title: Fifteen-year results of a randomized prospective trial of hyperfractionated chest wall irradiation versus once-daily chest wall irradiation after chemotherapy and mastectomy for patients with locally advanced noninflammatory breast cancer.
abstract: OBJECTIVE
  To analyze the results of a Phase III clinical trial that investigated whether a hyperfractionated radiotherapy (RT) schedule could reduce the risk of locoregional recurrence in patients with locally advanced breast cancer treated with chemotherapy and mastectomy.
  
  
  METHODS
  Between 1985 and 1989, 200 patients with clinical Stage III noninflammatory breast cancer were enrolled in a prospective study investigating neoadjuvant and adjuvant chemotherapy. Of the 179 patients treated with mastectomy after neoadjuvant chemotherapy, 108 participated in a randomized component of the trial that compared a dose-escalated, hyperfractionated (twice-daily, b.i.d.) chest wall RT schedule (72 Gy in 1.2-Gy b.i.d. fractions) with a once-daily (q.d.) schedule (60 Gy in 2-Gy q.d. fractions). In both arms of the study, the supraclavicular fossa and axillary apex were treated once daily to 50 Gy. The median follow-up period was 15 years.
  
  
  RESULTS
  The 15-year actuarial locoregional recurrence rate was 7% for the q.d. arm and 12% for the b.i.d. arm (p=0.36). The rates of severe acute toxicity were similar (4% for q.d. vs. 5% for b.i.d.), but moist desquamation developed in 42% of patients in the b.i.d. arm compared with 28% of the patients in the q.d. arm (p=0.16). The 15-year actuarial rate of severe late RT complications did not differ between the two arms (6% for q.d. vs. 11% for b.i.d., p=0.54).
  
  
  CONCLUSIONS
  Although the sample size of this study was small, we found no evidence that this hyperfractionation schedule of postmastectomy RT offered a clinical advantage. Therefore, we have concluded that it should not be further studied in this cohort of patients.
authors.affiliation: Department of Radiation Oncology, University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. tbuchhol@mdanderson.org
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Buchholz
authors.forename: Eric A
authors.initials: EA
authors.lastname: Strom
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Oswald
authors.forename: George H
authors.initials: GH
authors.lastname: Perkins
authors.forename: Julia
authors.initials: J
authors.lastname: Oh
authors.forename: Delora
authors.initials: D
authors.lastname: Domain
authors.forename: Tse-Kuan
authors.initials: TK
authors.lastname: Yu
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Woodward
authors.forename: Welela
authors.initials: W
authors.lastname: Tereffe
authors.forename: S Eva
authors.initials: SE
authors.lastname: Singletary
authors.forename: Eva
authors.initials: E
authors.lastname: Thomas
authors.forename: Aman U
authors.initials: AU
authors.lastname: Buzdar
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
authors.forename: Marsha D
authors.initials: MD
authors.lastname: McNeese
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology; D011879:Radiotherapy Dosage
chemical_list: D000970:Antineoplastic Agents