In a review of 1,375 cases of bevacizumab-induced gastrointestinal perforation from the FAERS database, most occurred in the large intestine and death was reported in 40.3% of patients.
Observational (n=1,375)
What are the clinical characteristics and outcomes of bevacizumab-induced gastrointestinal perforations reported in post-market surveillance?
Bevacizumab-induced gastrointestinal perforations most commonly occur in the large intestine in patients with colorectal cancer and carry a high mortality rate of 40.3%.
BACKGROUND: Bevacizumab is used in the treatment of advanced malignancies and has a "black box" warning for gastrointestinal perforations. Despite this known side effect, there are no large descriptive series of patients who experience bevacizumab-induced gastrointestinal perforations. AIM: To review and describe post-market cases of bevacizumab-induced gastrointestinal perforation reported by healthcare professionals to the United States Food and Drug Association Adverse Event Reporting System (FAERS) database. METHODS: In total, 74 025 cases of bevacizumab-induced adverse drug reaction were reported to FAERS from January 1 2004 to July 6 2021. We identified 2874 cases of bevacizumab-induced gastrointestinal perforation. A total of 1375 cases were determined to contain complete patient demographic data after the removal of duplicates and were reviewed. Subgroup analysis was completed on gastro-oesophageal perforations given the lack of prior data. RESULTS: The average patient age was 61.9 ± 11.4 years. A total of 698 cases included descriptive locations of perforations with most occurring in the large intestine (385 cases, 55.2% of specifically described cases). Colorectal cancer was the most common indication for bevacizumab (691 cases, 50.3%) followed by ovarian cancer (197 cases, 14.3%) and non-small cell lung cancer (182 cases, 13.2%). Death was reported in 554 patients (40.3% of cases). Sixty-two cases of gastro-oesophageal perforation were identified. CONCLUSIONS: This is the largest collective descriptive study of bevacizumab-induced gastrointestinal perforations, and sheds light on this often fatal complication. We additionally identified and described a rare subgroup of patients experiencing bevacizumab-induced gastro-oesophageal perforation not previously described.
Wichelmann et al. (Thu,) conducted a observational in Bevacizumab-induced gastrointestinal perforation (n=1,375). Bevacizumab was evaluated on Death. In a review of 1,375 cases of bevacizumab-induced gastrointestinal perforation from the FAERS database, most occurred in the large intestine and death was reported in 40.3% of patients.
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