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



Shaw, Richard ORCID: 0000-0002-5157-4042, Tesfaye, Binyam, Bickerstaff, Matt, Silcocks, Paul and Butterworth, Christopher ORCID: 0000-0002-5025-7467
(2017) Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis). Oral Oncology, 64. 73 - 77.

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Abstract

Introduction:Mandibular osteoradionecrosis (ORN) is a common and serious complication of head andneck radiotherapy for which there is little reliable evidence for prevention or treatment. The diagnosisand classification of ORN have been inconsistently and imprecisely defined, even in clinical trials.Methods:A systematic review of diagnosis and classifications of ORN with specific focus on clinical trialsis presented. The most suitable classification was evaluated for consistency using blinded independentreview of outcome data (clinical photographs and radiographs) in the HOPON trial.Results:Of 16 ORN classifications found, only one (Notani) appeared suitable as an endpoint in clinicaltrials. Clinical records of 217 timepoints were analysed amongst 94 randomised patients in theHOPON trial. The only inconsistency in classification arose where minor bone spicules (MBS) were appar-ent, which occurred in 19% of patients. Some trial investigators judged MBS as clinically unimportant andnot reflecting ORN, others classified as ORN based on rigid definitions in common clinical use. When MBSwas added as a distinct category to the Notani classification this ambiguity was resolved and agreementbetween observers was achieved.Discussion:Most definitions and clinical classifications are based on retrospective case series and may beunsuitable for prospective interventional trials of ORN prevention or treatment. When ORN is used as aprimary or secondary outcome in prospective clinical trials, the use of Notani classification with the addi-tional category of MBS is recommended as it avoids subjectivity and enhances reliability and consistencyof reporting.

Item Type: Article
Additional Information: publisher: Elsevier articletitle: Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis) journaltitle: Oral Oncology articlelink: http://dx.doi.org/10.1016/j.oraloncology.2016.12.002 content_type: article copyright: © 2016 Elsevier Ltd. All rights reserved.
Uncontrolled Keywords: Osteoradionecrosis, Mandible, Definition, Classification, Clinical trial
Depositing User: Symplectic Admin
Date Deposited: 15 Jan 2018 07:39
Last Modified: 17 Oct 2020 13:10
DOI: 10.1016/j.oraloncology.2016.12.002
Related URLs:
URI: http://livrepository.liverpool.ac.uk/id/eprint/3015970