Real-world experience of fruquintinib in patients with metastatic colorectal cancer: A single-center retrospective study in the United States.

e15613 Background: There is a significant unmet need in patients with refractory metastatic colorectal cancer. Fruquintinib, a selective oral tyrosine kinase inhibitor, received FDA approval in November 2023 based on the FRESCO-2 study. There is limited real-world safety data on fruquintinib use in the United States, particularly in patients with higher ECOG scores ( > 1) who were excluded from the FRESCO-2 study. This study aimed to evaluate the safety and efficacy of fruquintinib in a real-world clinical setting. Methods: This single-center, IRB-approved, retrospective study included all patients with metastatic colorectal cancer who received at least one cycle of fruquintinib between January 1, 2024, and December 31, 2024, at the University of Kansas Cancer Center, total of 36 patients. The objective was to assess real-world safety, particularly in patients who did not meet the inclusion criteria for the FRESCO-2 trial, including those with ECOG > 1. The primary objective was to evaluate safety, while secondary objectives included response rate, progression-free survival (PFS), and overall survival (OS). Results: A total of 33 patients (92%) experienced treatment-emergent adverse events (TEAEs), with the most common fruquintinib-related TEAEs being fatigue (51%), loss of appetite (19%), hand-foot syndrome (16%), and hypertension (14%). Grade 3 or higher TEAEs occurred in 19 patients (52%), with a higher incidence in those with ECOG > 1 (71%) compared to ECOG 0 or 1 (43%). Dose reductions were required in 6 patients (16%), and treatment discontinuation due to toxicity occurred in 5 patients (14%). A partial response (PR) was observed in 1 patient (3%), while stable disease (SD) was noted in 14 patients (44%). Among those previously treated with regorafenib, the SD rate was 29%, whereas VEGF inhibitor-naïve patients had an SD rate of 67%. The median progression-free survival (PFS) was 3.4 months, and the median overall survival (OS) was 5 months. Conclusions: This study provides real-world insights into fruquintinib use in the United States, including patients with poor performance status. The safety profile was consistent with the FRESCO-2 study, though patients with ECOG > 1 experienced greater toxicity. Efficacy appeared lower in those previously treated with regorafenib. Future prospective studies are needed to validate these findings. Patient characteristics. Total no. of pts 36 ECOG PS (0/1/2/3/4/Unknown) 4(11.11%)/16(44.44%)/12(33.33%)/2(5.55%)/1(2.77%)/1(2.77%) Primary origin of the tumorColon/Rectal/Appendix 24(66.6)/9(25.0)/3(8.3) Metastatic siteLiver/Lung/Lymph node 29(80.5)/18(50)/15(41.6) Positive Mutation StatusKRASNRAS BRAFUnknown 26 (72.2) 0 (0)1 (2.7)3 (8.3) Prior lines of treatment2>2 18(50)18(50) Prior VEGF therapyBevacizumabRegorafenibBEV and RegPrior EGFR therapy 31(86.1)21(58.3)2(5.5)8(22.2)8(22.2)