Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma  

作　　者：Ming Bai Meng Wang Ting Deng Yuxian Bai Kai Zang Zhanhui Miao Wenlin Gai Liangzhi Xie Yi Ba 

机构地区：[1]Tianjin Medical University Cancer Institute and Hospital,National Clinical Research Center for Cancer,Tianjin’s Clinical Research Center for Cancer,Key Laboratory of Cancer Prevention and Therapy,Tianjin 300060,China [2]Department of Gastrointestinal Oncology,Harbin Medical University Cancer Hospital,Harbin 150081,China [3]Department of Medical Oncology,Henan Cancer Hospital,The Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China [4]Oncology Department,The First Affiliated Hospital of Xinxiang Medical University,Xinxiang 453100,China [5]Sinocelltech Ltd.,Beijing 100176,China [6]Beijing Engineering Research Center of Protein and Antibody,Beijing 100176,China [7]Cell Culture Engineering Center,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100176,China

出　　处：《Cancer Biology & Medicine》2022年第3期358-369,共12页癌症生物学与医学（英文版）

基　　金：supported by a grant from the Science&Technology Development Fund of the Tianjin Education Commission for Higher Education(Grant No.2018KJ046).

摘　　要：Objective:The mainstay treatment of esophageal squamous cell carcinoma(ESCC)involves chemotherapy and immunotherapy.However,alternative therapies are required for patients who are refractory or intolerant to existing therapies.Methods:In this single-arm,multicenter,open-label phase Ib study,30 patients received an intravenous infusion of SCT200,an antiepidermal growth factor receptor(EGFR)monoclonal antibody,6.0 mg/kg once a week for 6 weeks,followed by 8.0 mg/kg once every 2 weeks until disease progression or intolerable toxicity.The primary endpoint was the objective response rate(ORR).The secondary endpoints were progression-free survival(PFS),overall survival(OS),and safety.Results:Thirty patients were enrolled between July 2018 and May 2019.The ORR was 16.7%(95%CI:5.6%–34.7%).The median PFS and OS were 3.1 months(95%CI:1.5–4.3)and 6.8 months(95%CI:4.7–10.1),respectively.A numerical difference without any statistical significance in ORR was observed in patients with different EGFR expressions(≥50%:25.0%vs.<50%:0%,P=0.140)or TP53 mutation abundance(<10%:23.8%vs.≥10%:0%,P=0.286).Improved median PFS(3.4 vs.1.4 months,P=0.006)and OS(8.0 vs.4.2 months,P=0.027)were associated with TP53 mutation abundance of<10%.The most common treatment-related adverse events of grade 3 or 4(occurring in≥2 patients)were hypomagnesemia[7(23.3%)]and rash[2(6.7%)].No treatmentrelated death occurred.Conclusions:SCT200 monotherapy as the second-or further-line treatment for advanced ESCC showed favorable efficacy,with an acceptable safety profile.TP53 mutation abundance might serve as a potential predictive biomarker.

关 键 词：Epidermal growth factor receptor esophageal squamous cell carcinoma SCT200 monoclonal antibody 

分 类 号：R735.1[医药卫生—肿瘤]