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Interstitial lung diseases (ILD) induced by gefitinib in patients with advanced non-small cell lung cancer (NSCLC): Results of a West Japan Thoracic Oncology Group (WJTOG) epidemiological survey
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2004
Year
Systemic DiseasesAdvanced Lung DiseaseAug 31ImmunodeficienciesImmunologyEpidemiologic ResearchPathologyPopulation Health SciencesPharmacotherapyLogistic AnalysisAdverse Drug ReactionOncologyClinical EpidemiologyClinical TrialsEpidemiological SurveyEpidemiologic MethodPrevalencePublic HealthPulmonary FibrosisPatients Treated GefitinibResponse RateCancer TreatmentLung CancerEpidemiologyClinical DisordersInterstitial Lung DiseasesMedicinePharmacoepidemiology
7064 Background: Gefitinib was approved by the regulatory of Japanese Ministry, first in the world, on July 5, 2002. From Aug to Dec in 2002, more than 19,000 patients with NSCLC took gefitinib in Japan. It had seemed unlikely that gefitinib had lethal toxicity. However, 358 patients (approximately 1.9%) suffered from ILD, and 114 (approximately 0.6%) of them had been dead by Dec 13, 2002, according to the report from AstraZeneca. The high incidence and fatality of ILD became a serious social issue in Japan. To clarify the incidence of ILD induced by gefitinib, and to identify the risk factors related to ILD developing, we conducted a retrospective survey. Methods: Questionnaires were delivered to 112 affiliated institutions of WJTOG, which asked for patient's characteristics and their clinical information accompanied with treatment of gefitinib from Aug 31 to Dec 31 in 2002 in detail. Results: Eighty-four (75%) institutions replied with information containing a total of 1,976 patients. ILD occurred in 64 patients (3.2%, 95%CI: 2.5–4.1%), which was diagnosed by five experts for thoracic radiology in the extramurally reviews, and 25 (1.3%, 95%CI: 0.8–1.9%) had died. We analyzed the risk factors of ILD to compare 63 patients developing ILD with 1,661 patients as a control. Multivariate analysis indicated that the predictive risk factors of ILD developing were male (odds ratio: 4.35), smoker (4.76), and existence of idiopathic pulmonary fibrosis (IPF) (2.77). We also analyzed the predictive factors for response on our constructing database. The response rate was 20.4% of 1,724 patients treated gefitinib, although we did not evaluate it extramurally. Furthermore, we are going to evaluate survival for patients treated with gefitinib at the meeting. Conclusions: The highly risk group for developing ILD induced by gefitinib was identified clinically. Patients with NSCLC must be treated with gefitinib considering the risk and clinical benefit ratio. Further translational studies are needed to clarify the risk and benefit related to gefitinib on genomics and proteomics. No significant financial relationships to disclose.