title: A phase 2 trial of once-weekly hypofractionated breast irradiation: first report of acute toxicity, feasibility, and patient satisfaction.
abstract: OBJECTIVE
  To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS).
  
  
  METHODS
  Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23).
  
  
  RESULTS
  Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity-pain requiring a course of narcotic analgesics-was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period.
  
  
  CONCLUSIONS
  The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.
authors.affiliation: Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky, USA. aedrag01@louisville.edu
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Dragun
authors.forename: Amy R
authors.initials: AR
authors.lastname: Quillo
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Riley
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Roberts
authors.forename: Allison M
authors.initials: AM
authors.lastname: Hunter
authors.forename: Shesh N
authors.initials: SN
authors.lastname: Rai
authors.forename: Glenda G
authors.initials: GG
authors.lastname: Callender
authors.forename: Dharamvir
authors.initials: D
authors.lastname: Jain
authors.forename: Kelly M
authors.initials: KM
authors.lastname: McMasters
authors.forename: William J
authors.initials: WJ
authors.lastname: Spanos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001940:Breast / Q000033:anatomy & histology / Q000528:radiation effects; D001943:Breast Neoplasms / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy* / Q000601:surgery; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009929:Organ Size; D017060:Patient Satisfaction; D011832:Radiation Injuries / Q000150:complications / Q000473:pathology; D011855:Radiodermatitis / Q000473:pathology; D013997:Time Factors