TY - JOUR TI - Paclitaxel, cisplatin, leucovorin, and continuous infusion fluorouracil followed by concomitant chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck - A Hellenic cooperative oncology group phase II study AU - Fountzilas, G AU - Tolis, C AU - Kalogera-Fountzila, A AU - Misailidou, D AU - and Tsekeris, P AU - Karina, M AU - Nikolaou, A AU - Samantas, E and AU - Makatsoris, T AU - Athanassiou, E AU - Skarlos, D AU - Bamias, A and AU - Zamboglou, N AU - Economopoulos, T AU - Karanastassi, S AU - Pavlidis, N AU - and Daniilidis, J JO - Medical Oncology PY - 2005 VL - 22 TODO - 3 SP - 269-279 PB - Humana Press Inc. SN - 1357-0560, 1559-131X TODO - 10.1385/MO:22:3:269 TODO - paclitaxel; chemotherapy; head and neck cancer TODO - The primary objective of this phase II study was to access the complete response (CR) rate to a new innovative induction regimen in patients with locally advanced head and neck cancer (LA-HNC). From October 2000 until October 2003 a total of 38 eligible patients (33 men and 5 women) entered the study. The large majority of them presented with a performance status of 0-1 and with clinical stage IV disease. Treatment consisted of three cycles of induction chemotherapy (IC) with paclitaxel 175 mg/m(2) in a 3-h infusion on d 1, leucovorin (LV) 200 mg/m(2) over 20 min immediately followed by FU 400 mg/m(2) bolus and then 600 mg/m(2) as a 24-h continuous infusion on d 1 and 2 and a cisplatin 75 mg/m(2) over 1-h infusion on d 2 every 3 wk. This was then followed by radiation (70 Gy) and weekly cisplatin 40 mg/m(2). After the completion of IC, 6/38 (16%) patients had CR. The CR rate was increased to 66% post-concomitant chemoradiotherapy (CCRT). Neutropenia (37.5%), pain (62%), nausea/vomiting (21%), and alopecia (79%) were the most frequent side effects during IC. The most pronounced toxicities during chemoradiotherapy were stomatitis (62.5%) and xerostomia (53%). Median time to progression was 11.0 mo and median survival 16.7 mo. One- and 2-yr survival rates were 73% and 38%, respectively. In conclusion, this novel induction regimen is active, is well tolerated, and can be successfully followed by CCRT with weekly cisplatin. CCRT should remain standard treatment for patients with LA-HNC. Novel induction combinations, such as that reported in the present study, should be evaluated in combination with CCRT only in the context of clinical trials. ER -