Abstract 80P
Background
FGFR-targeting agents offer promising cancer therapies but are associated with side effects that can impact treatment outcomes and quality of life.
Methods
We analyzed four FDA-approved FGFR inhibitors (Erdafitinib, Pemigatinib, Infigratinib, and Futibatinib) using the FDA Adverse Event Reporting System database. Adverse events were categorized by the Medical Dictionary for Regulatory Activities (MedDRA) terminology. We assessed the relative reported risks of adverse outcomes in commonly reported events to compare safety profiles and identify common and serious side effects.
Results
1,611 adverse event reports linked to FGFR inhibitors were identified, with Erdafitinib accounting for 59.1% of reports. Common side effects included generalized deconditioning (19.5%), ocular issues (12.3%), gastrointestinal problems (7.7%), skin reactions (6.6%), renal issues (6.3%), mouth ulcers/dryness (7.8%), nail changes (7.3%), and liver toxicity (3.6%). Serious outcomes were reported in 67.3% of cases, with 25.1% resulting in death and 22.5% leading to hospitalization. Statistically significant findings from the table include a higher relative risk of mortality with gastrointestinal issues, renal issues, and mouth ulcers. Table: 80P
| Side Effect | Death | Hospitalization | ||||
| RR | 95% CI | P-value | RR | 95% CI | P-value | |
| Hyperphosphatemia | 1.42 | 0.85 - 2.39 | 0.164 | 1.17 | 0.71 - 1.92 | 0.531 |
| Fatigue | 1.73 | 1.09 - 2.74 | 0.012 | 1.22 | 0.81 - 1.83 | 0.325 |
| GI issues | 4.59 | 2.57 - 8.19 | <0.001 | 1.21 | 1.08 - 1.34 | <0.001 |
| Renal issues | 3.84 | 1.87 - 7.90 | <0.01 | 0.78 | 0.56 - 1.07 | 0.141 |
| Mouth ulcers/dryness | 4.29 | 1.83 - 10.07 | <0.01 | 1.34 | 0.82 - 2.17 | 0.225 |
| Liver toxicity | 1.22 | 0.73 - 2.04 | 0.426 | 0.53 | 0.38 - 0.73 | <0.001 |
Conclusions
Careful monitoring of patients undergoing treatment with FGFR inhibitors is essential, especially for those experiencing adverse events, as these can significantly impact overall survival. While guidelines recommend continuing FGFR inhibitors in cases of mild or moderate renal dysfunction, the link between renal dysfunction and increased mortality observed in this study underscores the need for heightened clinician vigilance. Tailoring treatment plans to individual patient needs is crucial for optimizing outcomes and minimizing the risks associated with severe complications.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.