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.

Brachytherapy Department Centrum Onkologii Instytut im Marii Skłodowskej Warsaw Poland

Center of Radiotherapy National Institute of Oncology Budapest Hungary

Department of Medical Informatics Biometry and Epidemiology University Erlangen Nuremberg Germany

Department of Radiation Oncology Catalan Institute of Oncology Barcelona Spain

Department of Radiation Oncology Clemenshospital Münster Germany

Department of Radiation Oncology Hospital Barmherzige Brüder Regensburg Germany

Department of Radiation Oncology Masaryk Memorial Cancer Institute Brno Czech Republic

Department of Radiation Oncology University Hospital AKH Wien Austria

Department of Radiation Oncology University Hospital Erlangen Germany

Department of Radiation Oncology University Hospital Inselspital Bern Switzerland

Department of Radiation Oncology University Hospital Jena Germany

Department of Radiation Oncology University Hospital Kiel Germany

Department of Radiation Oncology University Hospital Leipzig Germany

Department of Radiation Oncology University Hospital Rostock Germany

Department of Radiation Oncology University Hospital Würzburg Germany

Department of Radiation Oncology Valencian Institute of Oncology Spain

Department of Radiotherapy Municipal Hospital Cologne University Witten Herdecke Germany

Interdisciplinary Brachytherapy Unit University Hospital Lübeck UKSH Campus Lübeck Germany

Podkarpacki Hospital Cancer Center Brzozów Poland

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$a Ott, Oliver J $u Department of Radiation Oncology, University Hospital Erlangen, Germany. Electronic address: oliver.ott@uk-erlangen.de.

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$a 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 / $c OJ. Ott, V. Strnad, G. Hildebrandt, D. Kauer-Dorner, H. Knauerhase, T. Major, J. Łyczek, JL. Guinot, J. Dunst, CG. Miguelez, P. Slampa, M. Allgäuer, K. Lössl, B. Polat, G. Kovács, AR. Fischedick, TG. Wendt, R. Fietkau, RD. Kortmann, A. Resch, A. Kulik, L. Arribas, P. Niehoff, F. Guedea, A. Schlamann, R. Pötter, C. Gall, M. Malzer, W. Uter, C. Polgár, . ,

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$a 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.

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$a Strnad, Vratislav $u Department of Radiation Oncology, University Hospital Erlangen, Germany.

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$a Hildebrandt, Guido $u Department of Radiation Oncology, University Hospital Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Germany.

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$a Kauer-Dorner, Daniela $u Department of Radiation Oncology, University Hospital AKH Wien, Austria.

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$a Knauerhase, Hellen $u Department of Radiation Oncology, University Hospital Rostock, Germany.

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$a Major, Tibor $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

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$a Łyczek, Jaroslaw $u Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Poland.

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$a Guinot, José Luis $u Department of Radiation Oncology, Valencian Institute of Oncology, Spain.

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$a Dunst, Jürgen $u Department of Radiation Oncology, University Hospital Kiel, Germany.

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$a Miguelez, Cristina Gutierrez $u Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.

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$a Slampa, Pavel $u Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.

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$a Allgäuer, Michael $u Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Germany. $7 gn_A_00004514

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$a Lössl, Kristina $u Department of Radiation Oncology, University Hospital Inselspital Bern, Switzerland.

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$a Polat, Bülent $u Department of Radiation Oncology, University Hospital Würzburg, Germany.

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$a Kovács, György $u Interdisciplinary Brachytherapy Unit, University Hospital Lübeck/UKSH Campus Lübeck, Germany.

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$a Fischedick, Arnt-René $u Department of Radiation Oncology, Clemenshospital, Münster, Germany.

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$a Wendt, Thomas G $u Department of Radiation Oncology, University Hospital Jena, Germany.

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$a Fietkau, Rainer $u Department of Radiation Oncology, University Hospital Erlangen, Germany; Department of Radiation Oncology, University Hospital AKH Wien, Austria.

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$a Kortmann, Rolf-Dieter $u Department of Radiation Oncology, University Hospital Leipzig, Germany.

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$a Resch, Alexandra $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

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$a Kulik, Anna $u Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland.

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$a Arribas, Leo $u Department of Radiation Oncology, Valencian Institute of Oncology, Spain. $7 gn_A_00008867

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$a Niehoff, Peter $u Department of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Germany.

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$a Guedea, Ferran $u Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.

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$a Schlamann, Annika $u Department of Radiation Oncology, University Hospital Leipzig, Germany.

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$a Pötter, Richard $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

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$a Gall, Christine $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.

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$a Malzer, Martina $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.

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$a Uter, Wolfgang $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.

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$a Polgár, Csaba $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

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