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Anorectal dose–effect relations for late gastrointestinal toxicity following external beam radiotherapy for prostate cancer in the FLAME trial

•A higher radiation dose to the anorectum is associated with increased overall GI toxicity.•Increasing the dose to the anorectum should be weighed against the benefit of focal dose escalation.•Further increasing the dose to the tumor without increasing the anorectal dose should be explored. The phas...

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Published in:Radiotherapy and oncology 2021-09, Vol.162, p.98-104
Main Authors: Groen, Veerle H., Zuithoff, Nicolaas P.A., van Schie, Marcel, Monninkhof, Evelyn M., Kunze-Busch, Martina, de Boer, Hans C.J., van der Voort van Zyp, Jochem, Pos, Floris J., Smeenk, Robert Jan, Haustermans, Karin, Isebaert, Sofie, Draulans, Cédric, Depuydt, Tom, Verkooijen, Helena M., van der Heide, Uulke A., Kerkmeijer, Linda G.W.
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Language:English
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Summary:•A higher radiation dose to the anorectum is associated with increased overall GI toxicity.•Increasing the dose to the anorectum should be weighed against the benefit of focal dose escalation.•Further increasing the dose to the tumor without increasing the anorectal dose should be explored. The phase III FLAME trial (NCT01168479) showed an increase in five-year biochemical disease-free survival, with no significant increase in toxicity when adding a focal boost to external beam radiotherapy (EBRT) for localized prostate cancer [Kerkmeijer et al. JCO 2021]. The aim of this study was to investigate the association between delivered radiation dose to the anorectum and gastrointestinal (GI) toxicity (grade ≥2). All patients in the FLAME trial were analyzed, irrespective of treatment arm. The dose–effect relation of the anorectal dose parameters (D2cm3 and D50%) and GI toxicity grade ≥2 in four years of follow-up was assessed using a mixed model analysis for repeated measurements, adjusted for age, cardiovascular disease, diabetes mellitus, T-stage, baseline toxicity grade ≥1, hormonal therapy and institute. A dose–effect relation for D2cm3 and D50% was observed with adjusted odds ratios of 1.17 (95% CI 1.13–1.21, p 
ISSN:0167-8140
1879-0887
DOI:10.1016/j.radonc.2021.06.033