15525 Background: Concomitant chemo-radiation for head and neck cancer has emerged as the optimal method of treating advanced head and neck cancers, although the acute and late toxicities can be formidable. The addition of induction chemotherapy to concomitant chemo-radiation for head and neck cancer is designed to impact the incidence of distant metastasis while delivering aggressive local treatment. This trial evaluates the tolerability and effectiveness of induction chemotherapy followed by CBR with concurrent docetaxel and subcutaneous (SC) amifostine in locally advanced squamous cell carcinoma of the head and neck (SCCHN). Methods: Patients with stage III/IV nonmetastatic SCCHN received 3 cycles of primary chemotherapy with docetaxel and cisplatin, each at 75 mg/m2. Patients then received 4 weekly doses of docetaxel at 20 mg/m2 with concurrent CBR. SC amifostine was given at a dose of 500 mg in divided doses during each day of XRT. Results: The phase I component defined the MTD of concurrent docetaxel as 20 mg/m2 for 4 cycles during CBR. 18 patients are evaluated for response. No patient developed progressive disease during primary chemotherapy. Grade 3–4 mucositis was common, but all patients completed the planned concomitant docetaxel. At 6 months after treatment, 7/18 patients still used a feeding tube, though most have had them subsequently removed. Amifostine given by SC was well tolerated; 7 patients developed transient hypotension not requiring any intervention, with grade1 dermatitis and nausea reported. 2 patients discontinued amifostine due to rash or persistent hypotension. Conclusions: Response to induction chemotherapy was greater then 75% by radiological assessment, with no patient developing distant metastasis thus far. Local control has been excellent but side effects from docetaxel and CBR have necessitated prolonged use of feeding tubes for up to 6 months. SC amifostine has been well tolerated without significant side effects. This aggressive therapy is effective treatment for locally advanced SCCHN. No significant financial relationships to disclose.
Initial Evaluation of a Novel Cone-Beam CT-Based Semi-Automated Online Adaptive Radiotherapy System for Head and Neck Cancer Treatment – A Timing and Automation Quality Study
