Gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is one of the new biological treatments for lung cancer. EGFR mediates cancer cell growth, proliferation, invasion, and metastasis and inhibits apoptosis.

This was a multicentre trial of gefitinib in patients with symptomatic stage IIIb or IV NSCLC who had received first and second line chemotherapy. 221 patients were randomised to receive either 250 mg or 500 mg oral gefitinib for a median of 56 days (there was no placebo arm). Disease related symptoms improved in 43% of patients with 250 mg gefitinib and a 12% partial radiographic response rate was observed for a median of 7 months. Symptomatic improvement was associated with adenocarcinoma and a partial radiographic response, but responders had no identifiable characteristic features. There was no association between EGFR expression measured by immunohistochemistry and outcome after gefitinib treatment. Mild skin toxicity was seen in 62%, diarrhoea in 57%, and ocular toxicity in 19%. Similar outcomes were obtained for patients treated with 500 mg but there was a higher incidence of side effects.

In some patients with advanced NSCLC (particularly adenocarcinoma) unresponsive to chemotherapy, gefitinib provided a short term symptomatic and radiographic benefit. This study highlights the fact that new treatments derived from research into molecular mechanisms may be of potential use in improving outcomes in lung cancer.