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. 2015 Mar 3;48(1):88–97. doi: 10.4143/crt.2014.201

Table 4.

Reported incidence, mortality and risk factors of gefitinib-induced interstitial lung disease (ILD) in Japanese [9,13-18] and Taiwanese [19] studies

Year Study group No. of patients No. cases of ILD (%) No. ILD death (mortality, %) Risk factor
2004 National Cancer Center, Japan [14] 112 6 (5.4) 4 (66.7) Preexisting pulmonary fibrosis
2005 Okayama Lung Cancer Study Group [15] 330 15 (4.5) 8 (53.3) Preexisting pulmonary fibrosis, poor PS, prior thoracic irradiation
2006 West Japan Thoracic Oncology Group [13] 1,976 70 (3.5) 31 (44.3) Preexisting pulmonary fibrosis, male, smoking
2008 AstraZeneca [9] 1,482 59 (4.0) - (31.6) Preexisting chronic ILD, poor PS, smoker, older age (> 55 years), recent NSCLC diagnosis, reduced normal lung on computed tomography scan, concurrent cardiac disease
2009 Japan-Multinational Trial Organization [16] 526 17 (3.2) 7 (41.2) No risk factors found
2010 Okayama Lung Cancer Study Group [17] 330 8 (2.4) 5 (62.5) Preexisting pulmonary fibrosis, poor PS
2013 NEJ 002 and WJTOG 3405 trials [18] 201 (EGFR mutation positive) 10 (5.0) 2 (20.0) Smoking
2013 Chang et al. [19] 1,080 25 (2.3) 10 (40.0) Not evaluated
2013 This study 1,114 15 (1.3) 6 (40.0) Lower albumin level

PS, performance status; NSCLC, non-small cell lung cancer.