图源：摄图网 图源：摄图网 对于PD-L1阳性的晚期TNBC患者，免疫检查点抑制剂逐渐成为一种创新的治疗选择。 阿替利珠单抗是首个在TNBC一线治疗中显示出生存益处的免疫治疗药物。相关研究显示：阿替利珠单抗联合白蛋白结合型紫杉醇在晚期转移性TNBC的疗效，在PD-L1阳性患者中，联合治疗组PFS优于安慰剂组，分别为7.5个月和5.0个月，而OS亦显著获益，分别为25.4个月和17.9个月。成为首个获得美国食品药品监督管理局（FDA）加速批准的TNBC免疫治疗方案。 此外，帕博利珠单抗是唯一一个获得FDA批准用于TNBC的免疫检查点抑制剂，也是唯一一个被批准用于早期TNBC治疗的分子靶向药物。FDA于2020年批准了帕博利珠单抗联合化疗用于治疗肿瘤表达PD-L1阳性评分（CPS）≥10的局部复发或转移性TNBC患者。 在亚洲人群中进行的早期研究显示：帕博利珠单抗联合化疗组的PFS为11.7个月，CPS越高，疗效越好，且未增加严重不良事件的发生率。 在晚期一线治疗中获得的益处之外，帕博利珠单抗联合化疗在早期TNBC新辅助化疗中也取得了积极结果。KEYNOTE-522研究共纳入1174例早期TNBC患者，主要研究终点包括EFS和pCR，结果显示帕博利珠单抗联合新辅助化疗与单独新辅助化疗相比，可显著提高早期TNBC患者的pCR率，分别为64.8%与51.2%，并且36个月无事件生存率显著提高。基于这些结果，FDA于2021年批准帕博利珠单抗联合新辅助化疗和术后辅助单药维持治疗用于早期高危TNBC患者。 参考文献： [1]中国晚期三阴性乳腺癌临床诊疗指南(2024版)[J].中华肿瘤杂志,2024. [2]Molecular Features and Functional Implications of Germline Variants in Triple-Negative Breast Cancer[J]. J Natl Cancer Inst,2021. [3]10-Year Survival after Breast-Conserving Surgery Compared with Mastectomy in Louisiana Women with Early-Stage Breast Cancer: A Population-Based Study[J].J Am Coll Surg, 2021. [4]NCCN Guidelines Insights: Breast Cancer, Version 4.2021[J]. Natl Compr Canc Netw,2021. [5]Breast cancer outcomes following immediate breast reconstruction with implants versus autologous flaps: a propensity score-matched study[J]. Breast Cancer Res Treat,2022. [6]The effect of omitting axillary dissection and the impact of radiotherapy on patients with breast cancer sentinel node macrometastases: a cohort study following the ACOSOG Z0011 and AMAROS trials[J].Breast Cancer Res Treat,2021. [7]Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer:An Open-Label, Randomized, Multicenter, Phase Ⅲ Trial[J]. J Clin Oncol,2020. [8]Survival analysis of the randomised phase Ⅲ GeparOcto trial comparing neoadjuvant chemotherapy of intense dose-dense epirubicin,paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for patients with high-risk early breast cancer[J]. Eur J Cancer,2022. [9]Adjuvant Olaparib for Patients with BRCA1 or BRCA2-Mutated Breast Cancer[J]. Med, 2021. [10]Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer[J]. Med, 2021. [11]Primary results from adouble-blind, placebo-controlled, randomised phase Ⅲ trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer[J]. Ann Oncol, 2021. [12]Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer[J]. Med, 2022.
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