Informace o publikaci

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

Autoři	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
Rok publikování	2016
Druh	Článek v odborném periodiku
Časopis / Zdroj	Lancet
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
Doi	http://dx.doi.org/10.1016/S0140-6736(15)00471-7
Obor	Onkologie a hematologie
Klíčová slova	LUMPECTOMY PLUS TAMOXIFEN; BEAM RADIATION-THERAPY; INTRAOPERATIVE RADIOTHERAPY; FOLLOW-UP; CANCER; WOMEN; MANAGEMENT; TOXICITY; SURVIVAL; HEART
Popis	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.