title: Decline of cosmetic outcomes following accelerated partial breast irradiation using intensity modulated radiation therapy: results of a single-institution prospective clinical trial.
abstract: OBJECTIVE
  To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC).
  
  
  METHODS
  Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years.
  
  
  RESULTS
  A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled.
  
  
  CONCLUSIONS
  In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Adam L
authors.initials: AL
authors.lastname: Liss
authors.affiliation: Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan, Israel.
authors.forename: Merav A
authors.initials: MA
authors.lastname: Ben-David
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Reshma
authors.initials: R
authors.lastname: Jagsi
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: James A
authors.initials: JA
authors.lastname: Hayman
authors.affiliation: Biostatistics Unit, University of Michigan, Ann Arbor, Michigan.
authors.forename: Kent A
authors.initials: KA
authors.lastname: Griffith
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Jean M
authors.initials: JM
authors.lastname: Moran
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Robin B
authors.initials: RB
authors.lastname: Marsh
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. Electronic address: ljpierce@umich.edu.
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Pierce
mesh_terms: D000328:Adult; D000368:Aged; D001940:Breast / Q000473:pathology / Q000528:radiation effects*; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D062485:Breath Holding; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D019583:Dose Fractionation, Radiation; D057239:Early Termination of Clinical Trials; D004954:Esthetics; D005260:Female; D005355:Fibrosis; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009068:Movement; D011446:Prospective Studies; D011832:Radiation Injuries / Q000473:pathology*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods