Department of Internal Medicine, UT Southwestern Medical Center, Dallas, USA.
Department of Pharmacy, The University of Chicago, Chicago, USA.
Expert Rev Anticancer Ther. 2020 Mar;20(3):151-158. doi: 10.1080/14737140.2020.1732211. Epub 2020 Feb 27.
: In March 2019, atezolizumab became the first immune checkpoint inhibitor to receive a breast cancer-specific approval. Based on a significant improvement in progression-free survival as well as a 10-month improvement in overall survival (on interim analysis) seen in the IMpassion 130 trial, the combination of atezolizumab and nab-paclitaxel was approved for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).: This article reviews current data and ongoing research on atezolizumab for the treatment of breast cancer. Results of atezolizumab monotherapy trials in the context of other early immune checkpoint blockade trials in breast cancer are discussed as well as data from combination clinical trials with chemotherapy in both early-stage and metastatic breast cancer. We focus on the safety and efficacy analyses from the phase III IMpassion trial that led to FDA and EMA approval of atezolizumab and nab-paclitaxel in patients whose tumor tested positive for PD-L1 by the Ventana SP142 companion diagnostic immunohistochemical assay.: The FDA and EMA approvals of atezolizumab mark an important advance for treatment of metastatic TNBC. However, ongoing investigations need to define better biomarkers of response, determine resistance mechanisms, and identify strategies to increase response rates.
在 2019 年 3 月，阿替利珠单抗成为首个获得乳腺癌特异性批准的免疫检查点抑制剂。基于 IMpassion130 试验中观察到的无进展生存期显著改善（以及中期分析中总生存期改善了 10 个月），阿替利珠单抗联合 nab-紫杉醇获批用于治疗不可切除的局部晚期或转移性三阴性乳腺癌（TNBC）。本文回顾了阿替利珠单抗治疗乳腺癌的现有数据和正在进行的研究。讨论了阿替利珠单抗单药治疗试验的结果，以及与化疗联合用于早期和转移性乳腺癌的临床试验数据。我们重点关注导致 FDA 和 EMA 批准阿替利珠单抗联合 nab-紫杉醇用于肿瘤 PD-L1 检测由 Ventana SP142 伴随诊断免疫组化检测阳性的患者的 III 期 IMpassion 试验的安全性和疗效分析。FDA 和 EMA 对阿替利珠单抗的批准标志着转移性 TNBC 治疗的重要进展。然而，正在进行的研究需要更好地确定反应的生物标志物，确定耐药机制，并确定提高反应率的策略。
