A phase II trial of neoadjuvant chemotherapy (NCT), organ-sparing surgery, and radiation in squamous cell head and neck cancer (SCHNC): Results of neoadjuvant chemotherapy

Abstract

5617 Background: NCT with radiation has facilitated organ-sparing treatment in locally advanced SCHNC. We conducted a phase II study of patients (pts) with SCHNC to evaluate a combination of NCT, radiation, and surgery to evaluate response to NCT as well as evaluate overall survival and recurrence patterns. Methods: Pts had resectable untreated stage III, IV SCHNC of the oral cavity, oropharynx, hyopharynx, or larynryx, and stage II cancer of the base of tongue, hypopharynx, and larynx. An ANC ≥ 1500/μl, platelet ≥ 100K/μl, serum creatinine ≤ 1.5mg/dl, bilirubin ≤ 1.5 mg/dl, liver function tests < 2.5 ULN, Karnofsky Performance Status (KPS) ≥ 60%, and signed informed consent were required. NCT consisted of docetaxel 60 mg/m2, then a 96-hour infusion of cisplatin 25mg/m2/d, 5-fluorouracil 700 mg/m2/d, and leucovorin 500 mg/m2/d. After 2 courses (C), those with at least a partial response received a third C. Pts with clinical complete response (CCR) or tumors < T1 were received radiation or chemoradiation and, as needed, surgery including modified lymph node dissection. Results: A total of 31 pts (1 with tonsillar lymphoepithelioma) were enrolled with response data for NCT in the first 25 pts presented. Pts had stage III (9), IVa (13), IVb (2), and stage II (1) disease. Median age was 63 yrs and 84% had a KPS ≥ 80%. After 2 Cs, 23/25 pts were in response, 6 in clinical complete response (CCR) in both neck and primary site. After a third cycle, 11/22 were in CCR with 16/22 in CCR at the primary site. Biopsies and/or surgical resection were performed in 18 of these pts; 11 pathologic complete responses (PCR) were seen. PCR was seen in 15/18 primary sites, and no pt required laryngectomy or base of tongue resection. Hemiglossectomy was performed in 2 pts and tonsillectomy in 3 pts (with 2/3 in PCR). C 2 dose reductions were needed in 12/24 pts and most required growth factor support. C 3 included 7/23 pts without dose reductions. Conclusions: NCT using a multi-agent regimen induces promising response rates allowing organ-sparing surgery in a high percentage of pts with SCHNC. Supported in part by grants from Aventis and CA 33572. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis