Osteonecrosis of the Jaw in Myeloma Patients Receiving Denosumab or Zoledronic Acid. A Commentary of the Pivotal Trial by Raje et al. Published on Lancet Oncology.

Vittorio Fusco,Paul De Boissieu,Federico Monaco,Anna Baraldi,Giuseppina Campisi,Alberto Bedogni,Gianmauro Numico

doi:10.3390/dj6030042

Abstract

The recent randomized trial, published by Raje et al., on Lancet Oncology is potentially practice changing. It proposes that denosumab is a valid alternative to zoledronic acid in the treatment of myeloma patients. However, several points need further data and more details, such as information on incidence, diagnosis, and follow-up of osteonecrosis of the jaw (ONJ) cases, observed among treated patients. Adopted definition to adjudicate ONJ cases, type of registration of potential ONJ cases, length of observation are possible causes of potential underestimation of ONJ incidence in their study. Future updated evaluations with longer follow-up, and including actuarial estimation, are required for final judgment on ONJ risk in myeloma patients receiving denosumab, and comparison with ONJ risk by zoledronic acid.

Highlights

Service D’épidémiologie et de Santé Publique, Hôpitaux Universitaires Paris-Sud, 94270 Paris, France; Haematology Unit, Azienda Ospedaliera di Alessandria, 15121 Alessandria, Italy; Regional Center for Prevention, Diagnosis and Treatment of Medication and Radiation-Related Bone
A monoclonal antibody targeting receptor activator of nuclear factor kappa-B ligand (RANKL), showed to reduce SREs associated with bone lesions or metastases in patients with advanced solid tumors
We read the paper from Raje et al [1] with great interest, on the safety results of monthly administration of denosumab versus zoledronic acid in myeloma patients

Summary

Introduction

Service D’épidémiologie et de Santé Publique, Hôpitaux Universitaires Paris-Sud, 94270 Paris, France; Haematology Unit, Azienda Ospedaliera di Alessandria, 15121 Alessandria, Italy; Regional Center for Prevention, Diagnosis and Treatment of Medication and Radiation-Related Bone. The study by Raje et al [1] aimed to assess the efficacy and safety of denosumab, compared with zoledronic acid, for the prevention of SREs in patients with newly diagnosed multiple myeloma. We read the paper from Raje et al [1] with great interest, on the safety results of monthly administration of denosumab versus zoledronic acid in myeloma patients.

Results

Conclusion