Background and objectives Patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombosis (PVTT) are presently lacking effective treatment options. We aimed to compare the efficacy and safety of lenvatinib with or without SBRT for HCC with PVTT. Materials and methods This retrospective analysis included 37 patients treated with lenvatinib in combination with SBRT and 77 patients treated with lenvatinib alone from August 2018 to August 2021. Overall survival (OS), progression-free survival (PFS), intrahepatic PFS (IHPFS) and objective remission rate (ORR) were compared between the two groups, while adverse events (AEs) was analyzed between the two groups to assess safety profiles. Results Median OS, PFS and IHPFS were significantly prolonged in the combination treatment group compared with the single treatment group (median OS, 19.3 vs. 11.2 months, p < 0.001; median PFS: 10.3 vs. 5.3 months, p < 0.001; median IHPFS, 10.7 vs. 5.3 months, p < 0.001). Moreover, a higher ORR (56.8% vs. 20.8%, P < 0.001) were observed in the lenvatinib combined with SBRT group. In subgroup analyses of Vp1-2 and Vp3-4 group, median OS, PFS and IHPFS were also significantly longer in the lenvatinib combined with SBRT group than those in the lenvatinib alone group. AEs in the combined therapy group were mostly manageable and the incidence was not statistically significant compared to the monotherapy group. Conclusion Lenvatinib plus SBRT had a significantly better survival benefit than lenvatinib monotherapy in the treatment of HCC patients with PVTT and was well tolerated.

Background and objectives: Patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombosis (PVTT) are presently lacking effective treatment options. We aimed to compare the efficacy and safety of lenvatinib with or without SBRT for HCC with PVTT. Materials and Methods: This retrospective analysis included 37 patients treated with lenvatinib in combination with SBRT and 77 patients treated with lenvatinib alone from August 2018 to August 2021. Overall survival (OS), progression-free survival (PFS), intrahepatic PFS (IHPFS) and objective remission rate (ORR) were compared between the two groups, while adverse events (AEs) was analyzed between the two groups to assess safety profiles. Results: Median OS, PFS and IHPFS were significantly prolonged in the combination treatment group compared with the single treatment group (median OS, 19.3 vs. 11.2 months, p < 0.001; median PFS: 10.3 vs. 5.3 months, p < 0.001; median IHPFS, 10.7 vs. 5.3 months, p < 0.001). Moreover, a higher ORR (56.8% vs. 20.8%, P < 0.001) were observed in the lenvatinib combined with SBRT group. In subgroup analyses of Vp1-2 and Vp3-4 group, median OS, PFS and IHPFS were also significantly longer in the lenvatinib combined with SBRT group than those in the lenvatinib alone group. AEs in the combined therapy group were mostly manageable and the incidence was not statistically significant compared to the monotherapy group. Conclusion: Lenvatinib plus SBRT had a significantly better survival benefit than lenvatinib monotherapy in the treatment of HCC patients with PVTT and was well tolerated.

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Background and objectives: The purpose of this study was to investigate the survival benefit of Stereotactic Body Radiotherapy (SBRT) versus lenvatinib as first-line therapy in the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). Materials and Methods 147 HCC patients with PVTT were included in this retrospective study, 70 were treated with SBRT and 77 of were treated with lenvatinib. Propensity score matching (PSM) analysis was employed to balance the differences in baseline characteristics between the two groups. Overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) were compared between the two groups. In addition, the safety of patients in both groups was also evaluated. Results After PSM, 38 patients were matched in each of the two groups. The median OS was 14.5 (95% CI: 10.1–18.9) and 11.1 (95% CI: 9.3–12.9) months in the SBRT and lenvatinib groups, respectively (P = 0.014). The median PFS was 6.8 (95% CI: 5.1–8.5) and 5.0 (95% CI: 3.0–7.0) months, respectively (P = 0.010). The 1-, 2-years OS rates in the two groups were 65.8% vs. 39.5% and 31.6% vs. 10.5%, respectively. The 6-, 12-months PFS rates in the two groups were 57.9% vs. 44.7% and 28.9% vs. 10.5%, respectively. In addition, the SBRT group had a better ORR than the lenvatinib group (52.6% vs. 23.7%, P = 0.009). Patients with good response to SBRT had better survival. Cox proportional hazard model showed that SBRT was an important prognostic factor for OS and PFS. The incidence of hypertension (34.2% vs 0%) was higher in the LEN group, however, both treatment modalities were well tolerated in the two groups of patients. Conclusion In HCC patients with PVTT, SBRT had a better survival benefit than Lenvatinib treatment as first-line therapy.