Ou Dan, Cai Rong, Qi Wei-Xiang, Cui Can, Cao Lu, Wang Shu-Bei, Li Huan, Ma Tao, Miao Ying, Xu Cheng, Cai Gang, Cao Wei-Guo, Gao Yun-Sheng, Chen Jia-Yi, Xu Hao-Ping
Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 197 Ruijin Second Road, Shanghai, 200025, China.
John H. Stroger, Jr. Hospital of Cook County, Chicago, 60612, USA.
Cancer Immunol Immunother. 2024 Oct 3;73(12):244. doi: 10.1007/s00262-024-03823-1.
This phase I/II trial (ChiCTR2000032879) assessed the safety and efficacy of toripalimab combined with chemoradiotherapy for locally advanced cervical squamous cell carcinoma.
Twenty-two patients, regardless of their programmed death ligand-1 (PD-L1) status, received toripalimab combined with concurrent chemoradiotherapy (CCRT). CCRT included cisplatin (40 mg/m, once weekly for 5 weeks), radiotherapy (45-50.4 Gy/25-28 Fx, 5 fractions weekly), followed by brachytherapy (24-30 Gy/3-5 Fx) and toripalimab (240 mg, intravenous) on days 1, 22 and 43 during CCRT. The primary endpoints were safety and 2-year progression-free survival (PFS). The secondary endpoints included 2-year local control (LC), local regional control and overall survival (OS).
All patients successfully completed CCRT and toripalimab treatment. Grade III and higher adverse events (AEs) were observed in 11 patients (11/22, 50%), and no patient experienced grade V AEs. The objective response rate (ORR) was 100%. At the data cutoff (June 30, 2023), the median follow-up was 31.8 months (9.5 to 37.8 months). The 2-year PFS rate was 81.8%. The 2-year LC and local regional control rates were both 95.5%, and the 2-year OS rate was 90.9%.
Toripalimab combined with CCRT achieved good tolerance and showed promising anti-tumor effects in patients with locally advanced cervical cancer.
本I/II期试验（ChiCTR2000032879）评估了托瑞帕利单抗联合放化疗治疗局部晚期宫颈鳞状细胞癌的安全性和疗效。
22例患者，无论其程序性死亡配体-1（PD-L1）状态如何，均接受托瑞帕利单抗联合同步放化疗（CCRT）。CCRT包括顺铂（40mg/m，每周一次，共5周）、放疗（45-50.4Gy/25-28次分割，每周5次分割），随后在CCRT期间的第1、22和43天进行近距离放疗（24-30Gy/3-5次分割）和托瑞帕利单抗（240mg，静脉注射）。主要终点是安全性和2年无进展生存期（PFS）。次要终点包括2年局部控制（LC）、局部区域控制和总生存期（OS）。
所有患者均成功完成CCRT和托瑞帕利单抗治疗。11例患者（11/22，50%）观察到3级及以上不良事件（AE），无患者发生5级AE。客观缓解率（ORR）为100%。在数据截止日期（2023年6月30日），中位随访时间为31.8个月（9.5至37.8个月）。2年PFS率为81.8%。2年LC和局部区域控制率均为95.5%，2年OS率为90.9%。
托瑞帕利单抗联合CCRT耐受性良好，在局部晚期宫颈癌患者中显示出有前景的抗肿瘤效果。
