MRONJ is a well-known side effect from antiresorptive (AR) drugs, and the vast majority of cases occur in cancer patients who typically receive high-dose AR therapy.
Because surgical tooth extraction is the most important independent risk factor for developing MRONJ, some researchers have proposed pausing AR medication perioperatively, Dr. Thomas Kofod of Copenhagen University Hospital and colleagues note in the journal Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology.
Dr. Deepak Kademani, chair of the American Association of Oral and Maxillofacial Surgeons' Committee on Oral, Head and Neck Oncologic and Reconstructive Surgery, welcomed the new research.
"This is an important study, because it shows that a drug holiday does not reduce the risk of developing MRONJ," Dr. Kademani, who was not involved in the work, told Reuters Health by email.
The single-blind, single-center study included 23 older cancer patients (11 men) on high-dose AR therapy from 2018 to 2019. Thirteen patients were taking denosumab, and 10 were on bisphosphonates.
The researchers randomly assigned 13 patients to a drug holiday lasting from one month before tooth extraction until three months after. The other 10 patients continued to receive AR therapy as usual. In all, 31 teeth were extracted from these 23 patients.
Four patients in the drug-holiday group developed MRONJ, including three with exposed bone and one with non-exposed MRONJ. All had been receiving denosumab as well as antineoplastic agents. No patients in the continuation group developed MRONJ.
Three patients, all of whom had been receiving denosumab, died during the study. Two of the deceased had developed MRONJ.
Three patients experienced cancer progression at the three-month follow-up, and a further three did so at six months. These patients had all been taking denosumab and were in the drug-holiday group.
Patients in the drug-holiday group had a lower patient-reported health state than did patients in the continuation group, as measured on the EQ-5D-5L questionnaire. The difference was statistically significant only at one month.
The researchers note that there has been no consensus on the value of drug holidays in this setting, but that "many clinicians pause AR in connection with tooth extraction."
To the authors' knowledge, theirs was the first randomized trial to evaluate the question.
By Scott Baltic
SOURCE: https://bit.ly/3hdcxh6 Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, online June 9, 2021.
Posted on
site created by:
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy