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

J 2017

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

POLGAR, C., O.J. OTT, G. HILDEBRANDT, D. KAUER-DORNER, H. KNAUERHASE et. al.

Basic information

Original name

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

Edition

Lancet Oncology, New York, Elsevier Science INC, 2017, 1470-2045

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 36.421

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/S1470-2045(17)30011-6

UT WoS

000396343000052

Keywords in English

accelerated partial breast irradiation

Abstract

V originále

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).

Citovat

POLGAR, C., O.J. OTT, G. HILDEBRANDT, D. KAUER-DORNER, H. KNAUERHASE, T. MAJOR, J. LYCZEK, J.L. GUINOT, J. DUNST, C.G. MIGUELEZ, Pavel ŠLAMPA, M. ALLGAUER, K. LOSSL, B. POLAT, G. KOVACS, A.R. FISCHEDICK, R. FIETKAU, A. RESCH, A. KULIK, L. ARRIBAS, P. NIEHOFF, F. GUEDEA, A. SCHLAMANN, R. POTTER, C. GALL, W. UTER and V. STRNAD. 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. Lancet Oncology. New York: Elsevier Science INC, 2017, vol. 18, No 2, p. 259-268. ISSN 1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(17)30011-6.

@article{1398901,
   author = {Polgar, C. and Ott, O.J. and Hildebrandt, G. and KauerandDorner, D. and Knauerhase, H. and Major, T. and Lyczek, J. and Guinot, J.L. and Dunst, J. and Miguelez, C.G. and Šlampa, Pavel and Allgauer, M. and Lossl, K. and Polat, B. and Kovacs, G. and Fischedick, A.R. and Fietkau, R. and Resch, A. and Kulik, A. and Arribas, L. and Niehoff, P. and Guedea, F. and Schlamann, A. and Potter, R. and Gall, C. and Uter, W. and Strnad, V.},
   article_location = {New York},
   article_number = {2},
   doi = {http://dx.doi.org/10.1016/S1470-2045(17)30011-6},
   keywords = {accelerated partial breast irradiation},
   language = {eng},
   issn = {1470-2045},
   journal = {Lancet Oncology},
   title = {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},
   url = {http://dx.doi.org/10.1016/S1470-2045(17)30011-6},
   volume = {18},
   year = {2017}
}

TY  - JOUR
ID  - 1398901
AU  - 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.
PY  - 2017
TI  - 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
JF  - Lancet Oncology
VL  - 18
IS  - 2
SP  - 259-268
EP  - 259-268
PB  - Elsevier Science INC
SN  - 14702045
KW  - accelerated partial breast irradiation
UR  - http://dx.doi.org/10.1016/S1470-2045(17)30011-6
L2  - http://dx.doi.org/10.1016/S1470-2045(17)30011-6
N2  - 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).
ER  -

POLGAR, C., O.J. OTT, G. HILDEBRANDT, D. KAUER-DORNER, H. KNAUERHASE, T. MAJOR, J. LYCZEK, J.L. GUINOT, J. DUNST, C.G. MIGUELEZ, Pavel ŠLAMPA, M. ALLGAUER, K. LOSSL, B. POLAT, G. KOVACS, A.R. FISCHEDICK, R. FIETKAU, A. RESCH, A. KULIK, L. ARRIBAS, P. NIEHOFF, F. GUEDEA, A. SCHLAMANN, R. POTTER, C. GALL, W. UTER and V. STRNAD. 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. \textit{Lancet Oncology}. New York: Elsevier Science INC, 2017, vol.~18, No~2, p.~259-268. ISSN~1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(17)30011-6.

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