Beom Seung-Hoon, Kim Dong-Wan, Sim Sung Hoon, Keam Bhumsuk, Park Jin Hyun, Lee Jeong-Ok, Kim Tae Min, Lee Se-Hoon, Heo Dae Seog
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea ; Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Cancer Res Treat. 2016 Jan;48(1):88-97. doi: 10.4143/crt.2014.201. Epub 2015 Mar 3.
Interstitial lung disease (ILD) is a serious adverse effect of gefitinib. We examined the incidence and clinical characteristics of drug-induced ILD in Korean non-small cell lung carcinoma patients treated with gefitinib.
A retrospective cohort study was performed in non-small cell lung cancer (NSCLC) patients who started gefitinib treatment at Seoul National University Hospital from January 2002 through December 2011. Patients who developed new abnormal radiologic findings with respiratory symptoms after gefitinib treatment were defined as having possible adverse pulmonary reactions. The patients' medical records were reviewed independently by investigators to identify the causes of pulmonary toxicities.
Among the 1,114 patients evaluated, 128 patients (11.5%) developed pulmonary adverse reactions after taking gefitinib. An infectious complication occurred in 98 patients (8.8%) and 15 patients (1.3%) developed ILD. Nine of the 15 patients (60.0%) with gefitinib-induced ILD experienced a fatal clinical course that met either the Common Terminology Criteria for Adverse Events grade 4 (n=3) or grade 5 (n=6). In the multivariate analysis, a lower serum albumin level (≤ 3.0 g/dL) at baseline was significantly associated with the development of gefitinib-induced ILD (odds ratio, 3.91; 95% confidence interval, 1.20 to 12.71).
The incidence of gefitinib-induced ILD in Korean NSCLC patients was similar to that reported worldwide, but lower than values reported for Japanese population. ILD was usually a life-threatening adverse effect of gefitinib, and the development of ILD was significantly associated with a lower baseline serum albumin level.
间质性肺疾病（ILD）是吉非替尼的一种严重不良反应。我们研究了在接受吉非替尼治疗的韩国非小细胞肺癌患者中药物性ILD的发生率及临床特征。
对2002年1月至2011年12月在首尔国立大学医院开始接受吉非替尼治疗的非小细胞肺癌（NSCLC）患者进行了一项回顾性队列研究。在吉非替尼治疗后出现新的伴有呼吸道症状的异常影像学表现的患者被定义为可能发生了肺部不良反应。研究人员独立查阅患者的病历以确定肺部毒性的原因。
在评估的1114例患者中，128例（11.5%）在服用吉非替尼后出现了肺部不良反应。98例（8.8%）发生了感染性并发症，15例（1.3%）发生了ILD。15例吉非替尼诱导的ILD患者中有9例（60.0%）经历了符合不良事件通用术语标准4级（n = 3）或5级（n = 6）的致命临床过程。在多变量分析中，基线时较低的血清白蛋白水平（≤3.0 g/dL）与吉非替尼诱导的ILD发生显著相关（比值比，3.91；95%置信区间，1.20至12.71）。
韩国NSCLC患者中吉非替尼诱导的ILD发生率与全球报道相似，但低于日本人群报道的值。ILD通常是吉非替尼的一种危及生命的不良反应，且ILD的发生与较低的基线血清白蛋白水平显著相关。
