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

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

Center of Radiotherapy National Institute of Oncology Budapest Hungary

Department of Medical Informatics Biometry and Epidemiology University Erlangen Nuremberg Erlangen Germany

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 Erlangen Erlangen Germany; Department of Radiation Oncology University Hospital Rostock Rostock Germany

Department of Radiation Oncology University Hospital Jena Jena Germany

Department of Radiation Oncology University Hospital Kiel Germany

Department of Radiation Oncology University Hospital Kiel Germany; Department of Radiotherapy Municipal Hospital Cologne University Witten Herdecke Witten Germany

Department of Radiation Oncology University Hospital Leipzig Leipzig 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 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

Lancet. 2016 Jan 16;387(10015):201-2. doi: 10.1016/S0140-6736(15)00518-8. PubMed

Strahlenther Onkol. 2016 Feb;192(2):127-9. doi: 10.1007/s00066-015-0932-1. PubMed

Lancet. 2016 Apr 23;387(10029):1717. doi: 10.1016/S0140-6736(16)30255-0. PubMed

Lancet. 2016 Apr 23;387(10029):1717-8. doi: 10.1016/S0140-6736(16)30256-2. PubMed

Lancet. 2016 Apr 23;387(10029):1718-9. doi: 10.1016/S0140-6736(16)00697-8. PubMed

Int J Radiat Oncol Biol Phys. 2016 Jul 15;95(4):1089-91. doi: 10.1016/j.ijrobp.2016.02.034. PubMed

Citace poskytuje Crossref.org

Special Techniques of Adjuvant Breast Carcinoma Radiotherapy

Accelerated partial breast irradiation in elderly breast cancer patients

Zobrazit více v PubMed

ClinicalTrials.gov
NCT00402519