Clinical benefit in NSCLC: advanced-stage patients require symptom-improving palliation. Experiences from the 'Iressa' expanded access program.

Background: The molecular genesis of lung cancer and its treatment remain hot spots of medical research because of the high mortality rates especially associated with non-small-cell lung cancer (NSCLC). New agents are required. The epidermal growth factor receptor (EGFR) pathway inhibitor gefitinib (Iressa) has been the first approved drug for NSCLC within this new therapeutic class.

Patients And Methods: The anti-tumor activity of gefitinib in a monocentric and prospective case series of 72 patients with refractory NSCLC is analyzed. Patients who had histologically confirmed NSCLC with one or more previous chemotherapies were eligible for enrollment. Patients received 250 mg gefitinib orally once daily for at least 28 days.

Results: An 8% response rate (PR) and an additional 42% rate of disease stabilizations (SD) have been found in our patient collective. The median survival of all patients was 8.6 weeks (95% CI 5.9-11.2). Comparing responders, patients with stable disease, and progressive patients it becomes evident that patients sensitive to gefitinib get a clinical benefit in terms of palliation and overall survival. Adenocarcinoma histology and former nicotine abstention seem to favor sensitivity to gefitinib. CTC grade 3/4 toxicities were observed in only one patient in form of skin reactions. Mild toxicities (CTC grade 1/2) were diarrhea, conjunctivitis and elevation of transaminases.

Conclusion: These prospective data suggest an activity of gefitinib in pre-treated NSCLC patients without relevant toxicities. They are in agreement with other published data.