞（TILs）情况，并探索其对新辅助治疗疗效的预测价值。方法    回顾性分析2016年1月至2019年12月北京大学第一医院接受新辅助治疗的早期TNBC病人的临床病理及随访资料，共收治新发早期乳腺癌2183例，TNBC 259例（11.9%），57例病人纳入研究。采用DAKO公司鼠抗人单克隆抗体（克隆号：22C3）作为检测试剂盒检测CPS，采用TILs国际工作组乳腺癌评估指南推荐的评估流程检测TILs百分比，验证并定义CPS≥10作为阳性标准，TILs>10%为中高水平。结果    CPS阳性病人26例（45.6%），TILs中高水平病人38例（66.7%），其中24例（42.1%）病人CPS阳性且TILs中高水平。CPS阳性与TILs中高水平具有明显相关性（P＜0.001）。12例（21%）病人新辅助治疗后病理完全缓解（pCR）。CPS阳性、TILs中高水平以及CPS阳性且TILs中高水平的病人新辅助治疗获得pCR的病人分别有9例（34.6%），11例（28.9%）与8例（33.3%）。Logistic多因素分析结果显示，CPS≥10与新辅助治疗后pCR显著相关（P=0.042）。中位随访时间48.5个月，多因素COX回归分析发现淋巴结阳性（P=0.002）与TILs>30%（P=0.038）是3年无复发生存率的独立影响因素。结论    近半数TNBC病人CPS阳性及TILs中高水平，且CPS与TILs水平呈明显相关性。两者分别对TNBC新辅助治疗pCR与预后具有预测价值。

An exploratory study on CPS and TILs expression levels in early-stage triple-negative breast cancer and their predictive value for neoadjuvant therapy response        ZHOU Si-cheng*, LIANG Li, LI Dong, et al.   *Department of Thyroid and Breast Surgery, Peking University First Hospital, Beijing 100034,China
Corresponding author：XIN Ling,E-mail:07453@pkufh.com
ZHOU Si-cheng and LIANG Li are the first authors who contributed equally to the article
Abstract    Objective    To investigate the programmed cell death ligand-1（PD-L1）combined positive score（CPS）and tumor infiltrating lymphocytes（TILs） levels in early-stage triple-negative breast cancer（TNBC），and to explore their predictive value for neoadjuvant therapy response. Methods    The clinicopathological data and follow-up information of early-stage triple-negative breast cancer patients who received neoadjuvant therapy in Peking University First Hospital during January 2016 to December 2019 were retrospectively analyzed. A total of 2183 newly diagnosed early breast cancer patients were treated, of which 259 (11.9%) had TNBC. Fifty-seven patients were included in the study. DAKO murine anti-human monoclonal antibody（clone number：22C3）was used as the test kit to detect CPS，and TILs percentage was evaluated in accordance with the procedure recommended by the TILs International Working Group Breast Cancer Evaluation Guidelines. Define  CPS≥10 as positive CPS and TILs > 10% as moderate to high level. Results    There were 26 patients（45.6%）with positive CPS and 38 patients（66.7%）with moderate to high level of TILs，of which 24 cases had both positive CPS and moderate to high level of TILs. There was a significant correlation between positive CPS and moderate to high level of TILs（P＜0.001）. Twelve patients（21%）achieved pathological complete response（pCR）after neoadjuvant therapy. There were 9 patients (34.6%), 11 (28.9%) and 8 patients (33.3%) with positive CPS, moderate to high level of TILs, and both positive CPS and moderate to high level of TILs achieved pCR after neoadjuvant therapy. Logistic multivariate analysis showed that CPS≥10 was significantly associated with pCR after neoadjuvant therapy（P=0.042）. The median follow-up time was 48.5 months. Multivariate COX regression analysis showed that  lymph node positive（P=0.002）and TILs>30%（P=0.038）were independent prognostic factors affecting 3-year recurrence-free survival rate. Conclusion    Nearly half of TNBC patients had both positive CPS and moderate to high level of TILs , and there was a significant correlation between CPS and TILs  levels，both of which had predictive value for pCR and prognosis after neoadjuvant therapy.