Abstract | PURPOSE: PATIENTS AND METHODS: 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:
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Authors | Pramila Rani Anné, Mitchell Machtay, David I Rosenthal, David M Brizel, William H Morrison, David H Irwin, Prakash B Chougule, Noel C Estopinal, Anthony Berson, Walter J Curran Jr |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 67
Issue 2
Pg. 445-52
(Feb 01 2007)
ISSN: 0360-3016 [Print] United States |
PMID | 17141978
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Radiation-Protective Agents
- Amifostine
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Topics |
- Adult
- Aged
- Amifostine
(administration & dosage, adverse effects)
- Combined Modality Therapy
(methods)
- Female
- Head and Neck Neoplasms
(radiotherapy)
- Humans
- Incidence
- Injections, Subcutaneous
- Male
- Middle Aged
- Nausea
(chemically induced)
- Patient Compliance
- Radiation-Protective Agents
(administration & dosage, adverse effects)
- Vomiting
(chemically induced)
- Xerostomia
(epidemiology, etiology, prevention & control)
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