KEY TAKEAWAYS
- The phase 3 study assessed the comparative efficacy of fruquintinib in a third-line setting for metastatic CRC (mCRC) patients using a matched population from the FRESCO trial and real-world data with other TKIs.
- The baseline characteristics of the two arms were balanced by propensity score matching (PSM).
- The patients in the fruquintinib group showed a significant increase in median PFS compared to other TKIs group (3.71 vs. 2.49 months, HR = 0.67, 95% CI, 0.48-0.94, p = 0.019).
The FRESCO phase III trial evaluated the efficacy of fruquintinib in treating metastatic colorectal cancer patients who had progressed after two or more lines of chemotherapy. The two groups, who met the eligibility criteria of FRESCO and received other TKIs, were balanced based on their propensity score matching (PSM). To evaluate the progression-free survival (PFS) of the patients, the Kaplan-Meier method and Cox proportional hazard model were utilized to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).
Using PSM, the study successfully matched 128 patients in each group (fruquintinib and other TKIs). The group that received fruquintinib showed a significant increase in median PFS compared to the other TKIs group (3.71 vs. 2.49 months, HR = 0.67, 95%CI, 0.48-0.94, p = 0.019).
The analysis found that fruquintinib was more effective in prolonging PFS than other TKIs for patients who had received two or three previous chemotherapy treatments, had rectal cancer, had left-sided primary tumor location, had multiple metastasis sites, and had lung metastasis. The results were expressed in hazard ratios (HR) with corresponding confidence intervals and p-values. Specifically, the hazard ratios (HR) for these groups were 0.58 (95% CI: 0.40-0.84; p=0.004), 0.52 (95% CI: 0.31-0.87; p=0.013), 0.62 (95% CI: 0.42-0.90; p=0.011), 0.68 (95% CI: 0.48-0.97; p=0.034), and 0.65 (95% CI: 0.43-0.98; p=0.042), respectively.
The study showed that fruquintinib treatment resulted in a significant extension of PFS compared to other TKIs in third-line mCRC patients by using RWD to establish an external control arm.
Source: https://pubmed.ncbi.nlm.nih.gov/36505849/
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT02314819
Jin Y, Li J, Shen L, Xu J, Zhang Y, Zhang J, Pan H, Qu X, Chen Y, Zhang Q, Li J, Sun M, Qin S. A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer. Front Oncol. 2022 Nov 24;12:1044328. doi: 10.3389/fonc.2022.1044328. PMID: 36505849; PMCID: PMC9730021.
