结直肠癌
医学
放化疗
置信区间
肿瘤科
临床终点
随机对照试验
抗体
免疫组织化学
内科学
癌症
胃肠病学
免疫学
作者
Weiwei Xiao,Gong Chen,Yuanhong Gao,Junzhong Lin,Xiaojun Wu,Huilong Luo,Zhenhai Lu,Qiaoxuan Wang,Rui Sun,Peiqiang Cai,Chong-Mei Zhu,Min Liu,Jibin Li,Yi‐Rui Wang,Ying Jin,Rui Wang,Haitao Luo,Cailing Li,Zhizhong Pan,Rui‐Hua Xu
标识
DOI:10.1016/j.ccell.2024.07.004
摘要
Neoadjuvant chemoradiotherapy (NACRT) was the standard treatment for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) proteins. In this randomized phase 2 trial (ClinicalTrial.gov: NCT04304209), 134 pMMR LARC patients were randomly (1:1) assigned to receive NACRT or NACRT and the programmed cell death protein 1 (PD-1) antibody sintilimab. As the primary endpoint, the total complete response (CR) rate is 26.9% (18/67, 95% confidence interval [CI] 16.0%–37.8%) and 44.8% (30/67, 95% CI 32.6%–57.0%) in the control and experimental arm, respectively, with significant difference (p = 0.031 for chi-squared test). Response ratio is 1.667 (95% CI 1.035–2.683). Immunohistochemistry shows PD-1 ligand 1 (PD-L1) combined positive score is associated with the synergistic effect. The safety profile is similar between the arms. Adding the PD-1 antibody sintilimab to NACRT significantly increases the CR rate in pMMR LARC, with a manageable safety profile. PD-L1 positivity may help identify patients who might benefit most from the combination therapy.
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