Study Finds Comparable Outcomes for Regorafenib and FTD/TPI Sequencing in Metastatic Colorectal Cancer
Key Takeaways:
- Slight improvement in overall survival (OS): The median OS was slightly higher at 12.8 months for patients with metastatic colorectal cancer (mCRC) treated with regorafenib and then trifluridine/tipiracil (FTD/TPI) (R-T). Patients treated with FTD/TPI and then regorafenib (T-R) had a median OS of 10.2 months.
- No change in progression free survival (PFS): Both R-T and T-R groups had a median PFS of 3.4 months.
- Slight improvement in time to next treatment (TTNT): The median TTNT was 9.3 months for patients in the R-T cohort and 8.6 months for patients in the T-R cohort.
Regorafenib and FTD/TPI have been approved by the US Food and Drug Administration (FDA) to treat mCRC. Both drugs have been shown to be effective in prolonging survival for patients with mCRC who are in later lines of therapy, but there are not many US studies evaluating the impact of sequencing on patient outcomes.
This retrospective study observed outcomes of patients in the US Oncology Network diagnosed with mCRC and treated with sequential regorafenib and FTD/TPI ± bevacizumab between the first and sixth lines of therapy.
The study assessed the OS, PFS, and TTNT of 308 patients diagnosed with mCRC. Of this group, 156 patients were treated with regorafenib and then FTD/TPI (R-T), and 152 patients were treated with FTD/TPI and then regorafenib (T-R).
Study Findings
The median OS for the R-T cohort was slightly longer than that of the T-R cohort (12.8 vs 10.2 months). Survival might also have been impacted by stage IV diagnosis and prior anti-vascular endothelial growth factor (VEGF) treatment.
There was also no significant difference in PFS between cohorts. Both R-T and T-R groups had a median PFS of 3.4 months.
The median TTNT was 9.3 months for patients in the R-T cohort and 8.6 months for patients in the T-R cohort. Just like with OS, TTNT was slightly longer for the R-T group than the T-R group, but the improvement is not enough to be statistically significant.
Implications for Providers
This study showed that regorafenib and FTD/TPI have comparable efficacies in treating patients with mCRC. Patients treated first with FTD/TPI may have had slightly better outcomes, but the data should not determine prescribed treatment. The authors said, “...the findings should be interpreted within the framework of other studies with similar directional results. Treatment decisions should be tailored to individual patient profiles in order to maximize the clinical benefit of life-prolonging medication.”
Reference
Bekaii-Saab T, Sruti I, Shi J, et al. Real-world treatment patterns and outcomes among patients initiating sequential regorafenib and trifluridine/tipiracil ± bevacizumab in patients with metastatic colorectal cancer in a US community setting (SEQRT2). Frontiers Oncol. 2025;15:1591245. doi: 10.3389/fonc.2025.1591245
