title: Interstitial lung disease in gefitinib-treated Japanese patients with non-small cell lung cancer - a retrospective analysis: JMTO LC03-02.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan. noooooi@kuhp.kyoto-u.ac.jp
authors: Masatsugu
authors: M
authors: Nakagawa
authors: Tsutomu
authors: T
authors: Nishimura
authors: Satoshi
authors: S
authors: Teramukai
authors: Harue
authors: H
authors: Tada
authors: Fumihiro
authors: F
authors: Tanaka
authors: Kazuhiro
authors: K
authors: Yanagihara
authors: Kiyoyuki
authors: K
authors: Furuse
authors: Hiromi
authors: H
authors: Wada
authors: Masanori
authors: M
authors: Fukushima