title: Daily amifostine given concomitantly to chemoradiation in head and neck cancer. A pilot study.
abstract: BACKGROUND
  In patients with loco-regionally advanced head and neck cancer conventionally fractionated radiotherapy alone results in poor loco-regional control and survival rates. Treatment intensification by simultaneous administration of cytotoxic drugs produces higher acute morbidity. Therefore chemical radioprotection of normal tissues may be of clinical benefit.
  
  
  METHODS
  In a pilot study patients with advanced nonresectable head and neck cancer treated with conventionally fractionated radical radiotherapy (60 to 66 Gy total doses) and concomitantly given 5-fluorouracil as protracted venous infusion, 250 mg/sqm/24 h over the entire treatment period were given amifostine 300 mg absolutely before each fraction. Acute treatment related morbidity was scored according to CTC classification and loco-regional control and survival rates were estimated. Comparison was made with a historical control group of identical chemoradiation but without amifostine application.
  
  
  RESULTS
  Chemoradiation induced oral mucositis was delayed and showed significant lower degrees at all 10 Gy increments (p < 0.05) except 60 Gy and over (p > 0.05). No significant toxicity was recorded with respect to blood pressure, serum calcium, potassium, hematologic parameters, emesis, nausea or body weight loss. Progression free survival and overall survival probability at 2 years were not statistically different in both cohorts.
  
  
  CONCLUSIONS
  Amifostine given before each fraction of radiotherapy over 6 weeks has no cumulative toxicity, was well tolerated and may reduce treatment induced oral mucositis. No tumor protective effect was observed.
authors.affiliation: Department of Radiation Oncology, Friedrich-Schiller-University Jena, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Trog
authors.forename: P
authors.initials: P
authors.lastname: Bank
authors.forename: T G
authors.initials: TG
authors.lastname: Wendt
authors.forename: S
authors.initials: S
authors.lastname: Koscielny
authors.forename: E
authors.initials: E
authors.lastname: Beleites
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D015331:Cohort Studies; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects; D009367:Neoplasm Staging; D010039:Otorhinolaryngologic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D010865:Pilot Projects; D011292:Premedication; D011832:Radiation Injuries / Q000517:prevention & control; D011837:Radiation-Protective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D013280:Stomatitis / Q000517:prevention & control; D015996:Survival Rate
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine