Abstract
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. 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. 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. 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.
Highlights
The results of the present trial indicate that a high-dose antiresorptive medication (AR) drug holiday 1 month preoperatively to 3 months postoperatively does not prevent development of Medication-related osteonecrosis of the jaw (MRONJ) and that the patientreported health state declines during drug holiday compared with drug continuation
The results of the present trial failed to indicate such a difference and a positive effect of denosumab drug holiday. This is in accordance with other studies indicating that a denosumab drug holiday has no effect on healing outcomes[21,22] and that no evidence exists regarding the effectiveness of denosumab discontinuation.[23]
In the present feasibility trial, all patients receiving denosumab therapy were simultaneously treated with antineoplastic agents, which may have had an additive effect on MRONJ development
Summary
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction to high-dose antiresorptive medication (AR) in patients with cancer. 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. 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. Prospective studies of good quality are urgently needed to conclude whether a drug holiday is indicated when tooth extraction is unavoidable in this specific group of patients
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