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

被引：85

作者：

Ott, Oliver J. ^{[1
]}

Strnad, Vratislav ^{[1
]}

Hildebrandt, Guido ^{[2
,3
]}

Kauer-Dorner, Daniela ^{[4
]}

Knauerhase, Hellen ^{[3
]}

Major, Tibor ^{[5
]}

Lyczek, Jaroslaw ^{[6
,7
]}

Luis Guinot, Jose ^{[8
]}

Dunst, Juergen ^{[9
]}

Gutierrez Miguelez, Cristina ^{[10
]}

Slampa, Pavel ^{[11
]}

Allgaeuer, Michael ^{[13
]}

Lossl, Kristina ^{[12
]}

Polat, Buelent ^{[16
]}

Kovacs, Gyoergy ^{[14
]}

Fischedick, Arnt-Rene ^{[15
]}

Wendt, Thomas G. ^{[17
]}

Fietkau, Rainer ^{[1
,4
]}

Kortmann, Rolf-Dieter ^{[2
]}

Resch, Alexandra ^{[5
]}

Kulik, Anna ^{[6
]}

Arribas, Leo ^{[8
]}

Niehoff, Peter ^{[9
,18
]}

Guedea, Ferran ^{[10
]}

Schlamann, Annika ^{[2
]}

Potter, Richard ^{[5
]}

Gall, Christine ^{[19
]}

Malzer, Martina ^{[19
]}

Uter, Wolfgang ^{[19
]}

Polgar, Csaba ^{[5
]}

机构：

[1] Univ Hosp Erlangen, Dept Radiat Oncol, Univ Str 27, D-91054 Erlangen, Germany

[2] Univ Hosp Leipzig, Dept Radiat Oncol, Leipzig, Germany

[3] Univ Hosp Rostock, Dept Radiat Oncol, Rostock, Germany

[4] Univ Hosp AKH Wien, Dept Radiat Oncol, Vienna, Austria

[5] Natl Inst Oncol, Ctr Radiotherapy, Budapest, Hungary

[6] Ctr Onkol Inst Marii Sklodowskej, Brachytherapy Dept, Warsaw, Poland

[7] Podkarpacki Hosp, Canc Ctr Brzozow, Brzozow, Poland

[8] Valencian Inst Oncol, Dept Radiat Oncol, Valencia, Spain

[9] Univ Hosp Kiel, Dept Radiat Oncol, Kiel, Germany

[10] Catalan Inst Oncol, Dept Radiat Oncol, Barcelona, Spain

[11] Masaryk Mem Canc Inst, Dept Radiat Oncol, Brno, Czech Republic

[12] Inselspital Bern, Univ Hosp, Dept Radiat Oncol, Bern, Switzerland

[13] Hosp Barmherzige Bruder Regensburg, Dept Radiat Oncol, Regensburg, Germany

[14] Univ Hosp Lubeck UKSH Campus Lubeck, Interdisciplinary Brachytherapy Unit, Lubeck, Germany

[15] Clemenshospital, Dept Radiat Oncol, Munster, Germany

[16] Univ Hosp Wurzburg, Dept Radiat Oncol, Wurzburg, Germany

[17] Univ Hosp Jena, Dept Radiat Oncol, Jena, Germany

[18] Univ Witten Herdecke, Municipal Hosp Cologne, Dept Radiotherapy, Witten, Germany

[19] Univ Erlangen Nurnberg, Dept Med Informat Biometry & Epidemiol, Erlangen, Germany

来源：

RADIOTHERAPY AND ONCOLOGY | 2016年 / 120卷 / 01期

关键词：

Breast cancer; Accelerated partial breast irradiation; Multicatheter brachytherapy; Randomized trial; Early toxicity; GEC-ESTRO APBI trial; TARGETED INTRAOPERATIVE RADIOTHERAPY; RADIATION-THERAPY; LOCAL-CONTROL; CANCER; OUTCOMES; TRIAL;

D O I：

10.1016/j.radonc.2016.06.019

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 50 Gy and a boost of 10 Gy or APBI with either 32.0 Gy/8 fractions, or 30.1 Gy/7 fractions (HDR-brachytherapy), or 50 Gy/0.60-0.80 Gy 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. (C) 2016 Elsevier Ireland Ltd. All rights reserved.

引用

页码：119 / 123

页数：5

共 18 条

[1]

[Anonymous], 1995, Radiother Oncol, V35, P17

[2] The Evolving Role of Partial Breast Irradiation in Early-Stage Breast Cancer [J].

Barry, Mitchel ;

Ho, Alice ;

Morrow, Monica .

ANNALS OF SURGICAL ONCOLOGY, 2013, 20 (08) :2534-2540

[3] TOXICITY CRITERIA OF THE RADIATION-THERAPY ONCOLOGY GROUP (RTOG) AND THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER (EORTC) [J].

COX, JD ;

STETZ, J ;

PAJAK, TF .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 1995, 31 (05) :1341-1346

[4] Accelerated partial-breast irradiation using high-dose-rate interstitial brachytherapy: 12-year update of a prospective clinical study [J].

Csaba Polgar ;

Major, Tibor ;

Janos Fodor ;

Sulyok, Zoltan ;

Andras Somogyi ;

Katalin Loeyey ;

Gyoergy Nemeth ;

Miklos Kasler .

RADIOTHERAPY AND ONCOLOGY, 2010, 94 (03) :274-279

[5] A randomised study of whole-breast vs tumour-bed irradiation after local excision and axillary dissection for early breast cancer [J].

Dodwell, DJ ;

Dyker, K ;

Brown, J ;

Hawkins, K ;

Cohen, D ;

Stead, M ;

Ash, D .

CLINICAL ONCOLOGY, 2005, 17 (08) :618-622

[6]

ICRU, 1997, ICRU Report 58

[7] Radiation exposure of the heart, lung and skin by radiation therapy for breast cancer: A dosimetric comparison between partial breast irradiation using multicatheter brachytherapy and whole breast teletherapy [J].

Lettmaier, Sebastian ;

Kreppner, Stephan ;

Lotter, Michael ;

Walser, Marc ;

Ott, Oliver J. ;

Fietkau, Rainer ;

Strnad, Vratislav .

RADIOTHERAPY AND ONCOLOGY, 2011, 100 (02) :189-194

[8]

Livi L, 2015, EUR J CANC

[9] Interim Cosmetic and Toxicity Results From RAPID: A Randomized Trial of Accelerated Partial Breast Irradiation Using Three-Dimensional Conformal External Beam Radiation Therapy [J].

Olivotto, Ivo A. ;

Whelan, Timothy J. ;

Parpia, Sameer ;

Kim, Do-Hoon ;

Berrang, Tanya ;

Truong, Pauline T. ;

Kong, Iwa ;

Cochrane, Brandy ;

Nichol, Alan ;

Roy, Isabelle ;

Germain, Isabelle ;

Akra, Mohamed ;

Reed, Melanie ;

Fyles, Anthony ;

Trotter, Theresa ;

Perera, Francisco ;

Beckham, Wayne ;

Levine, Mark N. ;

Julian, Jim A. .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (32) :4038-+

[10] Accelerated partial breast irradiation with multi-catheter brachytherapy:: Local control, side effects and cosmetic outcome for 274 patients.: Results of the German-Austrian multi-centre trial [J].

Ott, Oliver J. ;

Hildebrandt, Guido ;

Poetter, Richard ;

Hammer, Josef ;

Lotter, Michael ;

Resch, Alexandra ;

Sauer, Rolf ;

Strnad, Vratislav .

RADIOTHERAPY AND ONCOLOGY, 2007, 82 (03) :281-286

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