Amato RJ et al. - In a trial to evaluate the combination of interferon with tyrosine kinase inhibitors of epithelial growth factor receptor, gefitinib, or c-Kit and platelet-derived growth factor receptor-β, imatinib, for efficacy and safety, it was shown that combination of gefitinib with interferon safely delays progression of refractory metastatic renal cell carcinoma (MRCC) Methods
Pts with MRCC received 12-week cycles of interferon and either gefitinib (500 mg daily) or imatinib (600 mg daily)
The gefitinib/imatinib dose was reduced as needed owing to toxicity
The primary endpoint was objective tumor response
Secondary endpoints were time to tumor progression (TTP), overall survival (OS), and safety
Results
17 pts were enrolled; 6 of 17 had clear cell and 6 of 17 papillary tumors
14 were treated on the gefitinib arm, including 2 pts who crossed over from the imatinib arm after experiencing disease progression
Objective tumor responses were evaluable in 14 pts; of the 14, partial responses occurred in 3, stable disease in 7, and progressive disease in 4
The most frequent treatment-related adverse events were skin rash, flu-like symptoms, and fatigue (both arms); diarrhea (gefitinib arm); and thrombocytopenia and leukopenia (imatinib arm)
Median TTP for pts on the gefitinib arm only was 4.27 months and median OS was 11.42+ months
