title: Intensity-modulated and hypofractionated simultaneous integrated boost adjuvant breast radiation employing statics ports of tomotherapy (TomoDirect): a prospective phase II trial.
abstract: OBJECTIVE
  To report the 1-year outcomes of a prospective phase II study on hypofractionated whole-breast intensity-modulated radiotherapy (IM-WBRT) with a simultaneous integrated boost (SIB) to the tumor bed delivered with static ports of tomotherapy (TomoDirect) (TD).
  
  
  METHODS
  A prospective cohort of 82 patients was enrolled between 2011 and 2012. Treatment schedule consisted of 45 Gy/20 fractions to the whole breast and 50 Gy/20 fractions to the surgical bed delivered concomitantly with TD over 4 weeks. A one-armed optimal two-stage Simon's design was selected to test the hypothesis that treatment modality under investigation would decrease acute skin toxicity over historical data using conventional fractionation and sequential boost. Primary endpoint was acute skin toxicity. Secondary endpoints included late toxicity, cosmesis, quality of life and local control.
  
  
  RESULTS
  Median follow-up was 12 months (range 6-18). Maximum detected acute skin toxicity was G0 41 %; G1 53 %; G2 6 %; G3 <1 %. With two G2-G3 acute skin toxicity events in the first stage and four in the second, the study fulfilled the requirements for the definition of the treatment approach under investigation as promising. Late skin toxicity was mild with no >G2 events. Cosmesis was good/excellent in 91 % of patients and fair/poor in 9 %. Quality of life was preserved over time, with the exception of fatigue, which was transiently increased.
  
  
  CONCLUSIONS
  Hypofractionated IM-WBRT with a SIB to the tumor bed delivered with TD provides consistent clinical results and it is able to reduce acute skin toxicity rate over conventionally fractionated and sequential boost tomotherapy-based IM-WBRT.
authors.affiliation: Radiation Oncology Department, Tomotherapy Unit, Ospedale Regionale 'U. Parini', AUSL Valle d'Aosta, Viale Ginevra 3, 11100, Aosta, Italy, pfranco@ausl.vda.it.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Franco
authors.forename: Michele
authors.initials: M
authors.lastname: Zeverino
authors.forename: Fernanda
authors.initials: F
authors.lastname: Migliaccio
authors.forename: Domenico
authors.initials: D
authors.lastname: Cante
authors.forename: Piera
authors.initials: P
authors.lastname: Sciacero
authors.forename: Valeria
authors.initials: V
authors.lastname: Casanova Borca
authors.forename: Paolo
authors.initials: P
authors.lastname: Torielli
authors.forename: Cecilia
authors.initials: C
authors.lastname: Arrichiello
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Girelli
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: La Porta
authors.forename: Santi
authors.initials: S
authors.lastname: Tofani
authors.forename: Gianmauro
authors.initials: G
authors.lastname: Numico
authors.forename: Umberto
authors.initials: U
authors.lastname: Ricardi
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D015331:Cohort Studies; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011880:Radiotherapy Planning, Computer-Assisted; D018714:Radiotherapy, Adjuvant; D050397:Radiotherapy, Intensity-Modulated