Biweekly paclitaxel, cisplatin, tegafur, and leucovorin as neoadjuvant chemotherapy for unresectable squamous cell carcinoma of the head and neck

BACKGROUND. The goal of the current study was to evaluate the efficacy and toxicity of paclitaxel, cisplatin (P), tegafur (T), and leucovorin (L) as a neoadjuvant chemotherapy (CT) for patients with advanced, unresectable squamous cell carcinoma of the head and neck. METHODS. From November 1999 to January 2001, 21 consecutive patients (Stage IV, 100%; T4, 86%; and N3, 41%) were treated with paclitaxel-PTL (Day 1: paclitaxel, 120 mg/m² intravenous infusion for 3 hours; Day 1: P, 50 mg/m²; T, 800 mg; and L, 60 mg orally daily over a 14-day cycle). Evaluation after three cycles led to CT termination if primary tumor responses were less than partial responses. Otherwise, paclitaxel-PTL was continued for up to six cycles before commencement of locoregional therapy. RESULTS. CT responses were analyzed on an intent-to-treat basis. Response rates (RR) for the primary tumors were 81% (17 of 21), with 28.6% (6 of 21) showing a complete response (CR). RR and CR rates for the neck lymph nodes were 85.3% (15 of 18) and 22% (4 of 18), respectively. The combined RR for primary tumors and neck lymph nodes was 81% (95% confidence interval, 62.9-99.3%) with a CR rate of 19%. Grade 3/4 toxicities according to World Health Organization criteria included leukopenia, 19.0%; emesis, 9.5%; asthenia, 9.5%; mucositis, 4.8%; and neuropathy, 4.8%. Both the overall and disease-free survival rates were 14.3% (3 of 21), with a median follow-up of 41 months. CONCLUSIONS. The relatively low toxicities and encouraging response rates demonstrated in the current study suggested that paclitaxel-PTL merits future trials in the setting of resectable tumors with more favorable characteristics.