Nakagawa Masatsugu, Nishimura Tsutomu, Teramukai Satoshi, Tada Harue, Tanaka Fumihiro, Yanagihara Kazuhiro, Furuse Kiyoyuki, Wada Hiromi, Fukushima Masanori
Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan.
BMC Res Notes. 2009 Aug 5;2:157. doi: 10.1186/1756-0500-2-157.
In Japan, high incidences of interstitial lung disease (ILD) and ILD-related deaths have been reported among gefitinib-treated patients with non-small cell lung cancer (NSCLC). We investigated the efficacy of gefitinib, the incidence of ILD and risk factors for ILD in these patients.
We obtained patient data retrospectively using questionnaires sent to 22 institutions. We asked for demographic and clinical data on NSCLC patients for whom gefitinib treatment had begun between July 2002 and February 2003. Data from a total of 526 patients were analyzed. The patient characteristics were as follows: 64% male, 69% with adenocarcinoma, 61% with a performance score of 0-1, and 5% with concurrent interstitial pneumonitis. The objective response proportion was 80/439 (18.2%; 95% CI: 14.7-22.0). ILD developed in 17 patients (3.2%; 95% CI 1.9-5.1%), of whom 7 died. According to multivariate analysis, female sex, history of prior chemotherapy, low absolute neutrophil count before gefitinib treatment, and adenocarcinoma histology were associated with response to gefitinib treatment. None of the factors we evaluated were associated with the development of ILD.
The results of this study are consistent with previously published values for treatment response proportions and incidence of ILD during gefitinib treatment in Japanese patients. Future studies should be aimed at identifying factors indicating that a patient has a high probability of receiving benefit from gefitinib and a low risk of developing ILD.
在日本，据报道在接受吉非替尼治疗的非小细胞肺癌（NSCLC）患者中，间质性肺疾病（ILD）的发病率及与ILD相关的死亡发生率较高。我们调查了这些患者中吉非替尼的疗效、ILD的发生率及ILD的危险因素。
我们通过向22家机构发送调查问卷，回顾性地获取了患者数据。我们询问了2002年7月至2003年2月期间开始接受吉非替尼治疗的NSCLC患者的人口统计学和临床数据。共分析了526例患者的数据。患者特征如下：男性占64%，腺癌患者占69%，体能状态评分为0 - 1的患者占61%，合并间质性肺炎的患者占5%。客观缓解率为80/439（18.2%；95%置信区间：14.7 - 22.0）。17例患者（3.2%；95%置信区间1.9 - 5.1%）发生了ILD，其中7例死亡。多因素分析显示，女性、既往化疗史、吉非替尼治疗前绝对中性粒细胞计数低以及腺癌组织学与吉非替尼治疗反应相关。我们评估的因素均与ILD的发生无关。
本研究结果与之前发表的日本患者吉非替尼治疗反应率及ILD发生率的值一致。未来的研究应致力于确定能表明患者从吉非替尼治疗中获益可能性高且发生ILD风险低的因素。
