Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib phase IV study.

e15512 Background: Most patients with colorectal cancer (CRC) are aged ≥65 years, but late elderly patients (≥75 years) are underrepresented in previous studies. In addition, CRC is on the rise among young adults ( < 50 years) in China. Recently, a phase IV trial evaluating the safety of fruquintinib in Chinese patients with metastatic CRC (mCRC) showed a manageable profile. This subgroup analysis of the phase IV study primarily aims to evaluate the safety of fruquintinib in the young and the late elderly age groups. Methods: The data of colorectal cancer patients from the phase IV Fruquintinib trial (NCT04005066) were collected for the young ( < 50 years) and the late elderly CRC (≥75 years) patients who were enrolled between April 24, 2019, and September 27, 2022. The safety outcomes including Treatment Emergent Adverse Events (TEAE) and Treatment related AE (TRAE) were analyzed. Results: A total of 2798 CRC patients enrolled in the phase IV study were analyzed for the two subgroups, of which 512 were young (age < 50) with a median age of 42 years and 239 were late elderly (aged ≥75) with a median age of 78 years. The young CRC subgroup received more intense treatment with a median treatment duration of 2.75 months, and the late elderly received a median treatment of 2.4 months, while it was 2.7 months for all CRC patients. The duration of combination therapy of patients was longer than that of monotherapy in young (4.10 vs 2.40 months), late elderly (3.90 vs 2.10 months), and all CRC (3.60 vs 2.50 months). Grade ≥3 TEAEs were reported in 24.66% of all CRC patients and 24.22%, and 26.78%, in young and late elderly CRC patients, respectively. In young CRC, the most common TRAEs were palmar-plantar erythrodysesthesia (PPES) (20.31%), hypertension (14.06%), and dysphonia (10.16%), while for the late elderly, they were hypertension (20.50%), PPES (14.23%), and fatigue (12.97%). In the overall CRC group, the leading TRAEs were PPES (20.34%), hypertension (16.55%), and fatigue (10.44%). Conclusions: The safety profile of fruquintinib was comparable across the two age subgroups, with younger CRC patients receiving more intensive treatment. The duration of combination therapy with fruquintinib was longer than with fruquintinib alone, which may potentially lead to improved survival in both subgroups. Clinical trial information: NCT04005066 .