真实世界肺癌免疫治疗的有关问题和思考

近年来,免疫治疗研究在肺癌上取得突破性进展,能显著改善肺癌患者的总生存期,且耐受性良好。然而临床研究入组人群具有高度选择性,并不能完全代表真实世界人群。真实世界免疫治疗的疗效及安全性是否与临床研究的一致,何时应用,选择单药还是联合治疗,老年、PS≥2分、自身免疫疾病、使用激素、脑转移等特殊人群的应用,以及疗效标志物的选择,疗效评估标准,不良反应的管理等问题都值得进一步思考。本文通过真实世界数据与临床研究的比较,对真实世界免疫治疗存在问题进行初步分析。

Problems and thoughts on immunotherapy for lung cancer in the real world

In recent years,immunotherapy has made a breakthrough in lung cancer.The clinical trials have shown that immunotherapy significantly improves overall survival in lung cancer patients,with a favorable safety profile.However,the clinical trials are highly selective and not fully representative of the real-world population.There are some problems worthy of studies:whether the efficacy and safety of immunotherapy in the real world are consistent with the clinical research,when to use immunotherapy,whether a single drug or combination therapy is chosen,whether the elderly,poor PS score or other special populations with autoimmune diseases,administrating hormones or brain metastasis can receive immunotherapy,how to select predictive biomarkers,and how to evaluate the efficacy and manage adverse events.This paper reviews real-world research and clinical trials,and compares them to analyze these problems.