Objectives: To use concurrent chemoradiotherapy as primary treatment for resectable head and neck squamous cell carcinoma to (1) demonstrate the feasibility of an organ preservation approach for nonlaryngeal sites; (2) evaluate the toxic reactions and response to a new combination of two platinum compounds; and (3) monitor the effect of therapy on oral and pharyngeal function.
Design: Case series, a prospective single-armed trial.
Setting: Tertiary referral center.
Patients: Twenty-two patients with head and neck squamous cell carcinoma of the oral cavity, oropharynx, and hypopharynx for whom surgery would significantly compromise function were entered in this trial.
Intervention: Standard fractionation external-beam radiation therapy (2 Gy/Fx; total, 70 Gy) was given during a 9-week period, including a 2-week break after 40 Gy, concurrently with eight weekly doses of carboplatin and three doses of cisplatin (100 mg/m2) at 3-week intervals. A biopsy was performed 12 weeks after the completion of chemoradiotherapy to assess clinical response. All patients presenting with nodes greater than 3 cm had planned neck dissection.
Main outcome measures: Tumor response, toxic reactions, survival, and oral and pharyngeal function.
Results: Overall complete response was 86%. Estimated overall 2-year survival was 64%, and disease-specific survival was 71% (median follow-up time, 25 months). Five patients have died of disease and two of unrelated causes. Treatment was completed by all, with toxic reactions including myelosuppression, mucositis, and dysphagia. Half of the patients required gastrostomy.
Conclusions: Concurrent chemoradiotherapy using two platinum analogues was tolerated with good local control and survival. Notable dysphagia was common. This study provides pilot data for randomized clinical trials to confirm the usefulness of chemoradiotherapy for nonlaryngeal organ preservation.