Epidermal growth factor receptor targeted therapy with gefitinib in locally advanced and metastatic primary lung adenocarcinoma.

OBJECTIVE

To describe the efficacy of monotherapy with the epidermal growth factor receptor-tyrosine kinase inhibitor, gefitinib in patients with locally advanced and metastatic primary lung adenocarcinoma.

METHODS

A retrospective analysis was undertaken of patients who had locally advanced or metastatic lung adenocarcinoma treated with gefitinib 250 mg orally once daily until disease progression. All patients had either been previously treated with systemic cytotoxic chemotherapy and/or radiotherapy or had declined chemotherapy or were medically not fit for cytotoxic chemotherapy.

RESULTS

A total of 23 patients (13 men) (15 never smokers) with a median age of 51 years (range 35-79 years) received gefitinib monotherapy. Disease control occurred in 14 patients (61%); there was a reduction in the size of the primary and/or metastatic tumours (partial response (PR)) in 11 patients (48%), and 3 patients (13%) had stable disease. The response rate was significantly higher in those who had never smoked (10 of 15 (67%)) compared with that of smokers (1 of 8 (13%)) (odds ratio (95% confidence interval), 14.0 (1.33-147.43) P=0.027). In total, 11 of 18 patients (61%) with a WHO performance status 1 or 2 showed a PR, whereas none with a performance status 3 or 4 responded (P=0.037). Response was not affected by the patient's age, gender, disease stage, prior chemotherapy treatment, interval between diagnosis and commencement of gefitinib or the development of skin toxicity. The median time to symptom improvement was 1.5 (range 0.5-6) weeks. The median progression-free survival time was: 60 (range 15-138) weeks in patients with PR and 34 (range 7-38) weeks in patients with stable disease (P=0.368).

CONCLUSION

When given alone, gefitinib showed significant antitumour activity in patients with locally advanced and metastatic primary lung adenocarcinoma. An objective response was observed more frequently in never smokers and exclusively in patients with good performance status.