Cetuximab plus FOLFOXIRI versus cetuximab plus FOLFOX as conversion regimen in RAS/BRAF wild-type patients with initially unresectable colorectal liver metastases (TRICE trial): A randomized controlled trial

作者：De‐Shen Wang, Chao Ren, Shanshan Li, William Pat Fong, Xiaojun Wu, Jian Xiao, Binkui Li, Yun Zheng, Peirong Ding, Gong Chen, Miao‐Zhen Qiu, Zhi‐Qiang Wang, Feng‐Hua Wang, Hui Luo, Rui Wang, Xiaozhong Wang, Ling Yun Wang, De-Jin Xie, Tao Chen, Li Li, Zhenhai Lu, Xiaohui Zhai, Tianshu Liu, Ying Yuan, Ying Yuan, Jiaqi Chen, Zhizhong Pan, Desen Wan, De-Sen Wan, Rong Zhang, Yun-Fei Yuan, Yun-Fei Yuan, Rui‐Hua Xu, Yuhong Li · 发表于：PLoS Medicine · 年份：2024 · DOI：10.1371/journal.pmed.1004389 · 被引用次数：19 · 研究领域：Colorectal Cancer Treatments and Studies、Hepatocellular Carcinoma Treatment and Prognosis、Gastric Cancer Management and Outcomes

BACKGROUND: It remains unclear whether intensification of the chemotherapy backbone in tandem with an anti-EGFR can confer superior clinical outcomes in a cohort of RAS/BRAF wild-type colorectal cancer (CRC) patients with initially unresectable colorectal liver metastases (CRLM). To that end, we sought to comparatively evaluate the efficacy and safety of cetuximab plus FOLFOXIRI (triplet arm) versus cetuximab plus FOLFOX (doublet arm) as a conversion regimen (i.e., unresectable to resectable) in CRC patients with unresectable CRLM. METHODS AND FINDINGS: This open-label, randomized clinical trial was conducted from April 2018 to December 2022 in 7 medical centers across China, enrolling 146 RAS/BRAF wild-type CRC patients with initially unresectable CRLM. A stratified blocked randomization method was utilized to assign patients (1:1) to either the cetuximab plus FOLFOXIRI (n = 72) or cetuximab plus FOLFOX (n = 74) treatment arms. Stratification factors were tumor location (left versus right) and resectability (technically unresectable versus ≥5 metastases). The primary outcome was the objective response rate (ORR). Secondary outcomes included the median depth of tumor response (DpR), early tumor shrinkage (ETS), R0 resection rate, progression-free survival (PFS), overall survival (not mature at the time of analysis), and safety profile. Radiological tumor evaluations were conducted by radiologists blinded to the group allocation. Primary efficacy analyses were conducted based ...