Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study

Bin Qiu; Gaofeng Li; Feng Luo; Xiaohong Cai; Lin Wu; Jianhua Chen; Yanping Hu; Zhiliu Tang; Shuo Yang; Jie He

doi:10.21037/tlcr-20-1269

Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study

Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.

Authors

Bin Qiu¹, Gaofeng Li², Feng Luo³, Xiaohong Cai⁴, Lin Wu⁵, Jianhua Chen⁵, Yanping Hu⁶, Zhiliu Tang⁷, Shuo Yang⁸, Jie He¹

Affiliations

¹ Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.
² Yunnan Cancer Hospital, Kunming, China.
³ Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
⁴ Sichuan Cancer Hospital & Institute, Chengdu, China.
⁵ Hunan Cancer Hospital, Changsha, China.
⁶ Hubei Cancer Hospital, Hubei, China.
⁷ Bristol-Myers Squibb, Shanghai, China (was with BMS at the time when the research and the manuscript were conducted).
⁸ Bristol-Myers Squibb, Shanghai, China.

Abstract

Background: 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).

Methods: 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.

Discussion: 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.

Trial registration: NCT03505515; data registered on ClinicalTrials.gov: 12h Apr., 2018.

Keywords: China; clinical protocol; lung neoplasms.

Associated data

ClinicalTrials.gov/NCT03505515