phase II study of docetaxel, cisplatin and 5- fluorouracil [TPF] in patients with locally advanced head and neck carcinomas

ABSTRACT

The combination of cisplatin and 5-fluorouracil [PF] is currently considered a standard and effective regimen for the treatment of advanced head and neck carcinomas. The aim of this study was to evaluate the efficacy and safety of docetaxel, cisplatin and 5-fluorouracil [TPF] in patients with unresectable head and neck carcinomas. Forty-six patients with previously untreated non-metastatic stage IV head and neck carcinomas were enrolled. All patients received three cycle of induction chemotherapy with docetaxel [75mg/m[2]], cisplatin [40 mg/m[2]] [days 1-2/, and 5-FU [500 mg/m[2], days 1-3], repeated every 21 days. Following induction chemotherapy, all patients underwent concurrent chemoradiotherapy using weekly cisplatin [30 mg/m[2]] and a median total dose of 70 Gy was delivered. Clinical response rate and toxicity were the primary and secondary end-points of the study. There were 31 men and 15 women. All patients had non-metastatic stage IV [T2-3N2-3 or T4N0-3] of disease. Overall and complete response rates were 74% and 24% respectively. Advanced T4 classification was associated with poorer response rate [p value= 0.042]. The major [grade 3-4] treatment-related toxicities were myelosuppression [78%], anorexia [13%], diarrhea [7%], emesis [11%] and stomatitis/pharyngitis [24%]. In comparison with the data of historical published trials of the PF regimen, the TPF regimen was more effective. However, the TPF regimen appears to be associated with a higher incidence of major toxicities. Therefore, our limited findings support the TPF regimen as an alternative chemotherapeutic regimen for advanced head and neck carcinomas