title: GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance.
abstract: To compare early side effects and patient compliance of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to external beam whole breast irradiation (WBI) in a low-risk group of patients with breast cancer.
  
  
  
  Between April 2004 and July 2009, 1328 patients with UICC stage 0-IIA breast cancer were randomized to receive WBI with 50Gy and a boost of 10Gy or APBI with either 32.0Gy/8 fractions, or 30.1Gy/7 fractions (HDR-brachytherapy), or 50Gy/0.60-0.80Gy per pulse (PDR-brachytherapy). This report focuses on early side-effects and patient compliance observed in 1186 analyzable patients. ClinicalTrials.gov identifier: NCT00402519.
  
  
  
  Patient compliance was excellent in both arms. Both WBI and APBI were well tolerated with moderate early side-effects. No grade 4 toxicity had been observed. Grade 3 side effects were exclusively seen for early skin toxicity (radiation dermatitis) with 7% vs. 0.2% (p<0.0001), and breast infection with 0% vs. 0.2% (p=n.s.) for patients treated with WBI and APBI. The incidence of grades 1-2 early side effects for WBI and APBI was 86% vs. 21% (p<0.0001) for skin toxicity, 2% vs. 20% (p<0.0001) for mild hematoma, and 2% vs. 5% (p=0.01) for mild breast infection rates, respectively. No differences had been found regarding grades 1-2 early breast pain (26% vs. 29%, p=0.23).
  
  
  
  APBI with interstitial multicatheter brachytherapy was tolerated very well and dramatically reduced early skin toxicity in comparison to standard WBI.
authors.affiliation: Department of Radiation Oncology, University Hospital Erlangen, Germany. Electronic address: oliver.ott@uk-erlangen.de.
authors.forename: Oliver J
authors.initials: OJ
authors.lastname: Ott
authors.affiliation: Department of Radiation Oncology, University Hospital Erlangen, Germany.
authors.forename: Vratislav
authors.initials: V
authors.lastname: Strnad
authors.affiliation: Department of Radiation Oncology, University Hospital Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Germany.
authors.forename: Guido
authors.initials: G
authors.lastname: Hildebrandt
authors.affiliation: Department of Radiation Oncology, University Hospital AKH Wien, Austria.
authors.forename: Daniela
authors.initials: D
authors.lastname: Kauer-Dorner
authors.affiliation: Department of Radiation Oncology, University Hospital Rostock, Germany.
authors.forename: Hellen
authors.initials: H
authors.lastname: Knauerhase
authors.affiliation: Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
authors.forename: Tibor
authors.initials: T
authors.lastname: Major
authors.affiliation: Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Poland.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Łyczek
authors.affiliation: Department of Radiation Oncology, Valencian Institute of Oncology, Spain.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Guinot
authors.affiliation: Department of Radiation Oncology, University Hospital Kiel, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Dunst
authors.affiliation: Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
authors.forename: Cristina Gutierrez
authors.initials: CG
authors.lastname: Miguelez
authors.affiliation: Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
authors.forename: Pavel
authors.initials: P
authors.lastname: Slampa
authors.affiliation: Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Allgäuer
authors.affiliation: Department of Radiation Oncology, University Hospital Inselspital Bern, Switzerland.
authors.forename: Kristina
authors.initials: K
authors.lastname: Lössl
authors.affiliation: Department of Radiation Oncology, University Hospital Würzburg, Germany.
authors.forename: Bülent
authors.initials: B
authors.lastname: Polat
authors.affiliation: Interdisciplinary Brachytherapy Unit, University Hospital Lübeck/UKSH Campus Lübeck, Germany.
authors.forename: György
authors.initials: G
authors.lastname: Kovács
authors.affiliation: Department of Radiation Oncology, Clemenshospital, Münster, Germany.
authors.forename: Arnt-René
authors.initials: AR
authors.lastname: Fischedick
authors.affiliation: Department of Radiation Oncology, University Hospital Jena, Germany.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Wendt
authors.affiliation: Department of Radiation Oncology, University Hospital Erlangen, Germany; Department of Radiation Oncology, University Hospital AKH Wien, Austria.
authors.forename: Rainer
authors.initials: R
authors.lastname: Fietkau
authors.affiliation: Department of Radiation Oncology, University Hospital Leipzig, Germany.
authors.forename: Rolf-Dieter
authors.initials: RD
authors.lastname: Kortmann
authors.affiliation: Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Resch
authors.affiliation: Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Kulik
authors.affiliation: Department of Radiation Oncology, Valencian Institute of Oncology, Spain.
authors.forename: Leo
authors.initials: L
authors.lastname: Arribas
authors.affiliation: Department of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Niehoff
authors.affiliation: Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Guedea
authors.affiliation: Department of Radiation Oncology, University Hospital Leipzig, Germany.
authors.forename: Annika
authors.initials: A
authors.lastname: Schlamann
authors.affiliation: Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
authors.forename: Richard
authors.initials: R
authors.lastname: Pötter
authors.affiliation: Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Gall
authors.affiliation: Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Malzer
authors.affiliation: Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Uter
authors.affiliation: Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
authors.forename: Csaba
authors.initials: C
authors.lastname: Polgár
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D001940:Breast / Q000528:radiation effects*; D001943:Breast Neoplasms / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance
keywords: Accelerated partial breast irradiation; Breast cancer; Early toxicity; GEC-ESTRO APBI trial; Multicatheter brachytherapy; Randomized trial