Efficacy and Safety of Sequential Chemoradiation with Docetaxel, Cisplatin, and 5-Fluorouracil (TPF) in Treating the Patients with Squamous Cell Carcinoma of the Hypopharynx: A Phase II Clinical Trial

Efficacy and Safety of Sequential Chemoradiation with Docetaxel, Cisplatin, and 5-Fluorouracil (TPF) in Treating the Patients with Squamous Cell Carcinoma of the Hypopharynx: A Phase II Clinical Trial

Background: The present study aimed to investigate the efficacy and safety of sequential chemoradiation with docetaxel, cisplatin, and 5-Fluorouracil (TPF) in the patients with Squamous Cell Carcinoma (SCC) of the hypopharynx.

Patients and Methods: In this single arm phase II clinical trial, eligible patients had to have newly diagnosed, locally advanced (T3-T4 and/or N2-N3, M0) hypopharyngeal SCC, no prior therapy, Eastern Cooperative Oncology Group performance scale ≤1, and normal or acceptable organ function. The patients were assigned to receive three cycles of 3-weekly induction chemotherapy in an outpatient setting with docetaxel 75 mg/m2, cisplatin 75 mg/m2, and 5-fluorouracil 750 mg/m2 × 3 days of 8-hour infusion, followed by definite radiotherapy with a total dose of 70 Gy with concurrent cisplatin 30 mg/m2 weekly. Tumor response rates and treatmentrelated toxicity were the primary and secondary study endpoints, respectively.