A Phase II Study of Docetaxel, Cisplatin and 5- Fluorouracil (TPF) In Patients with Locally Advanced Head and Neck Carcinomas
نویسندگان
1 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
2 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
3 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
4 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
5 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
6 Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
doi
چکیده
Background: The combination of cisplatin and 5-fluorouracil (PF) is currently considered a standard and effectiveregimen for the treatment of advanced head and neck carcinomas. The aim of this study was to evaluate theefficacy and safety of docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with unresectable head and neckcarcinomas.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 patientsunderwent concurrent chemoradiotherapy using weekly cisplatin (30 mg/m2) and a median total dose of 70 Gy wasdelivered. 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) ofdisease. Overall and complete response rates were 74% and 24% respectively. Advanced T4 classification wasassociated with poorer response rate (p value=0.042). The major (grade 3-4) treatment-related toxicities weremyelosuppression (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 wasmore 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 advancedhead and neck carcinomas.