• Something wrong with this record ?

GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance

OJ. Ott, V. Strnad, G. Hildebrandt, D. Kauer-Dorner, H. Knauerhase, T. Major, J. Łyczek, JL. Guinot, J. Dunst, CG. Miguelez, P. Slampa, M. Allgäuer, K. Lössl, B. Polat, G. Kovács, AR. Fischedick, TG. Wendt, R. Fietkau, RD. Kortmann, A. Resch, A....

. 2016 ; 120 (1) : 119-23. [pub] 20160712

Language English Country Ireland

Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc17031580

BACKGROUND AND PURPOSE: To compare early side effects and patient compliance of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to external beam whole breast irradiation (WBI) in a low-risk group of patients with breast cancer. MATERIAL AND METHODS: Between April 2004 and July 2009, 1328 patients with UICC stage 0-IIA breast cancer were randomized to receive WBI with 50Gy and a boost of 10Gy or APBI with either 32.0Gy/8 fractions, or 30.1Gy/7 fractions (HDR-brachytherapy), or 50Gy/0.60-0.80Gy per pulse (PDR-brachytherapy). This report focuses on early side-effects and patient compliance observed in 1186 analyzable patients. ClinicalTrials.gov identifier: NCT00402519. RESULTS: Patient compliance was excellent in both arms. Both WBI and APBI were well tolerated with moderate early side-effects. No grade 4 toxicity had been observed. Grade 3 side effects were exclusively seen for early skin toxicity (radiation dermatitis) with 7% vs. 0.2% (p<0.0001), and breast infection with 0% vs. 0.2% (p=n.s.) for patients treated with WBI and APBI. The incidence of grades 1-2 early side effects for WBI and APBI was 86% vs. 21% (p<0.0001) for skin toxicity, 2% vs. 20% (p<0.0001) for mild hematoma, and 2% vs. 5% (p=0.01) for mild breast infection rates, respectively. No differences had been found regarding grades 1-2 early breast pain (26% vs. 29%, p=0.23). CONCLUSIONS: APBI with interstitial multicatheter brachytherapy was tolerated very well and dramatically reduced early skin toxicity in comparison to standard WBI.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17031580
003      
CZ-PrNML
005      
20171103102308.0
007      
ta
008      
171025s2016 ie f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.radonc.2016.06.019 $2 doi
035    __
$a (PubMed)27422584
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ie
100    1_
$a Ott, Oliver J $u Department of Radiation Oncology, University Hospital Erlangen, Germany. Electronic address: oliver.ott@uk-erlangen.de.
245    10
$a GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance / $c OJ. Ott, V. Strnad, G. Hildebrandt, D. Kauer-Dorner, H. Knauerhase, T. Major, J. Łyczek, JL. Guinot, J. Dunst, CG. Miguelez, P. Slampa, M. Allgäuer, K. Lössl, B. Polat, G. Kovács, AR. Fischedick, TG. Wendt, R. Fietkau, RD. Kortmann, A. Resch, A. Kulik, L. Arribas, P. Niehoff, F. Guedea, A. Schlamann, R. Pötter, C. Gall, M. Malzer, W. Uter, C. Polgár, . ,
520    9_
$a BACKGROUND AND PURPOSE: To compare early side effects and patient compliance of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to external beam whole breast irradiation (WBI) in a low-risk group of patients with breast cancer. MATERIAL AND METHODS: Between April 2004 and July 2009, 1328 patients with UICC stage 0-IIA breast cancer were randomized to receive WBI with 50Gy and a boost of 10Gy or APBI with either 32.0Gy/8 fractions, or 30.1Gy/7 fractions (HDR-brachytherapy), or 50Gy/0.60-0.80Gy per pulse (PDR-brachytherapy). This report focuses on early side-effects and patient compliance observed in 1186 analyzable patients. ClinicalTrials.gov identifier: NCT00402519. RESULTS: Patient compliance was excellent in both arms. Both WBI and APBI were well tolerated with moderate early side-effects. No grade 4 toxicity had been observed. Grade 3 side effects were exclusively seen for early skin toxicity (radiation dermatitis) with 7% vs. 0.2% (p<0.0001), and breast infection with 0% vs. 0.2% (p=n.s.) for patients treated with WBI and APBI. The incidence of grades 1-2 early side effects for WBI and APBI was 86% vs. 21% (p<0.0001) for skin toxicity, 2% vs. 20% (p<0.0001) for mild hematoma, and 2% vs. 5% (p=0.01) for mild breast infection rates, respectively. No differences had been found regarding grades 1-2 early breast pain (26% vs. 29%, p=0.23). CONCLUSIONS: APBI with interstitial multicatheter brachytherapy was tolerated very well and dramatically reduced early skin toxicity in comparison to standard WBI.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a brachyterapie $x škodlivé účinky $x metody $7 D001918
