S166 Osteonecrosis of the Jaw Associated With Bevacizumab in Treatment: A Case Series Using the FDA Adverse Event Reporting System (FAERS) Database

Introduction: Osteonecrosis of the jaw (ONJ) is a rare but serious adverse drug reaction (ADR) historically associated with denosumab and bisphosphonate therapy. Studies have demonstrated an association between ONJ and bevacizumab, a VEGF inhibitor now used for some gastrointestinal malignancies. This study reviewed cases of bevacizumab associated ONJ reported to the FDA Adverse Event Reporting System (FAERS) database Methods: The FAERS database was searched for all reported cases of ONJ from 2010 to 2021. Cases lacking patient age or gender were excluded from review. Only adults (age 18 and older) and reports from Healthcare Professions were included for analysis. Duplicate cases were removed. A dataset was created for bevacizumab associated ONJ and demographics were summarized. A subgroup analysis was performed for subjects receiving bevacizumab without prior or concomitant denosumab or bisphosphonate therapy. Results: 19,670 cases of ONJ were reported to the FAERS database from 2010 to 2021 with approximately half (9,556) containing complete patient demographic data. 146 cases (1.5%) of bevacizumab associated with ONJ were identified. 65.8% (96) of the patients were female and the average age was 60.9 years +/- 9.3 years. There were 34 cases without prior or concomitant bisphosphonate or denosumab therapy. Male gender was associated with 65% (22 of 34) of these cases and average age was 61 years +/- 12.0. Table/Figure depicts clinical indications for each of these 34 cases. Gastrointestinal malignancies (i.e., colon cancer and esophageal cancer) were present in 6/34 (17.6%) cases without prior denosumab/bisphosphonate therapy, 5 patients with breast cancer (14.7%) and 5 cases of prostate cancer (14.7%). Conclusion: 146 cases of bevacizumab associated with ONJ have been reported to the FAERS database and 23% of these cases did not involve medications known to cause ONJ. Clinicians should be aware that ONJ is a potential adverse effect of bevacizumab treatment.Figure 1.: This Figure represents the distribution of the clinical indications of bevacizumab-associated with ONJ as reported to the FAERS database from 2010 to 2021 Table 1. - This Table represents the distribution of the clinical indications of bevacizumab associated with ONJ as reported to the FAERS database from 2010 to 2021 along with the respective number of cases Indication for use Number of cases Colon cancer 5 Breast cancer 5 Prostate cancer 5 Unspecified 5 Renal cell cancer 4 Lung cancer 3 Other 3 Esophageal cancer 1 Brain cancer 1 Rheumatoid Arthritis 1 Plasma cell myeloma 1