C0087 - Osteonecrosis of the Jaw Associated With Bevacizumab in Treatment: A Case Series Using the FDA Adverse Event Reporting System (FAERS) Database

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Hardeep S. Ahdi, DO

Advocate Lutheran General Hospital
Chicago, IL

Hardeep S. Ahdi, DO¹, Thomas A. Wichelmann, DO², Sasirekha Pandravada, DO², Eli Ehrenpreis, MD, FACG³
¹Advocate Lutheran General Hospital, Chicago, IL; ²Advocate Lutheran General Hospital, Park Ridge, IL; ³Advocate Lutheran General, Evanston, IL

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 1 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%).

Discussion: 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: This figure represents the distribution of the clinical indications of bevacizumab-associated with ONJ as reported to the FAERS database from 2010 to 2021

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

Table: 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

Disclosures:

Hardeep Ahdi indicated no relevant financial relationships.

Thomas Wichelmann indicated no relevant financial relationships.

Sasirekha Pandravada indicated no relevant financial relationships.

Eli Ehrenpreis: E2Bio Life Sciences – Owner/Ownership Interest, Stock-privately held company. Evanston Hospital – Consultant. Level-Ex – Consultant.

Hardeep S. Ahdi, DO¹, Thomas A. Wichelmann, DO², Sasirekha Pandravada, DO², Eli Ehrenpreis, MD, FACG³. C0087 - Osteonecrosis of the Jaw Associated With Bevacizumab in Treatment: A Case Series Using the FDA Adverse Event Reporting System (FAERS) Database, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.