5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial
Language English Country Great Britain, England 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
26494415
DOI
10.1016/s0140-6736(15)00471-7
PII: S0140-6736(15)00471-7
Knihovny.cz E-resources
- MeSH
- Brachytherapy methods MeSH
- Radiotherapy Dosage MeSH
- Adult MeSH
- Carcinoma, Ductal, Breast radiotherapy surgery therapy MeSH
- Carcinoma in Situ radiotherapy surgery therapy MeSH
- Combined Modality Therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Breast Neoplasms radiotherapy surgery therapy MeSH
- Mastectomy, Segmental methods MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Catheters, Indwelling 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
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.
Brachytherapy Department Centrum Onkologii Instytut im Marii Skłodowskej 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 Regensburg Germany
Department of Radiation Oncology Masaryk Memorial Cancer Institute Brno Czech Republic
Department of Radiation Oncology University Hospital AKH Wien Vienna Austria
Department of Radiation Oncology University Hospital Bern Inselspital Bern Switzerland
Department of Radiation Oncology University Hospital Erlangen Erlangen Germany
Department of Radiation Oncology University Hospital Jena Jena Germany
Department of Radiation Oncology University Hospital 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
Interdisciplinary Brachytherapy Unit University of Lübeck UKSH Campus Lübeck Lübeck Germany
References provided by Crossref.org
Special Techniques of Adjuvant Breast Carcinoma Radiotherapy
Accelerated partial breast irradiation in elderly breast cancer patients
ClinicalTrials.gov
NCT00402519
