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Clinical Trial
. 2016 Jul;120(1):119-23.
doi: 10.1016/j.radonc.2016.06.019. Epub 2016 Jul 12.

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

Oliver J Ott  1 , Vratislav Strnad  2 , Guido Hildebrandt  3 , Daniela Kauer-Dorner  4 , Hellen Knauerhase  5 , Tibor Major  6 , Jaroslaw Łyczek  7 , José Luis Guinot  8 , Jürgen Dunst  9 , Cristina Gutierrez Miguelez  10 , Pavel Slampa  11 , Michael Allgäuer  12 , Kristina Lössl  13 , Bülent Polat  14 , György Kovács  15 , Arnt-René Fischedick  16 , Thomas G Wendt  17 , Rainer Fietkau  18 , Rolf-Dieter Kortmann  19 , Alexandra Resch  6 , Anna Kulik  20 , Leo Arribas  8 , Peter Niehoff  21 , Ferran Guedea  10 , Annika Schlamann  19 , Richard Pötter  6 , Christine Gall  22 , Martina Malzer  22 , Wolfgang Uter  22 , Csaba Polgár  6 ; Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO)
Affiliations
Clinical Trial

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

Oliver J Ott et al. Radiother Oncol. 2016 Jul.

Abstract

Background and purpose: 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.

Material and methods: 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.

Results: 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).

Conclusions: APBI with interstitial multicatheter brachytherapy was tolerated very well and dramatically reduced early skin toxicity in comparison to standard WBI.

Keywords: Accelerated partial breast irradiation; Breast cancer; Early toxicity; GEC-ESTRO APBI trial; Multicatheter brachytherapy; Randomized trial.

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