Objective Gemcitabine plus cisplatin is the standard adjuvant regimen for postoperative management of muscle-invasive upper tract urothelial carcinoma. This study investigated whether adding tislelizumab to gemcitabine plus cisplatin improves outcomes in patients with muscle-invasive upper tract urothelial carcinoma. Methods We conducted a retrospective, single-center cohort analysis of consecutive patients who underwent laparoscopic radical nephroureterectomy (April 2020 to April 2025) and received adjuvant gemcitabine plus cisplatin or tislelizumab combined with gemcitabine plus cisplatin within 90 days postsurgery (≥3 cycles). No patients were lost to follow-up. The observed outcomes were disease-free survival, distant metastasis-free survival, and adverse events. Results Among 67 patients (37, tislelizumab combined with gemcitabine plus cisplatin group; 30, gemcitabine plus cisplatin group), the median follow-up duration was 15.6 months. Median disease-free survival was not reached in the tislelizumab combined with gemcitabine plus cisplatin group compared with 27.1 months in the gemcitabine plus cisplatin group. Tislelizumab combined with gemcitabine plus cisplatin significantly improved disease-free survival (hazard ratio = 0.441, p = 0.035) and distant metastasis-free survival (hazard ratio = 0.389, p = 0.036). Adverse events were comparable between groups, with no severe immune-related toxicities or treatment-related deaths. Conclusions Adjuvant tislelizumab combined with gemcitabine plus cisplatin demonstrated superior disease-free survival and distant metastasis-free survival compared with gemcitabine plus cisplatin alone, with acceptable safety, supporting further investigation in patients with muscle-invasive upper tract urothelial carcinoma.
Zhang et al. (Sun,) studied this question.