European urology open science · 2025
Consolidative Radical Cystectomy Following Neoadjuvant Tislelizumab Plus Gemcitabine and Cisplatin in Clinically Lymph Node-positive Bladder Cancer: A Prospective Study.
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Zhuang Juntao, Yu Hao, Cao Qiang, Bai Rongjie, Feng Tianshuo, Cai Lingkai, Yang Xiao, Lu Qiang
Аннотация
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/m2 on days 1 and 8), and cisplatin (70 mg/m2 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 (<ypT2N0), progression-free survival, overall survival, and safety.
KEY FINDINGS AND LIMITATIONS: A total of 30 patients were enrolled, of whom 28 met the inclusion criteria and 19 completed neoadjuvant therapy followed by consolidative RC. The overall clinical complete response rate was 31%. Final pathological results showed that seven patients (37%) achieved a pCR. Ten patients (53%) experienced pathological downstaging. Pathological complete nodal response (pN0) occurred in 14 (74%) patients. The median follow-up was 28 mo (interquartile range 26-36). Disease progression or death occurred in 13 patients. Treatment-related adverse events of grade 3 or 4 accounted for 46% of complications. Limitations of this work included its single-centre, one-arm design and the absence of standardised cN+ diagnosis.
CONCLUSIONS AND CLINICAL IMPLICATIONS: The combination of tislelizumab and gemcitabine/cisplatin with consolidative RC appears to be a relatively safe neoadjuvant therapy in patients with lymph node-positive bladder cancer.
PATIENT SUMMARY: In this study, we investigated the efficacy of neoadjuvant chemoimmunotherapy in patients with clinically lymph node-positive bladder cancer. We found that the clinical effect of completing three neoadjuvant chemoimmunotherapy sessions combined with consolidative radical cystectomy was relatively good. Our conclusion is that neoadjuvant chemoimmunotherapy combined with consolidative radical cystectomy is safe and effective for patients with clinically positive lymph nodes.
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/m2 on days 1 and 8), and cisplatin (70 mg/m2 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 (<ypT2N0), progression-free survival, overall survival, and safety.
KEY FINDINGS AND LIMITATIONS: A total of 30 patients were enrolled, of whom 28 met the inclusion criteria and 19 completed neoadjuvant therapy followed by consolidative RC. The overall clinical complete response rate was 31%. Final pathological results showed that seven patients (37%) achieved a pCR. Ten patients (53%) experienced pathological downstaging. Pathological complete nodal response (pN0) occurred in 14 (74%) patients. The median follow-up was 28 mo (interquartile range 26-36). Disease progression or death occurred in 13 patients. Treatment-related adverse events of grade 3 or 4 accounted for 46% of complications. Limitations of this work included its single-centre, one-arm design and the absence of standardised cN+ diagnosis.
CONCLUSIONS AND CLINICAL IMPLICATIONS: The combination of tislelizumab and gemcitabine/cisplatin with consolidative RC appears to be a relatively safe neoadjuvant therapy in patients with lymph node-positive bladder cancer.
PATIENT SUMMARY: In this study, we investigated the efficacy of neoadjuvant chemoimmunotherapy in patients with clinically lymph node-positive bladder cancer. We found that the clinical effect of completing three neoadjuvant chemoimmunotherapy sessions combined with consolidative radical cystectomy was relatively good. Our conclusion is that neoadjuvant chemoimmunotherapy combined with consolidative radical cystectomy is safe and effective for patients with clinically positive lymph nodes.