Portal de Periódicos da CAPES

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

2016; Elsevier BV; Volume: 120; Issue: 1 Linguagem: Inglês

10.1016/j.radonc.2016.06.019

1879-0887

Oliver J. Ott, Vratislav Strnad, Guido Hildebrandt, Daniela Kauer-Dorner, Hellen Knauerhase, Tibor Major, Jarosław Łyczek, José Luis Guinot, Jürgen Dunst, Cristina Gutiérrez Miguélez, Pavel Šlampa, Michael Allgäuer, Kristina Lössl, Bülent Polat, György Kovács, Arnt-René Fischedick, Thomas Wendt, Rainer Fietkau, Rolf‐Dieter Kortmann, Alexandra Resch, Anna Kulik, Leo Arribas, Peter Niehoff, Ferràn Guedea, Annika Schlamann, Richard Pötter, Christine M. Gall, Martina Malzer, Wolfgang Uter, Csaba Polgár,

Advanced Radiotherapy Techniques

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.