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Abstract
BACKGROUND:
Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was non-inferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life.

METHODS:
We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0-IIA breast cancer were randomly assigned (1:1) after breast-conserving surgery (resection margins ≥2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials.gov, number NCT00402519.

FINDINGS:
Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. Quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; the response rate was similar during follow-up. Global health status (range 0-100) was stable in both groups: at baseline 1, APBI group mean score 65·5 (SD 20·6) versus whole-breast irradiation group 64·6 (19·6), p=0·37; at 5 years, APBI group 66·2 (22·2) versus whole-breast irradiation group 66·0 (21·8), p=0·94. The only moderate, significant difference (difference of 10-20 points) between the groups was found in the breast symptoms scale. Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13·6, 95% CI 9·7-17·5; p<0·0001) and at 3-month follow-up (difference of means 12·7, 95% CI 9·8-15·6; p<0·0001).

INTERPRETATION:
APBI with multicatheter brachytherapy was not associated with worse quality of life compared with whole-breast irradiation. This finding supports APBI as an alternative treatment option after breast-conserving surgery for patients with early breast cancer.

Author information

Schäfer R1, Strnad V2, Polgár C3, Uter W4, Hildebrandt G5, Ott OJ2, Kauer-Dorner D6, Knauerhase H7, Major T8, Lyczek J9, Guinot JL10, Dunst J11, Miguelez CG12, Slampa P13, Allgäuer M14, Lössl K15, Kovács G16, Fischedick AR17, Fietkau R18, Resch A6, Kulik A19, Arribas L10, Niehoff P20, Guedea F12, Schlamann A21, Gall C4, Polat B22; Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO).
1
Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany. Electronic address: schaefer_r2@ukw.de.
2
Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
3
Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary; Department of Oncology, Semmelweis University, Budapest, Hungary.
4
Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
5
Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
6
Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
7
Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
8
Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
9
Podkarpacki Hospital Cancer Center Brzozow, Brzozow, Poland; Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskiej, Warsaw, Poland.
10
Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.
11
Department of Radiation Oncology, University Hospital Kiel, Kiel, Germany.
12
Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
13
Department of Radiation Oncology, Masaryk Memorial Cancer Institute and Faculty of Medicine, Brno, Czech Republic.
14
Department of Radiation Oncology, Hospital Barmherzige Brüder, Regensburg, Germany.
15
Department of Radiation Oncology, University Hospital Bern, Inselspital, Switzerland.
16
Interdisciplinary Brachytherapy Unit, University of Lubeck/Universitätsklinikum Schleswig-Holstein Campus Lubeck, Lubeck, Germany.
17
Department of Radiation Oncology, Clemens Hospital, Münster, Germany.
18
Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
19
Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskiej, Warsaw, Poland.
20
Department of Radiation Oncology, University Hospital Kiel, Kiel, Germany; Department of Radiotherapy, Sana Hospital Offenbach, Offenbach, Germany.
21
Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.
22
Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany.