Qiu Bin, Li Gaofeng, Luo Feng, Cai Xiaohong, Wu Lin, Chen Jianhua, Hu Yanping, Tang Zhiliu, Yang Shuo, He Jie
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Yunnan Cancer Hospital, Kunming, China.
Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.
Lung cancer (LC) is the most common cancer worldwide. The prevalence of LC and rate of associated mortality are high and increasing faster in China than in Western countries. Non-small cell lung cancer (NSCLC) accounts for most LCs. This study aims to be the first large, multi-center, non-interventional retrospective study of treatment patterns (type/duration, number of lines, completion rate), real-world outcomes, and medical costs among Chinese patients with advanced/metastatic NSCLC (IIIb/IV) or extensive-stage small cell LC (ES-SCLC).
This study will enroll 8,800 patients (≥18 years, with a diagnosis of advanced/metastatic NSCLC made between 1 December 2013 to 30 November 2014) from 35 to 50 Chinese sites. Hospital information systems (HIS) and electronic medical records will be retrospectively reviewed, in adherence with regulatory and ethical requirements. Early-stage treatment (starting from 1 December 2010) of patients with recurrent disease or early disease progression will be examined. Data will be collected at baseline (diagnosis) and 6 and 12 months after this. Observation will end after 3 years or death. Data will be stratified by histology, staging, age, region, health insurance, and epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutation status. Treatment duration and overall survival will be estimated using Kaplan-Meier curves. Descriptive statistics will be used for disease characteristics and patient demographics. Cox-proportional hazards models will be used to examine the impact of demographics/treatment on survival. Treatment patterns and outcome predictors will be explored using multivariate logistic regression.
This protocol describes the methodology for collecting real-world data to guide evidence-based clinical practice and inform unmet needs in NSCLC treatment, with potential to identify gaps between guidelines and current practice.
NCT03505515; data registered on ClinicalTrials.gov: 12h Apr., 2018.
肺癌是全球最常见的癌症。在中国，肺癌的患病率和相关死亡率很高，且增长速度比西方国家更快。非小细胞肺癌占大多数肺癌病例。本研究旨在成为首个针对中国晚期/转移性非小细胞肺癌（IIIb/IV期）或广泛期小细胞肺癌（ES-SCLC）患者的大型、多中心、非干预性回顾性研究，内容包括治疗模式（类型/持续时间、线数、完成率）、真实世界结局和医疗成本。
本研究将从中国35至50个研究点招募8800名患者（≥18岁，在2013年12月1日至2014年11月30日期间被诊断为晚期/转移性非小细胞肺癌）。将按照监管和伦理要求，对医院信息系统（HIS）和电子病历进行回顾性审查。将检查复发性疾病或早期疾病进展患者的早期治疗情况（从2010年12月1日开始）。在基线（诊断时）以及此后6个月和12个月收集数据。观察将在3年或死亡后结束。数据将按组织学、分期、年龄、地区、医疗保险以及表皮生长因子受体（EGFR）/间变性淋巴瘤激酶（ALK）突变状态进行分层。使用Kaplan-Meier曲线估计治疗持续时间和总生存期。将使用描述性统计分析疾病特征和患者人口统计学资料。将使用Cox比例风险模型检查人口统计学/治疗对生存的影响。将使用多变量逻辑回归探索治疗模式和结局预测因素。
本方案描述了收集真实世界数据的方法，以指导循证临床实践并了解非小细胞肺癌治疗中未满足的需求，有可能识别指南与当前实践之间的差距。
NCT03505515；数据于2018年4月12日在ClinicalTrials.gov上注册。
