TY - JOUR

T1 - Tooth extractions in patients with cancer receiving high-dose antiresorptive medication

T2 - a randomized clinical feasibility trial of drug holiday versus drug continuation

AU - Ottesen, C

AU - Schiodt, M

AU - Jensen, S S

AU - Kofod, T

AU - Gotfredsen, K

N1 - Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2022/2

Y1 - 2022/2

N2 - OBJECTIVE: Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction to high-dose antiresorptive medication (AR) in patients with cancer. A temporary discontinuation of AR (drug holiday) has been suggested to potentially reduce the risk of MRONJ after oral surgery. However, no consensus exists. The aim of the present feasibility trial was to evaluate the impact of a high-dose AR drug holiday in connection with surgical tooth extraction on the development of MRONJ and patient-reported health state.STUDY DESIGN: Patients with cancer receiving high-dose AR were randomized to a drug holiday from 1 month before to 3 months after surgical tooth extraction or drug continuation. Follow-up was scheduled at 1, 3, and 6 months postoperatively. Patient health state was evaluated using the EQ-5D-5L questionnaire.RESULTS: The study included 23 patients (11 men, 12 women). AR included denosumab (n = 13) and bisphosphonate (n = 10) with median AR durations of 9 and 17.5 months, respectively. Four denosumab patients from the drug holiday group developed MRONJ. Differences in EQ-5D-5L between the treatment groups were found in favor of drug continuation.CONCLUSIONS: The results indicate that a high-dose AR drug holiday does not prevent development of MRONJ after surgical tooth extraction and that patient-reported health state declines during a drug holiday compared with drug continuation.

AB - OBJECTIVE: Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction to high-dose antiresorptive medication (AR) in patients with cancer. A temporary discontinuation of AR (drug holiday) has been suggested to potentially reduce the risk of MRONJ after oral surgery. However, no consensus exists. The aim of the present feasibility trial was to evaluate the impact of a high-dose AR drug holiday in connection with surgical tooth extraction on the development of MRONJ and patient-reported health state.STUDY DESIGN: Patients with cancer receiving high-dose AR were randomized to a drug holiday from 1 month before to 3 months after surgical tooth extraction or drug continuation. Follow-up was scheduled at 1, 3, and 6 months postoperatively. Patient health state was evaluated using the EQ-5D-5L questionnaire.RESULTS: The study included 23 patients (11 men, 12 women). AR included denosumab (n = 13) and bisphosphonate (n = 10) with median AR durations of 9 and 17.5 months, respectively. Four denosumab patients from the drug holiday group developed MRONJ. Differences in EQ-5D-5L between the treatment groups were found in favor of drug continuation.CONCLUSIONS: The results indicate that a high-dose AR drug holiday does not prevent development of MRONJ after surgical tooth extraction and that patient-reported health state declines during a drug holiday compared with drug continuation.

UR - http://www.scopus.com/inward/record.url?scp=85110440160&partnerID=8YFLogxK

U2 - 10.1016/j.oooo.2021.06.003

DO - 10.1016/j.oooo.2021.06.003

M3 - Journal article

C2 - 34275774

VL - 133

SP - 165

EP - 173

JO - Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics

JF - Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics

SN - 2212-4403

IS - 2

ER -