Prospective comparison of hypofractionated versus normofractionated intensity-modulated radiotherapy in breast cancer: late toxicity results of the non-inferiority KOSIMA Trial (ARO2010-3)
PurposeTo compare the late toxicity profile of hypofractionation and normofractionation for whole-breast radiotherapy in breast cancer (BC) patients after conserving surgery.MethodsSixty-year-old or older patients with pTis-pT3, pN0-pN1a, M0 BC were recruited and stratified to hypofractionated (arm...
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| Hauptverfasser: | , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
05 May 2022
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| In: |
Frontiers in oncology
Year: 2022, Jahrgang: 12, Pages: 1-8 |
| ISSN: | 2234-943X |
| DOI: | 10.3389/fonc.2022.824891 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.3389/fonc.2022.824891 Verlag, kostenfrei, Volltext: https://www.frontiersin.org/articles/10.3389/fonc.2022.824891 
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| Verfasserangaben: | Gustavo R. Sarria, Grit Welzel, Martin Polednik, Frederik Wenz and Yasser Abo-Madyan |
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| 245 | 1 | 0 | |a Prospective comparison of hypofractionated versus normofractionated intensity-modulated radiotherapy in breast cancer |b late toxicity results of the non-inferiority KOSIMA Trial (ARO2010-3) |c Gustavo R. Sarria, Grit Welzel, Martin Polednik, Frederik Wenz and Yasser Abo-Madyan |
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| 520 | |a PurposeTo compare the late toxicity profile of hypofractionation and normofractionation for whole-breast radiotherapy in breast cancer (BC) patients after conserving surgery.MethodsSixty-year-old or older patients with pTis-pT3, pN0-pN1a, M0 BC were recruited and stratified to hypofractionated (arm R-HF) or normofractionated (arm L-NF) intensity-modulated radiotherapy (IMRT), for right- and left-sided BC, respectively, in this single-center, non-randomized, non-inferiority trial. A boost was allowed if indicated. The primary outcome was the cumulative percentage of patients developing grade III fibrosis, grade I telangiectasia, and/or grade II hyperpigmentation after 2 years, with a pre-specified non-inferiority margin of 15% increase from an expected 2-year toxicity rate of 20%.ResultsThe Median follow-up was 4.93 (0.57-8.65) years for R-HF and 5.02 (0.65-8.72) years for L-NF (p=0.236). The median age was 68 (60-83 and 60-80) years, respectively. In total, 226 patients were recruited (107 for R-HF and 119 for L-NF), with 100 and 117 patients suitable for assessment, respectively. A boost was delivered in 51% and 53% of each arm, respectively. Median PTV volumes were 1013.6 (273-2805) cm3 (R-HF) and 1058.28 (315-2709) cm3 (L-NF, p=0.591). The 2-year primary endpoint rate was 6.1% (95% CI 1.3-11.7, n=5 of 82) and 13.3% (95% CI 7-20.2, n=14 of 105), respectively (absolute difference -7.2%, one-sided 95% CI ∞ to -0.26, favoring R-HF). No local recurrence-free- or overall-survival differences were found.ConclusionIn this prospective non-randomized study, hypofractionation did not have higher toxicity than normofractionated whole-breast IMRT. | ||
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