"Patient-reported outcome (PRO)-based symptom assessment in patients with advanced lung cancer receiving first-line combination immunotherapy: a protocol for a multicenter, prospective, observational study"

作者全名："Deng, Yuanle; Hu, Han; Jia, Rong; Dai, Wei; Wang, Dengfeng; Zhang, Purong; Zhang, Peng; Cheng, Kai; Tang, Jianning; Wen, Yan; Zhou, Xiang; Shi, Qiuling; Xiong, Zhujuan; Zhou, Jin"

作者地址："[Deng, Yuanle; Hu, Han; Xiong, Zhujuan] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Clin Nutr,Sichuan Clin Res Ctr Canc,Sichuan C, Chengdu, Peoples R China; [Jia, Rong; Tang, Jianning; Wen, Yan; Zhou, Jin] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Med Oncol,Sichuan Clin Res Ctr Canc,Sichuan C, Chengdu, Peoples R China; [Dai, Wei; Shi, Qiuling] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Thorac Surg,Sichuan Clin Res Ctr Canc,Sichuan, Chengdu, Peoples R China; [Wang, Dengfeng] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Gynecol Oncol Ctr,Sichuan Clin Res Ctr Canc,Sichua, Chengdu, Peoples R China; [Zhang, Purong] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Breast Surg,Sichuan Clin Res Ctr Canc,Sichuan, Chengdu, Peoples R China; [Zhang, Peng] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Radiat Oncol,Radiat Oncol Key Lab Sichuan Pro, Chengdu, Peoples R China; [Cheng, Kai] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Pharm,Sichuan Clin Res Ctr Canc,Sichuan Canc, Chengdu, Peoples R China; [Zhou, Xiang] Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Gastrointestinal Surg,Sichuan Clin Res Ctr Ca, Chengdu, Peoples R China; [Shi, Qiuling] Chongqing Med Univ, Sch Publ Hlth, Chongqing, Peoples R China"

通信作者："Xiong, ZJ (通讯作者)，Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Clin Nutr,Sichuan Clin Res Ctr Canc,Sichuan C, Chengdu, Peoples R China.; Zhou, J (通讯作者)，Univ Elect Sci & Technol China, Affiliated Canc Hosp, Sichuan Canc Ctr, Dept Med Oncol,Sichuan Clin Res Ctr Canc,Sichuan C, Chengdu, Peoples R China."

来源：BMC PULMONARY MEDICINE

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000989954000002

JCR分区：Q2

影响因子：2.6

年份：2023

卷号：23

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Patient-reported outcome; Lung cancer; Immunotherapy; Immune-related adverse events

摘要："BackgroundImmunotherapy is currently applied in the first-line treatment regimens for numerous advanced cancers, especially advanced lung cancer. Immune-related adverse events (irAEs) resulting from immunotherapy can vary in severity and cause a substantial symptom burden to patients. However, there are limited data on symptom burden in patients with advanced lung cancer following immunotherapy. To address this deficit, this study aims to provide insight into the symptom burden and severity through patient-reported outcome measurements and conduct an analysis of temporal trends and clinical consequences of symptom burden in patients with advanced lung cancer receiving combination immunotherapy.MethodsWe will prospectively recruit 168 eligible patients from 14 hospitals in China. Eligible patients will be aged >= 18 years, pathologically diagnosed with locally advanced or stage IV primary lung cancer without surgical indications, and agreed to receive immunotherapy in combination with other therapies. The primary outcome of this study is the symptom burden of patients during the immunotherapy course. Longitudinal symptom data will be collected using the MD Anderson Symptom Inventory-Lung Cancer module (MDASI-LC) and the symptomatic irAEs scale at baseline (once before treatment) and weekly after treatment, until 1 month after the last treatment cycle has been completed. The trajectory of symptom burden following combination immunotherapy will be depicted, and by linking it to clinical outcomes (the secondary outcome and exploratory outcome of this study), the consequence of symptom burden in patients with advanced lung cancer receiving combination immunotherapy will be examined further.DiscussionThis study intends to establish longitudinal symptom trajectories in patients with lung cancer receiving immunotherapy, and explore its association with clinical outcomes. These findings may serve as an important reference for clinicians in the symptomatic management of patients with lung cancer receiving immunotherapy."

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