e16615 Background: Recent studies suggest that the preservation of tumor-draining lymph nodes (TDLN) may enhance the sensitivity to immunotherapy. This study aims to evaluate the efficacy of neoadjuvant therapy with tislelizumab in patients with clinically node-positive urothelial carcinoma and to explore the role of preserved TDLN in subsequent immunotherapy for patients achieving a clinical complete response (cCR) in the primary tumor. Methods: In this single-arm, single-center, prospective clinical trial, we enrolled patients with no prior anti-tumor immunotherapy and imaging-confirmed cT2-T4NxM0 urothelial carcinoma (2023-SR-541). The treatment regimen included cisplatin (70 mg/m²) on Day 2-4, gemcitabine (1000 mg/m²) on Days 1 and 8, and tislelizumab (200 mg) on Day 8, administered every 21 days for three cycles. Patients who achieved clinical CR underwent radical surgery within six weeks of the last dose. Sentinel TDLN biopsy, accompanied by rapid pathological assessment, was conducted intraoperatively. If the biopsy results were negative, no further lymph node dissection was performed; if positive, standard lymph node dissection was carried out. Postoperatively, patients received adjuvant immunotherapy with tislelizumab (200 mg intravenously) every three weeks for one year or until disease relapse or trial termination. Results: In this study, ten patients have been enrolled to date, with eight patients had T2-stage tumors, while two patients had a T3-stage tumor. Imaging suggested TDLN metastasis in all cases. Following the completion of neoadjuvant therapy, all patients underwent radical cystectomy, and imaging results indicated a complete response in both primary tumors and TDLN. Postoperative pathology showed no residual pathological disease in any patient. At the most recent follow-up, with a median duration of 14.3 months, all ten patients remain free from recurrence or metastasis. Conclusions: The preservation of TDLN in patients achieving clinical CR after neoadjuvant therapy with tislelizumab is safe. This approach provides novel insights and methods for lymph node management and presents a potential new treatment option for the clinical management of this patient population.
Yang et al. (Thu,) studied this question.