International Journal of Clinical Case Reports 2024, Vol.14, No.3, 132-143 http://medscipublisher.com/index.php/ijccr 136 vaccine containing long multi-epitope peptides demonstrated significant tumor growth reduction and increased lifespan in HER-2+ TUBO-tumored mice (Zamani et al., 2020). This study highlighted the importance of using a suitable delivery system, such as liposomes, to enhance the vaccine's potency and induce strong immune responses. Moreover, the combination of peptide vaccines with other immunotherapeutic agents, such as checkpoint inhibitors, has shown promising results in animal models. This combinatorial approach can help overcome the immunosuppressive tumor microenvironment, which is a significant barrier to the efficacy of peptide-based vaccines (Parmiani et al., 2014; Liu et al., 2021; Buonaguro and Tagliamonte, 2023). For instance, the use of checkpoint inhibitors like anti-CTLA-4 and anti-PD-1/PD-L1 in combination with peptide vaccines has led to dramatic tumor shrinkage and prolonged survival in various cancer models (Khong and Overwijk, 2016; Bezu et al., 2018). 4.3 Translational research Translational research bridges the gap between preclinical studies and clinical applications, focusing on the practical implementation of peptide-based vaccines in treating oral cancer. One of the key challenges in this field is the limited clinical success of peptide vaccines despite encouraging preclinical data. This discrepancy is often due to the complex tumor microenvironment and the need for personalized approaches to vaccine design (Hirayama and Nishimura, 2016; Buonaguro and Tagliamonte, 2023). Recent advancements in genetic and bioinformatic analysis have facilitated the identification of neoantigens, which are mutation-derived antigens unique to individual tumors. Personalized peptide-based vaccines targeting these neoantigens have shown potential in eliciting robust anti-tumor immune responses10. Additionally, the combination of peptide vaccines with immune checkpoint blockade therapies has been explored to enhance their clinical efficacy. For example, a phase II clinical trial involving melanoma patients treated with peptide-based vaccination and interferon alpha showed encouraging relapse-free and overall survival rates, justifying further evaluation in clinical trials (Figure 2) (Urbani et al., 2020). Preclinical studies on peptide-based vaccines for oral cancer have demonstrated their potential in eliciting strong immune responses and reducing tumor growth. In vitro studies provide insights into the mechanisms of action, while animal models offer a more comprehensive understanding of the vaccine's efficacy and safety. Translational research focuses on overcoming the challenges associated with clinical application, emphasizing the need for personalized approaches and combinatorial therapies to enhance the efficacy of peptide-based vaccines in treating oral cancer. 5 Clinical Outcomes of Peptide-Based Vaccines in Oral Cancer 5.1 Overview of clinical trials Peptide-based vaccines have been extensively studied in various cancer types, including oral cancer, due to their ability to elicit specific immune responses against tumor-associated antigens (TAAs) or tumor-specific antigens (TSAs). Clinical trials have demonstrated the potential of these vaccines to induce robust immune responses and improve clinical outcomes. For instance, a phase I study on metastatic colorectal cancer patients using a combination of five therapeutic epitope-peptides showed promising safety and immunological responses, with some patients achieving stable disease and even complete response (Hazama et al., 2014). Similarly, a phase II randomized controlled trial on castration-resistant prostate cancer (CRPC) patients demonstrated that personalized peptide vaccine (PPV) immunotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to dexamethasone alone (Yoshimura et al., 2016). 5.2 Efficacy results The efficacy of peptide-based vaccines in clinical settings has been a focal point of research. In a study involving patients with advanced non-small-cell lung cancer (NSCLC), the universal cancer peptide-based vaccine (UCPVax) showed a 1-year overall survival (OS) rate of 34.1%, with a median OS of 9.7 months. Immune
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