Skip to main content
Journal cover image

A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer.

Publication ,  Journal Article
Anné, PR; Machtay, M; Rosenthal, DI; Brizel, DM; Morrison, WH; Irwin, DH; Chougule, PB; Estopinal, NC; Berson, A; Curran, WJ
Published in: Int J Radiat Oncol Biol Phys
February 1, 2007

PURPOSE: Intravenous amifostine 200 mg/m2 reduces xerostomia in head-and-neck cancer patients. This Phase II study evaluated subcutaneous (s.c.) amifostine in a similar patient population. PATIENTS AND METHODS: Patients received amifostine 500 mg, administered as two 250-mg s.c. injections 60 min before once-daily radiation for head-and-neck cancer (50-70 Gy in 5-7 weeks). The primary endpoint was the incidence of > or =Grade 2 acute xerostomia. RESULTS: Fifty-four patients received s.c. amifostine and radiotherapy. The incidence of > or =Grade 2 acute xerostomia was 56% (95% CI, 43-69%) and the incidence of > or =Grade 2 late xerostomia at 1 year was 45% (95% CI, 29-61%). The incidence of acute xerostomia was lower than reported previously with no amifostine in a controlled study; rates of acute xerostomia were similar between s.c. and i.v. amifostine in the two studies. The rate of late xerostomia with s.c. amifostine was intermediate between rates for i.v. amifostine and no amifostine, and not statistically significantly different from either historical control. Grades 1-2 nausea and emesis were the most common amifostine-related adverse events. Grade 3 amifostine-related adverse events reported by >1 patient included: dehydration (11%); rash (6%); and weight decrease, mucositis, dyspnea, and allergic reaction (each 4%). Seven patients (13%) had serious cutaneous adverse events outside the injection site. One-year rates of locoregional control, progression-free survival, and overall survival were 78%, 75%, and 85%, respectively. CONCLUSIONS: Subcutaneous amifostine provides a well-tolerated yet simpler alternative to i.v. amifostine for reducing acute xerostomia in head-and-neck cancer patients.

Duke Scholars

Published In

Int J Radiat Oncol Biol Phys

DOI

ISSN

0360-3016

Publication Date

February 1, 2007

Volume

67

Issue

2

Start / End Page

445 / 452

Location

United States

Related Subject Headings

  • Xerostomia
  • Vomiting
  • Radiation-Protective Agents
  • Patient Compliance
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Incidence
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Anné, P. R., Machtay, M., Rosenthal, D. I., Brizel, D. M., Morrison, W. H., Irwin, D. H., … Curran, W. J. (2007). A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys, 67(2), 445–452. https://doi.org/10.1016/j.ijrobp.2006.08.044
Anné, Pramila Rani, Mitchell Machtay, David I. Rosenthal, David M. Brizel, William H. Morrison, David H. Irwin, Prakash B. Chougule, Noel C. Estopinal, Anthony Berson, and Walter J. Curran. “A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer.Int J Radiat Oncol Biol Phys 67, no. 2 (February 1, 2007): 445–52. https://doi.org/10.1016/j.ijrobp.2006.08.044.
Anné PR, Machtay M, Rosenthal DI, Brizel DM, Morrison WH, Irwin DH, et al. A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):445–52.
Anné, Pramila Rani, et al. “A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer.Int J Radiat Oncol Biol Phys, vol. 67, no. 2, Feb. 2007, pp. 445–52. Pubmed, doi:10.1016/j.ijrobp.2006.08.044.
Anné PR, Machtay M, Rosenthal DI, Brizel DM, Morrison WH, Irwin DH, Chougule PB, Estopinal NC, Berson A, Curran WJ. A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):445–452.
Journal cover image

Published In

Int J Radiat Oncol Biol Phys

DOI

ISSN

0360-3016

Publication Date

February 1, 2007

Volume

67

Issue

2

Start / End Page

445 / 452

Location

United States

Related Subject Headings

  • Xerostomia
  • Vomiting
  • Radiation-Protective Agents
  • Patient Compliance
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Injections, Subcutaneous
  • Incidence