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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 预览

The efficacy of Nivolumab in patients with chemotherapy-refractory metastatic esophageal squamous cell carcinoma:A single-arm retrospectively study
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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.
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)
出处 《现代肿瘤医学》 CAS 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).
关键词 PD-1单抗 Nivolumab 晚期食管鳞状细胞癌 PD-1 monoclonal antibody Nivolumab advanced esophageal squamous cell carcinoma
作者简介 李丹阳(1992-),女,河南洛阳人,硕士,研究方向:消化道肿瘤内科。E-mail:576008029@qq.com;通讯作者:刘莺(1974-),女,河南郑州人,主任医师,硕士生导师,研究方向:消化道肿瘤内科。E-mail:yaya7207@126.com.
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