Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05)
Abstract
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 P value was <.0001, crossing the prespecified statistical significance threshold of P = .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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (41)
Chen Li
Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, USA.
Yantao Tian
Pancreatogastric Surgery, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China
Yanan Zheng
Fei Yuan
State Key Laboratory of Animal Biodiversity Conservation and Integrated Pest Management, Institute of Zoology, Chinese Academy of Sciences
Zheng Shi
Lin Yang
Hao Chen
Lixin Jiang
Xixun Wang
Gastrointestinal Surgery, Yantai Yuhuangding Hospital, Yantai, China
Ping Zhao
Benyan Zhang
Department of Pathology, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
Zhenqiang Wang
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
Qun Zhao
State Key Laboratory of Medical Proteomics, National Chromatographic Research & Analysis Center, Chinese Academy of Sciences Key Laboratory of Separation Science for Analytical Chemistry, Dalian Institute of Chemical Physics, Chinese Academy of Sciences
Jianhong Dong
Minimally Invasive Surgery of Digestive Endoscopy, Shanxi Provincial Cancer Hospital, Taiyuan, China
Changhong Lian
Sanrong Xu
Department of General Surgery, Affiliated Hospital of Jiangsu University, Zhenjiang, China
Aimin Zhang
Zhichao Zheng
Gastric Cancer Surgery, Liaoning Cancer Hospital & Institution, Shenyang, China
Kang Wang
Chengxue Dang
Dan Wu
Key Laboratory of Freshwater Fish Reproduction and Development, Ministry of Education, State Key Laboratory Breeding Base of Eco-Environments and Bio-Resources of the Three Gorges Reservoir Region, School of Life Sciences, Southwest University
Jian Chen
Yingwei Xue
Bo Liang
Xiangdong Cheng
Qian Wang
Luchuan Chen
Tao Xia
State Key Laboratory of Physical Chemistry of Solid Surfaces, Fujian Provincial Key Laboratory of Theoretical and Computational Chemistry, and College of Chemistry and Chemical Engineering
Heli Liu
Gastroenterology, Xiangya Hospital Central South University, Changsha, China
Dazhi Xu
Gastrosurgery, Fudan University Shanghai Cancer Center, Shanghai, China
Jing Zhuang
Tao Wu
Xi Zhao
Wei Wu
Hongzhi Wang
Junsheng Peng
Zhiguo Hou
School of Chemistry & Chemical Engineering Anhui University Hefei 230601 China
Rongrong Zheng
Yuting Chen
Department of Chemistry
Kai Yin
Zhenggang Zhu
Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China