A real-world study of tyrosine kinase inhibitors plus anti-PD-1 immunotherapy with or without chemoembolization for hepatocellular carcinoma patients with main portal vein invasion.

BACKGROUND: Although systemic therapies are recommended for hepatocellular carcinoma (HCC) patients with main portal vein (MPV) invasion and preserved liver function, the outcome is limited. In the real-world, chemoembolization is a commonly used local treatment for advanced HCC. PURPOSE: To evaluate whether the additional chemoembolization treatment yields survival benefits compared to systemic therapy for HCC patients with MPV invasion and preserved liver function (Child-Pugh score ≤ B7) in a real-world study from multiple centers. PATIENTS AND METHODS: Between January 2020 and December 2022, 91 consecutive HCC patients with MPV invasion who received either systemic medical therapy (i.e., tyrosine kinase inhibitors (TKIs) plus anti-PD-1 immunotherapy, S group, n = 43) or in combination with chemoembolization treatment (S-T group, n = 48) from five centers were enrolled in the study. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and treatment response. Adverse events (AEs) related to treatment were also recorded. Survival curves were constructed with the Kaplan-Meier method and compared using the log-rank test. RESULTS: The baseline characteristics were comparable between the two groups. The mean number of chemoembolization sessions per patient was 2.1 (range 1-3). The median OS was 10.0 months and 8.0 months in the S-T group and S group, respectively (P = 0.254). The median PFS between the two groups was similar (4.0 months vs. 4.0 months, P = 0.404). The disease control rate between the S-T and S groups were comparable (60.4% vs. 62.8%, P = 0.816). Although no chemoembolization-related deaths occurred, 13 grade 3-4 AEs occurred in the S-T group. CONCLUSIONS: The results of the real-world study demonstrated that additional chemoembolization treatment did not yield survival benefits compared to TKIs plus anti-PD-1 immunotherapy for the overall patients with advanced HCC and MPV invasion.

[Study on the quality standard of danmo capsule].

OBJECTIVE: To establish the quality standard for Danmo capsule. METHODS: TLC was used for the qualitative identification of Salviae Miltiorrhizae Radix Et Rhizoma and Lonicerae Japonicae Flos. HPLC was used to determine the content of Salvianolic acid B. RESULT: TLC spots were clear and well-separated without negative interference. The linear range of Salvianolic acid B was 0.120042 - 2.40084 microg (r = 0.9999) with an average recovery of 103.63%, RSD was 0.6% (n = 6). CONCLUSION: The method is simple, accurate and reliable. It can be used for the quality control of Danmo capsule.

A prognostic score model for predicting the survival benefits of patients undergoing sorafenib plus transarterial chemoembolization for hepatocellular carcinoma with portal vein invasion.

PURPOSE: The survival benefits and which patients with advanced hepatocellular carcinoma (HCC) would benefit from sorafenib plus transarterial chemoembolization (TACE) therapy remain controversial. We aimed to develop a prognostic score model for predicting different prognoses of patients with HCC and portal vein invasion who received sorafenib plus TACE. METHODS: This observational study included 167 patients with HCC and portal vein invasion undergoing sorafenib combined with TACE from January 2013 to June 2018 at two hospitals. Multivariate Cox regression analysis was performed using a training cohort (n = 83) to identify critical factors associated with survival. Then, a prognostic score model was established to classify different outcomes and confirmed using a validation cohort (n = 84). RESULTS: Three factors were determined to critically impact survival in the training cohort: portal vein invasion extent, sorafenib-related dermatologic response, and initial radiological response. Using the ß-coefficients of these factors, a prognostic score was calculated, and the survival time decreased as the score increased. Based on the prognostic score model, three different prognoses of patients with 0 points, 2-3 points, and > 3 points were stratified with a median survival of 38.0 months, 20.0 months, and 7.0 months, respectively (P < 0.001). Time to progression was also significantly different using the same prognostic index. The prognostic score model was confirmed by the validation cohort. CONCLUSION: Sorafenib plus TACE is a potential therapy for selected HCC patients with portal vein invasion. This prognostic score model can predict the survival benefits for these patients.