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Abstract

BACKGROUND:

In 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.

METHODS:

We 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.

FINDINGS:

Between 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).

INTERPRETATION:

The 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.

FUNDING: German Cancer Aid.

Comment in

Accelerated partial breast irradiation: the new standard? [Lancet. 2015] 

Author information

Strnad V1, Ott OJ2, Hildebrandt G3, Kauer-Dorner D4, Knauerhase H5, Major T6, Lyczek J7, Guinot JL8, Dunst J9, Gutierrez Miguelez C10, Slampa P11, Allgäuer M12, Lössl K13, Polat B14, Kovács G15, Fischedick AR16, Wendt TG17, Fietkau R18, Hindemith M19, Resch A4, Kulik A20, Arribas L8, Niehoff P21, Guedea F10, Schlamann A19, Pötter R4, Gall C22, Malzer M22, Uter W22, Polgár C6; Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).​

1Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. Electronic address: vratislav.strnad@uk-erlangen.de.

2Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.

3Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.

4Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.

5Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.

6Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.

7Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Brzozów, Poland.

8Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.

9Department of Radiation Oncology, University Hospital Kiel, Germany.

10Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.

11Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.

12Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Regensburg, Germany.

13Department of Radiation Oncology, University Hospital Bern, Inselspital, Bern, Switzerland.

14Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany.

15Interdisciplinary Brachytherapy Unit, University of Lübeck/UKSH Campus Lübeck, Lübeck, Germany.

16Department of Radiation Oncology, Clemens Hospital, Münster, Germany.

17Department of Radiation Oncology, University Hospital Jena, Jena, Germany.

18Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.

19Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.

20Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland.

21Department of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Witten, Germany.

22Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.