Combinations of immune checkpoint inhibitors and nab-paclitaxel have achieved significant therapeutic effects in the treatment of advanced urothelial carcinoma. Our aim was to assess the efficacy and safety of tislelizumab combined with low-dose nab-paclitaxel in patients with muscle-invasive bladder cancer (MIBC).
TRUCE-01 was a single-arm phase 2 study that included 62 patients with T2-4a N0/X M0 MIBC tumors with predominant urothelial carcinoma histology. Eligible patients received three 21-d cycles of intravenous 200 mg tislelizumab on day 1 plus intravenous 200 mg nab-paclitaxel on day 2, followed by surgical assessment. The primary study endpoint was a clinical complete response (cCR). Treatment-related adverse event (TRAE) profiles were recorded according to Common Terminology Criteria for Adverse Events version 5.0.
The safety analysis included all 62 patients and the efficacy analysis included 48 patients. The primary efficacy endpoint (cCR) was met by 25 patients (52%) patients. Among the 62 patients in the safety analysis, six (9.7%) had grade ≥3 TRAEs.
Tislelizumab combined with low-dose nab-paclitaxel showed promising antitumor effectiveness and was generally well tolerated, which makes it an excellent preoperative therapy option for MIBC.
We found that a combination of the drugs tislelizumab and low-dose nab-paclitaxel had satisfactory efficacy and safety for preoperative treatment of muscle-invasive bladder cancer.
European urology oncology. 2024 May 17 [Epub ahead of print]
Zhouliang Wu, Gangjian Zhao, Zhe Zhang, Chong Shen, Lili Wang, Guoping Xu, Yang Zhao, Rui Liang, Changping Li, Huanhuan Liu, Hongmei Wang, Hua Dong, Huaying Fu, Man Li, Hongjun Li, Yan Zhuang, La Da, Shiwang Huang, Kaipeng Jia, Houyuan Chen, Yiduo Bai, Shizheng Guo, Huanqing Cheng, Huina Wang, Haitao Wang, Yuanjie Niu, Hailong Hu
Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China; Tianjin Key Laboratory of Urology, Tianjin Institute of Urology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Medical Oncology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Radiology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Pathology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Health Statistics, School of Public Health, Tianjin Medical University, Tianjin, China., Acornmed Biotechnology, Beijing, China., Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China., Department of Nuclear Medicine, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Gastroenterology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Rheumatology and Immunology, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Respiratory, Second Hospital of Tianjin Medical University, Tianjin, China., Department of Medical Oncology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: ., Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China; Tianjin Key Laboratory of Urology, Tianjin Institute of Urology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: ., Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China; Tianjin Key Laboratory of Urology, Tianjin Institute of Urology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: .