Neoadjuvant chemotherapy/gefitinib followed by concurrent chemotherapy/radiation therapy/gefitinib for patients with locally advanced squamous carcinoma of the head and neck.

BACKGROUND: The authors evaluated the feasibility, toxicity, and efficacy of gefitinib added to first-line combined-modality therapy for patients with locally advanced squamous carcinoma of the head and neck.
METHODS: Patients with biopsy-proven locally advanced squamous carcinoma of the head and neck who had low expected cure rates with local treatment modalities alone were eligible for this treatment. All patients received a 6-week induction course of docetaxel, carboplatin, infusional 5-fluorouracil, and gefitinib (250 mg daily). Gefitinib was continued while patients received concurrent weekly docetaxel and radiation therapy. After the completion of radiation therapy, gefitinib was continued until patients developed disease progression or for a maximum of 24 months.
RESULTS: Sixty-two patients (53% with stage IV disease) received protocol treatment, and 50 patients (81%) were able to complete the regimen. The addition of gefitinib increased the incidence of grade 3/4 mucositis (27%) and diarrhea (16%) during induction therapy but did not appear to add substantially to toxicity during concurrent chemoradiation. The estimated 3-year progression-free and overall survival rates for the entire group were 41% and 54%, respectively.
CONCLUSIONS: The addition of gefitinib was associated with a moderate increase in toxicity with this combined modality regimen, particularly during induction therapy. Although this regimen was efficacious, the survival results overlap with results reported with chemoradiation alone. The role of epidermal growth factor receptor inhibitors in first-line, combined-modality therapy for patients with head and neck cancer remains undefined.