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

Abstract

Purpose: Intravenous amifostine 200 mg/m{sup 2} 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 {>=}Grade 2 acute xerostomia. Results: Fifty-four patients received s.c. amifostine and radiotherapy. The incidence of {>=}Grade 2 acute xerostomia was 56% (95% CI, 43-69%) and the incidence of {>=}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 cutaneousmore » 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.« less

Authors:
 [1];  [2];  [3];  [4];  [3];  [5];  [6];  [7];  [8];  [9]
  1. Thomas Jefferson University Hospital, Bodine Center for Cancer Research, Philadelphia, PA (United States). E-mail: rani.anne@mail.tju.edu
  2. Department of Radiation Oncology, Hospital of University of Pennsylvania, Philadelphia, PA (United States)
  3. University of Texas M. D. Anderson Cancer Center, Houston, TX (United States)
  4. Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States)
  5. Alta Bates Comprehensive Cancer Center, Berkeley, CA (United States)
  6. Rhode Island Hospital, Providence, RI (United States)
  7. Comprehensive Cancer Institute, Huntsville, AL (United States)
  8. St. Vincent's Cancer Center, New York, NY (United States)
  9. Thomas Jefferson University Hospital, Bodine Center for Cancer Research, Philadelphia, PA (United States)
Publication Date:
OSTI Identifier:
20944686
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal Issue: 2; Other Information: DOI: 10.1016/j.ijrobp.2006.08.044; PII: S0360-3016(06)02810-0; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; DEHYDRATION; HEAD; NAUSEA; NECK; PATIENTS; RADIOTHERAPY

Citation Formats

Anne, Pramila Rani, Machtay, Mitchell, Rosenthal, David I., Brizel, David M., Morrison, William H., Irwin, David H., Chougule, Prakash B., Estopinal, Noel C., Berson, Anthony, and Curran, Walter J. A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.08.044.
Anne, Pramila Rani, Machtay, Mitchell, Rosenthal, David I., Brizel, David M., Morrison, William H., Irwin, David H., Chougule, Prakash B., Estopinal, Noel C., Berson, Anthony, & Curran, Walter J. A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer. United States. doi:10.1016/j.ijrobp.2006.08.044.
Anne, Pramila Rani, Machtay, Mitchell, Rosenthal, David I., Brizel, David M., Morrison, William H., Irwin, David H., Chougule, Prakash B., Estopinal, Noel C., Berson, Anthony, and Curran, Walter J. Thu . "A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer". United States. doi:10.1016/j.ijrobp.2006.08.044.
@article{osti_20944686,
title = {A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer},
author = {Anne, Pramila Rani and Machtay, Mitchell and Rosenthal, David I. and Brizel, David M. and Morrison, William H. and Irwin, David H. and Chougule, Prakash B. and Estopinal, Noel C. and Berson, Anthony and Curran, Walter J.},
abstractNote = {Purpose: Intravenous amifostine 200 mg/m{sup 2} 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 {>=}Grade 2 acute xerostomia. Results: Fifty-four patients received s.c. amifostine and radiotherapy. The incidence of {>=}Grade 2 acute xerostomia was 56% (95% CI, 43-69%) and the incidence of {>=}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.},
doi = {10.1016/j.ijrobp.2006.08.044},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 2,
volume = 67,
place = {United States},
year = {Thu Feb 01 00:00:00 EST 2007},
month = {Thu Feb 01 00:00:00 EST 2007}
}