Phase II prospective trial of gefitinib given concurrently with cisplatin and radiotherapy in patients with locally advanced head and neck cancer.

OBJECTIVE: To examine a series of head and neck squamous cell cancer (HNSCC) patients treated with combined gefitinib and chemoradiotherapy (CRT) regarding treatment efficacy and tolerability and correlation with epidermal growth factor receptor (EGFR) factors. PATIENTS AND METHODS: Fifteen patients with locally advanced HNSCC were included in the study. The patients were scheduled to take gefitinib 250 mg in combination with concurrent radiotherapy (RT) +/- concomitant cisplatin. EGFR expression, activation and amplification; serum vascular endothelial growth factor (S-VEGF); and microvessel density were determined.
RESULTS: Locoregional tumour control at 3 months was achieved in 79% of the patients. The treatment was reasonably well tolerated. A tendency toward a correlation between complete tumour response and EGFR amplification was observed (p = .057). Patients with activated EGFR did not have significantly more complete responses than patients with no EGFR activation (p = .10). The baseline S-VEGF levels seemed to be higher in patients with HNSCC than in 40 healthy controls (p = .076).
CONCLUSION: The combination of gefitinib and RT with concurrent cisplatin was feasible. EGFR amplification status may correlate with the treatment response in HNSCC patients treated by gefitinib and CRT. S-VEGF level does not seem to correlate with treatment outcome.

RCT Entities:   Population Interventions Outcomes