2016 Volume 56 Issue 3 Pages 177-182
Objective. Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is a key drug in the treatment of EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). Gefitinib treatment is often associated with skin and mucosal toxicities, and liver dysfunction. There have been few reports on the efficacy and safety of gefitinib in elderly patients with EGFR mutation-positive advanced NSCLC. Methods. We retrospectively assessed the efficacy and safety of gefitinib in 52 patients with EGFR mutation-positive advanced NSCLC who were 70 years of age or older and who were treated with gefitinib (250 mg, once daily). In addition, we compared the efficacy and safety in patients who were 70 to 79 years of age with that in patients who were 80 years of age or older. Results. The study population included 52 patients (35 [67%] were females and 13 [25%] were performance status of ≥2). All of the patients had adenocarcinoma. The median age was 75 years (range, 70-89 years) and 15 patients (29%) were 80 years of age or older. The response rate was 73.1% (95% confidence interval, 59.0 to 84.4%) and the disease control rate was 90.4% (95% confidence interval, 79.0 to 96.8%). The median progression-free survival time was 10.7 months (range, 0 to 36 months) and the median survival time was 23.1 months (range, 0 to 66 months). The common adverse events were skin toxicities (51%), liver dysfunction (33%), and diarrhea (25%). Two patients (4%) died of gefitinib-related interstitial lung disease. The dose of gefitinib was reduced in 16 patients (31%) and gefitinib treatment was discontinued in 11 patients (21%) due to toxicities, mainly skin rashes and liver dysfunction. The response rates, survival rates, the incidence of adverse events, and the rates of dose reduction or gefitinib discontinuation did not differ between the two age groups. Conclusion. Gefitinib treatment is effective for elderly patients with EGFR mutation-positive advanced NSCLC; however, approximately half of the patients required a dose reduction or the discontinuation of gefitinib treatment due to toxicities. It is important for elderly patients to be treated with a suitable dose of gefitinib.
