International Journal of Clinical Case Reports 2024, Vol.14, No.3, 132-143 http://medscipublisher.com/index.php/ijccr 137 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). Figure 2 DTIC-IFN N Vaccine Trial Randomization Chart and Sample Size (Adopted from Urbani et al., 2020) Image caption: Intention-to-treat analysis of relapse-free (RFS) (A,C) and overall survival (OS) (B,D) by Kaplan–Meier method. All enrolled patients were included in the analysis (n=34). Months are calculated since time of randomization. Arm 1 patients (Pt) (n = 17) were treated with vaccination with Melan-A and NY-ESO-1 peptides (Vaccine) and interferon-α2b (IFN). Arm 2 patients (n = 17) received the same treatment of arm 1 patients with the addition of dacarbazine (DTIC) pretreatment. (A,B) Comparison between arms. (C,D) All patients (n=34). p value by log-rank test (Adopted from Urbani et al., 2020) 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
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