Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis)

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• 作者：Richard Shaw^a ; ^b ; ^{richard.shaw@liverpool.ac.uk} ; Binyam Tesfaye^b ; Matt Bickerstaff^b ; Paul Silcocks^b ; Christopher Butterworth^a ; ^c
• 关键词：Osteoradionecrosis ; Mandible ; Definition ; Classification ; Clinical trial
• 刊名：Oral Oncology
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：64
• 期：Complete
• 页码：73-77
• 全文大小：703 K
• 卷排序：64

文摘

The classification of mandibular osteoradionecrosis is vague and inconsistent, even in clinical trials. Here, we explore the definitions of ORN using the blinded clinical outcomes of the HOPON trial. Minor bone spicules (MBS) <20 mm2 are a common outcome, occurring in around 20% of patients in the trial. Some investigators will report MBS as ORN but others feel this is clinically less important, leading to potential ambiguity. MBS is worthy of a separate classification in trials addressing the management of ORN.