First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial
机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Beijing Key Lab Clin Study, Beijing, Peoples R China[2]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Beijing, Peoples R China[3]Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China[4]Jining Med Univ, Affiliated Hosp, Jining, Peoples R China[5]Nanchang Univ, Dept Gastroenterol, Affiliated Hosp 1, Nanchang, Peoples R China[6]Anhui Med Univ, Dept Anesthesiol, Affiliated Hosp 1, Hefei, Peoples R China[7]Fujian Canc Hosp, Fuzhou, Peoples R China[8]Gen Hosp Northern Theater Command, Shenyang, Peoples R China[9]Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China[10]Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China[11]Jilin Canc Hosp, Changchun, Peoples R China[12]Hunan Canc Hosp, Changsha, Peoples R China[13]China Med Univ, Hosp 1, Shenyang, Peoples R China[14]Harbin Med Univ Canc Hosp, Harbin, Peoples R China[15]Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China[16]Shanghai Gen Hosp, Shanghai, Peoples R China[17]Jiangsu Canc Hosp, Nanjing, Peoples R China[18]Jilin Univ, Hosp 1, Changchun, Jilin, Peoples R China[19]The Fourth Hospital of Hebei Medical University, Shijiazhuang, PR China河北医科大学第四医院肿瘤内科临床科室[20]Huaian First Peoples Hosp, Huaian, Peoples R China[21]Guangxi Med Univ, Affiliated Tumor Hosp, Nanning, Peoples R China[22]Army Med Univ, Dept Radiol, Affiliated Hosp 1, Chongqing, Peoples R China[23]Taizhou Mabtech Pharmaceut Co Ltd, State Key Lab Macromol Drugs & Large Scale Mfg, Taizhou, Peoples R China
Cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) represents a first-line therapeutic standard for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients. Despite this established approach, cetuximab beta (CMAB009), as a modified antibody of cetuximab, prospectively selected for dual RAS/BRAF wild-type patients, has not yet been validated in the Chinese mCRC patients through phase 3 trial. In this study (ClinicalTrials.gov identifier: NCT03206151), patients with RAS/BRAF wild-type mCRC who were not suitable for radical resection were randomly assigned in a 1:1 ratio to receive cetuximab beta plus FOLFIRI or FOLFIRI alone. The primary endpoint was blinded independent review committee-assessed progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), surgery rate for metastasis and R0 resection rate, and safety. From January 4, 2018 to September 2, 2021, a total of 505 eligible patients were enrolled and received study treatment; the median follow-up duration was 8.7 months (95% confidence interval [CI], 7.77 to 9.29) and 5.9 months (95% CI, 5.63 to 6.65) in cetuximab beta plus FOLFIRI group and FOLFIRI group, respectively. Compared to FOLFIRI alone, cetuximab beta plus FOLFIRI demonstrated statistically significant improvements in median PFS (13.1 vs. 9.6 months, hazard ratio [HR], 0.639; 95% CI, 0.468 to 0.872; P = 0.004), median OS (28.3 vs. 23.1 months, HR, 0.729; 95% CI, 0.551 to 0.965; P = 0.024), and ORR (69.1% vs. 42.3%, odds ratio, 3.090; 95% CI, 2.280 to 4.189; P < 0.001). Cetuximab beta plus FOLFIRI exhibited manageable toxicity without novel safety signals. This study demonstrated that cetuximab beta plus FOLFIRI provided significant clinical benefits as a first-line treatment for patients with RAS/BRAF wild-type mCRC. Compared to FOLFIRI alone, cetuximab beta plus FOLFIRI therapy led to prolonged median PFS and OS while maintaining a manageable safety profile, offering a new treatment option for this patient population.
基金：
Taizhou Mabtech Pharmaceutical Co., Ltd, P.R. China
第一作者机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Natl Clin Res Ctr Canc,Beijing Key Lab Clin Study, Beijing, Peoples R China
共同第一作者：
通讯作者：
通讯机构：[2]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Beijing, Peoples R China[3]Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China
推荐引用方式(GB/T 7714)：
Shi Yuankai,Ba Yi,Wang Junye,et al.First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial[J].SIGNAL TRANSDUCTION AND TARGETED THERAPY.2025,10(1):doi:10.1038/s41392-025-02229-4.
APA：
Shi, Yuankai,Ba, Yi,Wang, Junye,Xiong, Jianping,Gu, Kangsheng...&Hou, Sheng.(2025).First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial.SIGNAL TRANSDUCTION AND TARGETED THERAPY,10,(1)
MLA：
Shi, Yuankai,et al."First-line treatment of anti-EGFR monoclonal antibody cetuximab β plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial".SIGNAL TRANSDUCTION AND TARGETED THERAPY 10..1(2025)
医学