| Added by | JPPOUGET |
|---|---|
| Group name | EquipeJPP |
| Item Type | Journal Article |
| Title | 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 |
| Creator | Bourgier et al. |
| Author | Didier Cowen |
| Author | Florence Castan |
| Author | Claire Lemanski |
| Author | Sophie Gourgou |
| Author | Sofia Rivera |
| Author | Alain Labib |
| Author | Karine Peignaux |
| Author | Magali Le Blanc-Onfroy |
| Author | Ahmed Benyoucef |
| Author | Alice Mege |
| Author | Zineb Douadi-Gaci |
| Author | Igor Latorzeff |
| Author | Ulrike Schick |
| Author | Stephane Jacquot |
| Author | Carole Massabeau |
| Author | Philippe Guilbert |
| Author | Julien Geffrelot |
| Author | Stephen Ellis |
| Author | Isabelle Lecouillard |
| Author | Christel Breton-Callu |
| Author | Agnès Richard-Tallet |
| Author | Fatiha Boulbair |
| Author | Jacques Cretin |
| Author | Françoise Bons |
| Author | David Azria |
| Author | Pascal Fenoglietto |
| Abstract | 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, NCI-CTCAE 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. |
| Publication | Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology |
| Volume | 164 |
| Pages | 57-65 |
| Date | 2021-11 |
| Journal Abbr | Radiother Oncol |
| Language | eng |
| DOI | 10.1016/j.radonc.2021.09.014 |
| ISSN | 1879-0887 |
| Library Catalog | PubMed |
| Extra | PMID: 34571090 |
| Tags | Acute toxicities, Boost, Breast, Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, clinic, DCIS, Female, first, first-last-coresponding, Humans, Hypertrophy, Radiotherapy Planning, Computer-Assisted |
| Date Added | 2023/11/23 - 12:48:14 |
| Date Modified | 2024/12/15 - 11:25:21 |
| Notes and Attachments | PubMed entry (Attachment) |
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