Phase 2 pilot trial of tislelizumab plus low-dose nab-paclitaxel for extensive very high-risk non-muscle-invasive bladder cancer

IF 10 1区 医学 Q1 ONCOLOGY Clinical Cancer Research Pub Date : 2025-01-07 DOI:10.1158/1078-0432.ccr-24-3321
Yunkai Qie, Shiwang Huang, Chong Shen, Zhouliang Wu, La Da, Kaipeng Jia, Zhe Zhang, Gangjian Zhao, Lili Wang, Guoping Xu, Yang Zhao, Rui Liang, Jianing Guo, Changping Li, Hua Dong, Man Li, Hongjun Li, Houyuan Chen, Dawei Tian, Changli Wu, Wei Zhang, Zesheng An, Haitao Wang, Yuanjie Niu, Hailong Hu
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Abstract

Purpose: Combinations of immune checkpoint inhibitors and nab-paclitaxel have improved outcomes in advanced urothelial carcinoma and muscle-invasive bladder cancer. This study evaluates the safety and efficacy of tislelizumab combined with low-dose nab-paclitaxel in extensive very high-risk (VHR) non-muscle-invasive bladder cancer (NMIBC). Patients and Methods: TRUCE-02 was a single-arm phase 2 trial that included 63 patients with visually incomplete resection and/or high-volume high-grade T1 tumors (with or without carcinoma in situ), who were ineligible for or declined radical cystectomy. Patients received intravenous tislelizumab (200 mg on day 1) and nab-paclitaxel (200 mg on day 2) every 3 weeks, with assessment approximately 3 months after initial administration. The primary endpoint was the complete response rate of high-risk disease. Main secondary endpoints included safety and duration of complete response. Results: The safety analysis included all 63 patients and the efficacy analysis included 59 patients. Thirty-seven patients [62.7%; 95% confidence interval (CI), 49.1-75.0%] achieved a complete response of high-risk disease, with a 24-month sustained response rate of 96.3% (95% CI, 89.4-100.0%). Grade 3-4 treatment-related adverse events occurred in nine patients (14%), with no fatal events reported. Conclusions: Tislelizumab plus low-dose nab-paclitaxel was well-tolerated and showed promising antitumor activity, making it a potential alternative for extensive VHR NMIBC patients who are ineligible for or decline radical cystectomy.
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tislelizumab联合低剂量nab-紫杉醇治疗广泛的高危非肌肉侵袭性膀胱癌的2期试点试验
目的:免疫检查点抑制剂联合nab-紫杉醇可改善晚期尿路上皮癌和肌肉浸润性膀胱癌的预后。本研究评估了tislelizumab联合低剂量nab-紫杉醇治疗广泛高危(VHR)非肌肉浸润性膀胱癌(NMIBC)的安全性和有效性。患者和方法:休战-02是一项单臂2期试验,包括63例视力不完全切除和/或大容量高级别T1肿瘤(伴或不伴原位癌),不适合或拒绝根治性膀胱切除术的患者。患者每3周接受静脉注射tislelizumab(第1天200毫克)和nab-紫杉醇(第2天200毫克),在初始给药后约3个月进行评估。主要终点为高危疾病的完全缓解率。主要次要终点包括安全性和完全缓解持续时间。结果:63例患者纳入安全性分析,59例患者纳入疗效分析。37例[62.7%];95%可信区间(CI), 49.1-75.0%]实现了对高危疾病的完全缓解,24个月持续缓解率为96.3% (95% CI, 89.4-100.0%)。9例患者(14%)发生3-4级治疗相关不良事件,无致命事件报告。结论:Tislelizumab联合低剂量nab-紫杉醇具有良好的耐受性,并显示出良好的抗肿瘤活性,使其成为不适合或拒绝根治性膀胱切除术的广泛VHR NMIBC患者的潜在替代方案。
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来源期刊
Clinical Cancer Research
Clinical Cancer Research 医学-肿瘤学
CiteScore
20.10
自引率
1.70%
发文量
1207
审稿时长
2.1 months
期刊介绍: Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.
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