Abstract 83P
Background
Erdafitinib is a pan-FGFR inhibitor approved for treating locally advanced or metastatic urothelial carcinoma and solid tumors with FGFR alterations after previous systemic therapy. We aim to evaluate its safety and efficacy in patients with FGFR-altered solid tumors, including urothelial carcinoma.
Methods
Following PRISMA guidelines, a comprehensive literature search across Scopus, Cochrane Library, PubMed, and Web of Science databases identified phase 2 and 3 trials of Erdafitinib in patients with FGFR alterations. Key outcomes—overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and treatment-emergent adverse events (TEAEs) —were analyzed using a random-effects model and R version 4.3.2.
Results
Sex studies with 761 patients were included in our analysis, Erdafitinib demonstrated an ORR of 41.6% (95% CI: 37.3%-45.9%) in Urothelial tumors and 29.4% (95% CI: 23.7%-35.0%) in solid tumors. PFS was 49.2% (95% CI: 29.7%-68.6%) at 6 months and 21.3% (95% CI: 14.5%-28.0%) at 12 months. OS was 71% (95% CI: 60%-83%) at 6 months, and 46.3% (95% CI: 38.3%-54.3%) at 12 months. Overall TEAEs occurred in 57.2% of urothelial tumors and 54.5% of solid tumors, with notable grade ≥3 TEAEs including anemia (4.2% for urothelial, 8.3% for solid), stomatitis (10.2%), hyperphosphatemia (2.6%), fatigue (2.6%), and urinary tract infections (4.8%).
Conclusions
Erdafitinib demonstrates promising efficiency in managing solid tumors with FGFR mutations, especially in urothelial carcinoma. However, challenges such as adverse events and treatment resistance impede their sustained usefulness.
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.