| アブストラクト | Real-world safety profiles of targeted therapies for colorectal cancer (CRC) remain incompletely characterized, particularly across different chemotherapy backbones. This study characterizes adverse event (AE) reporting patterns for bevacizumab (BVZ), cetuximab (C225), and panitumumab (VEC), used as monotherapy or in combination with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) or folinic acid, fluorouracil, and irinotecan (FOLFIRI), within CRC-related reports. CRC-related AE reports from 2006 to 2025 for BVZ, C225, and VEC were extracted from the U.S. FDA Adverse Event Reporting System. Disproportionality signals were evaluated using 4 algorithms: the reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Time-to-onset, regimen-stratified, and exploratory univariable logistic regression analyses were also conducted. The non-case reference population was restricted to the CRC-related reporting subcohort rather than the entire FDA Adverse Event Reporting System database. A total of 38,117 reports were identified, mainly involving BVZ (n = 20,521). Hematologic, hepatobiliary, and gastrointestinal toxicities showed prominent reporting signals across regimens (ROR = 4.15, 2.84, and 2.46, respectively). BVZ was associated with proteinuria and hand-foot syndrome, while C225 and VEC showed prominent cutaneous and marrow-suppression signals. Nine AE terms overlapped across agents, including thrombocytopenia, with fatality proportions of 23%, 13%, and 10% for BVZ, C225, and VEC, respectively. Median onset of nonfatal thrombocytopenia differed by agent: 121 days for BVZ, 6 days for C225, and 40 days for VEC; fatal C225-associated events also occurred early (median 6 days, P = .006). FOLFOX strengthened thrombocytopenia signals, especially with VEC-FOLFOX (ROR = 10.5) and C225-FOLFOX (ROR = 9.3), and peripheral neuropathy was reported across FOLFOX-containing regimens. CRC targeted therapies showed agent- and regimen-specific AE reporting patterns. Thrombocytopenia varied by onset and fatality and was more prominent with FOLFOX-containing regimens. These findings support tailored monitoring, particularly platelet surveillance for C225 and FOLFOX-based combinations, with longer-term vigilance for BVZ. Given the limitations of spontaneous reporting, including potential co-medication, indication-related, and residual confounding, these signals should not be interpreted as establishing causality. |
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| 組織名 | The Second Department of General Surgery, The Fourth Hospital of Hebei Medical;University, Shijiazhuang, China.;Department of Gastrointestinal Surgery, Affiliated Hospital of Hebei University,;Baoding, Hebei, China. |
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