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@article{1366498,
author = {Strnad, Vratislav and Ott, Oliver J. and Hildebrandt, Guido and KauerandDorner, Daniela and Knauerhase, Helen and Major, Tibor and Lyczek, Jaroslaw and Guinot, Jose Luis and Dunst, Jürgen and Miguelez, Cristina Gutierrez and Šlampa, Pavel and Allgäuer, Michael and Lössl, Kristina and Polat, Bülent and Kovács, György and Fischedick, ArntandRené and Wendt, Thomas G. and Fietkau, Rainer and Hindemith, Marion and Resch, Alexandra and Kulik, Anna and Arribas, Leo and Niehoff, Peter and Guedea, Fernando and Schlamann, Annika and Pötter, Richard and Gall, Christine and Malzer, Martina and Uter, Wolfgang and Polgár, Csaba},
article_location = {New York},
article_number = {10015},
doi = {http://dx.doi.org/10.1016/S0140-6736(15)00471-7},
keywords = {LUMPECTOMY PLUS TAMOXIFEN; BEAM RADIATION-THERAPY; INTRAOPERATIVE RADIOTHERAPY; FOLLOW-UP; CANCER; WOMEN; MANAGEMENT; TOXICITY; SURVIVAL; HEART},
language = {eng},
issn = {0140-6736},
journal = {Lancet},
title = {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},
volume = {387},
year = {2016}
}
TY - JOUR
ID - 1366498
AU - Strnad, Vratislav - Ott, Oliver J. - Hildebrandt, Guido - Kauer-Dorner, Daniela - Knauerhase, Helen - Major, Tibor - Lyczek, Jaroslaw - Guinot, Jose Luis - Dunst, Jürgen - Miguelez, Cristina Gutierrez - Šlampa, Pavel - Allgäuer, Michael - Lössl, Kristina - Polat, Bülent - Kovács, György - Fischedick, Arnt-René - Wendt, Thomas G. - Fietkau, Rainer - Hindemith, Marion - Resch, Alexandra - Kulik, Anna - Arribas, Leo - Niehoff, Peter - Guedea, Fernando - Schlamann, Annika - Pötter, Richard - Gall, Christine - Malzer, Martina - Uter, Wolfgang - Polgár, Csaba
PY - 2016
TI - 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
JF - Lancet
VL - 387
IS - 10015
SP - 229-238
EP - 229-238
PB - Elsevier Science BV
SN - 01406736
KW - LUMPECTOMY PLUS TAMOXIFEN
KW - BEAM RADIATION-THERAPY
KW - INTRAOPERATIVE RADIOTHERAPY
KW - FOLLOW-UP
KW - CANCER
KW - WOMEN
KW - MANAGEMENT
KW - TOXICITY
KW - SURVIVAL
KW - HEART
N2 - 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.
ER -
STRNAD, Vratislav, Oliver J. OTT, Guido HILDEBRANDT, Daniela KAUER-DORNER, Helen KNAUERHASE, Tibor MAJOR, Jaroslaw LYCZEK, Jose Luis GUINOT, Jürgen DUNST, Cristina Gutierrez MIGUELEZ, Pavel ŠLAMPA, Michael ALLGÄUER, Kristina LÖSSL, Bülent POLAT, György KOVÁCS, Arnt-René FISCHEDICK, Thomas G. WENDT, Rainer FIETKAU, Marion HINDEMITH, Alexandra RESCH, Anna KULIK, Leo ARRIBAS, Peter NIEHOFF, Fernando GUEDEA, Annika SCHLAMANN, Richard PÖTTER, Christine GALL, Martina MALZER, Wolfgang UTER a Csaba POLGÁR. 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. \textit{Lancet}. New York: Elsevier Science BV, 2016, roč.~387, č.~10015, s.~229-238. ISSN~0140-6736. Dostupné z: https://dx.doi.org/10.1016/S0140-6736(15)00471-7.
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