Uab 0210: A Phase I/Ii Trial Of Induction Chemotherapy Followed By Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine For Advanced Squamous Cell Carcinoma Of The Head And Neck (Scchn)

6061 Background: Attempts to improve the outcome of locally advanced SCCHN have generally added chemotherapy to radiation, though the optimal manner of integration has been controversial. To impact distant and local control, we utilized neoadjuvant chemotherapy followed by concomitant boost radiation (CBR) with docetaxel as a radiosensitizer. To improve cytoprotection, subcutaneous amifostine was added during radiotherapy. Methods: From April 2003-March 2007 46 patients with stage III or IV newly diagnosed SCCHN were enrolled (30 Caucasian, 16 African-American). Treatment consisted of 3 cycles of neoadjuvant chemotherapy with cisplatin 75 mg/m2 and docetaxel 75 mg/m2 intravenously at 21 day intervals followed by CBR and concurrent dose-escalated weekly docetaxel starting at 20 mg/m2. Standard 2D radiotherapy was used in the majority of patients. Subcutaneous amifostine was administered at 500 mg during each day of radiation. Results: 39 patients were evaluable. The neoadjuvant chemotherapy was well tolerated by the majority of patients and appeared effective; no patient had progressive disease while on therapy. Three patients required a change to carboplatin due to toxicity. Weekly docetaxel during all weeks of CBR was not tolerable due to severe mucositis and the phase I component defined the MTD of concurrent docetaxel as 20 mg/m2 for 4 cycles during CBR. 4 patients (10%) had persistent disease at completion of treatment. Amifostine administration was well tolerated though 4 patients required discontinuation of the drug. The majority of recurrences have been localized at the primary site (6 patients). 3 patients developed isolated pulmonary metastasis. Only 2 patients remain PEG dependent with median follow-up of 24 months. Conclusions: Induction chemotherapy using cisplatin and docetaxel is feasible and easy to administer in the outpatient setting; those patients who had a major radiographic and clinical response did particularly well in follow-up. Weekly docetaxel can be safely and effectively administered during CBR with good local control. Amifostine can be safely administered via the subcutaneous route; the benefit in locally advanced patients is difficult to assess. No significant financial relationships to disclose.