Multicenter open-label extension trial of long-term treatment with gefitinib (IRESSA®)

Objective. To evaluate long-term safety, median overall and progression-free survival, of gefitinib by enrolling patients from clinical studies that had been completed or closed who may benefit from continued gefitinib monotherapy. Methods. A total of 77 patients worldwide (from 9 parent gefitinib trials), mainly with advanced NSCLC (n = 61), were enrolled into this extension trial between December 1999 and January 2002; the data cut-off was December 2002. Patients received gefitinib treatment once daily. Results. The safety profile of gefitinib reported in this trial was similar to that reported in earlier gefitinib clinical trials; no new safety issues were identified and gefitinib-related toxicity was predictable, with diarrhea and skin-related adverse events being the most common. For patients entering this trial from IDEAL 1 and 2 (n = 48), similar results for both the 250 mg and 500 mg doses were observed for median overall survival (22.2 and 20.8 months, respectively) and progression-free survival (13.7 and 14.0 months, respectively). Conclusions. No new safety issues were identified following long-term treatment with gefitinib and clinical benefit observed in the parent trial was maintained in the majority of patients.