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Interstitial lung disease (ILD) during gefitinib treatment in Japanese patients with non-small cell lung cancer (NSCLC): Okayama Lung Cancer Study Group.

7063 Background: Risk factors of ILD during gefitinib treatment in patients with NSCLC are undetermined. The objective of this study was to elucidate the risk factors of ILD by analyzing the characteristics of patients with ILD.


METHODS
We retrospectively reviewed the clinical records of 325 patients with NSCLC who had received gefitinib in 12 hospitals between November 2000 and October 2003. Correlations between the various factors and the frequency of ILD following gefitinib treatment were investigated.


RESULTS
Patients characteristics were as follows; male/female: 68%/32%, Ad/others: 74%/26%, median age: 67 (range; 29-88), and ECOG PS 0-1/2-4: 66%/34%. An objective response rate by gefitinib treatment was 20% (62/307 patients). The median survival time after the initiation of gefitinib treatment was 6.7 months, with a median follow-up time of 10.8 months. Toxicities (grade 3 or more by the National Cancer Institute-Common Toxicity Criteria) included hepatic toxicity (5.0%), skin rash (2.2%), diarrhea (0.6%), and nausea/vomiting (0.3%). Twenty-two patients (6.8%) developed ILD after gefitinib treatment. The median toxicity grade of ILD was 3 (range; 2-4), and 10 (3.1%) patients have died. The median time to ILD after initiation of gefitinib treatment was 18 days (range; 3-123). Half of the patients developing ILD manifested the acute onset of dyspnea. Radiographic findings of the ILD were characterized mainly by diffuse ground-glass opacity. Statistically significant factors affecting the occurrence of ILD by multivariate analysis were presence of pulmonary fibrosis before gefitinib treatment and poor PS.


CONCLUSIONS
The results of this study indicate that ILD during gefitinib treatment is considerably frequent. Physicians should carefully decide the indication of gefitinib treatment, especially for patients with lung comorbidities or poor PS. No significant financial relationships to disclose.