KEY TAKEAWAYS
- The Front phase 2 trial aimed to investigate the efficacy and safety of fruquintinib as maintenance therapy following 1L treatment for mCRC patients.
- The primary endpoint was to determine PFS.
- Researchers noticed that fruquintinib at a moderate dose level demonstrated improved PFS as maintenance therapy following 1L treatment for mCRC patients, with manageable toxicity.
Maintenance therapy and treatment discontinuation present viable options for metastatic colorectal cancer (mCRC) patients who respond to initial treatment.
Xiaojing Xu and the team aimed to evaluate the efficacy and safety of fruquintinib as maintenance therapy following first-line treatment for mCRC.
Researchers performed an inclusive analysis of an ongoing, multicenter, open-label, randomized clinical trial. Patients with unresectable right-sided mCRC or RAS-mutant left-sided mCRC, who had not experienced disease progression after 1L standard treatment (chemotherapy with or without bevacizumab) for 4 to 6 months, were eligible.
According to the protocol, 110 patients were randomly assigned (2:1) to the fruquintinib (FR) group (4mg once daily for 21 days, followed by 7 days off in 28-day cycles) or observation (OB) group via an interactive web response system. The primary endpoint was progression-free survival (PFS).
About 28 patients were enrolled in the FR group on Aug 22, 2023, and 14 in the OB group, of whom the median age was 61 (44 to 73) vs. 66.5 (36 to 81), including 20 (71%) vs. 10 (71%) males, respectively and 26 (93%) vs. 11 (79%) patients were RAS-mutant. In the full analysis set (FAS), median PFS was 5.26 (95% CI: 3.71-19.12) vs. 2.99 (95% CI: 1.91-4.63) months (HR=0.36; P=0.0158). 25 and 13 patients from 2 groups received at least one response evaluation after baseline, respectively.
The disease control rate (DCR) was 88.00% (22/25) vs. 53.85% (7/13) (OR=6.29, 95% CI: 1.31-36.7; P=0.0267). Regarding the per-protocol set (PPS), since 6 pts in the FR group initiated with a lower dose (3mg), the number of patients was 22 vs. 14. In the per-protocol set (PPS), median PFS was 6.51 months (95% CI: 3.88-19.12) vs. 2.99 months (95% CI: 1.91-4.63) (HR=0.25; P=0.0061). DCR was 89.47% (17/19) vs. 53.85% (7/13) (OR=7.29, 95% CI: 1.32-58.9; P=0.0331).
Common adverse events (AEs) in the FR group included hypertension, hand-foot syndrome, fatigue, rash, oral mucositis, and proteinuria, with AEs of grades ≥ 3 being hand-foot syndrome, hypertension, oral mucositis, and proteinuria.
The study concluded that fruquintinib at a moderate dose level demonstrated improved progression-free survival (PFS) as maintenance therapy following first-line treatment for metastatic colorectal cancer (mCRC), with acceptable toxicity.
The trial was sponsored by Shanghai Zhongshan Hospital.
Source: https://meetings.asco.org/abstracts-presentations/230535
Clinical Trial: https://clinicaltrials.gov/study/NCT04296019
Xu X, Yu Y, Liu Q, et al. (2024). “Preliminary efficacy and safety of fruquintinib as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, randomized, open-label clinical trial (the FRONT study).” Presented At ASCO- GI 2024 (Abstract 126).
