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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
V. Strnad, OJ. Ott, G. Hildebrandt, D. Kauer-Dorner, H. Knauerhase, T. Major, J. Lyczek, JL. Guinot, J. Dunst, C. Gutierrez Miguelez, P. Slampa, M. Allgäuer, K. Lössl, B. Polat, G. Kovács, AR. Fischedick, TG. Wendt, R. Fietkau, M. Hindemith, A....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 1992-01-04 do Před 3 měsíci
Nursing & Allied Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health & Medicine (ProQuest)
od 1992-01-04 do Před 3 měsíci
Family Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Psychology Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Health Management Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
Public Health Database (ProQuest)
od 1992-01-04 do Před 3 měsíci
- MeSH
- brachyterapie metody MeSH
- celková dávka radioterapie MeSH
- dospělí MeSH
- duktální karcinom prsu radioterapie chirurgie terapie MeSH
- karcinom in situ radioterapie chirurgie terapie MeSH
- kombinovaná terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu radioterapie chirurgie terapie MeSH
- segmentální mastektomie metody MeSH
- senioři MeSH
- výsledek terapie MeSH
- zaváděcí katétry MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie 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
Department of Radiotherapy Municipal Hospital Cologne University Witten Herdecke Witten Germany
Interdisciplinary Brachytherapy Unit University of Lübeck UKSH Campus Lübeck Lübeck Germany
Citace poskytuje Crossref.org
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