Phase II study of tolerance and efficacy of hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and paclitaxel (taxol) and amifostine (ethyol) in head and neck squamous cell carcinomas: A-3 protocol.
The objective of this study was to determine the toxicity and efficacy of the current phase II chemoradiation protocol. Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionated radiation (74.4 Gy at twice-daily fractions of 1.2 Gy) in combination with a 5-fluorouracil, cisplatin, paclitaxel regimen, and an amifostine infusion. Thirty-five of 36 eligible patients were evaluable. The overall survival (OVS) was 88%, 82%, and 66% at 1, 2, and 3 years respectively. Twenty-five patients (71%) had a complete response, which was maintained in 20 (57%) patients until last follow up or death. Disease-free survival (DFS) of the complete responders was 92% at 1 year and 77% at 2 years and 3 years, respectively. Percutaneous endoscopic gastrostomy dependency lasted for a median of 7 months. Grade 3 and 4 mucositis occurred in 23 and 3 patients, respectively. Comparison with a similar study (A-2) that did not include amifostine showed no significant benefit to the addition of amifostine in these patients. A locoregional control benefit should be confirmed in a prospective, randomized trial. Alternative amifostine delivery methods should be investigated.
Abitbol
Andre
A
University of Miami, Department of Radiation Oncology, Miami, Florida 33136, USA.
Abdel-Wahab
May
M
Harvey
Mark
M
Lewin
Alan
A
Troner
Michael
M
Hamilton-Nelson
Kara
K
Wu
Jiuhua
J
Markoe
Arnold
A
D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
D004999:Amifostine; D017239:Paclitaxel; D002945:Cisplatin; D005472:Fluorouracil