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, Francois J.

AU - Shaw, Richard J.

AU - Kanatas, Anastasios

AU - Butterworth, Chris J.

AU - Kjeller, Goran

AU - Alsner, Jan

AU - Overgaard, Jens

AU - Hillerup, Soren

AU - Hyldegaard, Ole

AU - Arnell, Per

AU - von Buchwald, Christian

AU - Kaanders, Johannes H. A. M.

AU - Smeele, Ludi E.

AU - Specht, Lena

AU - Johansen, Jorgen

AU - Witjes, Max J. H.

AU - Merkx, Matthias A. W.

AU - Jansen, Erik C.

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. (C) 2021 The Authors. Published by Elsevier B.V.

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. (C) 2021 The Authors. Published by Elsevier B.V.

KW - Osteoradionecrosis

KW - Hyperbaric oxygen treatment

KW - Randomised clinical trial

KW - Radiation therapy

KW - Head and neck cancer

KW - Mandible

KW - QUALITY-OF-LIFE

KW - INTENSITY-MODULATED RADIOTHERAPY

KW - NECK-CANCER

KW - RADIATION-THERAPY

KW - HEAD

KW - OUTCOMES

KW - SURGERY

KW - JAWS

KW - OROPHARYNGEAL

KW - MANAGEMENT

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 & Oncology

JF - Radiotherapy & Oncology

SN - 0167-8140

ER -