Purpose: To evaluate the tolerabiliy and activity of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non-small cell lung cancer (NSCLC).
Materials and methods: From July 2001 to August 2003, we analysed, retrospectively, the data of 125 previously treated advanced NSCLC patients receiving gefitinib 250 mg, orally once daily in a compassionate use program.
Results: Main toxicity was (% of patients): grade 1-2 skin changes in 7 (5.0%) and 8 (6.4%) patients, respectively. Grade 1 diarrhea in 16 (12.8%) patients. Grade 1 and 2 hypertransaminasemia in 1 (0.8%) patient, respectively. Grade 2 onychopathy in 1 (0.8%) patient and epistaxis in 1 (0.8%) case. There were 1 complete response (0.8%), 6 partial responses (4.8%) and 22 (17.6%) stable disease with an overall control of disease in 23.2% of cases. Median progression-free survival and overall survival were 8.8 and 21.5 weeks, respectively.
Conclusion: Gefitinib is active, feasible and well-tolerated in pretreated patients affected by advanced NSCLC.