Abstract
Background: The molecular genesis of lung cancer andits treatment remain hot spots of medical research be-causeof the high mortality rates especially associatedwith non-small-cell lung cancer (NSCLC). New agents arerequired. The epidermal growth factor receptor (EGFR)pathway inhibitor gefitinib (Iressa™) has been the firstapproved drug for NSCLC within this new therapeuticclass. Patients and Methods: The anti-tumor activity ofgefitinib in a monocentric and prospective case series of72 patients with refractory NSCLC is analyzed. Patientswho had histologically confirmed NSCLC with one ormore previous chemotherapies were eligible for enroll-ment.Patients received 250 mg gefitinib orally once dailyfor 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 mediansurvival of all patients was 8.6 weeks (95% CI 5.9-11.2).Comparing responders, patients with stable disease, andprogressive patients it becomes evident that patientssensitive to gefitinib get a clinical benefit in terms of pal-liationand overall survival. Adenocarcinoma histologyand former nicotine abstention seem to favor sensitivityto gefitinib. CTC grade 3/4 toxicities were observed inonly one patient in form of skin reactions. Mild toxicities(CTC grade 1/2) were diarrhea, conjunctivitis and eleva-tionof transaminases. Conclusion: These prospectivedata suggest an activity of gefitinib in pre-treated NSCLCpatients without relevant toxicities. They are in agree-mentwith other published data.
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