title: Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial.
abstract: OBJECTIVE
  Conventionally fractionated whole-breast irradiation (WBI) with a boost takes approximately 6 to 7 weeks. We evaluated a short course of hypofractionated (HF), accelerated WBI in which therapy was completed in 3 weeks inclusive of a sequential boost.
  
  
  METHODS
  We delivered a whole-breast dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days, followed by a lumpectomy bed boost in 4 fractions of 3.33 Gy delivered once daily for a total of 15 treatment days. Acute toxicities were scored using Common Terminology Criteria for Adverse Events version 4. Late toxicities were scored using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scale. Cosmesis was scored using the Harvard Cosmesis Scale. Our primary endpoint was freedom from locoregional failure; we incorporated early stopping criteria based on predefined toxicity thresholds. Cosmesis was examined as a secondary endpoint.
  
  
  RESULTS
  We enrolled 83 women with stages 0 to IIIa breast cancer. After a median follow-up of 40 months, 2 cases of isolated ipsilateral breast tumor recurrence occurred (2 of 83; crude rate, 2.4%). Three-year estimated local recurrence-free survival was 95.9% (95% confidence interval [CI]: 87.8%-98.7%). The 3-year estimated distant recurrence-free survival was 97.3% (95% CI: 89.8%-99.3%). Three-year secondary malignancy-free survival was 94.3% (95% CI: 85.3%-97.8%). Twenty-nine patients (34%) had grade 2 acute toxicity, and 1 patient had a late grade 2 toxicity (fibrosis). One patient had acute grade 3 dermatitis, whereas 2 patients experienced grade 3 late skin toxicity. Ninety-four percent of evaluable patients had good or excellent cosmesis.
  
  
  CONCLUSIONS
  Our phase 2 institutional study offers one of the shortest courses of HF therapy, delivered in 15 fractions inclusive of a sequential boost. We demonstrated expected low toxicity and high local control rates with good to excellent cosmetic outcomes. This fractionation scheme is feasible and well tolerated and offers women WBI in a highly convenient schedule.
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey.
authors.forename: Stuti
authors.initials: S
authors.lastname: Ahlawat
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey.
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Haffty
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey.
authors.forename: Sharad
authors.initials: S
authors.lastname: Goyal
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kearney
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey.
authors.forename: Laurie
authors.initials: L
authors.lastname: Kirstein
authors.affiliation: Rutgers School of Public Health, Piscataway, New Jersey.
authors.forename: Chunxia
authors.initials: C
authors.lastname: Chen
authors.affiliation: Rutgers School of Public Health, Piscataway, New Jersey.
authors.forename: Dirk F
authors.initials: DF
authors.lastname: Moore
authors.affiliation: Rutgers Cancer Institute of New Jersey, New Jersey. Electronic address: khanat@cinj.rutgers.edu.
authors.forename: Atif J
authors.initials: AJ
authors.lastname: Khan
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D002278:Carcinoma in Situ / Q000473:pathology / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000532:radiotherapy*; D018275:Carcinoma, Lobular / Q000473:pathology / Q000532:radiotherapy*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D000069473:Radiation Dose Hypofractionation; D011832:Radiation Injuries / Q000473:pathology; D011855:Radiodermatitis / Q000473:pathology; D013997:Time Factors