Abstract
BACKGROUND: The liver is the most common site of metastasis in colorectal cancer. In patients with unresectable colorectal liver metastases, the 5-year survival rate is less than 5%. Many patients with colorectal liver metastases require effective subsequent therapy after the failure of standard first-line/second-line therapy. The purpose of this study is to investigate the efficacy and safety of TACE combined with Regorafenib versus TACE in the third-line treatment of patients with colorectal liver metastases. METHOD: The clinical data of 132 patients with colorectal liver metastases were collected. There were two groups: TACE + Regorafenib group (N = 63); TACE group (N = 69). TACE uses CalliSpheres® drug-loaded microspheres (loaded with irinotecan). Regorafenib is administered at a dose of 120 mg once daily. If the patient is severely intolerable, the regorafenib dose is adjusted to 80 mg once daily. Primary study endpoints were (1) to evaluate the tumor response, ORR, and DCR and (2) to evaluate OS and PFS in the two groups. Secondary study endpoints were (1) to compare the performance status, CEA, CA19-9 after treatment between the two groups and (2) to compare the incidence of adverse events between the two groups. RESULTS: There were significant differences in tumor response, ORR, DCR, OS, and PFS after treatment between the two groups. TACE combined with the Regorafenib group versus the TACE group: ORR (57.1% vs 33.3%), DCR (82.5% vs 68.1%), mOS (18.2 months vs 11.3 months), and mPFS (8.9 months vs 5.3 months). The performance status after treatment was better in the TACE + Regorafenib group than in the TACE group (P < 0.05). The CEA and CA19-9 negative rates after treatment were higher in the TACE + Regorafenib group than in the TACE group (P < 0.05). CONCLUSION: For the third-line treatment of colorectal liver metastases, the combination of TACE + Regorafenib had better tumor response, OS, and PFS than TACE TACE + Regorafenib combination could be considered as salvage therapy for colorectal liver metastases who failed the first- and second-line standard therapy.