TY - JOUR
T1 - Pathologic Response of Phase III Study
T2 - Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05)
AU - Li, Chen
AU - Tian, Yantao
AU - Zheng, Yanan
AU - Yuan, Fei
AU - Shi, Zheng
AU - Yang, Lin
AU - Chen, Hao
AU - Jiang, Lixin
AU - Wang, Xixun
AU - Zhao, Ping
AU - Zhang, Benyan
AU - Wang, Zhenqiang
AU - Zhao, Qun
AU - Dong, Jianhong
AU - Lian, Changhong
AU - Xu, Sanrong
AU - Zhang, Aimin
AU - Zheng, Zhichao
AU - Wang, Kang
AU - Dang, Chengxue
AU - Wu, Dan
AU - Chen, Jian
AU - Xue, Yingwei
AU - Liang, Bo
AU - Cheng, Xiangdong
AU - Wang, Qian
AU - Chen, Luchuan
AU - Xia, Tao
AU - Liu, Heli
AU - Xu, Dazhi
AU - Zhuang, Jing
AU - Wu, Tao
AU - Zhao, Xi
AU - Wu, Wei
AU - Wang, Hongzhi
AU - Peng, Junsheng
AU - Hou, Zhiguo
AU - Zheng, Rongrong
AU - Chen, Yuting
AU - Yin, Kai
AU - Zhu, Zhenggang
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2025/2/1
Y1 - 2025/2/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85207329223
U2 - 10.1200/JCO.24.00795
DO - 10.1200/JCO.24.00795
M3 - 文章
C2 - 39383487
AN - SCOPUS:85207329223
SN - 0732-183X
VL - 43
SP - 464
EP - 474
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 4
ER -
