Background: Combined modality therapy plays a central role in the management of advanced head and neck tumors. The objective of our Phase II study was to determine the feasibility, toxicity, and clinical and pathologic response of preoperative induction chemotherapy, followed by concurrent chemoradiotherapy in patients with Stage III or IV squamous cell carcinoma according to the American Joint Committee on Cancer Staging of the oral cavity and oropharynx with no distant metastases.
Methods: After staging, 62 patients with locally advanced carcinoma of the oral cavity and oropharynx were treated preoperatively with chemotherapy (1 cycle of cisplatin and 5-fluorouracil [P-5FU]) followed by concurrent chemoradiotherapy (3 cycles of P-5FU combined with radiotherapy, 60 grays [Gy] given in 33 fractions of 1.8 Gy). After evaluation, patients underwent surgery either as a diagnostic (biopsy) or therapeutic procedure (resection of the primary tumor and/or the neck). Surgery was performed with the intent to spare organ function.
Results: Grade 3-4 mucositis was observed in 37 patients (59%). Overall clinical response was obtained in 87%, and the complete clinical response rate was 50%. Surgery was performed in 53 patients, 50 at the primary tumor site (11 biopsies, 14 marginal excisions, and 25 wide excision) and 46 patients had neck dissection. Pathologic complete remission was observed in 29 patients (46%). After a median follow-up of 39 months, locoregional control rate was 76%, estimated 3-year disease free survival rate was 73% (+/- 4%), and estimated 3-year overall survival rate was 76% (+/- 4%).
Conclusions: This intensive multimodality treatment is feasible, and toxicity is significant but tolerable. The treatment results appear promising and durable. Organ-preserving surgery can be performed in many patients.