Consolidative Radical Cystectomy Following Neoadjuvant Tislelizumab Plus Gemcitabine and Cisplatin in Clinically Lymph Node-positive Bladder Cancer: A Prospective Study.

BACKGROUND AND OBJECTIVE: Although multiple clinical trials have demonstrated that neoadjuvant immune checkpoint inhibitors combined with gemcitabine plus cisplatin achieve promising pathological complete response (pCR) rates in muscle-invasive bladder cancer patients, these studies generally excluded those with lymph node metastasis. This study aims to evaluate the efficacy and prognostic outcomes of neoadjuvant tislelizumab combined with gemcitabine plus cisplatin, followed by consolidative radical cystectomy (RC), in patients with clinically lymph node-positive bladder cancer. METHODS: In this prospective study (NCT04570410), patients with cT2-4N1-3M0 bladder cancer were enrolled. The treatment regimen consisted of tislelizumab (200 mg on day 8), gemcitabine (1000 mg/m(2) on days 1 and 8), and cisplatin (70 mg/m(2) divided over days 2-4), administered every 21 d for three cycles. RC was performed within 6 wk following the final dose of neoadjuvant therapy. The primary endpoint was pCR (ypT0N0). The secondary endpoints included pathological downstaging (