Toripalimab combined with definitive chemoradiotherapy for locally advanced cervical squamous cell carcinoma patients (TRACE): A single-arm, phase I/II trial.

IF 4.6 2区医学 Q2 IMMUNOLOGY

Cancer Immunology, Immunotherapy Pub Date : 2024-10-03 DOI:10.1007/s00262-024-03823-1

Dan Ou, Rong Cai, Wei-Xiang Qi, Can Cui, Lu Cao, Shu-Bei Wang, Huan Li, Tao Ma, Ying Miao, Cheng Xu, Gang Cai, Wei-Guo Cao, Yun-Sheng Gao, Jia-Yi Chen, Hao-Ping Xu

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引用次数: 0

Abstract

Purpose: This phase I/II trial (ChiCTR2000032879) assessed the safety and efficacy of toripalimab combined with chemoradiotherapy for locally advanced cervical squamous cell carcinoma.

Methods and materials: 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/m², 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).

Results: 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%.

Conclusions: Toripalimab combined with CCRT achieved good tolerance and showed promising anti-tumor effects in patients with locally advanced cervical cancer.

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局部晚期宫颈鳞状细胞癌患者托利帕利单抗联合放化疗（TRACE）：单臂 I/II 期试验。

目的：这项I/II期试验（ChiCTR2000032879）评估了托利帕利单抗联合化放疗治疗局部晚期宫颈鳞癌的安全性和有效性：22名患者，无论其程序性死亡配体-1（PD-L1）状态如何，均接受了托利帕利单抗联合同期化放疗（CCRT）。CCRT包括顺铂（40 mg/m2，每周一次，持续5周）、放疗（45-50.4 Gy/25-28 Fx，每周5次），然后是近距离放射治疗（24-30 Gy/3-5 Fx），以及在CCRT期间的第1、22和43天使用托利帕利单抗（240 mg，静脉注射）。主要终点是安全性和两年无进展生存期（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）：所有患者都顺利完成了CCRT和托瑞帕利单抗治疗。11名患者（11/22，50%）出现了III级及以上不良反应（AEs），没有患者出现V级不良反应。客观反应率（ORR）为100%。截至数据截止日（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%：结论：托利帕利单抗联合CCRT对局部晚期宫颈癌患者具有良好的耐受性和抗肿瘤效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Immunology, Immunotherapy 医学-免疫学

CiteScore

10.50

自引率

1.70%

发文量

207

审稿时长

1 months

期刊介绍： Cancer Immunology, Immunotherapy has the basic aim of keeping readers informed of the latest research results in the fields of oncology and immunology. As knowledge expands, the scope of the journal has broadened to include more of the progress being made in the areas of biology concerned with biological response modifiers. This helps keep readers up to date on the latest advances in our understanding of tumor-host interactions. The journal publishes short editorials including "position papers," general reviews, original articles, and short communications, providing a forum for the most current experimental and clinical advances in tumor immunology.