ABSTRACT
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.
Subject(s)
Carcinoma, Non-Small-Cell Lung , Drug-Related Side Effects and Adverse Reactions , Lung Neoplasms , Adverse Drug Reaction Reporting Systems , Aged , Bevacizumab/adverse effects , Humans , Middle Aged , United States/epidemiology , United States Food and Drug AdministrationABSTRACT
Hepatoid adenocarcinoma of the stomach (HAS), a rare and unique histological subtype of gastric cancer, accounts for less than 1.5% of all gastric cancers. Historically, this subtype is found to have a poor prognosis in comparison to other types of gastric cancer. While the diagnosis is made based on pathological findings, most cases described in the literature are associated with elevated alpha-fetoprotein (AFP) levels. We present a case of AFP-negative HAS with additional unique pathologic findings of signet ring cells which has been reported only once in the literature. Given the rare and late presentation of the disease, AFP-negative HAS should be included in the differential diagnosis in patients with suspicion for gastric cancer.
