title: Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial.
abstract: OBJECTIVE
  To evaluate with a randomized clinical trial the possibility of treating the index quadrant with external intensity-modulated radiotherapy (IMRT) in a selected group of patients with early-stage breast cancer and to analyze the acute toxicity.
  
  
  METHODS
  From September 2005, a randomized Phase III clinical trial has been conducted to compare conventional (tangential field) fractionated whole breast treatment (Arm A) with accelerated partial breast irradiation plus intensity-modulated radiotherapy (Arm B). For intensity-modulated radiotherapy, the clinical target volume was drawn with a uniform 1-cm margin around the surgical clips in three dimensions. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk. All the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations.
  
  
  RESULTS
  In September 2008, 259 patients were randomized and treated. The mean clinical target volume in Arm B was 44 cm(3) and the mean planning target volume was 123 cm(3). The mean value of the ratio between the planning target volume and the ipsilateral breast volume was 21%. The rate of Grade 1 and Grade 2 acute skin toxicity was 22% and 19% in Arm A (Radiation Therapy Oncology Group scale), respectively. The tolerance in Arm B was excellent with only 5% Grade 1 and 0.8% Grade 2 acute skin toxicity. The planning constraints were fully satisfied in most patients. In a very few cases, this was not possible because of very unfavorable anatomy. Quality assurance procedures were performed according to our internal quality assurance protocol, with excellent results.
  
  
  CONCLUSIONS
  In the present preliminary analysis, we have demonstrated that accelerated partial breast irradiation is feasible, with very low acute toxicity.
authors.affiliation: Radiotherapy Unit, University of Florence, Florence, Italy. l.livi@dfc.unifi.it
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livi
authors.forename: Fabrizio Banci
authors.initials: FB
authors.lastname: Buonamici
authors.forename: Gabriele
authors.initials: G
authors.lastname: Simontacchi
authors.forename: Vieri
authors.initials: V
authors.lastname: Scotti
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fambrini
authors.forename: Antonella
authors.initials: A
authors.lastname: Compagnucci
authors.forename: Fabiola
authors.initials: F
authors.lastname: Paiar
authors.forename: Silvia
authors.initials: S
authors.lastname: Scoccianti
authors.forename: Stefania
authors.initials: S
authors.lastname: Pallotta
authors.forename: Beatrice
authors.initials: B
authors.lastname: Detti
authors.forename: Benedetta
authors.initials: B
authors.lastname: Agresti
authors.forename: Cinzia
authors.initials: C
authors.lastname: Talamonti
authors.forename: Monica
authors.initials: M
authors.lastname: Mangoni
authors.forename: Simonetta
authors.initials: S
authors.lastname: Bianchi
authors.forename: Luigi
authors.initials: L
authors.lastname: Cataliotti
authors.forename: Livia
authors.initials: L
authors.lastname: Marrazzo
authors.forename: Marta
authors.initials: M
authors.lastname: Bucciolini
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Biti
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D011832:Radiation Injuries / Q000209:etiology; D011859:Radiography; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D047368:Tumor Burden