A phase ii study of docetaxel, cisplatin and 5- fluorouracil (TPF)‎ in patients with locally advanced head and neck carcinomas

Abstract EN

Background: 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.

Methods: Forty-six patients with previously untreated non-metastatic stage IV head and neck carcinomas were enrolled.

All patients received three cycles of induction chemotherapy with docetaxel (75 mg/m2), cisplatin (40 mg/m2) (days 1-2), and 5-FU (500 mg/m2, days 1-3), repeated every 21 days.

Following induction chemotherapy, all patients underwent concurrent chemoradiotherapy using weekly cisplatin (30 mg/m2) 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.

Results: 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%).

Conclusion: 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.