A phase II trial of gefitinib in recurrent and metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy

Abstract

6042 Background: Epidermal growth factor receptor (EGFR) is commonly expressed in nasopharyngeal carcinoma (NPC) and strong EGFR expression appears to correlate with poor survival. Gefitinib, a small-molecule inhibitor of the EGFR tyrosine kinase, has been shown to inhibit the growth of NPC cell lines. Methods: Nineteen patients with recurrent or metastatic NPC were recruited into the study. Eligibility criteria included: radiographic progression of disease, ECOG PS < 2, 1 or more prior platinum-based chemotherapy regimens, normal organ function. Fifteen patients were treated for first relapse, 3 for second relapse, and 1 for third relapse. Local disease was present in 8, nodal disease in 3, and distant metastases in 14. All patients had previously received platinum-based chemotherapy as adjuvant and/or palliative treatments, and 89.5% had 2 or more regimens. Patients received gefitinib 250 mg po daily. Median treatment duration was 10 weeks and median follow-up time was 9 months. Results: Minor response was observed in 2 patients treated for advanced local recurrence. There were no complete or partial responders. Seven patients had stable disease and 12 had progressive disease. Median time to progression was 4 months and median survival was 14 months. Progression-free rate at 6 months was 22% and 1-year survival rate was 70%. Treatment was generally well tolerated and only grade 1–2 adverse events were observed, with acneiform rash (68.5%), fatigue (36.9%), diarrhea (31.6%), and anorexia (31.6%) most common. In 15 patients with symptoms related to NPC, 5 reported improvement, 5 reported no changes, and 5 reported worsening during gefitinib treatment. Conclusions: Gefitinib has little activity in terms of response rate in recurrent and metastatic NPC, although disease stabilization and symptomatic improvement were observed in some patients. Evaluation of markers of EGFR pathway on tumor tissue is currently being performed. No significant financial relationships to disclose.