KEY TAKEAWAYS
- The observational study compared fruquintinib alone vs. with ICIs in MSS mCRC safety.
- The primary endpoint was OS, PFS, and AEs.
- The result demonstrated that real-world data suggests fruquintinib suffices for MSS mCRC.
Fruquintinib has gained approval as a third-line intervention for individuals confronting metastatic colorectal cancer (mCRC) in China. Notably, no prospective randomized controlled studies have compared the effectiveness of fruquintinib alone versus in combination with immune checkpoint inhibitors (ICIs).
Zhiqiang Wang and his researchers aimed to study the efficacy and safety profiles of fruquintinib monotherapy against its combination with ICIs, specifically in the microsatellite-stable subtype of mCRC (MSS mCRC).
To derive the desired outcome, a retrospective analysis was conducted on mCRC patients treated with fruquintinib at Sun Yat-sen University Cancer Center between January 2020 and January 2022. The primary endpoints included overall survival (OS), progression-free survival (PFS), and adverse events, while secondary endpoints included objective remission rate (ORR) and disease control rate (DCR).
This study comprised 184 mCRC patients, with 61 receiving fruquintinib in combination with ICIs. Predominantly, patients had undergone second-line or subsequent treatments prior to this study. The ORR for Groups A (n=61) and B (n=123) stood at 14.3% and 3.6%, respectively, while DCR were 55.1% and 39.8%. Group A exhibited a notably extended median PFS compared to Group B (3.9 months vs. 3.3 months, P=0.015). Conversely, median overall survival (mOS) demonstrated no significant variance between the cohorts (9.3 months vs. 7.9 months, P=0.414).
In third-line treatments or beyond, OS and PFS did not manifest statistically distinct outcomes between the groups. The multivariate analysis pinpointed baseline liver metastasis and lactate dehydrogenase (LDH) levels ≥313.3 as factors correlating with abbreviated PFS within the cohort.
Adverse effects were comparable across both groups (91.8% vs. 93.2%, P=0.738), with predominant effects encompassing hand-foot skin reactions, hoarseness, and hypertension. Notably, the incidence of grade 3 or higher treatment-related adverse events (TRAEs) was analogous between the groups (14.1% vs. 14.6%, P=0.916)
The result concluded that in practical clinical settings, discernible disparities in both OS and adverse events were not observed among patients with MSS mCRC undergoing treatment with fruquintinib either as monotherapy or in combination with ICIs. The study was sponsored by Hutchmed.
Clinical Trial: https://clinicaltrials.gov/study/NCT04005066
Wang Z, Fu H, Huiyan L, et al. “Comparison of the efficacy and safety of fruquintinib and fruquintinib combined with immune checkpoint inhibitors in the treatment of metastatic microsatellite stable colorectal cancer: A real-world study”. Presented at ESMO Asia Congress 2023. (Abstract: 111P)
