Gefitinib-Related Interstitial Lung Disease in Taiwanese Patients With Non-Small-Cell Lung Cancer

Gefitinib is effective in the treatment of non-small-cell lung cancer (NSCLC), especially in the Asian population. However, interstitial lung disease (ILD) is usually a serious pulmonary adverse effect. The incidence and clinical outcome of 1080 Taiwanese patients with advanced NSCLC who received gefitinib treatment was investigated. Taiwanese patients with NSCLC had a relatively high incidence (2.3%) of ILD with poor outcome (40% mortality) during gefitinib treatment. Background: Gefitinib (Iressa; AstreZeneca, Wilmington, DE) is effective in the treatment of NSCLC, especially in the Asian population. However, ILD is usually a serious pulmonary adverse effect and almost leads to cessation of gefitinib treatment. In this study, we investigated the incidence, clinical features, and prognosis of gefitinib-related ILD in Taiwanese patients with NSCLC. Patients and Methods: This was a retrospective observational study conducted in 2 medical centers and a local teaching hospital. Results: A total of 1080 patients with NSCLC, who received at least 1 dose (250 mg per day) of gefitinib treatment, were enrolled. Of these, 42 patients were diagnosed with ILD. Twenty-five of the 42 patients were diagnosed with gefitinib-related ILD (incidence, 2.3%). The main manifestations of ILD included dyspnea, cough, and hypoxemia. Six of the 25 patients (24%) with gefitinib-related ILD required invasive mechanical ventilation and all patients were treated with steroids. Twenty-two patients (88%) discontinued gefitinib treatment without further rechallenge. Ten (40%) patients died directly from ILD and in-hospital mortality was 52%. Eleven patients received subsequent cytotoxic chemotherapy with a mean of 33.5 days after ILD events. Kaplan-Meier analysis demonstrated that gefitinib nonresponder and gefitinib use rather than first-line treatment were associated with poor prognosis when ILD developed during gefitinib treatment. Conclusion: Taiwanese patients with NSCLC had a relatively high incidence of ILD during gefitinib treatment. Gefitinib-related ILD is usually life-threatening, especially in gefitinib nonresponders and gefitinib use rather than first-line treatment. Clinical Lung Cancer, Vol. 14, No. 1, 55-61 Crown Copyright (C) 2013 Published by Elsevier Inc. All rights reserved.