Interim results from a multicenter clinical study of tislelizumab combined with gemcitabine and cisplatin as neoadjuvant therapy for patients with cT2-T4aN0M0 MIBC.

作者：Tianxin Lin, Kaiwen Li, Jinhai Fan, Shaogang Wang, Dexin Yu, Tao Xu, Jiaju Lyu, Kaijie Wu, Zheng Liu, Zhiquan Hu, Fan Li, Liangkuan Bi, Zhiqiang Zhang, Lingyu Yu, Sentai Ding, Jian Huang · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.2022.40.16_suppl.4580 · 被引用次数：9 · 研究领域：Bladder and Urothelial Cancer Treatments、Urinary and Genital Oncology Studies、Cancer Immunotherapy and Biomarkers

4580 Background: To evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin as neoadjuvant therapy for patients (pts) with clinical T2-T4aN0M0 (cT2-T4aN0M0) muscle-invasive bladder urothelial cancer (MIBC). Methods: This multicenter, open-label, single arm phase II study enrolled pts tolerated with the cisplatin therapy. Eligible pts received tislelizumab 200 mg in day 1 (D1), cisplatin 70 mg/m 2 D2, and gemcitabine 1000 mg/m 2 D1 and D8 every 21 days for four cycles. Radical cystectomy (RC) was performed within 6 weeks after last dose treatment. The primary end point was pathologic complete response (pCR, pT0N0M0). Secondary end points were pathologic downstaging (≤pT1N0M0), EFS, OS and safety. Simon two-stage design was used. If > 5 pts achieved pCR in the first stage (n = 22), study would proceed to the second stage and enroll 33 additional pts. If > 18 of 55 pts achieved pCR, we would deem the study to have met the primary endpoint. Results: We reported the results in the first stage. By Oct 2021, 23 eligible pts were enrolled. Eighteen pts have completed neoadjuvant therapy, with median age of 62 (48-72) years and 8 (44.4%) pts of PD-L1 positive, among whom 17 pts underwent RC and one declined RC. At the data cut off time of 14 th Jan 2022, among 17 evaluable pts (12 cT2, 3 cT3, and 2 cT4a), 10 (58.8% [95% CI, 32.9-81.6]) pts achieved pCR and 13 (76.5% [95% CI, 50.1-93.2]) achieved pathologic downstaging. No significant differences ...