Quality assurance program and early toxicities in the phase III BONBIS randomized trial evaluating the role of a localized radiation boost in ductal carcinoma in situ

被引：6

作者：

Bourgier, Celine ^{[1
,2
,3
]}

Cowen, Didier ^{[4
]}

Castan, Florence ^{[5
]}

Lemanski, Claire ^{[2
,3
]}

Gourgou, Sophie ^{[5
]}

Rivera, Sofia ^{[6
,7
]}

Labib, Alain ^{[8
]}

Peignaux, Karine ^{[9
]}

Le Blanc-Onfroy, Magali ^{[10
]}

Benyoucef, Ahmed ^{[11
]}

Mege, Alice ^{[12
]}

Douadi-Gaci, Zineb ^{[13
]}

Racadot, Severine ^{[14
]}

Latorzeff, Igor ^{[15
]}

Schick, Ulrike ^{[16
]}

Jacquot, Stephane ^{[17
]}

Massabeau, Carole ^{[18
]}

Guilbert, Philippe ^{[19
]}

Geffrelot, Julien ^{[20
]}

Ellis, Stephen ^{[21
]}

Lecouillard, Isabelle ^{[22
]}

Breton-Callu, Christel ^{[23
]}

Richard-Tallet, Agnes ^{[24
,25
]}

Boulbair, Fatiha ^{[26
]}

Cretin, Jacques ^{[27
]}

Belkacemi, Yazid ^{[28
,29
]}

Bons, Francoise ^{[3
,30
]}

Azria, David ^{[1
,2
,3
]}

Fenoglietto, Pascal ^{[2
,3
]}

机构：

[1] Univ Montpellier, Montpellier, France

[2] Inst Rech Cancerol Montpellier IRCM, INSERM U1194, Montpellier, France

[3] Federat Univ Oncol Radiotherapie Occitanie Medite, Inst Reg Canc Montpellier ICM, Montpellier, France

[4] Aix Marseille Univ, Hop Timone Hop Nord, AP HM, Dept Radiotherapie, Marseille, France

[5] Inst Reg Canc Montpellier ICM, Unite Biometrie, Montpellier, France

[6] Gustave Roussy, Dept Oncol Radiotherapie, Villejuif, France

[7] Univ Paris Saclay, U1030, INSERM, Villejuif, France

[8] Inst Curie, Paris, France

[9] Ctr Georges Francois LECLERC, Dept Oncol Radiotherapie, Dijon, France

[10] ICO Rene Gauducheau, Serv Radiotherapie, St Herblain, France

[11] Ctr Henri Becquerel, Dept Radiotherapie & Phys Med, Rouen, France

[12] Inst Canc Avignon Provence, St Catherine, Avignon, France

[13] Hop Prive Confluent, Nantes, France

[14] Ctr Leon Berard, Serv Radiotherapie, Lyon, France

[15] Clin Pasteur, Dept Radiotherapie Oncol, Toulouse, France

[16] UBO, Univ Hosp Brest, Dept Radiat Oncol, LaTIM UMR 1101, Brest, France

[17] Ctr Cancerol Grand Montpellier, Montpellier, France

[18] Inst Claudius Regaud IUCT O, Dept Radiotherapie, Toulouse, France

[19] Inst Godinot, Dept Radiotherapie, Reims, France

[20] Ctr Francois Baclesse, Serv Radiotherapie, Caen, France

[21] Ctr Catalan Oncol, Serv Radiotherapie, Perpignan, France

[22] Ctr Eugene Marquis, Dept Radiotherapie, Rennes, France

[23] Ctr Hosp Brive, Pole Oncol, Marseille, France

[24] Inst Paoli Calmettes, Dept Oncol Radiotherapie, Marseille, France

[25] Ctr Rech Cancerol Marseille CRCM, INSERM UMR 1068, Marseille, France

[26] CHRU Besancon, Serv Oncol Radiotherapie, Nimes, France

[27] Ctr Med ONCOGARD ICG, Nimes, France

[28] Univ Paris Est UPEC, Henri Mondor Univ Hosp, AP HP, Dept Radiat Oncol,INSERM Unit 955,Team 21,IMRB, Creteil, France

[29] Univ Paris Est UPEC, Henri Mondor Univ Hosp, AP HP, Henri Mondor Breast Ctr,INSERM Unit 955,Team 21,I, Creteil, France

[30] CHU Nimes, Serv Radiotherapie, Nimes, France

来源：

RADIOTHERAPY AND ONCOLOGY | 2021年 / 164卷

关键词：

DCIS; Boost; Randomized trial; Quality assurance; Acute toxicities; BREAST-CONSERVING SURGERY; TARGET VOLUME DELINEATION; SURGICAL CLIPS; HYPOFRACTIONATED RADIOTHERAPY; ELECTRON BOOST; TUMOR BED; CANCER; VARIABILITY; THERAPY; IRRADIATION;

D O I：

10.1016/j.radonc.2021.09.014

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: To describe the quality assurance (QA) program and early toxicities in the phase III randomized trial BONBIS (NCT00907868) on the role of a localized radiation boost in ductal carcinoma in situ (DCIS). Materials and methods: From November 2008 to July 2014, 2004 patients were randomized in arm A (only whole breast radiotherapy, WBRT) and arm B (WBRT + boost). The QA program involved 44 participant centers that performed the dummy run (DR). Compliance and uniformity of clinical target volume (CTV) delineations, and dose prescription and delivery according to the BONBIS trial radiotherapy guidelines were analyzed. Acute toxicities (during and up to 3 months after radiotherapy completion, NCICTCAE v3.0 classification) were evaluated in 1929 patients. Results: The differences in whole breast CTV (CTV1) and planning target volume (PTV1) were <10%, and the differences in boost CTV (CTV2) and PTV (PTV2) were >20% compared with the reference DR values; 95% of the prescribed dose encompassed 98.7% and 100% of the median CTV1 and CTV2. Grade >2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p < 0.001), grade >2 dermatitis (2.8% vs. 0.7%, p < 0.001), and grade 2 hyperpigmentation (6.9% vs. 3.6%, p = 0.005) were more frequent in arm B than arm A. No acute lung or cardiac toxicity was observed. Smoking history, large breast size, and large breast CTV were strong predictive factors of grade >2 acute skin toxicities. Conclusions: The QA program showed deviations in breast and tumor bed delineation. The boost significantly increased acute skin toxicities. (c) 2021 Elsevier B.V. All rights reserved. Radiotherapy and Oncology 164 (2021) 57-65

引用

页码：57 / 65

页数：9

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