International Journal of Clinical Case Reports 2024, Vol.14, No.3, 130-140 http://medscipublisher.com/index.php/ijccr 135 responders had significantly better outcomes, with a 1-year progression-free survival (PFS) of 17.2% and a median OS of 11.6 months (Adotévi et al., 2022). Another study on metastatic colorectal cancer patients using a 7-peptide cocktail vaccine combined with oral chemotherapy reported partial responses in some patients and stable disease in others, indicating the potential of peptide vaccines to control tumor progression (Okuno et al., 2014). 5.3 Safety and side effects Safety is a critical aspect of any cancer therapy, and peptide-based vaccines have generally shown a favorable safety profile. In the phase I study on metastatic colorectal cancer, the combination vaccine treatment was well tolerated, with no severe treatment-associated systemic adverse events reported. The most common side effects were mild, such as injection site redness and induration6. Similarly, the phase II trial on CRPC patients reported that PPV immunotherapy was well tolerated, with no significant adverse events compared to the control group (Yoshimura et al., 2016). The UCPVax study also confirmed the safety of the vaccine, with no dose-limiting toxicities observed (Adotévi et al., 2022). 5.4 Case studies Case Study 1: metastatic colorectal cancer A phase I clinical trial was conducted to evaluate the safety and immunological response of a combination vaccine treatment using five novel HLA-A*2402-restricted peptides in patients with advanced colorectal cancer6. Eighteen patients who had failed standard therapy were enrolled in the study. The vaccine treatment was well tolerated, and dose-dependent induction of peptide-specific cytotoxic T lymphocytes was observed. One patient achieved complete response, and six patients revealed stable disease for 4 to 7 months. The median overall survival time (MST) was 13.5 months. Patients with induction of cytotoxic T lymphocytes specific to three or more peptides had significantly better prognosis (MST; 27.8 months) compared to those with poorer immune responses (MST; 3.7 months) (Hazama et al., 2014). Case Study 2: castration-resistant prostate cancer A phase II randomized controlled trial was conducted to evaluate the safety and clinical outcomes of personalized peptide vaccine (PPV) immunotherapy in chemotherapy-naive castration-resistant prostate cancer (CRPC) patients2. Thirty-seven patients received peptide vaccinations, and 35 received dexamethasone alone. The primary endpoint was PSA progression-free survival (PFS), which was significantly longer in the vaccination group than in the dexamethasone group (22.0 vs 7.0 months; p=0.0076). Median overall survival (OS) was also significantly longer in the vaccination group (73.9 vs 34.9 months; p=0.00084). The study concluded that PPV immunotherapy was well tolerated and associated with longer PSA PFS and OS in men with chemotherapy-naive CRPC (Yoshimura et al., 2016). Case Study 3: Non-Small-Cell lung cancer A phase Ib/IIa trial was designed to test the safety, immunogenicity, and efficacy of a universal cancer peptide-based vaccine (UCPVax) in patients with metastatic non-small-cell lung cancer (NSCLC)3. Fifty-nine patients received UCPVax, and no dose-limiting toxicity was observed. The vaccine induced specific CD4+ T helper 1 response in 56% and 87.2% of patients after the third and sixth doses, respectively. Twenty-one patients achieved disease control (stable disease, n=20; complete response, n=1). The 1-year overall survival (OS) was 34.1%, and the median OS was 9.7 months. The study concluded that UCPVax was highly immunogenic and safe, providing an interesting 1-year OS rate in heavily pretreated advanced NSCLC (Adotévi et al., 2022). These case studies highlight the potential of peptide-based vaccines in improving clinical outcomes for cancer patients, including those with oral cancer. The favorable safety profile and ability to induce robust immune responses make these vaccines a promising approach in cancer immunotherapy (Parmiani et al., 2014; Liu et al., 2021; Abd-Aziz and Poh, 2022).
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