Personalized peptide vaccination as second-line treatment for metastatic upper tract urothelial carcinoma

Summary

This study investigated on the applicability of personalized peptide vaccination (PPV) for patients with metastatic upper tract urothelial cancer (mUTUC) after failure of platinum-based chemotherapy. In this single arm, open-label, phase II clinical trial, patients with mUTUC received PPV at a single institution. PPV treatment used a maximum of four peptides chosen from 27 candidate peptides according to human leukocyte antigen types and peptide-reactive immunoglobulin G titers, for 6 subcutaneous injections weekly as one cycle. The safety of PPV, as well as its influence on host immunity and effect on OS were assessed. Forty-eight patients were enrolled in this study. PPV were well tolerated without severe adverse events. Median survival time (MST) was 7.3 months (95% CI, 5.3 to 13.1) with 13.0 months for patients receiving combined salvage chemotherapy (95% CI, 5.7 to 17.5) and 4.5 months for patients receiving PPV alone (95% CI, 1.7 to 10.1) (p=0.080). Patients with positive cytotoxic T lymphocyte (CTL) responses demonstrated a significantly longer survival than patients with negative CTL responses (HR, 0.37; 95%CI, 0.16 to 0.85; p = 0.019). Multivariate Cox regression analysis showed that lower numbers of Bellmunt risk factors and lower levels of B cell activating factor (BAFF) were significantly associated with favorable OS for patients under PPV treatment. This study demonstrated that PPV for patients with mUTUC after failure of platinum-based chemotherapy induced substantial peptide-specific CTL responses without severe adverse events and has the potential to prolong survival when combined with salvage chemotherapy.

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