title: A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head-and-neck cancer.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Thomas Jefferson University Hospital, Bodine Center for Cancer Research, Philadelphia, PA 19107, USA. rani.anne@mail.tju.edu
authors.forename: Pramila Rani
authors.initials: PR
authors.lastname: Anné
authors.forename: Mitchell
authors.initials: M
authors.lastname: Machtay
authors.forename: David I
authors.initials: DI
authors.lastname: Rosenthal
authors.forename: David M
authors.initials: DM
authors.lastname: Brizel
authors.forename: William H
authors.initials: WH
authors.lastname: Morrison
authors.forename: David H
authors.initials: DH
authors.lastname: Irwin
authors.forename: Prakash B
authors.initials: PB
authors.lastname: Chougule
authors.forename: Noel C
authors.initials: NC
authors.lastname: Estopinal
authors.forename: Anthony
authors.initials: A
authors.lastname: Berson
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010349:Patient Compliance; D011837:Radiation-Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced; D014987:Xerostomia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine