典型文献
Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma
文献摘要：
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 anti-epidermal 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 treatment-related 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.
文献关键词：
中图分类号：
作者姓名：
Ming Bai;Meng Wang;Ting Deng;Yuxian Bai;Kai Zang;Zhanhui Miao;Wenlin Gai;Liangzhi Xie;Yi Ba
作者机构：
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;Department of Gastrointestinal Oncology,Harbin Medical University Cancer Hospital,Harbin 150081,China;Department of Medical Oncology,Henan Cancer Hospital,The Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou 450008,China;Oncology Department,The First Affiliated Hospital of Xinxiang Medical University,Xinxiang 453100,China;Sinocelltech Ltd.,Beijing 100176,China;Beijing Engineering Research Center of Protein and Antibody,Beijing 100176,China;Cell Culture Engineering Center,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100176,China
文献出处：
引用格式：
[1]Ming Bai;Meng Wang;Ting Deng;Yuxian Bai;Kai Zang;Zhanhui Miao;Wenlin Gai;Liangzhi Xie;Yi Ba-.Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma)[J].癌症生物学与医学（英文版）,2022(03):358-369
A类：
SCT200,intolerant
B类：
Safety,efficacy,EGFR,monoclonal,antibody,line,advanced,esophageal,squamous,cell,carcinoma,Objective,mainstay,treatment,ESCC,involves,chemotherapy,immunotherapy,However,alternative,therapies,are,required,patients,who,refractory,existing,Methods,In,this,single,arm,multicenter,open,label,phase,Ib,study,received,intravenous,infusion,epidermal,growth,receptor,once,weeks,followed,by,every,until,disease,progression,intolerable,toxicity,primary,was,objective,response,rate,ORR,secondary,endpoints,were,free,survival,PFS,overall,OS,safety,Results,Thirty,enrolled,between,July,May,median,months,respectively,numerical,difference,without,any,statistical,significance,observed,different,expressions,TP53,mutation,abundance,Improved,associated,most,common,related,adverse,events,grade,occurring,hypomagnesemia,rash,No,death,occurred,Conclusions,monotherapy,further,showed,favorable,acceptable,profile,might,potential,predictive,biomarker
AB值：
0.560898
相似文献
机标中图分类号，由域田数据科技根据网络公开资料自动分析生成，仅供学习研究参考。
