111P - 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

Background

In China, fruquintinib is approved for third-line treatment of patients with metastatic colorectal cancer(mCRC). There are no prospective randomized controlled studies comparing the efficacy of fruquintinib and fruquintinib in combination with immune checkpoint inhibitors (ICIs). In this study, we aimed to compare the efficacy and safety of fruquintinib monotherapy versus combination with ICIs in MSS mCRC.

Methods

We retrospectively analyzed mCRC patients who received fruquintinib in Sun Yat-sen University Cancer Center from January 2020 to January 2022. The primary endpoints were overall survival (OS), progression-free survival (PFS) and adverse events. The secondary endpoints were objective remission rate (ORR) and disease control rate (DCR).

Results

A total of 184 patients with mCRC were included in this study, and 61 patients received ICIs combined with fruquintinib. Most patients received second line and above treatment before the study treatment. The ORR of fruquintinib combined with ICIs group (Group A, n=61) and fruquintinib group (Group B, n=123) were 14.3% and 3.6%; the DCR were 55.1% and 39.8%, respectively. Group A had a significant longer median PFS than Group B (3.9 months vs 3.3 months, P=0.015). However, the median OS was no significant difference between the two groups (mOS: 9.3 months vs 7.9 months, P=0.414). In the third line and above, there was no statistically significant difference in OS and PFS between the two groups. Multivariate analysis showed that baseline liver metastasis and lactate dehydrogenase (LDH)of≥313.3 were associated with shorter PFS in those 184 patients. Adverse effects of two groups were generally similar (91.8% vs 93.2%, P=0.738), and the most common adverse effects of two groups were the hand–foot skin reaction, hoarseness and hypertension. The probability of treatment-related adverse events (TRAEs)of grade 3 or higher was broadly similar in both groups (14.1% vs 14.6%, P=0.916).

Conclusions

In the real world, there was no difference in OS and in the incidence of adverse events between patients with MSS mCRC patients treated with fruquintinib monotherapy versus in combination with ICIs.

Clinical trial identification

NCT04005066.

Editorial acknowledgement

Legal entity responsible for the study

State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.