Perioperative toripalimab plus neoadjuvant chemotherapy might improve outcomes in resectable esophageal cancer: an interim analysis of a phase III randomized clinical trial

IF 20.1 1区医学 Q1 ONCOLOGY Cancer Communications Pub Date : 2024-09-02 DOI:10.1002/cac2.12604

Yan Zheng, Guanghui Liang, Dongfeng Yuan, Xianben Liu, Yufeng Ba, Zimin Qin, Sining Shen, Zhenxuan Li, Haibo Sun, Baoxing Liu, Quanli Gao, Peng Li, Zongfei Wang, Shilei Liu, Jianping Zhu, Haoran Wang, Haibo Ma, Zhenzhen Liu, Fei Zhao, Jun Zhang, He Zhang, Daoyuan Wu, Jinrong Qu, Jie Ma, Peng Zhang, Wenjie Ma, Ming Yan, Yongkui Yu, Qing Li, Jiangong Zhang, Wenqun Xing

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Abstract

Background

In the era of immunotherapy, neoadjuvant immunochemotherapy (NAIC) for the treatment of locally advanced esophageal squamous cell carcinoma (ESCC) is used clinically but lacks of high-level clinical evidence. This study aimed to compare the safety and long-term efficacy of NAIC followed by minimally invasive esophagectomy (MIE) with those of neoadjuvant chemotherapy (NAC) followed by MIE.

Methods

A prospective, single-center, open-label, randomized phase III clinical trial was conducted at Henan Cancer Hospital, Zhengzhou, China. Patients were randomly assigned to receive either neoadjuvant toripalimab (240 mg) plus paclitaxel (175 mg/m²) + cisplatin (75 mg/m²) (toripalimab group) or paclitaxel + cisplatin alone (chemotherapy group) every 3 weeks for 2 cycles. After surgery, the toripalimab group received toripalimab (240 mg every 3 weeks for up to 6 months). The primary endpoint was event-free survival (EFS). The pathological complete response (pCR) and overall survival (OS) were key secondary endpoints. Adverse events (AEs) and quality of life were also assessed.

Results

Between May 15, 2020 and August 13, 2021, 252 ESCC patients ranging from T1N1-3M0 to T2-3N0-3M0 were enrolled for interim analysis, with 127 in the toripalimab group and 125 in the chemotherapy group. The 1-year EFS rate was 77.9% in the toripalimab group compared to 64.3% in the chemotherapy group (hazard ratio [HR] = 0.62; 95% confidence interval [CI] = 0.39 to 1.00; P = 0.05). The 1-year OS rates were 94.1% and 83.0% in the toripalimab and chemotherapy groups, respectively (HR = 0.48; 95% CI = 0.24 to 0.97; P = 0.037). The patients in the toripalimab group had a higher pCR rate (18.6% vs. 4.6%; P = 0.001). The rates of postoperative Clavien-Dindo grade IIIb or higher morbidity were 9.8% in the toripalimab group and 6.8% in the chemotherapy group, with no significant difference observed (P = 0.460). The rates of grade 3 or 4 treatment-related AEs did not differ between the two groups (12.5% versus 12.4%).

Conclusions

The interim results of this ongoing trial showed that in resectable ESCC, the addition of perioperative toripalimab to NAC is safe, may improve OS and might change the standard treatment in the future.

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围手术期托利帕利单抗加新辅助化疗可改善可切除食管癌的预后：一项III期随机临床试验的中期分析。

背景：在免疫疗法时代，新辅助免疫化疗（NAIC）被用于治疗局部晚期食管鳞状细胞癌（ESCC），但缺乏高水平的临床证据。本研究旨在比较新辅助化疗（NAC）后进行微创食管切除术（MIE）与新辅助化疗后进行微创食管切除术（MIE）的安全性和长期疗效：中国郑州市河南省肿瘤医院开展了一项前瞻性、单中心、开放标签、随机III期临床试验。患者被随机分配接受新辅助托瑞帕利单抗（240毫克）+紫杉醇（175毫克/平方米）+顺铂（75毫克/平方米）（托瑞帕利单抗组）或单独紫杉醇+顺铂（化疗组）治疗，每3周1次，共2个周期。手术后，托里帕利单抗组接受托里帕利单抗治疗（每3周240毫克，最长6个月）。主要终点是无事件生存期（EFS）。病理完全反应（pCR）和总生存期（OS）是次要终点。此外，还对不良事件（AEs）和生活质量进行了评估：2020年5月15日至2021年8月13日，252名T1N1-3M0至T2-3N0-3M0的ESCC患者入组进行中期分析，其中托利帕单抗组127人，化疗组125人。托利帕利单抗组的1年EFS率为77.9%，化疗组为64.3%（危险比[HR] = 0.62；95%置信区间[CI] = 0.39至1.00；P = 0.05）。托利帕利单抗组和化疗组的1年OS率分别为94.1%和83.0%（HR = 0.48；95% CI = 0.24至0.97；P = 0.037）。托利帕单抗组患者的 pCR 率更高（18.6% 对 4.6%；P = 0.001）。术后Clavien-Dindo IIIb级或更高的发病率在托利帕利单抗组为9.8%，在化疗组为6.8%，没有观察到显著差异（P = 0.460）。两组的3级或4级治疗相关AEs发生率没有差异（12.5%对12.4%）：这项正在进行的试验的中期结果表明，对于可切除的 ESCC，在 NAC 的基础上加用围术期托利帕利单抗是安全的，可改善 OS，并有可能在未来改变标准治疗方法。

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 Communications Biochemistry, Genetics and Molecular Biology-Cancer Research

CiteScore

25.50

自引率

4.30%

发文量

153

审稿时长

4 weeks

期刊介绍： Cancer Communications is an open access, peer-reviewed online journal that encompasses basic, clinical, and translational cancer research. The journal welcomes submissions concerning clinical trials, epidemiology, molecular and cellular biology, and genetics.