Tooth extractions in patients with cancer receiving high-dose antiresorptive medication: a randomized clinical feasibility trial of drug holiday versus drug continuation.

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.