Objective: A retrospective analysis of patients with advanced nonsmallcell lung cancer treated with gefitinib on an expanded accessprogram. Methods: Patients with advanced non-small cell lung cancerand Karnofsky performance status ≥ 50% were allowed to enroll. Theyreceived gefitinib 250 mg orally once a day. No other systemic anticancertreatment was allowed during the trial. Results: From June 2002 toApril 2003, 31 patients were included. The age range was 38 to 84years, with 20 men and 11 women. The median Karnofsky performancestatus was 80% and 25 patients had a history of smoking. Thirty patientswere clinical stage IV and one patient was stage IIIB. The objectiveresponse rate was 14%. There was no complete response. An additional36% of patients (n=10) had stable disease for more than 6 months,giving a response plus disease stabilization rate of 50%. The medianprogression free survival was 3.6 months, and the median overallsurvival was 4 months. The one year survival rate was 19%. Toxicitieswere mild in this cohort, with grade 1 (42%) and 2 (11%) diarrhea andgrade 1 rash (16%) being the most commonly observed side effects.Conclusions: Despite the small sample, our data are similar to publishedtrials, confirming efficacy in a setting of pretreated patients and tolerableside effects. In this study patients had to meet only a few essentialeligibility criteria for enrollment, making our data reproducible andapplicable to patients seen in a community setting.