Lilly Suzhou Pharmaceutical Co. Ltd Shanghai, China.
Real World Analytics, Eli Lilly GmbH Vienna, Austria.
Thorac Cancer. 2014 Jul;5(4):319-24. doi: 10.1111/1759-7714.12095. Epub 2014 Jul 3.
This study examined the prognostic factors associated with survival in advanced non-small cell lung cancer (NSCLC) patients receiving gemcitabine-platinum regimens as first-line therapy in real-world clinical settings in China.
Data was analyzed from a multinational, prospective, non-interventional, observational study of individuals receiving gemcitabine-platinum regimens as first-line therapy for NSCLC, focusing on 300 patients from mainland China. A Cox regression model was used to determine the association of 38 prognostic factors, including patient smoking characteristics, with overall survival.
In these 300 patients, the mean age was 58.9 (±10.8) years, with males comprising 71% of the population. Thirty percent of patients had an Eastern Cooperative Oncology Group performance status (PS) of 0 and 70% had a PS of 1. The majority of patients had NSCLC of adenocarcinoma origin (57%). Multivariate Cox regression analyses adjusted for baseline factors revealed that gender, tumor (T) staging, metastasis (M) staging, liver metastases, serum albumin, and superior vena cava obstruction were significant prognostic factors. Smoking during therapy was not significantly associated with survival, although numbers were small for this variable (n = 16). Weight loss of >10% was a significant prognostic factor for adverse events.
Gender, T staging, M staging, liver metastases, superior vena cava obstruction, and serum albumin are prognostic factors affecting overall survival in mainland Chinese patients receiving first-line gemcitabine-platinum regimens for advanced NSCLC. These negative prognostic factors may warrant further investigation in clinical trials.
本研究考察了接受吉西他滨联合铂类方案作为一线治疗的中国晚期非小细胞肺癌(NSCLC)患者的生存预后相关因素。
该研究是一项多中心、前瞻性、非干预性、观察性研究,纳入了接受吉西他滨联合铂类方案作为一线治疗的 NSCLC 患者,共分析了来自中国大陆的 300 例患者的数据。采用 Cox 回归模型分析了包括患者吸烟特征在内的 38 个预后因素与总生存期的相关性。
在这 300 例患者中,平均年龄为 58.9(±10.8)岁,男性占 71%。30%的患者 ECOG 体能状态(PS)评分为 0,70%的患者 PS 评分为 1。大多数患者为腺癌起源的 NSCLC(57%)。多变量 Cox 回归分析调整基线因素后显示,性别、肿瘤(T)分期、转移(M)分期、肝转移、血清白蛋白和上腔静脉阻塞是显著的预后因素。尽管该变量的例数较少(n=16),但治疗期间吸烟与生存无显著相关性。体重减轻>10%是不良事件的显著预后因素。
性别、T 分期、M 分期、肝转移、上腔静脉阻塞和血清白蛋白是影响中国大陆接受吉西他滨联合铂类方案一线治疗的晚期 NSCLC 患者总生存期的预后因素。这些负性预后因素可能需要在临床试验中进一步研究。