III期研究的病理反应：围手术期卡瑞利珠单抗联合瑞戈非尼及化疗对比单纯化疗治疗局部进展期胃癌（DRAGON IV/CAP 05）
Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05).
作者信息
Li Chen, Tian Yantao, Zheng Yanan, Yuan Fei, Shi Zheng, Yang Lin, Chen Hao, Jiang Lixin, Wang Xixun, Zhao Ping, Zhang Benyan, Wang Zhenqiang, Zhao Qun, Dong Jianhong, Lian Changhong, Xu Sanrong, Zhang Aimin, Zheng Zhichao, Wang Kang, Dang Chengxue, Wu Dan, Chen Jian, Xue Yingwei, Liang Bo, Cheng Xiangdong, Wang Qian, Chen Luchuan, Xia Tao, Liu Heli, Xu Dazhi, Zhuang Jing, Wu Tao, Zhao Xi, Wu Wei, Wang Hongzhi, Peng Junsheng, Hou Zhiguo, Zheng Rongrong, Chen Yuting, Yin Kai, Zhu Zhenggang
机构信息
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
Pancreatogastric Surgery, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.
出版信息
J Clin Oncol. 2025 Feb;43(4):464-474. doi: 10.1200/JCO.24.00795. Epub 2024 Oct 9.
PURPOSE
This multicenter, randomized phase III trial evaluated the efficacy and safety of perioperative camrelizumab (an anti-PD-1 antibody) plus low-dose rivoceranib (a VEGFR-2 inhibitor) and S-1 and oxaliplatin (SOX) (SOXRC), high-dose rivoceranib plus SOX (SOXR), and SOX alone (SOX) for locally advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
METHODS
Patients with T3-4aN + M0 G/GEJ adenocarcinoma were randomly assigned (1:1:1) to receive perioperative treatment with SOXRC, SOXR, or SOX. The primary end points were pathologic complete response (pCR) and event-free survival. The Independent Data Monitoring Committee recommended stopping enrollment in the SOXR group on the basis of the safety data of the first 103 randomly assigned patients in the three groups. The patients were then randomly assigned 1:1 to the SOXRC or SOX groups. This report presents the pCR results obtained per protocol for the first 360 randomly assigned patients who had the opportunity for surgery in the SOXRC and SOX groups.
RESULTS
In the SOXRC and SOX groups, of the 180 patients in each group, 99% and 98% of patients received neoadjuvant therapy, 91% and 94% completed planned neoadjuvant therapy, and 86% and 87% underwent surgery, respectively. The pCR was significantly higher in the SOXRC group at 18.3% (95% CI, 13.0 to 24.8) compared with 5.0% (95% CI, 2.3 to 9.3) in the SOX group (difference of 13.7%; 95% CI, 7.2 to 20.1; odds ratio of 4.5 [95% CI, 2.1 to 9.9]). The one-sided value was <.0001, crossing the prespecified statistical significance threshold of = .005. Surgical complications and grade ≥3 neoadjuvant treatment-related adverse events were 27% versus 33% and 34% versus 17% for SOXRC and SOX, respectively.
CONCLUSION
The SOXRC regimen significantly improved pCR compared with SOX alone in patients with G/GEJ adenocarcinoma with a tolerable safety profile.
目的
本多中心、随机III期试验评估了围手术期卡瑞利珠单抗（一种抗程序性死亡蛋白1抗体）联合低剂量瑞戈非尼（一种血管内皮生长因子受体2抑制剂）与S-1及奥沙利铂（SOX）（SOXRC）、高剂量瑞戈非尼联合SOX（SOXR）以及单纯SOX方案用于局部进展期胃或胃食管交界（G/GEJ）腺癌的疗效和安全性。
方法
T3-4aN+M0 G/GEJ腺癌患者被随机分配（1:1:1）接受SOXRC、SOXR或SOX围手术期治疗。主要终点为病理完全缓解（pCR）和无事件生存期。独立数据监测委员会根据三组中最初随机分配的103例患者的安全性数据，建议停止SOXR组的入组。然后患者被1:1随机分配至SOXRC或SOX组。本报告展示了SOXRC组和SOX组中最初随机分配的有机会接受手术的360例患者按照方案获得的pCR结果。
结果
在SOXRC组和SOX组中，每组180例患者，分别有99%和98%的患者接受了新辅助治疗，91%和94%的患者完成了计划的新辅助治疗，86%和87%的患者接受了手术。SOXRC组的pCR显著更高，为18.3%（95%置信区间，13.0至24.8），而SOX组为5.0%（95%置信区间，2.3至9.3）（差值为13.7%；95%置信区间，7.2至20.1；优势比为4.5 [95%置信区间，2.1至9.9]）。单侧P值<.0001，超过了预先设定的统计显著性阈值α = .005。SOXRC组和SOX组的手术并发症及3级及以上新辅助治疗相关不良事件分别为27%对33%以及34%对17%。
结论
与单纯SOX方案相比，SOXRC方案在G/GEJ腺癌患者中显著提高了pCR，且安全性可耐受。
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