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Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1

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Forner, Lone E ; Dieleman, François J ; Shaw, Richard J ; Kanatas, Anastasios ; Butterworth, Chris J ; Kjeller, Göran ; Alsner, Jan ; Overgaard, Jens ; Hillerup, Søren ; Hyldegaard, Ole ; Arnell, Per ; von Buchwald, Christian ; H A M Kaanders, Johannes ; Smeele, Ludi E ; Specht, Lena ; Johansen, Jørgen ; J H Witjes, Max ; Merkx, Matthias A W ; Jansen, Erik C. / Hyperbaric oxygen treatment of mandibular osteoradionecrosis : Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1. In: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2022 ; Vol. 166. pp. 137-144.

Bibtex

@article{e35e294d232d4f69ab9dd42b2af0e379,
title = "Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1",
abstract = "PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials.METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups.RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients.CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.",
keywords = "Head and neck cancer, Hyperbaric oxygen treatment, Mandible, Osteoradionecrosis, Radiation therapy, Randomised clinical trial",
author = "Forner, {Lone E} and Dieleman, {Fran{\c c}ois J} and Shaw, {Richard J} and Anastasios Kanatas and Butterworth, {Chris J} and G{\"o}ran Kjeller and Jan Alsner and Jens Overgaard and S{\o}ren Hillerup and Ole Hyldegaard and Per Arnell and {von Buchwald}, Christian and {H A M Kaanders}, Johannes and Smeele, {Ludi E} and Lena Specht and J{\o}rgen Johansen and {J H Witjes}, Max and Merkx, {Matthias A W} and Jansen, {Erik C}",
note = "Copyright {\textcopyright} 2021. Published by Elsevier B.V.",
year = "2022",
month = jan,
doi = "10.1016/j.radonc.2021.11.021",
language = "English",
volume = "166",
pages = "137--144",
journal = "Radiotherapy and Oncology",
issn = "0167-8140",
publisher = "Elsevier Ireland Ltd",

}

RIS

TY - JOUR

T1 - Hyperbaric oxygen treatment of mandibular osteoradionecrosis

T2 - Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1

AU - Forner, Lone E

AU - Dieleman, François J

AU - Shaw, Richard J

AU - Kanatas, Anastasios

AU - Butterworth, Chris J

AU - Kjeller, Göran

AU - Alsner, Jan

AU - Overgaard, Jens

AU - Hillerup, Søren

AU - Hyldegaard, Ole

AU - Arnell, Per

AU - von Buchwald, Christian

AU - H A M Kaanders, Johannes

AU - Smeele, Ludi E

AU - Specht, Lena

AU - Johansen, Jørgen

AU - J H Witjes, Max

AU - Merkx, Matthias A W

AU - Jansen, Erik C

N1 - Copyright © 2021. Published by Elsevier B.V.

PY - 2022/1

Y1 - 2022/1

N2 - PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials.METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups.RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients.CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.

AB - PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials.METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups.RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients.CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.

KW - Head and neck cancer

KW - Hyperbaric oxygen treatment

KW - Mandible

KW - Osteoradionecrosis

KW - Radiation therapy

KW - Randomised clinical trial

UR - http://www.scopus.com/inward/record.url?scp=85120882971&partnerID=8YFLogxK

U2 - 10.1016/j.radonc.2021.11.021

DO - 10.1016/j.radonc.2021.11.021

M3 - Journal article

C2 - 34843843

VL - 166

SP - 137

EP - 144

JO - Radiotherapy and Oncology

JF - Radiotherapy and Oncology

SN - 0167-8140

ER -

ID: 69402906