A Phase 2 Study of Tislelizumab as Neoadjuvant Treatment of Cisplatin-Ineligible High-Risk Upper Tract Urothelial Carcinoma

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PURPOSE: We investigated the efficacy and safety of tislelizumab as neoadjuvant therapy in patients with cisplatin-ineligible high-risk upper tract urothelial carcinoma (UTUC). MATERIALS AND METHODS: In this single-arm phase 2 trial (NCT04672330), 20 patients with high-risk UTUC were enrolled. Eligibility criteria included high-risk UTUC (defined as high-grade UTUC confirmed by endoscopic biopsy or urinary cytology, radiographic evidence of invasion [cT2-T4N0-2M0], and/or hydronephrosis), an Eastern Cooperative Oncology Group performance status of 0 to 2, no previous systemic therapy, and cisplatin ineligibility. Patients received neoadjuvant tislelizumab before radical surgery. Contrast-enhanced MRI was performed before the third dose and again before surgery. The primary end point was pathological complete response rate (ypT0N0). Secondary end points included pathological response rate (≤ypT1N0), objective response rate, disease-free survival, safety profile, and perioperative complications. Multiplex immunofluorescence assessed immune cell populations in the tumor microenvironment. RESULTS: T cells in the tumor stroma of partial and complete responders. CONCLUSIONS: macrophages in the tumor stroma may serve as potential predictors of response to neoadjuvant tislelizumab.

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