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

Andre Abitbol, May Abdel-Wahab, Mark Harvey, Alan Lewin, Michael Troner, Kara Hamilton-Nelson, Jiuhua Wu, Arnold Markoe

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)449-455
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume28
Issue number5
DOIs
StatePublished - Oct 1 2005

Fingerprint

Amifostine
Paclitaxel
Fluorouracil
Radiotherapy
Radiation Dosage
Hypopharynx
Mucositis
Oropharynx
Gastrostomy
Nasopharynx
Paranasal Sinuses
Larynx
varespladib methyl
Disease-Free Survival
Mouth
TP protocol
Carcinoma, squamous cell of head and neck
Survival

Keywords

  • Chemotherapy
  • Head/neck cancer
  • Hyperfractionated radiotherapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. / Abitbol, Andre; Abdel-Wahab, May; Harvey, Mark; Lewin, Alan; Troner, Michael; Hamilton-Nelson, Kara; Wu, Jiuhua; Markoe, Arnold.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 28, No. 5, 01.10.2005, p. 449-455.

Research output: Contribution to journalArticle

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