Quality-of-life results for accelerated partial breast
irradiation with interstitial brachytherapy versus whole-breast
irradiation in early breast cancer after breast-conserving
surgery (GEC-ESTRO): 5-year results of a randomised, phase 3
trial

J 2018

Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial

SCHAFER, Rebekka, Vratislav STRNAD, Csaba POLGAR, Wolfgang UTER, Guido HILDEBRANDT et. al.

Basic information

Original name

Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial

Authors

SCHAFER, Rebekka (276 Germany, guarantor), Vratislav STRNAD (276 Germany), Csaba POLGAR (348 Hungary), Wolfgang UTER (276 Germany), Guido HILDEBRANDT (276 Germany), Oliver J. OTT (276 Germany), Daniela KAUER-DORNER (40 Austria), Hellen KNAUERHASE (276 Germany), Tibor MAJOR (348 Hungary), Jaroslav LYCZEK (616 Poland), Jose Luis GUINOT (724 Spain), Juergen DUNST (276 Germany), Cristina G. MIGUELEZ (724 Spain), Pavel ŠLAMPA (203 Czech Republic, belonging to the institution), Michael ALLGAUER (276 Germany), Kristina LOSSL (756 Switzerland), Gyoergy KOVACS (276 Germany), Arnt-Rene FISCHEDICK (276 Germany), Rainer FIETKAU (276 Germany), Alexandra RESCH (40 Austria), Anna KULIK (616 Poland), Leo ARRIBAS (724 Spain), Peter NIEHOFF (276 Germany), Ferran GUEDEA (724 Spain), Annika SCHLAMANN (276 Germany), Christine GALL (276 Germany) and Buelent POLAT (276 Germany)

Edition

Lancet Oncology, New York, Elsevier Science INC, 2018, 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

Impact factor

Impact factor: 35.386

RIV identification code

RIV/00216224:14110/18:00106238

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/S1470-2045(18)30195-5

UT WoS

000434153000048

Keywords in English

GEC-ESTRO

Abstract

V originále

Background Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was noninferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life. Methods We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0-IIA breast cancer were randomly assigned (1:1) after breast-conserving surgery (resection margins >= 2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials. gov, number NCT00402519. Findings Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. Quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; the response rate was similar during follow-up.Global health status (range 0-100) was stable in both groups: at baseline 1, APBI group mean score 65.5 (SD 20.6) versus whole-breast irradiation group 64.6 (19.6), p=0.37; at 5 years, APBI group 66.2 (22.2) versus whole-breast irradiation group 66.0 (21.8), p=0.94.The only moderate, significant difference (difference of 10-20 points) between the groups was found in the breast symptoms scale.Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13.6, 95% CI 9.7-17.5; p<0.0001) and at 3-month follow-up (difference of means 12.7, 95% CI 9.8-15.6; p<0.0001). Interpretation APBI with multicatheter brachytherapy was not associated with worse quality of life compared with whole-breast irradiation.This finding supports APBI as an alternative treatment option after breast-conserving surgery for patients with early breast cancer. Copyright (c) 2018 Elsevier Ltd.All rights reserved.

Citovat

SCHAFER, Rebekka, Vratislav STRNAD, Csaba POLGAR, Wolfgang UTER, Guido HILDEBRANDT, Oliver J. OTT, Daniela KAUER-DORNER, Hellen KNAUERHASE, Tibor MAJOR, Jaroslav LYCZEK, Jose Luis GUINOT, Juergen DUNST, Cristina G. MIGUELEZ, Pavel ŠLAMPA, Michael ALLGAUER, Kristina LOSSL, Gyoergy KOVACS, Arnt-Rene FISCHEDICK, Rainer FIETKAU, Alexandra RESCH, Anna KULIK, Leo ARRIBAS, Peter NIEHOFF, Ferran GUEDEA, Annika SCHLAMANN, Christine GALL and Buelent POLAT. Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial. Lancet Oncology. New York: Elsevier Science INC, 2018, vol. 19, No 6, p. 834-844. ISSN 1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(18)30195-5.

