Abstract. The aim of the present study was to evaluate the clinical effectiveness and toxicity of docetaxel with 5-fluorouracil and cisplatin as combination treatment in patients with curable or metastatic/recurrent head and neck cancer by a retrospective cohort study of patients treated at a single institution between 2007 and 2012. Patients with locally advanced, metastatic and/or recurrent squamous cell carcinoma of the head and neck (SCCHN), who were treated with a combination therapy including docetaxel, were considered as eligible. Survival data, clinical side effects, quality of life (QoL) and toxicity profile were retrieved from patient charts, analyzed and scored according to the National Cancer Institute Common Toxicity Criteria, version 4, and the Response Evaluation Criteria In Solid Tumors, version 1.1. An overall response rate of 86% and a 3-year survival of 65.1% were observed. The median progression-free survival was 32 months. The cumulative incidence after 3 years was 16.9% for local recurrence and 10.4% for distant metastasis. Leukopenia (58%) and anemia (51%) were the most common hematological toxicities, followed by hepatotoxicity (53%) and nausea (27%). A total of 31% of the patients experienced a compromise in their QoL following therapy completion. In conclusion, docetaxel in combination with cisplatin and 5-fluorouracil was found to effectively prolong survival in patients with locally advanced and/or recurrent metastatic SCCHN. The overall survival, progression-free survival and response rates were in accordance with those reported by previous clinical trials. Therefore, this therapy protocol is recommended for patients with SCCHN in the curative as well as the palliative settings. IntroductionHead and neck cancer is mostly of squamous cell origin (squamous cell carcinoma of the head and neck; SCCHN) and is the 10th most common type of cancer, with >630,000 cases diagnosed annually (1). Over 350,000 deaths from head and neck cancer were estimated to have occurred in 2008 worldwide (2). The frequency, incidence rates and locations of SCCHN vary widely among countries and continents (2-4).Following the introduction of the TAX 323 and 324 studies, induction chemotherapy drew significant scientific and clinical interest, leading to further investigations (3,5,6). The use of docetaxel in the treatment regimen was evaluated in those studies. Docetaxel promotes tubulin polymerization and affects the formation of stable microtubules, which leads to cell death (7). Recent results from multicenter studies and a current meta-analysis demonstrated that the combination of docetaxel with 5-fluorouracil (5-FU) and cisplatin (TPF regimen) is more efficacious compared with the classic regimen of cisplatin plus 5-FU (PF regimen) as induction chemotherapy for advanced head and neck cancer (8). The TPF regimen achieved longer progression-free survival, better locoregional control and higher response rates (9,10). An explanation for this advantage may be a better control of local and metastatic disease. Ano...