title: Hypofractionated and accelerated radiotherapy with subcutaneous amifostine cytoprotection as short adjuvant regimen after breast-conserving surgery: interim report.
abstract: OBJECTIVE
  Short radiotherapy schedules might be more convenient for patients and overloaded radiotherapy departments, provided late toxicity is not increased. We evaluated the efficacy and toxicity of a hypofractionated and highly accelerated radiotherapy regimen supported with cytoprotection provided by amifostine in breast cancer patients treated with breast-conserving surgery.
  
  
  METHODS
  A total of 92 patients received 12 consecutive fractions of radiotherapy (3.5 Gy/fraction for 10 fractions) to the breast and/or axillary/supraclavicular area and 4 Gy/fraction for 2 fractions to the tumor bed). Amifostine at a dose of 1,000 mg/d was administered subcutaneously. The follow-up of patients was 30-60 months (median, 39).
  
  
  RESULTS
  Using a dose individualization algorithm, 77.1% of patients received 1,000 mg and 16.3% received 750 mg of amifostine daily. Of the 92 patients, 13% interrupted amifostine because of fever/rash symptoms. Acute Grade 2 breast toxicity developed in 6.5% of patients receiving 1,000 mg of amifostine compared with 46.6% of the rest of the patients (p < .0001). The incidence of Grade 2 late sequelae was less frequent in the high amifostine dose group (3.2% vs. 6.6%; p = NS). Grade 1 lung fibrosis was infrequent (3.3%). The in-field relapse rate was 3.3%, and an additional 2.2% of patients developed a relapse in the nonirradiated supraclavicular area. c-erbB-2 overexpression was linked to local control failure (p = .01). Distant metastasis appeared in 13% of patients, and this was marginally related to more advanced T/N stage (p = .06).
  
  
  CONCLUSIONS
  Within a minimal follow-up of 2.5 years after therapy, hypofractionated and accelerated radiotherapy with subcutaneous amifostine cytoprotection has proved a well-tolerated and effective regimen. Longer follow-up is required to assess the long-term late sequelae.
authors.affiliation: Department of Radiotherapy/Oncology, Democritus University of Thrace, Alexandroupolis, Greece. targ@her.forthnet.gr
authors.forename: Michael I
authors.initials: MI
authors.lastname: Koukourakis
authors.forename: Pelagia G
authors.initials: PG
authors.lastname: Tsoutsou
authors.forename: Ioannis M
authors.initials: IM
authors.lastname: Abatzoglou
authors.forename: Kyriaki
authors.initials: K
authors.lastname: Sismanidou
authors.forename: Alexandra
authors.initials: A
authors.lastname: Giatromanolaki
authors.forename: Efthimios
authors.initials: E
authors.lastname: Sivridis
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000009:adverse effects / Q000627:therapeutic use*; D001941:Breast Diseases / Q000517:prevention & control; D001943:Breast Neoplasms / Q000378:metabolism / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000378:metabolism; D011837:Radiation-Protective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011855:Radiodermatitis / Q000517:prevention & control; D011878:Radiotherapy / Q000379:methods; D011879:Radiotherapy Dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D004999:Amifostine; D009363:Neoplasm Proteins; D011837:Radiation-Protective Agents; D018719:Erb-b2 Receptor Tyrosine Kinases