Neoadjuvant and concomitant chemotherapy and radiation therapy in patients with advanced head and neck carcinoma

Our study evaluated the effectiveness of neoadjuvant chemotherapy and concomitant chemotherapy with radiotherapy compared to standard surgery and radiation therapy in patients with resectable stage III/IV head and neck squamous cell carcinoma. Forty-two eligible patients received neoadjuvant chemotherapy (cisplatin 100 mg/m2 intravenously day 1, and 5-fluorouracil 1 g/m2 /day continuous infusion days 1-5 every 3 weeks for 3 courses) followed by radiotherapy (65-70 Gy in 32-39 fractions to the primary site and lymph nodes; 50 Gy in 25-28 fractions to areas at risk) and concomitant chemotherapy (cisplatin 80 mg/m 2 intravenously every 3 weeks starting on day 1 of radiotherapy). Neoadjuvant therapy induced grade 4 cytopenias (12/42 patients) and grade 4 gastrointestinal toxicities (7/42 patients). Concomitant radiochemotherapy-induced grade 4 toxicities (6 patients). Neoadjuvant chemotherapy biopsy-proven complete responses were 15 of 42 patients (36%), partial responses in 23 of 42 patients (55%), and an overall response rate of 91%. Thirty-seven of 38 responders received concomitant radiochemotherapy. Complete responses in 35 of 42 patients (83%), partial response in 7 of 42 patients (7%), and overall response in 90%. The 3-year disease-free and overall survival for chemotherapy plus radiotherapy versus surgery plus radiotherapy: 61% versus 43% (P = 0.17) and 71% versus 43% (P = 0.02). These data suggest that a randomized trial of concomitant radiochemotherapy versus neoadjuvant plus concomitant radiochemotherapy should be considered.

B-2.