Publication details

Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial

Authors

POLGAR C. OTT O.J. HILDEBRANDT G. KAUER-DORNER D. KNAUERHASE H. MAJOR T. LYCZEK J. GUINOT J.L. DUNST J. MIGUELEZ C.G. ŠLAMPA Pavel ALLGAUER M. LOSSL K. POLAT B. KOVACS G. FISCHEDICK A.R. FIETKAU R. RESCH A. KULIK A. ARRIBAS L. NIEHOFF P. GUEDEA F. SCHLAMANN A. POTTER R. GALL C. UTER W. STRNAD V.

Year of publication 2017
Type Article in Periodical
Magazine / Source Lancet Oncology
MU Faculty or unit

Faculty of Medicine

Citation
Web http://dx.doi.org/10.1016/S1470-2045(17)30011-6
Doi http://dx.doi.org/10.1016/S1470-2045(17)30011-6
Field Oncology and hematology
Keywords accelerated partial breast irradiation
Description Background We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. Methods We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0-IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1: 1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratified by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-effects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. Findings Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6.6 years (IQR 5.8-7.6), no patients had any grade 4 toxities, and three (< 1%) of 484 patients in the APBI group and seven (2%) of 393 in the whole-breast irradiation group had grade 3 late skin toxicity (p= 0.16). No patients in the APBI group and two (< 1%) in the whole-breast irradiation group developed grade 3 late subcutaneous tissue toxicity (p= 0.10). The cumulative incidence of any late side-eff ect of grade 2 or worse at 5 years was 27.0% (95% CI 23.0-30.9) in the whole-breast irradiation group versus 23.3% (19.9-26.8) in the APBI group (p= 012). The cumulative incidence of grade 2-3 late skin toxicity at 5 years was 10.7% (95% CI 80-13.4) in the whole-breast irradiation group versus 69% (48-90) in the APBI group (diff erence -38%, 95% CI -72 to 0.4; p= 0020).

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