肺癌免疫治疗PRO-CTCAE子集的构建

Development of a PRO-CTCAE-based subset for patients with lung cancer receiving immunotherapy

目的构建肺癌患者免疫治疗不良反应症状自我报告工具:肺癌免疫治疗PRO-CTCAE子集。方法以PRO-CTCAE为研究工具,对肺癌免疫治疗患者的症状发生率进行横断面调查。提取免疫检查点抑制剂(ICIs)说明书中的不良反应,与PRO-CTCAE症状进行对比,形成子集条目池。结合上述研究结果,组织临床医护专家论证会,讨论条目池内每个症状的保留与删除,形成肺癌免疫治疗PRO-CTCAE子集。结果共调查160例肺癌免疫治疗患者的PRO-CTCAE症状发生率,收集国内批准上市的6种ICIs的药品说明书,结合专家论证会的专家意见,最终组成包含69个症状、116个条目的肺癌免疫治疗PRO-CTCAE子集。结论本研究构建了含有69个症状的PRO-CTCAE子集,用于肺癌患者免疫治疗期间的症状监测。未来的研究需要在临床实践中验证这种基于PRO-CTCAE的肺癌免疫治疗子集的有效性和可行性。

Objective To develop a self-report tool for immune-related adverse events:A PRO-CTCAE-based subset for patients receiving lung cancer immunotherapy.Methods Using PRO-CTCAE as a research tool,a cross-sectional survey was conducted to investigate the incidence of symptoms in patients receiving lung cancer immunotherapy.The adverse events were extracted from the instructions of immune checkpoint inhibitors(ICIs),compared with the symptoms of PRO-CTCAE,to develop the subset's pool of items.Combined with the above research results,an expert meeting of clinicians and nurses was organized to discuss the retention and deletion of each symptom in the pool of items and form a PRO-CTCAE-based subset for lung cancer immunotherapy.Results The incidence of symptoms from PRO-CTCAE in 160 patients with lung cancer immunotherapy was investigated,and 6 kinds of drug instructions of ICIs approved for marketing in China were collected.Combined with the expert opinions from the demonstration meeting,the PRO-CTCAE-based subset containing 69 symptoms and 116 items was finally developed.Conclusion In this study,a PRO-CTCAE-based subset containing 69 symptoms is constructed for symptom monitoring during immunotherapy in lung cancer patients.Future studies are needed to confirm the efficacy and feasibility of this PRO-CTCAE-based subset of lung cancer immunotherapy in clinical practice.