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7 záznamů v Medvik Filtry

Článek

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

Strnad, Vratislav
Autor Strnad, Vratislav Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. Electronic address: vratislav.strnad@uk-erlangen.de
Ott, Oliver J
Autor Ott, Oliver J Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany
Hildebrandt, Guido
Autor Hildebrandt, Guido Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany
Kauer-Dorner, Daniela
Autor Kauer-Dorner, Daniela Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria
Knauerhase, Hellen
Autor Knauerhase, Hellen Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany
Major, Tibor
Autor Major, Tibor Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary
Lyczek, Jaroslaw
Autor Lyczek, Jaroslaw Brachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland Podkarpacki Hospital Cancer Center Brzozów, Brzozów, Poland
Guinot, Jose Luis
Autor Guinot, Jose Luis Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain
Dunst, Jürgen
Autor Dunst, Jürgen Department of Radiation Oncology, University Hospital Kiel, Germany
Gutierrez Miguelez, Cristina
Autor Gutierrez Miguelez, Cristina Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain

Lancet. 2016 ; 387 (10015) : 229-38. [pub] 20151019

ISSN 1474-547X
Medvik
Zdroj

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.