title: Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy.
abstract: OBJECTIVE
  To report interim cosmetic and toxicity results of a multicenter randomized trial comparing accelerated partial-breast irradiation (APBI) using three-dimensional conformal external beam radiation therapy (3D-CRT) with whole-breast irradiation (WBI).
  
  
  METHODS
  Women age > 40 years with invasive or in situ breast cancer ≤ 3 cm were randomly assigned after breast-conserving surgery to 3D-CRT APBI (38.5 Gy in 10 fractions twice daily) or WBI (42.5 Gy in 16 or 50 Gy in 25 daily fractions ± boost irradiation). The primary outcome was ipsilateral breast tumor recurrence (IBTR). Secondary outcomes were cosmesis and toxicity. Adverse cosmesis was defined as a fair or poor global cosmetic score. After a planned interim cosmetic analysis, the data, safety, and monitoring committee recommended release of results. There have been too few IBTR events to trigger an efficacy analysis.
  
  
  RESULTS
  Between 2006 and 2011, 2,135 women were randomly assigned to 3D-CRT APBI or WBI. Median follow-up was 36 months. Adverse cosmesis at 3 years was increased among those treated with APBI compared with WBI as assessed by trained nurses (29% v 17%; P < .001), by patients (26% v 18%; P = .0022), and by physicians reviewing digital photographs (35% v 17%; P < .001). Grade 3 toxicities were rare in both treatment arms (1.4% v 0%), but grade 1 and 2 toxicities were increased among those who received APBI compared with WBI (P < .001).
  
  
  CONCLUSIONS
  3D-CRT APBI increased rates of adverse cosmesis and late radiation toxicity compared with standard WBI. Clinicians and patients are cautioned against the use of 3D-CRT APBI outside the context of a controlled trial.
authors.affiliation: Ivo A. Olivotto, Tanya Berrang, Pauline T. Truong, Alan Nichol, Melanie Reed, and Wayne Beckham, British Columbia Cancer Agency; Ivo A. Olivotto, Tanya Berrang, and Pauline T. Truong, University of British Columbia; Wayne Beckham, University of Victoria, Victoria; Alan Nichol, University of British Columbia, Vancouver; Melanie Reed, University of British Columbia, Kelowna, British Columbia; Timothy J. Whelan, Do-Hoon Kim, Iwa Kong, and Mark N. Levine, Juravinski Cancer Centre; Timothy J. Whelan, Sameer Parpia, Do-Hoon Kim, Iwa Kong, Brandy Cochrane, Mark N. Levine, and Jim A. Julian, McMaster University; Timothy J. Whelan, Sameer Parpia, Brandy Cochrane, Mark N. Levine, and Jim A. Julian, Ontario Clinical Oncology Group, Hamilton; Anthony Fyles, Princess Margaret Hospital, University of Toronto, Toronto; Francisco Perera, London Regional Cancer Centre, University of Western Ontario, London, Ontario; Isabelle Roy, Hôpital Notre-Dame, University of Montreal, Montreal; Isabelle Germain, Hôtel-Dieu de Quebec, Laval University, Quebec City, Quebec; Mohamed Akra, Cancer Care Manitoba, University of Manitoba, Winnipeg, Manitoba; and Theresa Trotter, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Ivo A
authors.initials: IA
authors.lastname: Olivotto
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Whelan
authors.forename: Sameer
authors.initials: S
authors.lastname: Parpia
authors.forename: Do-Hoon
authors.initials: DH
authors.lastname: Kim
authors.forename: Tanya
authors.initials: T
authors.lastname: Berrang
authors.forename: Pauline T
authors.initials: PT
authors.lastname: Truong
authors.forename: Iwa
authors.initials: I
authors.lastname: Kong
authors.forename: Brandy
authors.initials: B
authors.lastname: Cochrane
authors.forename: Alan
authors.initials: A
authors.lastname: Nichol
authors.forename: Isabelle
authors.initials: I
authors.lastname: Roy
authors.forename: Isabelle
authors.initials: I
authors.lastname: Germain
authors.forename: Mohamed
authors.initials: M
authors.lastname: Akra
authors.forename: Melanie
authors.initials: M
authors.lastname: Reed
authors.forename: Anthony
authors.initials: A
authors.lastname: Fyles
authors.forename: Theresa
authors.initials: T
authors.lastname: Trotter
authors.forename: Francisco
authors.initials: F
authors.lastname: Perera
authors.forename: Wayne
authors.initials: W
authors.lastname: Beckham
authors.forename: Mark N
authors.initials: MN
authors.lastname: Levine
authors.forename: Jim A
authors.initials: JA
authors.lastname: Julian
mesh_terms: D001943:Breast Neoplasms / Q000532:radiotherapy*; D002278:Carcinoma in Situ / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000532:radiotherapy*; D004954:Esthetics; D005260:Female; D006801:Humans; D008875:Middle Aged; D011832:Radiation Injuries / Q000453:epidemiology; D011880:Radiotherapy Planning, Computer-Assisted; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects* / Q000379:methods*; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D016896:Treatment Outcome