Cancer Genetics and Epigenetics 2024, Vol.12, No.6, 306-316 http://medscipublisher.com/index.php/cge 306 Review Article Open Access Efficacy of Immune Checkpoint Inhibitors in Triple-Negative Breast Cancer: Current Status and Future Directions Qiyan Lou, Xiaoying Xu Biotechnology Research Center, Cuixi Academy of Biotechnology, Zhuji, 311800, Zhejiang, China Corresponding author: xiaoying.xu@cuixi.org Cancer Genetics and Epigenetics, 2024, Vol.12, No.6 doi: 10.5376/cge.2024.12.0029 Received: 08 Sep., 2024 Accepted: 14 Oct., 2024 Published: 09 Nov., 2024 Copyright © 2024 Lou and Xu, This is an open access article published under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Preferred citation for this article: Lou Q.Y., and Xu X.Y., 2024, Efficacy of immune checkpoint inhibitors in triple-negative breast cancer: current status and future directions, Cancer Genetics and Epigenetics, 12(6): 306-316 (doi: 10.5376/cge.2024.12.0029) Abstract Immune checkpoint inhibitors (ICIs), as a novel immunotherapy, restore anti-tumor immune responses by blocking immune suppressive pathways, demonstrating potential in treating triple-negative breast cancer (TNBC). This review systematically evaluates the clinical applications of ICIs in TNBC, including efficacy, biological basis, and associated challenges, while exploring combination therapy strategies and the predictive value of biomarkers. It also proposes future research directions. ICIs provide a groundbreaking therapeutic option for TNBC patients, significantly improving survival in some cases. Trials such as IMpassion130 and Keynote-355 have shown that PD-L1-positive TNBC patients respond well to ICIs combined with chemotherapy, though outcomes remain limited by patient heterogeneity and the accuracy of biomarkers. Additionally, combination strategies involving ICIs with chemotherapy, targeted therapies (e.g., PARP inhibitors, VEGF inhibitors), and radiotherapy exhibit synergistic effects, markedly enhancing efficacy. However, challenges such as heterogeneous efficacy, limitations of biomarker prediction, and issues of economic accessibility need to be addressed. This review provides a theoretical basis for optimizing ICI combination therapies and developing personalized immunotherapy. Future efforts should focus on biomarker development and multidisciplinary collaboration to improve global access and treatment outcomes for TNBC patients. Keywords Triple-negative breast cancer (TNBC); immune checkpoint inhibitors (ICIs); combination therapy; biomarkers; immune-related adverse events (irAEs) 1 Introduction Triple-negative breast cancer (TNBC) is recognized as the most aggressive subtype of breast cancer, characterized by the absence of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) expressions (Farshbafnadi et al., 2021; Singh et al., 2021). This subtype is notorious for its high recurrence rates, rapid progression, and poor prognosis compared to other breast cancer types (Tomioka et al., 2017; Zhao et al., 2023). The lack of specific molecular targets has historically limited the treatment options for TNBC, making it a challenging disease to manage (Blackley and Loi, 2019; Farshbafnadi et al., 2021). Conventional therapies for TNBC, primarily involving chemotherapy, have shown limited efficacy and are often associated with significant adverse effects (Farshbafnadi et al., 2021; Singh et al., 2021). Despite initial responses, many patients experience relapse and metastasis, leading to poor long-term outcomes (Varma et al., 2022; Zhao et al., 2023). The absence of hormone receptors and HER2 expression precludes the use of targeted therapies that are effective in other breast cancer subtypes, further complicating treatment strategies (Blackley and Loi, 2019; Farshbafnadi et al., 2021). Consequently, there is a critical need for novel therapeutic approaches that can improve survival and quality of life for TNBC patients (Singh et al., 2021; Uchimiak et al., 2022). Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic approach for TNBC, leveraging the body's immune system to target and destroy cancer cells (Farshbafnadi et al., 2021; Singh et al., 2021). ICIs, such as pembrolizumab and atezolizumab, have shown potential in improving outcomes for TNBC patients by blocking inhibitory pathways that prevent immune cells from attacking tumors (Cyprian et al., 2019; Uchimiak et al., 2022). Clinical trials have demonstrated that ICIs, particularly when combined with chemotherapy, can enhance pathologic complete response rates and progression-free survival in both early-stage and metastatic TNBC
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