Antitumor Activity and Tolerability of Gefitinib in Patients with Non–Small-Cell Lung Cancer Treated in an Expanded Access Program

Abstract

We present a series of cases that illustrate potential benefits of the targeted agent gefitinib for patients with advanced and heavily pretreated non–small-cell lung cancer (NSCLC). In 2 phase II clinical trials, 250 mg/day of gefitinib produced objective tumor response rates of 18% and 11%, with excellent tolerance in patients with advanced NSCLC who had previously received standard chemotherapy. Treatment with gefitinib also led to improvements in disease-related symptoms in approximately 40% of cases. Gefitinib is one of a class of agents that selectively inhibit the epidermal growth factor receptor–tyrosine kinase, which is aberrantly activated in many human solid tumors. Gefitinib treatment resulted in objective radiographic regressions of tumor and symptom improvement in patients with advanced, heavily pretreated NSCLC in clinical trials and in the Expanded Access Program. This series illustrates that the benefits of gefitinib are not limited to patients selected for clinical trial participation but can be generalized to the broader population of patients with NSCLC.