• Vratislav Strnad, Oliver J Ott, Guido Hildebrandt, Daniela Kauer-Dorner, Hellen Knauerhase, Tibor Major, Jaroslaw Lyczek, Jose Luis Guinot, Jürgen Dunst, Gutierrez MiguelezCristinaCDepartment of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain., Pavel Slampa, Michael Allgäuer, Kristina Lössl, Bülent Polat, György Kovács, Arnt-René Fischedick, Thomas G Wendt, Rainer Fietkau, Marion Hindemith, Alexandra Resch, Anna Kulik, Leo Arribas, Peter Niehoff, Fernando Guedea, Annika Schlamann, Richard Pötter, Christine Gall, Martina Malzer, Wolfgang Uter, Csaba Polgár, and Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).
• Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. Electronic address: vratislav.strnad@uk-erlangen.de.
• Lancet. 2016 Jan 16; 387 (10015): 229-38.

BackgroundIn a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results.MethodsWe did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519.FindingsBetween April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1.44% (95% CI 0.51-2.38) with APBI and 0.92% (0.12-1.73) with whole-breast irradiation (difference 0.52%, 95% CI -0.72 to 1.75; p=0.42). No grade 4 late side-effects were reported. The 5-year risk of grade 2-3 late side-effects to the skin was 3.2% with APBI versus 5.7% with whole-breast irradiation (p=0.08), and 5-year risk of grade 2-3 subcutaneous tissue late side-effects was 7.6% versus 6.3% (p=0.53). The risk of severe (grade 3) fibrosis at 5 years was 0.2% with whole-breast irradiation and 0% with APBI (p=0.46).InterpretationThe difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival.FundingGerman Cancer Aid.Copyright © 2016 Elsevier Ltd. All rights reserved.

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