Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study
Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study
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DOI：
10.1634/theoncologist.2018-0618
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发表时间：
2019-06-01
期刊：
影响因子：
5.8
通讯作者：
Ficorella, Corrado
中科院分区：
文献类型：
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作者：
Cortellini, Alessio;Buti, Sebastiano;Ficorella, Corrado
背景有自身免疫性疾病（AIDS）病史的患者通常不包括在免疫检查点抑制剂的临床试验中。材料与方法根据是否存在AIDS，对接受抗程序性死亡-1（PD-1）药物治疗的连续性晚期癌症患者进行评估。比较各亚组间免疫相关不良事件（irAE）的发生率和临床结局。结果共纳入751例患者，中位年龄为69岁。原发性肿瘤如下：非小细胞肺癌492例（65.5%）;黑色素瘤159例（21.2%）;肾癌94例（12.5%）;其他6例（0.8%）。男女比例为499/252。85例患者（11.3%）有既存艾滋病，进一步区分为临床活动性（17.6%）和非活动性（82.4%）。在既存AIDS患者中，任何级别的irAE发生率均显著高于无AIDS患者（65.9% vs. 39.9%）。在多变量分析中，非活动性（p = 0.0005）和活动性既存AIDS（p = 0.0162）、女性（p = 0.0004）和东部肿瘤协作组体力状态（P = 0.0005）均与患者的年龄、性别、性别和年龄有关。
Background Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors. Materials and Methods Consecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups. Results A total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (p = .0005) and active pre-existing AIDs (p = .0162), female sex (p = .0004), and Eastern Cooperative Oncology Group Performance Status