Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
29695348
DOI
10.1016/s1470-2045(18)30195-5
PII: S1470-2045(18)30195-5
Knihovny.cz E-resources
- MeSH
- Radiotherapy, Adjuvant MeSH
- Brachytherapy adverse effects methods MeSH
- Time Factors MeSH
- Adult MeSH
- Carcinoma pathology therapy MeSH
- Quality of Life * MeSH
- Middle Aged MeSH
- Humans MeSH
- Breast Neoplasms pathology therapy MeSH
- Surveys and Questionnaires MeSH
- Mastectomy, Segmental * adverse effects MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Neoplasm Grading MeSH
- Treatment Outcome MeSH
- Health Status MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
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. FUNDING: German Cancer Aid.
Brachytherapy Department Centrum Onkologii Instytut im Marii Skłodowskiej Warsaw Poland
Center of Radiotherapy National Institute of Oncology Budapest Hungary
Department of Radiation Oncology Catalan Institute of Oncology Barcelona Spain
Department of Radiation Oncology Clemens Hospital Münster Germany
Department of Radiation Oncology Hospital Barmherzige Brüder Regensburg Germany
Department of Radiation Oncology University Hospital AKH Wien Vienna Austria
Department of Radiation Oncology University Hospital Bern Inselspital Switzerland
Department of Radiation Oncology University Hospital Erlangen Erlangen Germany
Department of Radiation Oncology University Hospital Kiel Kiel Germany
Department of Radiation Oncology University Hospital Leipzig Leipzig Germany
Department of Radiation Oncology University Hospital Rostock Rostock Germany
Department of Radiation Oncology University Hospital Würzburg Würzburg Germany
Department of Radiation Oncology Valencian Institute of Oncology Valencia Spain
References provided by Crossref.org
ClinicalTrials.gov
NCT00402519
