Gefitinib as salvage therapy in pretreated patients with advanced non-small cell lung cancer. Data from a compassionate use program.

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.