650    _2
$a prsy $x účinky záření $7 D001940
650    _2
$a nádory prsu $x radioterapie $7 D001943
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a lidé středního věku $7 D008875
650    12
$a adherence pacienta $7 D010349
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Strnad, Vratislav $u Department of Radiation Oncology, University Hospital Erlangen, Germany.
700    1_
$a Hildebrandt, Guido $u Department of Radiation Oncology, University Hospital Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Germany.
700    1_
$a Kauer-Dorner, Daniela $u Department of Radiation Oncology, University Hospital AKH Wien, Austria.
700    1_
$a Knauerhase, Hellen $u Department of Radiation Oncology, University Hospital Rostock, Germany.
700    1_
$a Major, Tibor $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
700    1_
$a Łyczek, Jaroslaw $u Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Poland.
700    1_
$a Guinot, José Luis $u Department of Radiation Oncology, Valencian Institute of Oncology, Spain.
700    1_
$a Dunst, Jürgen $u Department of Radiation Oncology, University Hospital Kiel, Germany.
700    1_
$a Miguelez, Cristina Gutierrez $u Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
700    1_
$a Slampa, Pavel $u Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
700    1_
$a Allgäuer, Michael $u Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Germany. $7 gn_A_00004514
700    1_
$a Lössl, Kristina $u Department of Radiation Oncology, University Hospital Inselspital Bern, Switzerland.
700    1_
$a Polat, Bülent $u Department of Radiation Oncology, University Hospital Würzburg, Germany.
700    1_
$a Kovács, György $u Interdisciplinary Brachytherapy Unit, University Hospital Lübeck/UKSH Campus Lübeck, Germany.
700    1_
$a Fischedick, Arnt-René $u Department of Radiation Oncology, Clemenshospital, Münster, Germany.
700    1_
$a Wendt, Thomas G $u Department of Radiation Oncology, University Hospital Jena, Germany.
700    1_
$a Fietkau, Rainer $u Department of Radiation Oncology, University Hospital Erlangen, Germany; Department of Radiation Oncology, University Hospital AKH Wien, Austria.
700    1_
$a Kortmann, Rolf-Dieter $u Department of Radiation Oncology, University Hospital Leipzig, Germany.
700    1_
$a Resch, Alexandra $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
700    1_
$a Kulik, Anna $u Brachytherapy Department, Centrum Onkologii - Instytut im Marii Skłodowskej, Warsaw, Poland.
700    1_
$a Arribas, Leo $u Department of Radiation Oncology, Valencian Institute of Oncology, Spain. $7 gn_A_00008867
700    1_
$a Niehoff, Peter $u Department of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Germany.
700    1_
$a Guedea, Ferran $u Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
700    1_
$a Schlamann, Annika $u Department of Radiation Oncology, University Hospital Leipzig, Germany.
700    1_
$a Pötter, Richard $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
700    1_
$a Gall, Christine $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
700    1_
$a Malzer, Martina $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
700    1_
$a Uter, Wolfgang $u Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany.
700    1_
$a Polgár, Csaba $u Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
700    1_
$a ,
773    0_
$w MED00004049 $t Radiotherapy and oncology journal of the European Society for Therapeutic Radiology and Oncology $x 1879-0887 $g Roč. 120, č. 1 (2016), s. 119-23
856    41
$u https://pubmed.ncbi.nlm.nih.gov/27422584 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20171025 $b ABA008
991    __
$a 20171103102403 $b ABA008
999    __
$a ok $b bmc $g 1255173 $s 992607
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2016 $b 120 $c 1 $d 119-23 $e 20160712 $i 1879-0887 $m Radiotherapy and oncology $n Radiother Oncol $x MED00004049
LZP    __
$a Pubmed-20171025

Find record

Citation metrics

Archiving options