@article{1497896,
   author = {Schafer, Rebekka and Strnad, Vratislav and Polgar, Csaba and Uter, Wolfgang and Hildebrandt, Guido and Ott, Oliver J. and KauerandDorner, Daniela and Knauerhase, Hellen and Major, Tibor and Lyczek, Jaroslav and Guinot, Jose Luis and Dunst, Juergen and Miguelez, Cristina G. and Šlampa, Pavel and Allgauer, Michael and Lossl, Kristina and Kovacs, Gyoergy and Fischedick, ArntandRene and Fietkau, Rainer and Resch, Alexandra and Kulik, Anna and Arribas, Leo and Niehoff, Peter and Guedea, Ferran and Schlamann, Annika and Gall, Christine and Polat, Buelent},
   article_location = {New York},
   article_number = {6},
   doi = {http://dx.doi.org/10.1016/S1470-2045(18)30195-5},
   keywords = {GEC-ESTRO},
   language = {eng},
   issn = {1470-2045},
   journal = {Lancet Oncology},
   title = {Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial},
   volume = {19},
   year = {2018}
}

TY  - JOUR
ID  - 1497896
AU  - Schafer, Rebekka - Strnad, Vratislav - Polgar, Csaba - Uter, Wolfgang - Hildebrandt, Guido - Ott, Oliver J. - Kauer-Dorner, Daniela - Knauerhase, Hellen - Major, Tibor - Lyczek, Jaroslav - Guinot, Jose Luis - Dunst, Juergen - Miguelez, Cristina G. - Šlampa, Pavel - Allgauer, Michael - Lossl, Kristina - Kovacs, Gyoergy - Fischedick, Arnt-Rene - Fietkau, Rainer - Resch, Alexandra - Kulik, Anna - Arribas, Leo - Niehoff, Peter - Guedea, Ferran - Schlamann, Annika - Gall, Christine - Polat, Buelent
PY  - 2018
TI  - Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial
JF  - Lancet Oncology
VL  - 19
IS  - 6
SP  - 834-844
EP  - 834-844
PB  - Elsevier Science INC
SN  - 14702045
KW  - GEC-ESTRO
N2  - Background Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was noninferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life. Methods We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0-IIA breast cancer were randomly assigned (1:1) after breast-conserving surgery (resection margins >= 2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials. gov, number NCT00402519. Findings Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. Quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; the response rate was similar during follow-up.Global health status (range 0-100) was stable in both groups: at baseline 1, APBI group mean score 65.5 (SD 20.6) versus whole-breast irradiation group 64.6 (19.6), p=0.37; at 5 years, APBI group 66.2 (22.2) versus whole-breast irradiation group 66.0 (21.8), p=0.94.The only moderate, significant difference (difference of 10-20 points) between the groups was found in the breast symptoms scale.Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13.6, 95% CI 9.7-17.5; p<0.0001) and at 3-month follow-up (difference of means 12.7, 95% CI 9.8-15.6; p<0.0001). Interpretation APBI with multicatheter brachytherapy was not associated with worse quality of life compared with whole-breast irradiation.This finding supports APBI as an alternative treatment option after breast-conserving surgery for patients with early breast cancer. Copyright (c) 2018 Elsevier Ltd.All rights reserved.
ER  -

SCHAFER, Rebekka, Vratislav STRNAD, Csaba POLGAR, Wolfgang UTER, Guido HILDEBRANDT, Oliver J. OTT, Daniela KAUER-DORNER, Hellen KNAUERHASE, Tibor MAJOR, Jaroslav LYCZEK, Jose Luis GUINOT, Juergen DUNST, Cristina G. MIGUELEZ, Pavel ŠLAMPA, Michael ALLGAUER, Kristina LOSSL, Gyoergy KOVACS, Arnt-Rene FISCHEDICK, Rainer FIETKAU, Alexandra RESCH, Anna KULIK, Leo ARRIBAS, Peter NIEHOFF, Ferran GUEDEA, Annika SCHLAMANN, Christine GALL and Buelent POLAT. Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial. \textit{Lancet Oncology}. New York: Elsevier Science INC, 2018, vol.~19, No~6, p.~834-844. ISSN~1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(18)30195-5.

Detailed Information on Publication Record