Nivolumab治疗化疗后进展的晚期食管鳞状细胞癌患者的疗效分析:一项单臂回顾性研究  

The efficacy of Nivolumab in patients with chemotherapy-refractory metastatic esophageal squamous cell carcinoma:A single-arm retrospectively study

作　　者：李丹阳 刘莺 徐淑宁 乔磊 李克 Li Danyang;Liu Ying;Xu Shuning;Qiao Lei;Li Ke(Zhengzhou University Affiliated Cancer Hospital,Henan Cancer Hospital,Henan Zhengzhou 450000,China)

机构地区：[1]郑州大学附属肿瘤医院河南省肿瘤医院

出　　处：《现代肿瘤医学》2019年第18期3233-3237,共5页Journal of Modern Oncology

基　　金：国家自然科学基金(编号:81201954);河南省医学科技攻关计划项目(编号:201701033)

摘　　要：目的:回顾性分析PD-1单抗(Nivolumab)在化疗后进展的晚期食管鳞癌患者中的疗效及安全性。方法:研究入组化疗后进展的食管鳞状细胞癌患者接受Nivolumab单药治疗,3 mg/kg,静脉输注大于30分钟,每2周重复一次,治疗至疾病进展或不能耐受。主要研究终点为客观缓解率(ORR)及安全性,次要研究终点为无进展生存(PFS)和总生存(OS)。结果:2016年1月至2018年1月,共27例患者接受了Nivolumab单药的治疗,客观缓解率(ORR)为7%,疾病控制率(DCR)为63%。治疗相关1-2级不良反应及发生率为:皮疹4例(15%)、转氨酶升高3例(11%)、肺炎3例(11%)、腹痛2例(7%)、腹泻2例(7%)、高胆红素血症2例(7%)、皮肤血管瘤2例(7%)、甲状腺功能减退2例(7%)、血肌酐升高1例(4%)。3-4级不良事件及发生率分别为:皮肤血管瘤1例(4%)、咳嗽1例(4%)、血小板减少1例(4%)及贫血1例(4%)。未观察到与治疗相关死亡事件的发生。中位无进展生存(mP FS)为2. 8月(95%CI:2. 2~3. 4月),中位总生存(mO S)为5. 6月(95%CI:4. 1~7. 1月)。结论:免疫检查点抑制剂Nivolumab在化疗后进展的晚期食管鳞癌的治疗中,疾病控制率高,不良事件发生率低,可作为食管鳞癌患者后线治疗的选择进一步探索。Objective:To analyze the safety and efficacy of programmed death receptor-1 monoclonal(Nivolumab) in patients with metastatic esophageal squamous cell carcinoma who were confirmed progressionafter chemotherapy.Methods:Patients with metastasis esophageal squamous cell carcinoma who experience disease progression after chemotherapyreceived the treatment of Nivolumab,3 mg/kg,intravenous infusion over 30 minutes,repeated every 2 weeks,until disease progression or intolerance.The primary endpoints wereobjective response rate(ORR) and safety.The secondary endpoints were progression-free survival(PFS) and overall survival(OS).Results:From January 2016 to January 2018,a total of 27 patients met the criteria.They received Nivolumab as subsequent treatment.The objective response rate(ORR) and disease control rate(DCR) was 7% and 63%,respectively.Treatment related grade 1-2 adverse eventswere rash(15%),elevated transaminase(11%),pneumonia(11%),abdominal pain(7%),diarrhea(7%),hyperbilirubinemia(7%),cutaneous hemangioma(7%),hypothyroidism(7%) and hypercreatinemia(4%).Grade 3-4 treatment related adverse events included cutaneous hemangioma(4%),cough(4%),thrombocytopenia(4%) and anemia(4%).No treatment-related death was observed.The median progression-free survival(mPFS) and median overall survival(mOS) was 2.8 months(95%CI:2.2~3.4 months) and 5.6 months(95%CI:4.1~7.1 months).Conclusion:Nivolumabhad high disease control and low incidence of adverse events in chemotherapy-refractory metastatic esophageal squamous cell carcinoma.It could be an effective and safetreatment option for patients with advanced esophageal squamous cell carcinoma.And further exploration is essential in the future.

关 键 词：PD-1单抗 Nivolumab 晚期食管鳞状细胞癌 

分 类 号：R735.1[医药卫生—肿瘤]