Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck
Combination chemotherapy with cisplatin and fluorouracil (CF) is the standard treatment for
patients with locally advanced squamous cancer of the head and neck. CF chemotherapy has
been reported to increase survival and disease free survival in patients with unresectable
disease when given before definitive radiotherapy, showing overall response rate as 75-85%
including of CR rate of 25-35%. To improvement of treatment, docetaxel was incorporated into
CF as induction treatment and it showed the prolongation of progression free survival and
overall survival in large scale of randomized phase III trials, therefore triple combination
induction regimen would be standard treatment in advanced head and neck cancer. Recently,
the introduction of oral fluoropyrimidine showed similar or enhanced response rate, also
favorable safety and convenience than intravenous fluoropyrimidine in advanced gastric
cancer. Of the oral fluoropyrimidines, S-1 showed promising preliminary result in
combination chemotherapy with cisplatin in head and neck cancer. In patients with advanced
gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was
reported and the recommended doses were 40mg/m2 bid, 60mg/m2 (D1) and 60mg/m2 (D1),
respectively. Therefore, the aim of this study was to evaluate the efficacy and safety of
docetaxel, cisplatin and S-1 combination chemotherapy according to above dosage.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
After completion of CCRT, response rate was assessed. Patients underwent examination by an otolaryngologist, CT or MRI imaging of the primary tumor and neck. A biopsy of the primary site was recommended if possible. Tumor response was assessed according to the RECIST. For all patients with complete response (CR) on physical examination and CT or MRI scan, PET scan was performed for confirmation at 1 month after CT or MRI confirmation.
Response rate was evaluated 1 months after completion of CCRT
Sang-Hee Cho, M.D.Ph.D.
Korea: Institutional Review Board