A comprehensive analysis of the adverse drug events of metastatic and unresectable gastrointestinal stromal tumor treatment options: avapritinib, imatinib, regorafenib, ripretinib, and sunitinib safety insights and implications.

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Original abstract

<h4>Background</h4>Treatments for metastatic, unresectable, or treatment-resistant gastrointestinal stromal tumors (GIST) include avapritinib, imatinib, regorafenib, ripretinib, and sunitinib. The FDA Adverse Event Reporting System (FAERS) database collects medication-related adverse events (AEs).<h4>Design and methods</h4>Reports in the FAERS database from each medication's FDA approval to June 30, 2025 were analyzed. Reports containing other medications or indications outside of GIST treatment were excluded.<h4>Results</h4>Avapritinib was associated with fatigue (<i>n =</i> 826, 10.2%), nausea/vomiting (<i>n =</i> 574, 7.1%), eye/facial swelling (<i>n =</i> 631, 7.8%), diarrhea <i>n =</i> 361, 4.5%), peripheral edema (<i>n =</i> 231, 2.5%). Imatinib was associated with nausea/vomiting (<i>n =</i> 677, 4.4%), fatigue (<i>n =</i> 549, 3.6%), anemia (<i>n =</i> 404, 2.6%), abdominal pain (<i>n =</i> 400, 2.6%), and rash (<i>n =</i> 340, 2.2%), hemorrhage (317 AEs, 2.1%). Regorafenib was associated with fatigue (<i>n =</i> 104, 8.6%), palmar-plantar erythrodyesthesia syndrome (<i>n =</i> 66, 5.4%), diarrhea (<i>n =</i> 60, 4.9%). Ripretinib was associated with fatigue (<i>n =</i> 534, 8.4%), alopecia (<i>n =</i> 355, 5.6%), nausea/vomiting (<i>n =</i> 273, 4.3%). Sunitinib was associated with fatigue (<i>n =</i> 420, 6.1%%), nausea/vomiting (<i>n =</i> 284, 4.2%), diarrhea (<i>n =</i> 262, 3.8 %), hemorrhage (<i>n =</i> 149, 2.2%).<h4>Conclusions</h4>The FAERS database revealed multiorgan AEs associated with five GIST treatment medications. Novel findings include eye/facial and peripheral edema with avapritinib, palmar-plantar erythrodyesthesia syndrome, headache/migraine, and gait abnormalities across all five medications, pancytopenia with imatinib, and hemorrhage with imatinib and sunitinib.

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