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Gefitinib (Iressa), a tyrosine kinase inhibitor, showed modest activity in a phase II study involving patients with squamous cell carcinomas of the head and neck (SCCHN; Clin Cancer Res 2005; 11:8418). To evaluate the role of this agent further, investigators conducted an industry-supported, multicenter, randomized, phase III trial of gefitinib versus standard methotrexate in 486 patients who had recurrent or metastatic SCCHN that was incurable with surgery or radiation.
Patients were stratified based on whether they had received prior platinum-based chemotherapy (group A) or were deemed too ill to receive such treatment (group B). As expected, patients in group A were younger and had better performance status. Patients in each group were ra…